Earnings release
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1 Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. Shanghai Henlius Biotech, Inc. ʮ̡ (A joint stock company incorporated in the People ’s Republic of China with limited liability) (Stock code: 2696) INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED 30 JUNE 2026 AND CHANGE OF PRINCIPAL PLACE OF BUSINESS IN HONG KONG The board of directors (the “Board ”) of Shanghai Henlius Biotech, Inc. (the “Company ” or “Henlius ”) is pleased to announce the unaudited consolidated financial results of the Company and its subsidiaries (collectively referred to as the “Group” or “we”) for the six months ended 30 June 2026 (the “Reporting Period ”), prepared under International Financial Reporting Standards (“IFRS”). FINANCIAL SUMMARY: IFRS measures 1. The Group ’s total revenue increased by approximately RMB768.7 million or approximately 27.3% to approximately RMB3,588.2 million for the six months ended 30 June 2026, compared to approximately RMB2,819.5 million for the six months ended 30 June 2025. Such revenue was mainly from drug sales, research and development ( “R&D”) services provided to customers, and license income. Global product sales revenue (including revenue from product supply and royalty income based on sales) amounted to approximately RMB2,938.6 million, representing an increase of approximately 14.9%. 2. For the six months ended 30 June 2026, the Group recognised R&D expenditure of approximately RMB1,450.7 million, representing an increase of approximately RMB455.3 million as compared to approximately RMB995.4 million for the six months ended 30 June 2025. Such expenditure was primarily used to increase investment in innovative research and development projects, accelerating the Group ’s innovation transformation. Among this, the expensed R&D expenditure was approximately RMB826.0 million, representing an increase of approximately RMB240.5 million as compared to approximately RMB585.5 million for the six months ended 30 June 2025. 3. The Group ’s total profit was approximately RMB430.4 million for the six months ended 30 June 2026, representing an increase of approximately RMB40.3 million in profit from a profit of approximately RMB390.1 million for the six months ended 30 June 2025, mainly due to the continuous increase in sales volume of core commercialized products, the substantial growth in overseas commercialization profit, and the expansion of R&D clinical activities.
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2 4. For the six months ended 30 June 2026, the Group ’s revenue from sales of overseas products (including revenue from supply of overseas products and royalty income based on sales) was approximately RMB105.3 million. Profit from overseas products (including gross profit from overseas product supply and profit from royalty based on sales) amounted to approximately RMB59.5 million, representing a breakthrough growth of more than 4 times as compared with the same period of last year, which was mainly due to the fact that the Group adhered to the internationalisation strategy and increased the sales volume in the United States market, which contributed to the continuous improvement of international profitability. Non-IFRS measures (1) 5. The Group ’s Non-IFRS profit increased by approximately RMB182.2 million to approximately RMB572.3 million for the six months ended 30 June 2026, compared to approximately RMB390.1 million for the six months ended 30 June 2025. 6. The Group ’s Non-IFRS EBITDA increased by approximately RMB235.4 million to approximately RMB904.1 million for the six months ended 30 June 2026, compared to approximately RMB668.7 million for the six months ended 30 June 2025. BUSINESS HIGHLIGHTS: As of the Latest Practicable Date, 10 products (41 indications) of the Group have been successfully approved for marketing in China, the United States, Europe, Canada, Australia, Brazil, South Korea, Indonesia, the Dominican Republic and other countries/regions, including 7 products approved for marketing in multiple overseas markets, covering over 60 countries/ regions, benefiting over 1,100,000 patients around the world. 1 Forward-looking internationalisation strategy to accelerate deepening of global markets: HANSIZHUANG was approved for new indications in the EU and other regions (trade name in Europe: Hetronifly ®), further expanding the treatment landscape in the European market and continuously deepening the layout in key cancers with high incidence In May 2026, HANSIZHUANG (trade name in Europe: Hetronifly ®) in combination with fluoropyrimidine and platinum-based chemotherapy indicated for the first-line treatment of adult patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), and in combination with carboplatin and pemetrexed indicated for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma (nsNSCLC) were approved in the EU as two new indications. In June 2026, HANSIZHUANG (trade name in Europe: Hetronifly ®) in combination with carboplatin and nab-paclitaxel indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma (sqNSCLC) was approved in the EU as one new indication. (1) The Group uses Non-IFRS measures in order to more clearly illustrate normal operating results by eliminating potential impacts of items that the management considers are not indicative of the Group ’s operating performance, thereby facilitating the comparison of operating performance across different periods and companies to the extent applicable. Non-IFRS measures are not financial measures defined under IFRS, and represent corresponding financial measures under IFRS excluding the effect brought by certain non-cash items. Please refer to “Management Discussion and Analysis – Financial Review – (XI). Non-International Financial Reporting Standards (Non-IFRS) Measures ” for more information about the Non-IFRS measures.
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3 During January to July 2026, HANSIZHUANG was approved in Hong Kong, the Republic of Korea, Brazil, El Salvador, Honduras and other countries/regions for the treatment of extensive-stage small cell lung cancer (ES-SCLC). As at the Latest Practicable Date, HANSIZHUANG has been approved for marketing in a total of 50 countries and regions and has been granted Orphan-drug Designations by drug regulatory authorities in the United States, Switzerland, the Republic of Korea, and Mexico, respectively. It has also been included in the national reimbursement drug lists of 12 EU member states. HLX11 (pertuzumab injection) was approved for marketing in the EU and other regions (trade name in Europe: POHERDY ®) In April and May 2026, HLX11 (trade name in Europe: POHERDY ®) was respectively approved for marketing by the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). HLX11 is indicated for neoadjuvant/ adjuvant treatment of HER2-positive early breast cancer and metastatic breast cancer and all other indications for which the reference products have been approved in the local market. Two products of HLX14 (denosumab injection) were approved for marketing in Canada (trade names in Canada: BILDYOS ® and TUZEMTY ®) In March 2026, two products of HLX14 were approved for marketing by Health Canada (trade names in Canada: BILDYOS ® and TUZEMTY ®). BILDYOS ® is indicated for osteoporosis and all other indications for which the reference products have been approved in the local market, while TUZEMTY ® is indicated for cancer-related bone disease and all other indications for which the reference products have been approved in the local market, thereby broadening therapeutic options for an increasing aging population. Expanding the global commercial footprint through licensing-out In February 2026, the Company entered into a license agreement with Eisai Co., Ltd., pursuant to which the Company agreed to grant a license to commercialise HANSIZHUANG (serplulimab injection) in Japan. In February 2026, the Company entered into an amendment agreement with Abbott Products Operations AG, pursuant to which the Company agreed to grant a further license to commercialise HANSIZHUANG (serplulimab injection) in the agreed regions covering Asia, the Middle East, Africa and Eastern Europe (42 countries/regions in total), including the Terminated Territories (as defined below) and other agreed countries or regions. In early 2026, the Company had separately reached termination arrangements with PT Kalbe Genexine Biologics and Fosun Industrial Co., Limited in connection with the commercialisation rights of HANSIZHUANG (serplulimab injection) in the agreed Southeast Asian countries (excluding Indonesia), Middle Eastern and North African countries, Hong Kong and Macau regions of China. In August 2026, the Company entered into a collaboration framework agreement with Sandoz AG, pursuant to which the parties will collaborate within the agreed territories on up to 10 monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components as mutually agreed from time to time. Currently, the parties have entered into product annexes for the first batch of three collaboration products (cetuximab biosimilar HLX05-N, evolocumab biosimilar HLX16, and belimumab biosimilar) and terms on an option for a potential collaboration product (hyaluronidase HLXTE-HAase1001).
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4 2 Orientation toward clinical value and injecting impetus toward the pipeline: The Group ’s early-stage R&D is centered around patients ’ needs and guided by clinical value. Leveraging a new drug discovery platform driven by deep data-driven and biocomputing accelerated molecular design technology, the Group continues to develop high-quality and affordable innovative drugs to treat complex diseases with the help of network biology and polypharmacology. During the Reporting Period, the Group also actively further expanded its product pipeline through in-licensing. In May 2026, the Company entered into a project cooperation agreement with Jiangsu Chuangte Pharmaceutical Technology Co., Ltd., and Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., pursuant to which the Company obtained the exclusive commercialisation rights in Chinese Mainland and Macau for the third-generation EGFR inhibitor FHND9041 (the Company ’s product code: HLX903). As of the Latest Practicable Date, the Group has built an R&D pipeline encompassing over 50 early-stage innovative assets and approximately 10 R&D platforms, covering a wealth of drug forms, such as monoclonal antibody, multi-specific antibody, antibody-drug conjugates (ADC), fusion proteins, small molecule drugs and other forms of drugs. • In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial of HLX701 (recombinant human SIRPα -IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer was approved by the NMPA. • In January 2026, an investigational new drug application (IND) for HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) in combination with HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) and HANSIZHUANG (serplulimab injection) for the treatment of advanced solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX97 (KAT6A/ B small molecule inhibitor) for a phase 1 clinical trial in patients with advanced or metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX3901 for injection (a tetra-specific antibody targeting dual epitopes of DLL3, CD3 and CD28) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX316 for injection (B7-H3-targeting sialidase Fc fusion protein) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLXTE-HAase02 (recombinant human hyaluronidase injection) was approved by the NMPA.
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5 • In March 2026, investigational new drug applications (INDs) for a pertuzumab and trastuzumab biosimilar HLX319 (pertuzumab and trastuzumab injection (subcutaneous injection)) for the phase 1 clinical trials were approved by the NMPA. • In April and May 2026, investigational new drug applications (INDs) for a phase 1 clinical trial of a cetuximab biosimilar HLX05-N (recombinant anti-EGFR chimeric human-murine monoclonal antibody injection) for the treatment of metastatic colorectal cancer (mCRC) were approved by the NMPA and the United States Food and Drug Administration (FDA), respectively. • In May 2026, the clinical trial notification of the international multicenter phase 2/3 clinical trial of HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) as a monotherapy or in combination with HLX07 (a recombinant anti-EGFR humanized monoclonal antibody injection) versus docetaxel for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was granted implied approval by the PMDA of Japan. • In May 2026, the phase 1 clinical trial of HLX48 for injection (an antibody-drug conjugate targeting c-MET and EGFR) for the treatment of advanced/metastatic solid tumours was approved to commence in Australia and Chinese Mainland, respectively. • In May 2026, the phase 2 clinical trial of HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) in combination with HANSIZHUANG (serplulimab injection) for the neoadjuvant treatment of non-small cell lung cancer (NSCLC) was approved to commence in Australia. • In May and June 2026, the phase 1 clinical trial of HLX3902 injection (a trispecific antibody drug targeting STEAP1, CD3 and CD28) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumours was approved to commence in Australia and Chinese Mainland, respectively. • In July 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLX37 (recombinant humanised anti-PD-L1 and anti-VEGF bispecific antibody injection) in combination with chemotherapy or HLX43 for injection (a PD- L1-targeted antibody-drug conjugate) for the treatment of advanced/metastatic solid tumours was approved by the NMPA. • In July 2026, an investigational new drug (IND) application for HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) in combination with bevacizumab, with or without chemotherapy, for the treatment of advanced/metastatic solid tumours was approved by the NMPA.
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6 3 Sustained and effective global development of clinical-stage products: HLX43 for Injection (antibody-drug conjugate targeting PD-L1) In January 2026, an investigational new drug application (IND) for a clinical trial of HLX43 in combination with HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection antibody injection) and HANSIZHUANG (serplulimab injection) for the treatment of advanced solid tumours was approved by the NMPA. In February 2026, the first patient was dosed in a phase 1b/2 clinical study of HLX43 in combination with HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) or HANSIZHUANG (serplulimab injection) in patients with advanced or metastatic colorectal cancer in Chinese Mainland. In May 2026, the clinical trial notification for the international multicenter phase 2/3 clinical trial of HLX43 as a monotherapy or in combination with HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) versus docetaxel for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) obtained implied approval from the PMDA of Japan, and the dosing of the first patient in the relevant clinical study was completed in Chinese Mainland in the same month. In May 2026, the first patient in an EU country (Spain) was dosed in an international multicentre phase 2 clinical study of HLX43 in patients with advanced non-small cell lung cancer (NSCLC). In May 2026, the phase 2 clinical trial of HLX43 in combination with HANSIZHUANG (serplulimab injection) for neoadjuvant therapy of non-small cell lung cancer (NSCLC) was approved to commence in Australia. HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) In February 2026, the first patient was dosed in a phase 2/3 clinical study of HLX22 in combination with HLX87 for injection (antibody-drug conjugate targeting HER2) for first- line treatment of patients with HER2-positive recurrent or metastatic breast cancer (BC) in Chinese Mainland. HANSIZHUANG (serplulimab injection) In March 2026, the investigational new drug application (IND) for clinical trial of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was approved by the NMPA. In April 2026, the phase 2/3 clinical study of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was approved to commence in Australia.
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7 In May 2026, the first patient was dosed in an international multicenter phase 2/3 clinical study of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) in Chinese Mainland. Other products In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial of HLX701 (recombinant human SIRPα -IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in March 2026. In February 2026, investigational new drug (IND) applications for a phase 1 clinical trial of a daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection – subcutaneous injection) for the treatment of multiple myeloma were approved by the United States Food and Drug Administration (FDA) and the NMPA, respectively. In May 2026 and July 2026, the first patient in Chinese Mainland and the first patient in the United States were dosed in such international multicenter phase 1 clinical study, respectively. In March 2026, an investigational new drug application (IND) for HLX97 (KAT6A/B small molecule inhibitor) for a phase 1 clinical trial in patients with advanced or metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in May 2026. In March 2026, an investigational new drug application (IND) for HLX3901 for injection (a tetra-specific antibody targeting dual epitopes of DLL3, CD3 and CD28) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in April 2026. In March 2026, an investigational new drug application (IND) for HLX316 for injection (B7-H3-targeting sialidase Fc fusion protein) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in May 2026. In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of a nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) for the treatment of multiple solid tumours was approved by the NMPA. The first patient was dosed in such international multicenter phase 1 clinical study in Chinese Mainland in July 2026. In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLXTE-HAase02 (recombinant human hyaluronidase injection) was approved by the NMPA. The first subject was dosed in a phase 1 clinical study conducted in healthy Chinese adult male subjects in April 2026.
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8 In March 2026, the investigational new drug applications (INDs) for the phase 1 clinical trials of a pertuzumab and trastuzumab biosimilar HLX319 were approved by the NMPA. The first subject was dosed in a phase 1 clinical study conducted in healthy Chinese male subjects in April 2026. In April and May 2026, investigational new drug applications (INDs) for a phase 1 clinical trial of a cetuximab biosimilar HLX05-N (recombinant anti-EGFR chimeric human-murine monoclonal antibody injection) for the treatment of metastatic colorectal cancer (mCRC) were approved by the NMPA and the United States Food and Drug Administration (FDA), respectively. The first patient was dosed in the clinical study in Chinese Mainland in July 2026. In May 2026, the phase 1 clinical trial of HLX48 for injection (an antibody-drug conjugate targeting c-MET and EGFR) for the treatment of advanced/metastatic solid tumours was approved to commence in Australia and Chinese Mainland, respectively. The first patient was dosed in the clinical study in Chinese Mainland in June 2026. In May and June 2026, the phase 1 clinical trial of HLX3902 injection (a trispecific antibody targeting STEAP1, CD3 and CD28) for the treatment of metastatic castration- resistant prostate cancer and other advanced solid tumours was approved to commence in Australia and Chinese Mainland, respectively. The first patient was dosed in the clinical study in Chinese Mainland in July 2026. In June 2026, the first patient in the United States was dosed in the international multicenter phase 1 clinical study of a biosimilar of pembrolizumab HLX17 (recombinant humanised anti-PD-1 monoclonal antibody injection) in patients with various resected solid tumours. In June 2026, HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection) met its primary endpoint in the international multicenter phase 3 clinical study for the treatment of wet age-related macular degeneration (wAMD) in patients. In June 2026, the first patient in the United States was dosed in the international multicenter phase 1 clinical study of a biosimilar of ipilimumab HLX13 (recombinant anti- CTLA-4 fully human monoclonal antibody injection) for the first-line treatment of patients with unresectable advanced hepatocellular carcinoma (HCC).
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9 In July 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLX37 (recombinant humanised anti-PD-L1 and anti-VEGF bispecific antibody injection) in combination with chemotherapy or HLX43 for injection (a PD-L1-targeted antibody- drug conjugate) for the treatment of advanced/metastatic solid tumours was approved by the NMPA. In July 2026, an investigational new drug application (IND) for a clinical trial of HLX43 for injection (antibody-drug conjugate targeting PD-L1) in combination with bevacizumab with or without chemotherapy for the treatment of patients with advanced/metastatic solid tumours was approved by the NMPA. 4 High-quality supply of products worldwide: As a strong guarantee for the high-quality supply of products worldwide, Henlius ’ global manufacturing bases fully supplied markets in China, the United States, Europe, Canada, Latin America, Southeast Asia and India. During the Reporting Period, the Xuhui Facility underwent a pre-marketing GMP inspection by the United States Food and Drug Administration (FDA) for HANBEITAI. In June 2026, the Group received the Notice of Pharmaceutical GMP Compliance Inspection (ۜGMP) issued by the Shanghai Municipal Medical Products Administration (္ຖ၍ଣ҅ ), indicating that the HLX11-related production line at Songjiang First Plant has met the quality management system requirements under the PRC GMP regulations. The Phase I project of Songjiang Second Plant has completed the overall completion acceptance. The installation, commissioning and verification of equipment in two main production buildings including production lines of drug substances and drug products and the Prefilled Syringes System (PFS) have been completed. For details of the above, please refer to this announcement and (if applicable) the Company ’s previous announcements published on the websites of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange ”) and the Company.
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10 PRODUCT PORTFOLIO AND PIPELINE HLX208(17) BRAF V600E Solid tumours Innovative mAb Biosimilar mAbInnovative ADC Innovative fusion protein Innovative multi-specific antibody Small molecule Bridging study in U.S. Global MRCT Approved in global markets (10) NDA under review in China. Business partner: Essex. (11) Exclusive commercialisation rights and development rights in Chinese Mainland and Macau (12) IND approvals obtained in China/the U.S./Japan/the EU, Generic name under pINN status (13) The development and exclusive commercialization rights obtained in China and select ex-China markets. (14) Exclusive license obtained in China. Phase 3 MRCT enrolling globally. IND approval obtained in China (15) IND approvals obtained in China/the U.S. (16) IND approvals obtained in China/the U.S./Japan/Austra- lia/Europe. (17) Exclusive license obtained in China. (18) Exclusive rights in China (excl. Taiwan), several countries in Southeast Asia, and other selected countries and regions; Phase 1b/2a conducting in countries such as China and the U.S. (19) IND approvals obtained in China/the U.S. Business partner: Dr. Reddy's, etc. (20) Business partner: Sandoz, etc. (1) Approved in 50 countries and regions, including China, the UK, Germany, India, Singapore, trade name: Hetronifly ® in Europe. Business partners: KGbio/ Fosun Pharma/ Intas/ Lotus/ Abbott/ Eisai. (2) Approved in China and multiple Latin American countries. The first biosimilar approved in China. Business partners: Fosun Pharma/ Eurofarma/ Abbott/ Boston Oncology. (3) The first rituximab approved for the indication in China. (4) Approved in 50+ countries, including China, U.S., the UK, Germany, France and Australia, trade name in U.S.: HERCESSI™. Trade name in Europe: Zercepac ®. Business partners: Accord/ Elea/ Eurofarma/ Abbott/ KGbio/ Getz Pharma. (5) Business partners: Fosun Wanbang/ Getz Pharma. (6) Approved in China and multiple Latin American countries. Business partners: Eurofarma. (7) Approved in North America and Europe, Business partner: Organon. Trade name: BILDYOS ® (60mg/mL), BILPREVDA ® (120mg/1.7mL) in the U.S. and Europe. Marketing applications are under review in China (60mg/mL). (8) Approved in China, the U.S. and Europe. Trade name: POHERDY ® in the U.S. and Europe. Business partner: Organon. (9) Commercialization in China. BLA under FDA review HLX87 (13) + HLX22 (dulpatatug) (12) HER2 ADC + HER2 BC 1L PD-L1 x VEGF BsAb HLX37 Solid tumours DLL3 x DLL3 x CD3 x CD28 TetraAb HLX3901 SCLC, NEC TL1A x IL23(p19) BsAb HLX68 IBD (UC、CD, etc.) TSHR x IGF1R BsAb HLX320 TED Approved Serplulimab (1) + bevacizumab + Chemo PD-1+VEGF mCRC 1L Serplulimab (1) + HLX07(15) (pimurutamab) PD-1+EGFR Solid tumours (sqNSCLC, etc.) HLX07(15) (pimurutamab) EGFR Solid tumours (cSCC, etc.) HLX701 (18) CD47-SIRPα Blockade RAS/BRAF wild-type mCRC HLX6018 GARP/TGF-β1 IPF HLX43 (16) PD-L1 ADC Solid tumours (NSCLC, etc.) HLX43 (16) + Serplulimab (1) PD-L1 ADC + PD-1 Solid tumours Serplulimab (1) + Chemo PD-1 ES-SCLC 1L Serplulimab (1) + Chemo + Radio PD-1 LS-SCLC 1L HLX04-O (10) VEGF Wet AMD HLX04-O (10) VEGF Wet AMD POHERDY® (pertuzumab) (8) HER2 BC Phase 3Phase 1 Phase 2 Marketing Applications B7H3 x Sialidase HLX316 Solid tumours PD1 x IL2v HLX105 Solid tumours LIV-1 ADC HLX41 BC HER2 x HER2 ADC HLX49 Solid tumours (HER2+ BC/GC, etc.) CDH17 ADC HLX403 Gastrointestinal cancers IL-1R3 HLX109 Autoimmune diseases (AD, Psoriasis, etc.) ActRIIA/B HLX203 Lean management STEAP1 x CD3 x CD28 TsAb HLX3902 PCa HLX78 (14) (lasofoxifene) SERM BC Sialidase Fc Fusion Protein + CD20 HLX79 (17) + HLX01 (rituximab) (2) Active Glomerular Diseases HLX14 (7) (denosumab) RANKL Osteoporosis, Cancer-related bone disease, etc. HLX04 (bevacizumab) (6) VEGF mCRC, NSCLC, GBM, HCC, EOC, FTC or PPC, CC HLX901 (9) (neratinib) HER1/HER2/HER4 BC HLX903 (11) EGFR-TKI NSCLC 1L IND/ Pre-IND PD-1 HLX18 (15) (nivolumab) Solid tumours (NSCLC, MEL, etc.) HLX05-N (20) (cetuximab) EGFR mCRC, HNSCCHER2+HER2 HLX319 (pertuzumab + trastuzumab, SC) BC c-MET x EGFR BsADC HLX48 NSCLC, CRC KAT6A/B HLX97 ERα + Breast Cancer HLX15 (19) (daratumumab) CD38 Multiple myeloma HLX13 (20) (ipilimumab) CTLA-4 Melanoma, HCC, etc. HLX17 (pembrolizumab) PD-1 NSCLC, TNBC, etc. HLX22 (dulpatatug) (12) + trastuzumab+Chemo HER2+HER2 GC HLX22 (dulpatatug) (12) + T-DXd HER2 HER2-low/HR+ BC Serplulimab (1) PD-1 HLX01 (2) (rituximab) CD20 NHL, CLL, RA (3) RA, AS, Ps, UV, pJIA, pediatric Ps, CD, pediatric CD HLX03 (5) (adalimumab) TNF-α HLX02 (4) (trastuzumab) HER2 BC, mGCsqNSCLC, ES-SCLC, ESCC, nsNSCLC, GC BILDYOS® (denosumab) (7) RANKL Osteoporosis, etc. BILPREVDA® (denosumab) (7) RANKL Cancer-related bone disease, etc. HLX04 (bevacizumab) (6) VEGF mCRC, NSCLC, GBM, HCC, CC, EOC, etc. HLX87 (13) HER2 ADC BC Fovinaciclib (9) CDK4/6 BC HANSIZHUANG, HANLIKANG, HANQUYOU, HANDAYUAN and HANBEITAI, the core products of the Company, were all successfully launched.
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11 MANAGEMENT DISCUSSION AND ANALYSIS I. BUSINESS REVIEW FOR THE FIRST HALF OF THE YEAR As part of our commitment to provide high-quality and affordable biomedicines for patients worldwide, the Group has achieved remarkable success in the international market by leveraging its robust integrated platform of R&D, production and commercialisation. Building a solid business foundation through its global biosimilar operations and continuously empowering innovative R&D with sustained and stable operating cash flows, the Group is striding into the “Globalization 2.0 ” phase, gradually realising the transition from “product- based global expansion ” to “systematic global expansion ”. During the Reporting Period, while consolidating its traditional strongholds in the United States and Europe, the Group deepened its presence in emerging regions with high growth potential such as Latin America. It continues to consolidate its global localization operation capabilities spanning clinical operations, drug regulatory registration, and other functions, enabling efficient global product launches and sustaining the upward trajectory of international profitability. As of 20 August 2026, being the latest practicable date (the “Latest Practicable Date ”) for the publication of this announcement, 10 products (41 indications) of the Group have been successfully approved for marketing in China, the United States, Europe, Canada, Australia, Brazil, South Korea, Indonesia, the Dominican Republic and other countries/regions, including 7 products approved for marketing in multiple overseas markets, covering over 60 countries/regions, benefiting over 1,100,000 patients around the world. From the beginning of 2026 to date, the Group ’s “Go Global ” initiatives have yielded fruitful results. In January 2026, the Biologics License Application (BLA) for HANBEITAI was accepted by the United States Food and Drug Administration (FDA), further demonstrating the Company ’s outstanding capabilities in international registration and quality management. In April 2026, the marketing authorization application (MAA) for HLX11 (trade name in Europe: POHERDY ®) was approved by the European Commission (EC). The approved indications cover all indications for which the reference products have been approved in the local market. In May and June 2026, HANSIZHUANG (trade name in Europe: Hetronifly ®) was approved in the EU for three new indications, esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung carcinoma (nsNSCLC), and squamous non-small cell lung carcinoma (sqNSCLC), further expanding the treatment landscape in the European market. (I) Accelerating deep international reach through world-class operations Guided by its globalization strategy, the Group forged several new partnerships with internationally renowned companies during the Reporting Period, further expanding its global footprint. Meanwhile, the well-trained and mature global drug regulatory registration team collaborated closely with global clinical operations and medical teams to advance the development process of pipeline products both at home and abroad. During the Reporting Period, the Group achieved 32 investigational new drug application (IND) approvals and 25 new drug application (NDA) approvals spanning nearly 50 countries, including China, the United States, Europe, Japan, and Canada. As at the Latest Practicable Date, the in-house clinical operations teams in China, the United States, Australia, and Japan and other locations, were orderly advancing clinical studies in over 20 countries/regions.
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12 1. Expanding the global commercial footprint through licensing-out During the Reporting Period, the Group entered into several new agreements with leading international partners and continued to advance the commercial roll-out of existing overseas collaborations. • In February 2026, the Company entered into a license agreement with Eisai Co., Ltd., pursuant to which the Company agreed to grant a license to commercialise HANSIZHUANG (serplulimab injection) in Japan. • In February 2026, the Company entered into an amendment agreement with Abbott Products Operations AG, pursuant to which the Company agreed to grant a further license to commercialise HANSIZHUANG (serplulimab injection) in the agreed regions covering Asia, the Middle East, Africa and Eastern Europe (42 countries/ regions in total), including the Terminated Territories (as defined below) and other agreed countries or regions. In early 2026, the Company had separately reached termination arrangements with PT Kalbe Genexine Biologics and Fosun Industrial Co., Limited in connection with the commercialization rights of HANSIZHUANG (serplulimab injection) in the agreed Southeast Asian countries (excluding Indonesia), Middle Eastern and North African countries, Hong Kong and Macau regions of China (the “Terminated Territories ”). • In August 2026, the Company entered into a collaboration framework agreement with Sandoz AG, pursuant to which the parties will collaborate within the agreed territories on up to 10 monoclonal antibody (mAb) and/or antibody-drug conjugate (ADC) biosimilar products or components as mutually agreed from time to time. Currently, the parties have entered into product annexes for the first batch of three collaboration products (cetuximab biosimilar HLX05-N, evolocumab biosimilar HLX16, and belimumab biosimilar) and terms on an option for a potential collaboration product (hyaluronidase HLXTE-HAase1001). Meanwhile, based on the actual progress of the projects, the Group reached termination agreements with Cipla Limited in February 2026, regarding the previous commercialization collaborations for HANQUYOU in Australia, New Zealand and other markets. The Group will continue to explore collaboration opportunities for this product in international markets to further optimize the regional partnership layout of the Group ’s products.
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13 2. Globalisation strategy delivers strong results as overseas launches accelerate HANSIZHUANG was approved for new indications in the EU and other regions (trade name in Europe: Hetronifly ®), further expanding the treatment landscape in the European market and continuously deepening the layout in key cancers with high incidence With its excellent efficacy and data quality, HANSIZHUANG has been widely acknowledged in the international market. With its licenses-out areas covering over 120 countries and regions across the United States, Europe, Asia, and emerging markets, the international commercialisation has been carried out in an orderly manner. During the Reporting Period, HANSIZHUANG has accelerated its commercialisation in international markets: • In May 2026, HANSIZHUANG (trade name in Europe: Hetronifly ®) in combination with fluoropyrimidine and platinum-based chemotherapy indicated for the first-line treatment of adult patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), and in combination with carboplatin and pemetrexed indicated for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma (nsNSCLC) were approved in the EU as two new indications. • In June 2026, HANSIZHUANG (trade name in Europe: Hetronifly ®) in combination with carboplatin and nab-paclitaxel indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma (sqNSCLC) was approved in the EU as one new indication. • During January to July 2026, HANSIZHUANG was approved in Hong Kong, the Republic of Korea, Brazil, El Salvador, Honduras and other countries/regions for the treatment of extensive-stage small cell lung cancer (ES-SCLC). As at the Latest Practicable Date, HANSIZHUANG has been approved for marketing in a total of 50 countries and regions and has been granted Orphan-drug Designations by drug regulatory authorities in the United States, Switzerland, the Republic of Korea, and Mexico, and others, respectively. It has also been included in the national reimbursement drug lists of 12 EU member states. HLX11 (pertuzumab injection) was approved for marketing in the EU and other regions (trade name in Europe: POHERDY ®) In April and May 2026, HLX11 (trade name in Europe: POHERDY ®) was respectively approved for marketing by the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). HLX11 is indicated for neoadjuvant/ adjuvant treatment of HER2-positive early breast cancer and metastatic breast cancer and all other indications for which the reference products have been approved in the local market. In early 2026, the Company, together with Organon, its global partner of POHERDY ®, reached settlement with the originator of pertuzumab. The product is licensed to be launched on a country-by-country basis in the licensed territory as of the agreed-upon launch dates.
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14 Two products of HLX14 (denosumab injection) were approved for marketing in Canada (trade names in Canada: BILDYOS ® and TUZEMTY ®) In March 2026, two products of HLX14 were approved for marketing by Health Canada (trade names in Canada: BILDYOS ® and TUZEMTY ®). BILDYOS ® is indicated for osteoporosis and all other indications for which the reference products have been approved in the local market, while TUZEMTY ® is indicated for cancer-related bone disease and all other indications for which the reference products have been approved in the local market, thereby broadening therapeutic options for an increasing aging population. In early 2026, the Company, together with Organon, its global partner of HLX14, reached settlement with the originator of denosumab, pursuant to which the parties have agreed upon the launch date of HLX14 in the licensed territory. HANQUYOU was launched in China, the United States and Europe (US trade name: HERCESSI™; European trade name: Zercepac ®), and continued to expand its global commercial footprint With its high international quality standards, HANQUYOU has been approved for marketing in over 50 countries and regions (including the United States, Europe, Canada, Australia, etc.). Furthermore, the Group collaborated with internationally renowned biomedicine enterprises, including Abbott Operations Uruguay S.R.L., Accord Healthcare Limited, Eurofarma Laboratorios S.A. ( “Eurofarma ”), PT Kalbio Global Medika, Laboratorio ELEA Phoenix S.A., etc., to fully boost HANQUYOU ’s market share in Europe, the United States, Canada, and other regions, as well as many emerging markets, covering approximately 100 countries/regions around the world. Core products such as HANBEITAI also landed on the international stage In January 2026, the biologic license application (BLA) for HANBEITAI was accepted by the United States Food and Drug Administration (FDA). The Group will also work closely with partners such as Abbott Operations Uruguay S.R.L., Eurofarma, Boston Oncology, LLC and Getz Pharma to continuously promote the launch of HANLIKANG, HANDAYUAN and HANBEITAI in the international markets.
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15 3. High-quality supply of products worldwide As at the end of the Reporting Period, Henlius ’ global manufacturing bases are fully supporting the worldwide supply of all approved products. • The Group ’s Xuhui Facility has achieved normalized supply to the global market, currently covering markets including China, Europe, Canada, Latin America, Southeast Asia, and India. During the Reporting Period, the Xuhui Facility underwent a pre-marketing GMP inspection by the United States Food and Drug Administration (FDA) for HANBEITAI. In addition, the Facility also underwent and passed the pre-marketing GMP inspection by the Turkish Ministry of Health for HANSIZHUANG, and successfully completed the first shipments of HANSIZHUANG to countries including Peru, Mexico, Brazil, and Paraguay. • Songjiang First Plant of the Group in Songjiang District, Shanghai, has obtained GMP certifications from China, the United States and the European Union. In June 2026, the Group received the Notice of Pharmaceutical GMP Compliance Inspection (ۜGMP) issued by the Shanghai Municipal Medical Products Administration (္ຖ၍ଣ҅ ), indicating that the HLX11-related production line at Songjiang First Plant has met the quality management system requirements under the PRC GMP regulations, and the first batch of shipments of HLX11 in China was successfully completed during the Reporting Period. During the Reporting Period, Songjiang First Plant underwent the pre-marketing GMP compliance inspection for HLX14 (60mg/mL) conducted by the Shanghai Municipal Medical Products Administration. • In order to meet the Group ’s long-term demand for commercial production capacity, the construction of the Phase I project of Songjiang Second Plant, with a total planned land area of 200 acres, started in 2019 and overall final acceptance was achieved in 2025. The designed production capacity for the first and second stages of this project totals 36,000L. The installation, commissioning and verification of all equipment in two main production buildings including production lines of drug substances and drug products and the Prefilled Syringes System (PFS) have been completed. During the Reporting Period, Songjiang Second Plant underwent the pre-marketing GMP compliance inspection for HLX14 (60mg/mL) conducted by the Shanghai Municipal Medical Products Administration (္ຖ၍ଣ҅ ), and successfully completed the first batch of shipments of HLX14 to countries including Canada and Italy.
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16 (II) Driving innovation: from early R&D to global clinical development 1. Orientation toward clinical value and injecting impetus toward the pipeline The Group ’s early-stage R&D is centered around patients ’ needs and guided by clinical value. Leveraging a new drug discovery platform driven by deep data-driven and biocomputing accelerated molecular design technology, the Group continues to develop high-quality and affordable innovative drugs to treat complex diseases with the help of network biology and polypharmacology. By employing a comprehensive antibody drug technology platform to empower the development of innovative therapies, the Group is planning for the development of the next-generation innovative antibody drugs and antibody-based drugs. In terms of the development of T Cell Engager, the Group has developed highly specific products targeting solid tumours, which can effectively overcome the immunosuppressive tumour microenvironment and activate immune-mediated tumour cell killing. In terms of the development of antibody-drug conjugates (ADC), the Group ’s R&D platform Hanjugator has the ability to develop ADC products with high safety, high selectivity and high efficacy, and is able to effectively expand the application scenarios of ADC products, providing strong support for the Group in developing ADC products with differentiation advantage and significant clinical value. By deeply integrating artificial intelligence (AI) with biological data, the Group ’s HAI Club platform accelerates the identification of novel drug targets, leading to demonstrably higher drug discovery efficiency. By effectively harnessing the synergy across its multi-faceted early-stage R&D technology platforms, the Group has effectively accelerated the development of innovative drug candidates. This approach has established a robust technical foundation and pipeline reserve, enabling the Group to continuously address unmet clinical needs. During the Reporting Period, the Group also actively further expanded its product pipeline through in-licensing. In May 2026, the Company entered into a project cooperation agreement with Jiangsu Chuangte Pharmaceutical Technology Co., Ltd., and Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., pursuant to which the Company obtained the exclusive commercialisation rights in Chinese Mainland and Macau for the third-generation EGFR inhibitor FHND9041 (the Company ’s product code: HLX903). As of the Latest Practicable Date, the Group has built an R&D pipeline encompassing over 50 early-stage innovative assets and approximately 10 R&D platforms, covering a wealth of drug forms, such as monoclonal antibody, multi-specific antibody, antibody-drug conjugates (ADC), fusion proteins, small molecule drugs and other forms of drugs.
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17 The Group has also actively promoted the conversion of assets from early-stage to the clinical stage. This effort resulted in successful investigational new drug applications (IND) approvals and the initiation of clinical trials, from January 2026 to date, for the PD-L1-targeted ADC + PD-1 project and the c-MET x EGFR bispecific ADC, PD-L1 ADC + EGFR, HER2+HER2, B7H3 x Sialidase, DLL3xDLL3xCD3xCD28 tetraspecific antibody, KAT6A/B, and CD47-SIRPα blocker projects. • In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial of HLX701 (recombinant human SIRPα -IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer was approved by the NMPA. • In January 2026, an investigational new drug application (IND) for HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) in combination with HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) and HANSIZHUANG (serplulimab injection) for the treatment of advanced solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX97 (KAT6A/B small molecule inhibitor) for a phase 1 clinical trial in patients with advanced or metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX3901 for injection (a tetra-specific antibody targeting dual epitopes of DLL3, CD3 and CD28) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for HLX316 for injection (B7-H3-targeting sialidase Fc fusion protein) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. • In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLXTE-HAase02 (recombinant human hyaluronidase injection) was approved by the NMPA. • In March 2026, investigational new drug applications (INDs) for a pertuzumab and trastuzumab biosimilar HLX319 (pertuzumab and trastuzumab injection (subcutaneous injection)) for the phase 1 clinical trials were approved by the NMPA. • In April and May 2026, investigational new drug applications (INDs) for a phase 1 clinical trial of a cetuximab biosimilar HLX05-N (recombinant anti-EGFR chimeric human-murine monoclonal antibody injection) for the treatment of metastatic colorectal cancer (mCRC) were approved by the NMPA and the United States Food and Drug Administration (FDA), respectively.
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18 • In May 2026, the clinical trial notification of the international multicenter phase 2/3 clinical trial of HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) as a monotherapy or in combination with HLX07 (a recombinant anti-EGFR humanized monoclonal antibody injection) versus docetaxel for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was granted implied approval by the PMDA of Japan. • In May 2026, the phase 1 clinical trial of HLX48 for injection (an antibody-drug conjugate targeting c-MET and EGFR) for the treatment of advanced/metastatic solid tumours was approved to commence in Australia and Chinese Mainland, respectively. • In May 2026, the phase 2 clinical trial of HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) in combination with HANSIZHUANG (serplulimab injection) for the neoadjuvant treatment of non-small cell lung cancer (NSCLC) was approved to commence in Australia. • In May and June 2026, the phase 1 clinical trial of HLX3902 injection (a trispecific antibody drug targeting STEAP1, CD3 and CD28) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumours was approved to commence in Australia and Chinese Mainland, respectively. • In July 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLX37 (recombinant humanised anti-PD-L1 and anti-VEGF bispecific antibody injection) in combination with chemotherapy or HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) for the treatment of advanced/metastatic solid tumours was approved by the NMPA. • In July 2026, an investigational new drug (IND) application for HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) in combination with bevacizumab, with or without chemotherapy, for the treatment of advanced/ metastatic solid tumours was approved by the NMPA.
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19 2. Sustained and effective global development of clinical-stage products Addressing unmet clinical needs, the Group strategically planned and advanced the global clinical development of its pipeline products. During the Reporting Period, the progress was further promoted in clinical trials for innovative products, including HLX701(CD47-SIRPα Blockade), HLX43 (PD-L1 ADC), HLX22 (HER2), HLX87 (HER2 ADC), HLX97 (KAT6A/B), HLX316 (B7H3 x Sialidase), HLX3901 (DLL3xDLL3xCD3xCD28 tetraspecific antibody), HLX07 (EGFR), HANSIZHUANG (PD-1), HLX48 (c-MET x EGFR BsADC), and HLX04-O (VEGF), for a range of indications, such as colorectal cancer (CRC), solid tumours, breast cancer (BC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) or neuroendocrine carcinoma (NEC), wet age-related macular degeneration (wAMD). HLX43 for Injection (antibody-drug conjugate targeting PD-L1) • In January 2026, an investigational new drug application (IND) for a clinical trial of HLX43 in combination with HLX07 (recombinant humanised anti-EGFR monoclonal antibody injection) and HANSIZHUANG (serplulimab injection) for the treatment of advanced solid tumours was approved by the NMPA. • In February 2026, the first patient was dosed in a phase 1b/2 clinical study of HLX43 in combination with HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection antibody injection) or HANSIZHUANG (serplulimab injection) in patients with advanced or metastatic colorectal cancer in Chinese Mainland. • In May 2026, the clinical trial notification for the international multicenter phase 2/3 clinical trial of HLX43 as a monotherapy or in combination with HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) versus docetaxel for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) obtained implied approval from the PMDA of Japan, and the dosing of the first patient in the relevant clinical study was completed in Chinese Mainland in the same month. • In May 2026, the first patient in an EU country (Spain) was dosed in an international multicentre phase 2 clinical study of HLX43 in patients with advanced non-small cell lung cancer (NSCLC). • In May 2026, the phase 2 clinical trial of HLX43 in combination with HANSIZHUANG (serplulimab injection) for neoadjuvant therapy of non-small cell lung cancer (NSCLC) was approved to commence in Australia.
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20 During the Reporting Period, the key subgroup data of HLX43 in the treatment of non-small cell lung cancer (NSCLC) were presented orally at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation was based on a pooled analysis of NSCLC patients enrolled in the first-in-human Phase 1 study (HLX43-FIH101) and the global multicentre Phase 2 study (HLX43-NSCLC201), incorporating overseas patient data for the first time. Key efficacy endpoints were assessed by a Blinded Independent Central Review (BICR), and progression-free survival (PFS) data were disclosed for the first time. As of February 28, 2026, a total of 205 patients with advanced NSCLC had been enrolled in the study. Prior platinum-based chemotherapy had been administered in 99.0% of patients, while 82.0% had received prior immunotherapy, 41.0% had received targeted therapy, and 24.4% had previously been treated with docetaxel. Nearly 40% of patients had received three or more prior lines of therapy. In addition, 27.8% of patients had bone metastases, 13.7% of patients had brain metastases and 13.7% had liver metastases. The study population thus represented a heavily pretreated cohort with a substantial disease burden. Among patients with EGFR wild-type nonsquamous NSCLC (nsNSCLC), treated with HLX43 monotherapy at 2.5 mg/kg (n=19), the confirmed objective response rate (cORR) was 36.8%, the confirmed disease control rate (cDCR) was 94.7%, and the median progression-free survival (mPFS) was 6.67 months. In patients with squamous NSCLC (sqNSCLC) who had previously failed docetaxel treatment (2mg/kg, n=33), cORR and mPFS reached 33.3% and 6.34 months, respectively; and in patients with sqNSCLC who had previously failed docetaxel treatment and received third-line or later therapy (2mg/ kg, n=15), HLX43 monotherapy achieved a cORR of 46.7%, a cDCR of 80.0%, and an mPFS of 6.90 months. These results compare favourably with historically reported response rates for conventional chemotherapy (docetaxel) in this population. Among patients with PD-L1 positive tumours (TPS ≥1%, n=29) and those with PD-L1-negative or unevaluable tumours (TPS <1% or NE, n=39), the cORRs were 37.9% and 33.3%, respectively, while the cDCRs reached 89.7% and 84.6%, respectively, with no meaningful difference observed between the two groups. Notably, the mPFS in the PD-L1-positive subgroup reached 6.80 months, and 5.49 months in the PD-L1-negative group. These findings suggest that HLX43 may provide clinical benefit regardless of PD-L1 expression status. Regarding safety and tolerability, HLX43 demonstrated a consistent and favourable safety profile across the 205-patient analysis population encompassing multiple dose levels, NSCLC subtypes, and treatment backgrounds. HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) • In February 2026, the first patient was dosed in a phase 2/3 clinical study of HLX22 in combination with HLX87 for injection (antibody-drug conjugate targeting HER2) for first-line treatment of patients with HER2-positive recurrent or metastatic breast cancer (BC) in Chinese Mainland.
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21 During the Reporting Period, the trial design for HLX22-GC-301, an international, randomised, double-blind, multicentre phase 3 head-to-head study evaluating HLX22 as a first-line treatment for patients with HER2-positive advanced gastric or gastroesophageal junction cancer (G/GEJC), was presented in a poster session at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026). HLX22-GC-301 aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and XELOX versus trastuzumab and XELOX with or without ( ±) pembrolizumab in patients with HER2-positive, advanced G/GEJ cancer and no prior anti-tumour therapy in the advanced setting. The study ’s key inclusion criteria include previously untreated, histologically or cytologically confirmed locally advanced unresectable or metastatic HER2-positive G/GEJ adenocarcinoma. Key exclusion criteria include prior use of any HER2-targeted therapy. The stratification factors include HER2 immunohistochemistry (3+ vs 2+), geographic region (Asia vs Europe/North America vs rest of the world), primary tumour site (gastric vs gastroesophageal junction), and tumour PD-L1 expression (CPS < 1 vs 1 ≤ CPS < 10 vs CPS ≥ 10). The dual primary endpoints are PFS assessed by blinded independent central review per RECIST v1.1 and overall survival. Secondary endpoints include investigator-assessed PFS, objective response rate, PFS on the subsequent line of therapy, duration of response, safety, pharmacokinetics, immunogenicity, and quality of life. Importantly, the trial does not restrict enrolment based on PD-L1 expression status, and is aimed to support the continued evolution of global first-line treatment strategies for HER2-positive gastric cancer. HANSIZHUANG (serplulimab injection) • In March 2026, the investigational new drug application (IND) for clinical trial of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was approved by the NMPA. • In April 2026, the phase 2/3 clinical study of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) was approved to commence in Australia. • In May 2026, the first patient was dosed in an international multicenter phase 2/3 clinical study of HLX07 (recombinant anti-EGFR humanised monoclonal antibody injection) in combination with HANSIZHUANG and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) in Chinese Mainland.
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22 During the Reporting Period, data from ASTRUM-006, a Phase 3 clinical study of HANSIZHUANG as neoadjuvant/adjuvant treatment for gastric cancer, were formally presented for the first time as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published online in The Lancet (IF: 109), gaining recognition from two of the world ’s most prestigious academic platforms. As of the data cutoff date of August 19, 2025, a total of 588 patients were enrolled in the intention-to-treat (ITT) population across 57 clinical centers in China and randomized 1:1 to the serplulimab group (n=292) or the control group (n=296). The median follow-up was 35.9 months. The study met its primary endpoint, with investigator-assessed event-free survival (EFS) showing a significant improvement in the serplulimab group. The median EFS was not reached in the serplulimab group, compared with 35.9 months in the control group (HR=0.73; 95% CI, 0.56-0.94; p=0.015), demonstrating a statistically significant difference. The benefit was further reinforced by the BICR assessment: median EFS was also not reached in the serplulimab group versus 52.0 months in the control group (HR=0.67; 95% CI, 0.50-0.89; p=0.0061), corresponding to a 33% reduction in the risk of recurrence, disease progression, or death, thereby confirming the robustness of the efficacy findings. In terms of pathological response, the pCR rate in the serplulimab group reached 21.6%, more than tripling that observed in the control group (6.4%), with a marked between-group difference (odds ratio=3.95), indicating a substantially greater depth of tumour regression. ASTRUM-006 is the first trial in the perioperative treatment of gastric cancer to demonstrate that a chemotherapy-free approach – consisting of neoadjuvant immunotherapy plus chemotherapy followed by adjuvant immunotherapy alone { can deliver significantly improved efficacy while substantially reducing the toxicities associated with conventional full-course chemotherapy, thereby achieving dual benefits in efficacy and safety. Other products • In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial of HLX701 (recombinant human SIRPα -IgG4 Fc fusion protein injection) in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in March 2026. • In February 2026, investigational new drug (IND) applications for a phase 1 clinical trial of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection – subcutaneous injection) for the treatment of multiple myeloma were approved by the United States Food and Drug Administration (FDA) and the NMPA, respectively. In May 2026 and July 2026, the first patient in Chinese Mainland and the first patient in the United States were dosed in such international multicenter phase 1 clinical study, respectively.
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23 • In March 2026, an investigational new drug application (IND) for HLX97 (KAT6A/B small molecule inhibitor) for a phase 1 clinical trial in patients with advanced or metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in May 2026. • In March 2026, an investigational new drug application (IND) for HLX3901 for injection (a tetra-specific antibody targeting dual epitopes of DLL3, CD3 and CD28) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in April 2026. • In March 2026, an investigational new drug application (IND) for HLX316 for injection (B7-H3-targeting sialidase Fc fusion protein) for a phase 1 clinical trial in patients with advanced/metastatic solid tumours was approved by the NMPA. The first patient was dosed in such clinical study in Chinese Mainland in May 2026. • In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of a nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) for the treatment of multiple solid tumours was approved by the NMPA. The first patient was dosed in such international multicenter phase 1 clinical study in Chinese Mainland in July 2026. • In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLXTE-HAase02 (recombinant human hyaluronidase injection) was approved by the NMPA. The first subject was dosed in a phase 1 clinical study conducted in healthy Chinese adult male subjects in April 2026. • In March 2026, the investigational new drug applications (INDs) for the phase 1 clinical trials of a pertuzumab and trastuzumab biosimilar HLX319 were approved by the NMPA. The first subject was dosed in a phase 1 clinical study conducted in healthy Chinese male subjects in April 2026. • In April and May 2026, investigational new drug applications (INDs) for a phase 1 clinical trial of a cetuximab biosimilar HLX05-N (recombinant anti-EGFR chimeric human-murine monoclonal antibody injection) for the treatment of metastatic colorectal cancer (mCRC) were approved by the NMPA and the United States Food and Drug Administration (FDA), respectively. The first patient was dosed in the clinical study in Chinese Mainland in July 2026. • In May 2026, the phase 1 clinical trial of HLX48 for injection (an antibody-drug conjugate targeting c-MET and EGFR) for the treatment of advanced/metastatic solid tumours was approved to commence in Australia and Chinese Mainland, respectively. The first patient was dosed in the clinical study in Chinese Mainland in June 2026.
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24 • In May and June 2026, the phase 1 clinical trial of HLX3902 injection (a trispecific antibody targeting STEAP1, CD3 and CD28) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumours was approved to commence in Australia and Chinese Mainland, respectively. The first patient was dosed in the clinical study in Chinese Mainland in July 2026. • In June 2026, the first patient in the United States was dosed in the international multicenter phase 1 clinical study of a biosimilar of pembrolizumab HLX17 (recombinant humanised anti-PD-1 monoclonal antibody injection) in patients with various resected solid tumours. • In June 2026, HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection) met its primary endpoint in the international multicenter phase 3 clinical study for the treatment of wet age-related macular degeneration (wAMD) in patients. • In June 2026, the first patient in the United States was dosed in the international multicenter phase 1 clinical study of a biosimilar of ipilimumab HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) for the first-line treatment of patients with unresectable advanced hepatocellular carcinoma (HCC). • In July 2026, an investigational new drug application (IND) for a phase 1 clinical trial of HLX37 (recombinant humanised anti-PD-L1 and anti-VEGF bispecific antibody injection) in combination with chemotherapy or HLX43 for injection (a PD-L1-targeted antibody-drug conjugate) for the treatment of advanced/metastatic solid tumours was approved by the NMPA. • In July 2026, an investigational new drug application (IND) for a clinical trial of HLX43 for injection (antibody-drug conjugate targeting PD-L1) in combination with bevacizumab with or without chemotherapy for the treatment of patients with advanced/metastatic solid tumours was approved by the NMPA.
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25 The clinical and pre-clinical application results of the Group ’s products from the beginning of 2026 up to the Latest Practicable Date: Product name (targets) Indications Progress as of the Latest Practicable Date Continuous and efficient advancement of clinical research products Global development progress of HLX43 for injection (antibody-drug conjugate targeting PD-L1) HLX43 in combination with HLX07 and HANSIZHUANG (PD-L1 ADC+EGFR+PD-1) Solid tumour In January 2026, an investigational new drug application (IND) was approved by the NMPA HLX43 in combination with HLX07 or HANSIZHUANG (PD-L1 ADC+EGFR/ PD-1) Advanced or metastatic colorectal cancer (mCRC) In February 2026, the first patient has been dosed in a phase 1b/2 clinical study in Chinese Mainland HLX43 monotherapy or in combination with HLX07 (PD- L1 ADC/PD-L1 ADC+EGFR) Advanced squamous non-small cell lung cancer (sqNSCLC) In May 2026, the phase 2/3 clinical trial notification obtained implied approval from the PMDA of Japan. In May 2026, the first patient has been dosed in an international multi-center phase 2/3 clinical study in Chinese Mainland HLX43 (PD-L1 ADC) Advanced non-small cell lung cancer (NSCLC) In May 2026, the first patient in EU countries (Spain) was dosed in an international multi-centre phase 2 clinical study HLX43 in combination with HANSIZHUANG (PD-L1 ADC+PD-1) Neoadjuvant treatment for non-small cell lung cancer (NSCLC) In May 2026, a phase 2 clinical trial was approved to commence in Australia
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26 Product name (targets) Indications Progress as of the Latest Practicable Date Global development progress of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) HLX22 in combination with HLX87 (HER2+HER2 ADC) Breast cancer (BC) In February 2026, the first patient has been dosed in a phase 2/3 clinical study in Chinese Mainland Global development progress of HANSIZHUANG (serplulimab injection) HLX07 in combination with HANSIZHUANG and chemotherapy (EGFR+PD-1) Advanced squamous non-small cell lung cancer (sqNSCLC) In March 2026, an investigational new drug application (IND) was approved by the NMPA In April 2026, a phase 2/3 clinical trial was approved to commence in Australia In May 2026, the first patient has been dosed in an international multi-center phase 2/3 clinical study in Chinese Mainland Global development progress of other products HLX701 (CD47) in combination with cetuximab and chemotherapy Colorectal cancer (CRC) In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial was approved by the NMPA In March 2026, the first patient has been dosed in a phase 1b/2 clinical study in Chinese Mainland HLX15 (CD38) Multiple myeloma (MM) In February 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In February 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the FDA In May 2026, the first patient has been dosed in an international multi-center phase 1 clinical study in Chinese Mainland In July 2026, the first patient in the United States was dosed in an international multi-center phase 1 clinical study
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27 Product name (targets) Indications Progress as of the Latest Practicable Date HLX97 Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In May 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLX3901 (DLL3 ×DLL3× CD3×CD28) Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In April 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLX316 (B7-H3) Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In May 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLX18 (PD-1) Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In July 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLXTE-HAase02 (recombinant human hyaluronidase injection) Facilitating the diffusion and absorption of drugs administered via subcutaneous injection or subcutaneous infusion In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In April 2026, the first subject has been dosed in a phase 1 clinical study in Chinese Mainland
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28 Product name (targets) Indications Progress as of the Latest Practicable Date HLX319 (HER2+HER2) Breast cancer (BC) In March 2026, the investigational new drug applications (INDs) for a phase 1 clinical trial were approved by NMPA In April 2026, the first subject has been dosed in a phase 1 clinical study in Chinese Mainland HLX05-N (EGFR) Metastatic colorectal cancer (mCRC) In April 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In May 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the FDA In July 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLX48 (c-MET ×EGFR ADC) Solid tumour In May 2026, a phase 1 clinical trial was approved to commence in Australia In May 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In June 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland HLX3902 (STEAP1 × CD3 × CD28) Metastatic castration- resistant prostate cancer (mCRPC) and other advanced solid tumours In May 2026, a phase 1 clinical trial was approved to commence in Australia In June 2026, the investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In July 2026, the first patient has been dosed in a phase 1 clinical study in Chinese Mainland
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29 Product name (targets) Indications Progress as of the Latest Practicable Date HLX17 (PD-1) Various resected solid tumours In June 2026, the first patient has been dosed in an international multi-center phase 1 clinical study in the United States HLX04-O (VEGF) Wet age-related macular degeneration (wAMD) In June 2026, the international multi-center phase 3 clinical study met the primary study endpoint. HLX13 (CTLA-4) Hepatocellular carcinoma (HCC) In June 2026, the first patient in the United States has been dosed in an international multi-center phase 1 clinical study in the United States HLX37 in combination with chemotherapy or HLX43 (PD- L1×VEGF+PD-L1 ADC) Solid tumour In July 2026, the investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA HLX43 in combination with bevacizumab, with or without chemotherapy (PD- L1 ADC+VEGF) Solid tumour In July 2026, an investigational new drug application (IND) was approved by the NMPA Efficient advancement of IND filings for pre-clinical development projects HLX701 (CD47) in combination with cetuximab and chemotherapy Colorectal cancer (CRC) In January 2026, an investigational new drug application (IND) for a phase 1b/2 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland)
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30 Product name (targets) Indications Progress as of the Latest Practicable Date HLX43 in combination with HLX07 and HANSIZHUANG (PD-L1 ADC+EGFR+PD-1) Solid tumour In January 2026, an investigational new drug application (IND) was approved by the NMPA HLX97 Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland) HLX3901 (DLL3 ×DLL3× CD3×CD28) Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland) HLX316 (B7-H3) Solid tumour In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland) HLXTE-HAase02 (recombinant human hyaluronidase injection) Facilitating the diffusion and absorption of drugs administered via subcutaneous injection or subcutaneous infusion In March 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland) HLX319 (HER2+HER2) Breast cancer (BC) In March 2026, the investigational new drug applications (INDs) for a phase 1 clinical trial were approved by NMPA (Already in clinical phase in Chinese Mainland)
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31 Product name (targets) Indications Progress as of the Latest Practicable Date HLX05-N (EGFR) Metastatic colorectal cancer (mCRC) In April 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA In May 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the FDA (Already in clinical phase in Chinese Mainland) HLX43 monotherapy or in combination with HLX07 (PD- L1 ADC/PD-L1 ADC+EGFR) Advanced squamous non-small cell lung cancer (sqNSCLC) In May 2026, the Phase 2/3 clinical trial notification obtained implied approval from the PMDA of Japan. (Already in clinical phase in Chinese Mainland) HLX48 (c-MET × EGFR ADC) Solid tumour In May 2026, a phase 1 clinical trial was approved to commence in Australia In May 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland)
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32 Product name (targets) Indications Progress as of the Latest Practicable Date HLX43 in combination with HANSIZHUANG (PD-L1 ADC +PD-1) Neoadjuvant treatment for non-small cell lung cancer (NSCLC) In May 2026, a phase 2 clinical trial was approved to commence in Australia HLX3902 (STEAP1 × CD3 × CD28) Metastatic castration- resistant prostate cancer (mCRPC) and other advanced solid tumours In May 2026, a phase 1 clinical trial was approved to commence in Australia In June 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA (Already in clinical phase in Chinese Mainland) HLX37 in combination with chemotherapy or HLX43 (PD- L1×VEGF+PD-L1 ADC) Solid tumour In July 2026, an investigational new drug application (IND) for a phase 1 clinical trial was approved by the NMPA HLX43 in combination with bevacizumab, with or without chemotherapy (PD- L1 ADC+VEGF) Solid tumour In July 2026, an investigational new drug application (IND) was approved by the NMPA (III) Sustainable commercialisation fulfillment capabilities During the Reporting Period, the Group continued to strengthen its commercialisation system, and leveraged on product differentiation and synergistic promotion mechanisms etc. to deepen sustainable competitive advantages. As at the end of the Reporting Period, the Group ’s commercialisation team was approximately 1,800 people, promoting the commercialization of eight products, including HANQUYOU and HANSIZHUANG, in an orderly manner in Chinese Mainland.
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33 1. HANQUYOU (trastuzumab for injection, a therapeutic product for breast cancer and gastric cancer), a product with the largest market share in China ’s intravenous trastuzumab market, combined with HANBEIYOU to form a domestic “trastuzumab and pertuzumab dual-targeted ” combination approved in China, the United States and Europe, sequential treatment with HANNAIJIA (neratinib maleate) for the extended adjuvant treatment of breast cancer and synergized with FUTUONING (fuviciclib citrate capsules) to consolidate the Group ’s leading position in the field of breast cancer treatment HANQUYOU is the core product of the Group in the field of anti-tumour therapy, and was independently developed by the Group in accordance with the relevant regulations on biosimilar drugs of Chinese Mainland, the EU, and the United States. In Chinese Mainland, HANQUYOU has continued to penetrate the domestic market and generate significant sales revenue for the Group leveraging the Group ’s efficient market access and sales execution capabilities, as well as the differentiated advantages offered by HANQUYOU ’s flexible dose portfolio of 150mg and 60mg. During the Reporting Period, the Group has also strengthened the treatment ecosystem for patients with HER2-positive breast cancer and gastric cancer, further enhancing the market recognition of HANQUYOU. In July 2026, the 60mg specification of trastuzumab was included in the National Essential Medicines List (2026 Edition), which is expected to enhance its accessibility in medical institutions at all levels nationwide.
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34 HANBEIYOU is a pertuzumab injection independently developed by the Group. In May 2026, it was approved in Chinese Mainland for (1) early breast cancer: in combination with trastuzumab and chemotherapy for (i) the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence; and (2) metastatic breast cancer: in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic breast cancer, covering all the indications approved for the originator pertuzumab injection in Chinese Mainland. In the field of HER2-positive breast cancer treatment, HANQUYOU and HANBEIYOU constitute the first domestic trastuzumab and pertuzumab dual-targeted regimen approved in China, the EU, and the United States, further consolidating the Company ’s leading “whole-course, full-field and global ” layout in the field of breast cancer treatment. HANNAIJIA is an oral small-molecule pan-HER tyrosine kinase inhibitor (TKI) for the extended adjuvant therapy of HER2-positive early breast cancer in adult patients after adjuvant therapy containing trastuzumab. HANNAIJIA and HANQUYOU can achieve sequential synergy, with the potential to further reduce the 5-year and 10-year postoperative recurrence risks in patients with HER2-positive early-stage breast cancer, bringing survival benefits to more patients with HER2-positive early-stage breast cancer. HANNAIJIA has completed the tendering process on the procurement platform and has been included in the medical insurance procurement platform in all provinces in Chinese Mainland, with its market share gradually increasing. During the Reporting Period, the Group continued to advance the commercialization process of HANNAIJIA, consolidating its advantageous brand position in the extended adjuvant therapy of HER2-positive early breast cancer. Meanwhile, the Group actively promoted education on sequential treatment with neratinib, an extended adjuvant therapy, aiming to cure more patients with HER2-positive early-stage breast cancer.
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35 FUTUONING is an innovative CDK4/6 small molecule inhibitor which can commercially synergize with other existing breast cancer pipeline products of the Company. FUTUONING was approved in Chinese Mainland for (1) use in combination with Fulvestrant for the treatment of adult patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative recurrent or metastatic breast cancer, who have experienced disease progression after prior endocrine therapy; and (2) use in combination with an aromatase inhibitor as initial endocrine therapy for the treatment of adult patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative locally advanced or metastatic breast cancer. During the Reporting Period, FUTUONING has completed the tendering process on the procurement platform and has been included in the medical insurance procurement platform in all provinces within Chinese Mainland. 2. HANSIZHUANG (serplulimab injection) approved for a new indication, opening a new era of “Chemo-free ” perioperative immunotherapy for gastric cancer HANSIZHUANG is a core innovative PD-1 monoclonal antibody product independently developed by the Group. Several of its key clinical study results have been published in prestigious journals, including The Lancet (ɠ), the Journal of the American Medical Association (JAMA) (ᔼኪึᕏႦ), Nature Medicine ( І್ᔼኪ), Cancer Cell, Lancet Respir Med (ɠխіषኪ ), Cancer Communications, JAMA Oncology (ᔼኪึ໕ᆯᕏႦ), and Nature Communications, etc. Meanwhile, HANSIZHUANG was recommended by many guidelines, including the Guidelines of CSCO for Gastric Cancer ( CSCO), the Guidelines of CSCO for Small-Cell Lung Cancer ( CSCO), Guidelines of CSCO for Non-small Cell Lung Cancer ( CSCO), Guidelines of CSCO for Esophageal Cancer ( CSCO), Guidelines of CSCO for Immune Checkpoint Inhibitor Clinical Practice ( CSCO), and Chinese Guidelines for the Radiotherapy of Esophageal Cancer (ᐕ ). During the Reporting Period, HANSIZHUANG ® for the perioperative treatment of gastric cancer was included in the Guidelines of CSCO for Gastric Cancer (2026 Edition) (CSCOیܸ2026و)) for the first time.
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36 HANSIZHUANG has been approved in Chinese Mainland for the first-line treatment in combination with chemotherapy for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsNSCLC), and the neo/ adjuvant treatment in combination with chemotherapy for gastric cancer (GC). It has become the first monoclonal antibody drug targeting PD-1 approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) around the world, and its differentiated advantages of focusing on small cell lung cancer are uniquely competitive in the PD-1 market. In June 2026, the New Drug Application (NDA) for the new indication of HANSIZHUANG ® in combination with chemotherapy for the neo/adjuvant treatment of gastric cancer was approved by the NMPA, becoming the first treatment regimen using immune monotherapy to replace adjuvant chemotherapy after surgery in the perioperative period for gastric cancer approved worldwide. 3. Steady progress of the commercial sales of HANLIKANG (rituximab injection), HANDAYUAN (adalimumab injection) and HANBEITAI (bevacizumab injection) (therapeutic products for solid tumours, hematological tumours and autoimmune diseases) contributed to the continuous revenue HANLIKANG is the first monoclonal antibody drug approved for marketing under the Guidelines for the R&D and Evaluation of Biosimilars (Trial) (೯ၾ൙ᄆ ۆࡡ( ༊Б)) in China in 2019. The domestic commercial sale of HANLIKANG is undertaken by Fosun Yaohong, a subsidiary of Fosun Pharma, the controlling shareholder of the Company. In April 2026, the supplementary applications of HANLIKANG for two additional indications, being the combination with polatuzumab vedotin, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL); and the combination with bendamustine and polatuzumab vedotin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for hematopoietic stem cell transplantation, has been approved by the NMPA.
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37 HANDAYUAN is the third product of the Group marketed in Chinese Mainland. Its domestic commercial sale is undertaken by Fosun Wanbang, a subsidiary of Fosun Pharma, the controlling shareholder of the Company. HANDAYUAN covers all eight indications of originator adalimumab approved for marketing in Chinese Mainland, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn ’s disease and pediatric Crohn ’s disease. In July 2026, adalimumab was included in the National Essential Medicines List (2026 Edition). HANBEITAI is the fourth biosimilar product of the Group, which was approved for marketing and realised commercial sales, covering all indications of the originator bevacizumab approved for marketing in Chinese Mainland, including metastatic colorectal cancer, advanced, metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma, cervical cancer, as well as indications of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. During the Reporting Period, HANBEITAI focused on “dual-channel ” market and smoothly progressed towards its established commercialisation goals. In July 2026, bevacizumab was included in the National Essential Medicines List (2026 Edition).
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38 II. OUTLOOK FOR THE SECOND HALF OF 2026 In the second half of the year, the Group will continue to be guided by clinical needs, persist in deepening product innovation, and further consolidate its internationalised capability of “integrating research, production and marketing ”. (I) High-quality internationalised operations and innovation capabilities, with a focus on deepening the global market 1. Continue to facilitate the footprint of pipeline products worldwide In the second half of the year, the Group will continuously promote the marketing approval process of more products in the global market with experiences gained along the way. • The Biologics License Application (BLA) for HANSIZHUANG in combination with chemotherapy for the first line treatment of extensive-stage small cell lung cancer (ES-SCLC) is planned to be submitted to the United States Food and Drug Administration (FDA) in 2026. In addition, application for new indication of HANSIZHUANG in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer is also planned to be submitted in the EU in 2026. • The biologic license application (BLA) for HANBEITAI is expected to be approved in the United States in 2026. The marketing authorisation application (MAA) for such product is planned to be submitted to the EU in 2026. • HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection) is expected to be approved for marketing in Chinese Mainland in 2026. • The marketing authorisation application for HLX14 (120 mg/1.7 mL) in Chinese Mainland is planned to be submitted to the NMPA in the second half of the year. • The Biologics License Application (BLA) for HANSIZHUANG in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) is planned to be submitted in Japan in the first half of 2027. • HLX903 is expected to be approved for marketing in Chinese Mainland in the first half of 2027. • In the second half of the year, the Group will also proactively cooperate with international partners to facilitate the marketing approval process of HANLIKANG, HANQUYOU, HANDAYUAN, HANBEITAI, HANSIZHUANG, HLX04-O, HLX14 and other products in Chinese Mainland, the United States, the EU, Japan, the Philippines, Argentina, Chile, Serbia, Pakistan and other countries and regions.
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39 Meanwhile, the Group will, as always, promote the business cooperation and local market establishment of its self-developed products in international markets, deepen its global out-licensing strategy to expand the international influence and accelerate the global value realization. The Group will also continue to work closely with international partners, leverage forward-looking market insights and refined access strategies to enhance its global commercialization capabilities, promote to integrate products into the local market deeply to benefit more overseas patients. 2. Continue to expand the product pipeline based on patients ’ needs through innovative iteration Multiple key innovative assets of the Group are expected to achieve breakthrough clinical progress in the second half of 2026. Among them, the Group has cumulatively conducted more than ten clinical studies of HLX43 for injection (antibody-drug conjugate targeting PD-L1) as a monotherapy or in combination with other products, broadly covering cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), metastatic colorectal cancer (mCRC), gastric/gastroesophageal junction (G/GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC), breast cancer (BC), etc., to continuously explore and unearth the broad-spectrum therapeutic potential of HLX43 in solid tumours. In addition to monotherapy, based on the IO efficacy demonstrated by HLX43, the Company is also actively exploring combination therapy strategies of HLX43 with other diverse molecules such as the Company ’s self-developed innovative anti-EGFR mAb HLX07 and anti-PD-1 mAb HANSIZHUANG (serplulimab, European trade name: Hetronifly ®), in order to further evaluate its application potential in earlier lines of treatment and different combination scenarios. The Group will continue to integrate international resources and advantages to explore cutting-edge innovative products with significant clinical value. Meanwhile, the Group will actively deploy the in-depth application of artificial intelligence (AI) technology in the product research and development process, and accelerate the transformation of early research and development results. In the second half of 2026, Investigational New Drug (IND) applications are planned to be submitted for several products, such as HLX49 (HER2 × HER2 ADC) and HLX105 (PD-1 × IL2v) for the treatment of various solid tumours, HLX403 (CDH17 ADC) for the treatment of gastrointestinal cancer, and HLX109 (IL-1R3) for the treatment of autoimmune diseases further enriching the Group’s product pipeline. In addition, the Group will also focus on high-value and differentiated high-quality assets through diversified means such as in-licensing and co-development. Leveraging our established capability of “integrating research, production and marketing ”, we will drive in-depth integration of acquired assets and our existing technological capabilities to develop a globally competitive portfolio, thus promoting our long-term sustainable development.
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40 3. Maintain international high-quality manufacturing standards to support a stable global market supply of products In line with the product R&D and global commercialisation process, the Group has proactively planned the construction of production bases and the expansion of production capacity to provide strong support for the commercial sales of its products. In the second half of the year, the Xuhui Facility will expedite the preparatory work for the market supply of HLX04 in the United States. Songjiang Second Plant will continue to improve its international standard quality system and is expected to undergo pre-marketing GMP inspections for HANSIZHUANG and HLX14 (120 mg/1.7 mL) in Chinese Mainland in the second half of 2026. The supply scope of Songjiang First Plant is expected to expand to cover the supply of more products to European and Latin American markets. (II) Leverage first-mover advantages to achieve sustainable development in the domestic market As one of the leading domestic biopharma companies, the Group will continue to advance the successful commercialisation of more products in an all-round efficient commercial operation model, providing global patients with biological drugs of affordable price and high quality. At the same time, relying on the qualifications of Shanghai Henlius Pharmaceutical Trading Co., Ltd., a wholly-owned subsidiary of the Company, and its Good Supply Practice (GSP) certification in China, the Group will also explore more business cooperation possibilities, further expand the commercialised product pipeline and enrich the overall business format of the Group and promote the quality and growth of the commercialisation sector. • The Group has accumulated strong commercial capabilities in the field of breast cancer treatment. In the second half of the year, while continuing to expand into lower-tier markets to steadily increase the market share of HANQUYOU, the Group will accelerate the commercialisation of HANNAIJIA, including securing market access in core hospitals and, promoting comprehensive treatment coverage for all eligible patients within the intensified adjuvant target population, so as to further consolidate the Group’s leading position in the treatment of HER2-positive breast cancer. Meanwhile, for HR+/HER2 – advanced breast cancer, the inclusion of FUTUONING into the newly updated National Reimbursement Drug List has come into effect in 2026, which is expected to significantly enhance its accessibility and affordability. The Group will accelerate the commercial promotion of FUTUONING and proactively facilitate hospital access to ensure that more breast cancer patients benefit from innovative therapies as soon as possible.
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41 • In the second half of the year, the Group will continue to uphold the differentiated product strategy, strengthen the competitive advantages of HANSIZHUANG, consolidate its leading position in the treatment of small cell lung cancer, work in conjunction with the dedicated gastric cancer sales force for HANSIZHUANG and further expand its market share in the treatment fields including non-small cell lung cancer, esophageal cancer and gastric cancer, so that more patients can benefit from it. • In the second half of the year, HANBEITAI will continue to focus on the dual-channel market while actively pursuing hospital access opportunities in non-dual-channel regions with a view to further increasing the market share. • Fosun Yaohong and Fosun Wanbang, subsidiaries of Fosun Pharma, the controlling Shareholder of the Company, are responsible for the domestic commercial sales of HANLIKANG and HANDAYUAN, respectively. In the second half of the year, the Group will maintain close cooperation with Fosun Yaohong and Fosun Wanbang, thereby continuously carrying out commercial sales of products. III. FINANCIAL REVIEW During the Reporting Period, the Group continued to focus on unmet clinical needs. Relying on its platform-based innovation capabilities and global development network, the Group built a globally competitive innovative product pipeline, promoted the translation of innovation achievements into clinical efficacy and patient access, and created long-term and steady value in the global biopharmaceutical innovation ecosystem. The Group has established an end-to-end platform spanning global research and development (R&D), clinical trials, registration, manufacturing and commercialization, continuously expanded its global commercial cooperation network, and strengthened international operations. During the Reporting Period, the Group maintained steady and continuous profitability, expanded its strategic product portfolio, and was committed to delivering affordable, high-quality biopharmaceuticals worldwide. As an international innovative biopharmaceutical company, the Group has always adhered to a patient-centric philosophy and continuously broadened its forward-looking layout in new therapeutic areas, so as to bring high-quality and affordable innovative treatment solutions to patients worldwide. With a mature international operating model, the Group is steadily stepping into the “Globalization 2.0 ” stage. During the Reporting Period, the Group achieved robust international growth, with its overseas profit margins continuously increasing.
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42 (I) Revenue During the Reporting Period, the Group realised an operating income of approximately RMB3,588.2 million, representing an increase of approximately 27.3% compared to the same period last year, and the main revenue components were as follows: 1) Revenue from product sales HANQUYOU (trastuzumab for injection) was the first domestic trastuzumab approved for marketing independently developed by the Group and was also the first product of the Group to adopt its in-house team to conduct commercialisation promotion. It was commercially available on the domestic market in August 2020. During the Reporting Period, revenue from sales of HANQUYOU was approximately RMB1,473.5 million, representing an increase of approximately RMB66.1 million as compared to the same period in the last year. Revenue from sales of Zercepac ® and HERCESSI™ (including revenue from product and revenue from royalties based on sales) was approximately RMB10.9 million and licensing revenue was approximately RMB3.0 million. HANSIZHUANG (serplulimab injection) was the first self-developed and approved bio-innovative drug of the Group and was commercially available in the domestic market in March 2022. The approval of HANSIZHUANG will further enrich the Group ’s commercial product line and will also bring more treatment options for domestic patients. During the Reporting Period, revenue from sales of HANSIZHUANG was approximately RMB573.5 million. Revenue from sales of Zerpidio ® and Hetronifly ® (including revenue from product and revenue from royalties based on sales) was approximately RMB24.0 million. HANBEITAI (bevacizumab injection) is the fourth biosimilar product of the Group approved for marketing in Mainland China and commercialised by the Group ’s in-house team. It was commercially available in the domestic market in January 2023. During the Reporting Period, revenue from sales of HANBEITAI was approximately RMB218.2 million, representing an increase of approximately RMB101.9 million or approximately 87.6% as compared to the same period last year. In respect of HANLIKANG (rituximab injection), according to the cooperation agreement with Fosun Pharma, Fosun Pharma would reimburse all the expenses related to the clinical trials of HANLIKANG incurred by the Group after the relevant cooperation agreement was signed, and the Group was responsible for the production of HANLIKANG in China and the supply of HANLIKANG to Fosun Pharma after the commercialisation of HANLIKANG, and shall share the profits from the sales of HANLIKANG in China. During the Reporting Period, the Group recognised sales revenue of approximately RMB324.5 million under the aforementioned profit-sharing arrangement with its partners, and licensing income of approximately RMB11.2 million under the collaboration with Fosun Pharma and the license agreement entered into with Eurofarma in May 2022.
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43 In respect of HANDAYUAN (adalimumab injection), according to the cooperation agreement with Fosun Pharma, Fosun Pharma would reimburse all the expenses related to the clinical trials of HANDAYUAN incurred by the Group after the relevant cooperation agreement was signed, and the Group was responsible for the production of HANDAYUAN in China and the supply of HANDAYUAN to Fosun Pharma after the commercialisation of HANDAYUAN, and shall share the profits from the sales of HANDAYUAN in China. During the Reporting Period, revenue from sales of HANDAYUAN was approximately RMB29.8 million and licensing income was approximately RMB0.6 million under the aforementioned profit-sharing arrangement with its partners. HANNAIJIA (Neratinib Maleate Tablets) is another important product of the Group for breast cancer treatment, which is expected to form a sequential therapy with the existing product HANQUYOU in the pipeline, further reducing the 5-year and 10-year postoperative recurrence risks in patients with HER2-positive early breast cancer. HANNAIJIA started shipment in September 2024. During the Reporting Period, revenue from sales of HANNAIJIA was approximately RMB195.5 million. FUTUONING (Fovinaciclib Citrate Capsules) is an innovative small-molecule CDK4/6 inhibitor, and its commercial promotion in China is the responsibility of the Group. FUTUONING started shipment in September 2025. During the Reporting Period, revenue from sales of FUTUONING was approximately RMB10.7 million. HLX14 (Denosumab injection, with its trade names BILDYOS ® and BILPREVDA ® in the United States and Europe, and BILDYOS ® and TUZEMTY ® in Canada) has successfully become the first China-developed denosumab to enter overseas markets. In the second half of 2025, the United States Food and Drug Administration (FDA), the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the marketing for two products of HLX14, respectively. The approved indications cover all indications for which the reference products have been approved in the local market. During the Reporting Period, revenue from sales of BILDYOS ®, BILPREVDA ® and TUZEMTY ® (including revenue from product and revenue from royalties based on sales) was approximately RMB70.4 million, and licensing revenue amounted to approximately RMB2.7 million. HANBEIYOU (Pertuzumab Injection) is a pertuzumab independently developed by the Company. In May 2026, its New Drug Application (NDA) was approved by the NMPA, with approved indications covering all indications previously approved for the originator pertuzumab injection within mainland China. During the Reporting Period, HANBEIYOU achieved sales revenue of approximately RMB7.7 million and licensing revenue of approximately RMB2.8 million. 2) Revenue from joint development and licensing As the Group continues to deepen its international layout, the Group is exploring how to continuously expand into the United States, Europe, Japan, and emerging international markets. This strategy builds on fully leveraging the speed, efficiency, and resource advantages of local clinical R&D in China to accelerate the global rollout of innovative products and develop into a more globally competitive innovative pharmaceutical enterprise. During the Reporting Period, the Group also carried out business cooperation with many partners around the world based on various projects, including intellectual property licensing, joint development, commercialisation licensing, etc.
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44 In September 2019, the Group entered into a co-development and commercialization agreement with PT Kalbe Genexine Biologics in relation to HANSIZHUANG (serplulimab injection). With the continuous advancement of R&D services, the Group has recognised revenue from licensing and R&D services of approximately RMB2.5 million for the six months ended 30 June 2026. In May 2022, the Group entered into a license agreement with Eurofarma, granting it the license to develop, manufacture, and commercialize HANLIKANG (Rituximab Injection), HANQUYOU (Trastuzumab for Injection), and HANBEITAI (Bevacizumab Injection) within the licensed territory and for human oncology treatment. For the six months ended 30 June 2026, the Group has recognised licensing revenue of approximately RMB0.8 million. In June 2022, the Group entered into a license and supply agreement with Organon LLC, granting Organon LLC and its affiliates exclusive right to commercialise two products independently developed by the Group, being HLX11 (recombinant anti-HER2 domain II humanised monoclonal antibody injection) and HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) worldwide except for China, fully covering the United States, EU, Japan and other major biomedicine markets and many emerging markets. The Group has recognised revenue from licensing and R&D services of approximately RMB95.3 million for the six months ended 30 June 2026. In October 2023, the Group entered into a license agreement with Intas Pharmaceuticals Limited ( “Intas ”) in relation to HANSIZHUANG (serplulimab injection), granting Intas exclusive development and commercialization rights in specific territories as agreed therein. The Group has recognised licensing revenue of approximately RMB4.7 million for the six months ended 30 June 2026. In December 2024, the Group entered into an agreement with Abbott Products Operations AG, agreeing to grant it a license to commercialize 5 products in specified territories, covering 69 countries and regions in Asia, Latin America, etc. The Group has recognised licensing revenue of approximately RMB0.2 million for the six months ended 30 June 2026. In April and December 2025, the Group entered into a license agreement and an amendment agreement with Sandoz AG, respectively, granting it the exclusive rights to commercialize HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in the United States, agreed European countries (42 European countries), Japan, Australia, and Canada. The Group has recognised revenue from R&D services of approximately RMB49.5 million for the six months ended 30 June 2026. In February 2026, the Group entered into a license agreement with Eisai Co., Ltd. regarding HANSIZHUANG (Serplulimab Injection), granting it the license to develop, manufacture, and commercialize HANSIZHUANG (Serplulimab Injection) in Japan. For the six months ended 30 June 2026, the Group has recognised licensing and R&D service revenue of approximately RMB461.6 million. 3) Revenue from other R&D service businesses The Group has recognised revenue from CMC technical service of approximately RMB87.4 million for the six months ended 30 June 2026.
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45 (II) Cost of sales Cost of sales of the Group primarily represents reagents and consumables, employee compensation, outsourcing expenses, utilities expenses and depreciation and amortisation. During the Reporting Period, the Group recorded cost of sales of approximately RMB820.0 million, representing an increase of approximately RMB199.6 million as compared with that for the six months ended 30 June 2025, primarily due to an increase in the market sales volume of the Group ’s key commercialised products. (III) Gross profit During the Reporting Period, the Group recorded a gross profit of approximately RMB2,768.2 million, representing an increase of approximately RMB569.0 million, as compared with that for the six months ended 30 June 2025, mainly due to the increase in revenue from the Group ’s joint development and licensing, and the continuous growth in sales volume of HANBEITAI and HANNAIJIA. (IV) Other income and gains Other income of the Group mainly included government grants and bank interest income. Government grants mainly included (1) government grants for capital expenditure in relation to the purchase of machinery and equipment (recognised over the useful life of the relevant assets); and (2) incentives for R&D activities and other grants (recognised after satisfying certain conditions imposed by the government). During the Reporting Period, the Group recognised other income and gains of approximately RMB53.3 million. Six months ended 30 June 2026 2025 RMB’000 RMB’000 Government grants 45,653 10,615 Interest income 5,675 9,483 Others 2,019 28 Total 53,347 20,126
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46 (V) R&D expenditure Six months ended 30 June 2026 2025 RMB’000 RMB’000 Expensed R&D expenditures R&D employee salaries 213,916 151,688 Outsourcing fees 142,765 128,078 Reagents and consumables 87,476 64,424 Utilities expenses 18,352 8,209 Depreciation and amortisation 41,171 24,314 Consulting expense 1,561 5,515 Technology expense 38,979 30,185 Clinical trials 210,285 150,208 Share-based compensation 30,786 – Others 40,724 22,845 Total expensed R&D expenditures 826,015 585,466 Capitalised R&D expenditures Clinical trials 265,704 186,135 R&D employee salaries 97,114 86,502 Reagents and consumables 40,072 38,958 Depreciation and amortisation 21,916 17,872 Utilities expenses 13,047 5,791 Outsourcing fees 29,133 21,714 Technology expense 114,434 39,887 Consulting expense 1,479 2,072 Share-based compensation 11,103 – Others 30,703 11,032 Total capitalised R&D expenditures 624,705 409,963 During the Reporting Period, the Group recognised R&D expenditures of approximately RMB1,450.7 million, representing an increase of approximately RMB455.3 million as compared with approximately RMB995.4 million for the six months ended 30 June 2025. Such R&D expenditures were mainly used to increase investment in innovative R&D projects to accelerate the Group ’s innovation and transformation. Our R&D expenses mainly arose from advancing technology platform innovation, IND application, and clinical trials for new drugs.
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47 (VI) Administrative expenses Administrative expenses mainly included administrative staff costs, office administrative expenses, consulting fees and depreciation and amortisation, etc. For the six months ended 30 June 2026, the Group recognised administrative expenses of approximately RMB247.8 million, representing an increase of approximately 33.7% as compared with that of approximately RMB185.4 million for the six months ended 30 June 2025. The increase in the Group ’s administrative expenses was mainly due to (1) a corresponding increase in share incentive expenses as the Company expanded its management team or introduced core talents to facilitate business development; and (2) an increase in office administrative expenses. (VII) Selling and distribution expenses Selling and distribution expenses of the Group mainly included salaries, promotional expenses, etc. During the Reporting Period, the Group recognised selling and distribution expenses of approximately RMB1,190.4 million, which mainly comprised the marketing expenses incurred in the sales of HANSIZHUANG, HANQUYOU and HANBEITAI. (VIII) Other expenses For the six months ended 30 June 2026, the Group recognised other expenses of approximately RMB13.1 million, which were mainly non-operating expenses. (IX) Income tax expense For the six months ended 30 June 2026, the Group incurred income tax expense of approximately RMB67.4 million. (X) Profit for the period In view of the above, profit of the Group increased by approximately RMB40.3 million from a profit of approximately RMB390.1 million for the six months ended 30 June 2025 to a profit of approximately RMB430.4 million for the six months ended 30 June 2026.
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48 (XI) Non-International Financial Reporting Standards (Non-IFRS) Measures To supplement the consolidated financial statements of the Group presented in accordance with IFRS, the Group also uses Non-IFRS profit and Non-IFRS EBITDA as additional financial measures, which are not required by, or presented in accordance with, IFRS. The use of such Non-IFRS measures as analytical tools has limitations, and you should not consider them in isolation from, or as a substitute for, the analysis of the Group ’s operating results or financial position reported in accordance with IFRS. Such Non-IFRS information presented by the Group may not be comparable to similar measures presented by other companies. However, the Group believes that this Non-IFRS measurement method can reflect the Group ’s normal operating results by eliminating the potential impact of items that the management considers are not indicative of the Group ’s operating performance, thereby facilitating the comparison of operating performance across different periods and companies to the extent applicable. The following table sets forth the reconciliation of profit for the period to Non-IFRS profit for the period: Six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Profit for the period 430,436 390,127 Add: Share-based compensation expenses 141,889 – Non-IFRS profit for the period 572,325 390,127
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49 The following table sets forth the reconciliation of profit for the period to Non-IFRS EBITDA for the period: Six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Profit for the period 430,436 390,127 Adjustment: Finance costs 51,849 54,337 Depreciation and amortisation 212,525 220,589 Income tax 67,381 3,607 EBITDA 762,191 668,660 Add: Share-based compensation expenses 141,889 – Non-IFRS EBITDA for the period 904,080 668,660 (XII) Liquidity and capital resources As of 30 June 2026, cash and bank balances of the Group were approximately RMB818.4 million, mainly denominated in Renminbi ( “RMB ”), United States Dollars ( “USD ”), Singapore Dollars ( “SGD”), Hong Kong Dollars ( “HKD”), Euro ( “EUR”) and Japanese Yen ( “JPY”), and as of 31 December 2025, cash and bank balances of the Group were approximately RMB772.2 million, representing an increase of approximately RMB46.2 million.
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50 As of 30 June 2026, the current assets of the Group were approximately RMB3,643.2 million, including cash and cash equivalents of approximately RMB434.7 million and time deposits with maturity over three months of approximately RMB383.7 million. The inventories were approximately RMB612.0 million, trade and notes receivables were approximately RMB1,699.7 million, prepayments, deposits and other receivables were approximately RMB476.4 million and contract assets were approximately RMB36.7 million. As of 30 June 2026, the current liabilities of the Group were approximately RMB4,698.1 million, mainly including trade payables of approximately RMB763.4 million, other payables and accruals of approximately RMB1,264.2 million, contract liabilities of approximately RMB360.2 million and interest-bearing bank and other borrowings of approximately RMB2,266.8 million. As at 30 June 2026, the cash and bank balances denominated by currencies were as follows: RMB’000 RMB 452,458 HKD 7,976 USD 336,591 EUR 9,141 NTD 2,630 JPY 9,586 Original amount ’000 RMB 452,458 HKD 9,184 USD 49,420 EUR 1,177 NTD 500 JPY 227,997 (XIII) Inventories Inventories of the Group decreased from approximately RMB612.4 million as at 31 December 2025 to approximately RMB612.0 million as at 30 June 2026, mainly due to further improvement in inventory management.
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51 (XIV) Trade and notes receivables As of 30 June 2026 and 31 December 2025, trade and notes receivables from customer contracts were approximately RMB1,700.0 million and RMB1,815.9 million, respectively. There were no changes in accounting estimates or material assumptions made in the provision of the expected credit losses of trade and notes receivables in both periods. The following table sets forth the ageing analysis of the trade receivables as at the end of each reporting period, based on the invoice date and net of loss allowance: 30 June 2026 31 December 2025 RMB’000 RMB’000 Within 3 months 1,691,640 1,815,602 3 to 6 months 333 255 Total 1,691,973 1,815,857 (XV) Interest-bearing bank and other borrowings As of 30 June 2026, borrowings from bank and other institutions (exclusive of lease liabilities) of the Group were approximately RMB3,797.2 million. The Group incurred new borrowings for the following reasons: ongoing clinical research trials and preclinical research for drug candidates, selling expenses of commercialisation of products, plant construction and normal operating expenses. The borrowings of the Group were denominated in RMB. Such borrowings bear interest at fixed annual and floating interest rates. There is no significant seasonal impact on the Group ’s borrowing requirements. (XVI) Maturity structure of outstanding debts The following table sets forth the maturity structure of outstanding debts as at 30 June 2026 and 31 December 2025, of which lease liabilities were recognised in accordance with IFRS 16 Leases . 30 June 2026 31 December 2025 RMB’000 RMB’000 Within one year 2,266,834 2,246,628 In the second year 963,397 481,516 In the third to fifth year (inclusive) 718,523 850,100 Over five years – 18,780 Total 3,948,754 3,597,024
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52 (XVII) Collateral and pledged assets As of 30 June 2026, the Group ’s pledged assets in relation to borrowings included property, plant and equipment of approximately RMB1,148.3 million and right-of-use assets of approximately RMB182.0 million. (XVIII) Key financial ratios 30 June 2026 31 December 2025 Current ratio (1): 77.5% 70.6% Quick ratio (2): 64.5% 58.2% Gearing ratio (3): 40.8% 43.2% Notes: (1) Current ratio is calculated as current assets divided by current liabilities. (2) Quick ratio is calculated as current assets minus inventories and then divided by current liabilities. (3) Gearing ratio is calculated as net debt divided by equity attributable to owners of the parent plus net debt, multiplied by 100%. Net debt represents the balance of indebtedness less non-restricted cash and bank balances as at the end of the period. (XIX) Material investment In order to satisfy the expected market demand for drug candidates, the Group is currently constructing a new manufacturing facility in Shanghai, the Songjiang Second Plant, to significantly increase our overall production capacity. We designed the Songjiang Second Plant to incorporate substantially similar manufacturing equipment, technologies and processes as those being used and to be implemented at our Xuhui Facility. This project is expected to become the monoclonal antibody biological drug R&D, pilot test and production base of the Group when completed, which is conducive to further strengthening the Group ’s R&D capabilities in the field of biomedicine (especially monoclonal antibody biomedicine) and meeting the global commercial production needs of the Group ’s biosimilar and bio- innovative products. The Company is expected to invest not more than RMB2.54 billion for the construction of the Phase I project of the Songjiang Second Plant (first stage, second stage and third stage). As at the end of the Reporting Period, the facility is under construction and the subsequent stages of construction will be gradually carried out based on the strategy of the Group. The capital expenditure of the construction of the Songjiang Second Plant will be mainly funded through debt financing. Save as disclosed in this announcement, as of 30 June 2026, the Group did not make other material investments.
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53 (XX) Capital commitments and capital expenditures The following table sets forth the Group ’s capital expenditures during each of the Reporting Period: 30 June 2026 31 December 2025 RMB’000 RMB’000 Construction in progress 50,093 115,482 Leasehold improvements 1,740 976 Total 51,833 116,458 We had capital commitments for plant and machinery contracted but not provided for of approximately RMB83.8 million as of 30 June 2026. These capital commitments primarily relate to expenditures expected to be incurred for the purchase of machinery, renovation of our existing laboratories and buildings and the R&D expenditure to be capitalised. (XXI) Contingent liabilities As of 30 June 2026, the Group did not have any material contingent liabilities. (XXII) Material acquisitions and disposals As of 30 June 2026, the Group did not have any material acquisitions and disposals. (XXIII) Interim dividends The Company did not pay or declare any dividend for the Reporting Period. IV. RISK MANAGEMENT (I) Foreign exchange risk As at 30 June 2026, the Group was principally engaged in business in the PRC, in which most of the transactions were settled in RMB with no significant foreign exchange risk. No financial instrument for hedging foreign exchange risk or other hedging purposes was employed. (II) Exchange rate risk Currently, the major business operations of the Group are in the PRC and most of the revenue and expenses are settled in RMB, which is the Group ’s reporting currency. With the acceleration of the Group ’s development in overseas markets, it is expected that the sales revenue and licensing revenue denominated in USD and EUR will increase in the future. Fluctuations in exchange rates may affect the Group ’s cash flows, revenues, earnings and financial position.
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54 (III) Potential risks 1. Market Risk The biologics market is highly competitive, and the Group ’s existing commercialised products and products that may be commercialised in the future face competition from pharmaceutical companies around the world in respect of various factors such as indication treatment, drug novelty, drug quality and reputation, breadth of drug portfolio, manufacturing and distribution capacity, drug price, breadth and depth of customer coverage, consumer behaviour and supply chain relationships. The Group ’s ability to remain competitive depends to a large extent on our ability to innovate, develop and promote new products and technologies that meet market needs in a timely manner to capture market share. Meanwhile, after the advancement and implementation of the relevant centralised procurement policies in the PRC, the resulting impact on the Group’s relevant products is uncertain. The Group will continue to track the subsequent policy developments and the impact on the Group. 2. Business and Operational Risk The global situation is ever-changing and the global biologics market is also constantly evolving, and the Group invests significant amounts of human and capital resources in R&D, to develop, enhance or acquire technologies that will allow the Group to expand the scope of the business and improve the quality of the products and services. Currently, the Group has independently developed products and successfully made them available on the market as follows: HANSIZHUANG, HANLIKANG, HANQUYOU, HANDAYUAN, HANBEITAI, BILDYOS ®eBILPREVDA ® and HANBEIYOU. Most of the Group ’s drug candidates are still under development and are in the clinical development stages, and the course of clinical development involves a lengthy and expensive process with uncertainties in various aspects, as there can be no assurance from the Group for the development and clinical results. Furthermore, if the clinical development and regulatory approval process of the drug candidates is delayed or terminated, the successful development and commercialisation of the Group ’s drug candidates in a timely manner may be adversely affected. 3. Force Majeure Risk and Other Uncontrollable Risks Our business, financial condition and results of operations may be materially and adversely affected by natural disasters or other unanticipated catastrophic events such as earthquakes, fires, terrorist attacks and wars as well as external environmental factors beyond the Group ’s control, such as the dynamic evolution of the geopolitical and economic landscape. For example, the ability of our facilities to operate may be impaired, our equipment may be damaged, the development timeline or the regulatory filing and approval schedules of our drug candidates may be prolonged and even lead to a decrease in the demand for our products. The occurrence of any such event could adversely affect our business and financial condition.
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55 V. EMPLOYEES AND REMUNERATION POLICIES The following table sets forth the breakdown of our employees by function as at 30 June 2026: Function Number of employees R&D and technology 1,074 Manufacturing 1,009 Commercial Operation 1,724 General and administrative 275 Total 4,082 The individual employment contracts entered into by the Group with our employees set out terms such as salaries, bonuses, grounds for termination and confidentiality. Employment contracts with our R&D personnel also typically contain a non-competition agreement. The Group also provides benefits to our employees as part of their compensation package which we believe are in line with industry norms. For example, PRC-based employees are entitled to employee benefits as mandated by the PRC Social Insurance Law and Regulations on the Administration of Housing Provident Fund, including pension, basic medical insurance, maternity insurance, work-related injury insurance, unemployment insurance and housing provident fund. To stay competitive in the market for talents, the Group has also adopted share award schemes (i.e. Share Option Scheme and the RSU Scheme), to give incentives to our employees. The Group emphasizes on-the-job training as a constant and ongoing objective for the employees. All employees participate in formal training on an annual basis, where the Group focuses on the latest technical developments and updates in regulatory requirements.
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56 EVENTS AFTER THE REPORTING PERIOD On 17 July 2026, the Board resolved to make the Grants of a total of 4,130,000 Options to 27 Participants pursuant to the Share Option Scheme and a total of 230,000 RSUs to 11 Participants pursuant to the RSU Scheme, respectively. Please refer to the announcement of the Company dated 17 July 2026 for details. Except for those disclosed in this announcement, no major subsequent events have occurred since the end of the Reporting Period and up to the date of this announcement. CHANGE OF ADDRESS OF PRINCIPAL PLACE OF BUSINESS IN HONG KONG The board of directors of the Company hereby announces that with effect from 21 August 2026, the address of the principal place of business in Hong Kong of the Company will be changed to Room 1917, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong. PURCHASE, SALE AND REDEMPTION OF LISTED SECURITIES During the Reporting Period, neither the Company nor any of its subsidiaries have purchased, sold or redeemed any of the Company ’s listed securities (including the sale of treasury shares (as defined under the Listing Rules)). During the Reporting Period and as of the Latest Practicable Date, the Company did not hold any treasury shares as defined under the Listing Rules. INTERIM DIVIDEND The Board does not recommend the distribution of any interim dividend for the Reporting Period. COMPLIANCE WITH CORPORATE GOVERNANCE CODE The Company ’s corporate governance practices are based on the principles and code provisions set forth in the Corporate Governance Code (the “CG Code ”) contained in Appendix C1 to the Listing Rules. During the Reporting Period, the Company has complied with all principles and code provisions as set out in the CG Code.
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57 COMPLIANCE WITH CODE FOR SECURITIES TRANSACTIONS The Company has adopted the Model Code for Securities Transactions by Directors of Listed Issuers (the “Model Code ”) as set out in Appendix C3 to the Listing Rules as its code of conduct regarding directors ’ securities transactions. Having made specific enquiries to all of the directors of the Company, all directors of the Company confirmed that they have fully complied with all relevant requirements set out in the Model Code during the Reporting Period. Changes to Business Funds Management Rules Reference is made to the Company ’s announcement dated 20 December 2023 in relation to, among others, the Company amended the Business Funds Management Rules to specify the provision of prohibiting investments in stocks, bonds, funds and real estate. Taking into account the evolving global biopharmaceutical industry landscape in recent years as well as the development status and established internal control capabilities of the Company, further amendments to the Business Funds Management Rules of the Company have been approved by the Board, and the amended rules will allow the Company to make investments in shares and convertible bonds of companies in the biotechnology and pharmaceutical sectors, subject to compliance with the Listing Rules and applicable laws and regulations as well as the internal control policies in connection with investment business established accordingly by the Company. Such amendments afford the Company the flexibility to seize prospective investment opportunities, support the Company ’s long-term growth objectives and seeking to generate favorable returns for the Company ’s shareholders. As at the date of this announcement, the Company does not have a specific investment target and has not entered into any agreement, arrangement, understanding or undertaking in respect of any proposed investment. The Company will make further announcement(s) in accordance with the Listing Rules and the applicable laws and regulations as and when appropriate in connection with the above matters. REVIEW OF INTERIM RESULTS BY THE AUDIT COMMITTEE The Group ’s interim results for the six months ended 30 June 2026 have been reviewed by the audit committee of the Company.
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58 INTERIM CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS For the six months ended 30 June 2026 2026 2025 (Unaudited) (Unaudited) Notes RMB’000 RMB’000 REVENUE 3 3,588,228 2,819,540 Cost of sales (820,040) (620,359) Gross profit 2,768,188 2,199,181 Other income and gains 4 53,347 20,126 Selling and distribution expenses (1,190,431) (987,798) Research and development expenses (826,015) (585,466) Administrative expenses (247,768) (185,408) Reversal of/(Provision for) impairment losses on financial assets, net 5,401 (3,002) Other expenses (13,056) (9,562) Finance costs 6 (51,849) (54,337) PROFIT BEFORE TAX 5 497,817 393,734 Income tax expense 7 (67,381) (3,607) PROFIT FOR THE PERIOD 430,436 390,127 EARNINGS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT Basic for profit for the period (RMB) 9 0.79 0.72 Diluted for profit for the period (RMB) 9 0.79 0.72
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59 INTERIM CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME For the six months ended 30 June 2026 2026 2025 (Unaudited) (Unaudited) RMB’000 RMB’000 PROFIT FOR THE PERIOD 430,436 390,127 OTHER COMPREHENSIVE (LOSS)/INCOME Other comprehensive (loss)/income that may be reclassified to profit or loss in subsequent periods: Exchange differences: Exchange differences on translation of foreign operations (5,009) 2,698 OTHER COMPREHENSIVE (LOSS)/INCOME FOR THE PERIOD, NET OF TAX (5,009) 2,698 TOTAL COMPREHENSIVE INCOME FOR THE PERIOD 425,427 392,825
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60 INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION 30 June 2026 30 June 2026 31 December 2025 (Unaudited) (Audited) Notes RMB’000 RMB’000 NON-CURRENT ASSETS Property, plant and equipment 2,215,050 2,261,918 Intangible assets 6,698,136 6,162,288 Right-of-use assets 311,499 319,528 Other non-current assets 135,846 59,811 Deferred tax assets 92,529 71,516 Total non-current assets 9,453,060 8,875,061 CURRENT ASSETS Inventories 612,014 612,412 Trade and notes receivables 10 1,699,687 1,815,857 Contract assets 36,656 17,408 Prepayments, deposits and other receivables 11 476,429 268,146 Cash and bank balances 818,383 772,209 Total current assets 3,643,169 3,486,032 CURRENT LIABILITIES Trade payables 12 763,426 831,012 Other payables and accruals 1,264,186 1,293,921 Tax payable 43,461 51,173 Contract liabilities 360,170 518,115 Interest-bearing bank and other borrowings 2,266,834 2,246,628 Total current liabilities 4,698,077 4,940,849 NET CURRENT LIABILITIES (1,054,908) (1,454,817) TOTAL ASSETS LESS CURRENT LIABILITIES 8,398,152 7,420,244
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61 30 June 2026 31 December 2025 (Unaudited) (Audited) RMB’000 RMB’000 NON-CURRENT LIABILITIES Interest-bearing bank and other borrowings 1,681,920 1,350,396 Other long-term payables 279,825 188,877 Contract liabilities 1,629,578 1,643,322 Deferred income 268,326 277,180 Total non-current liabilities 3,859,649 3,459,775 Net assets 4,538,503 3,960,469 EQUITY Share capital 545,207 543,495 Reserves 3,993,296 3,416,974 Total equity 4,538,503 3,960,469
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62 NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL INFORMATION 30 June 2026 1. BASIS OF PRESENTATION AND CHANGES TO THE GROUP ’S ACCOUNTING POLICIES 1.1 BASIS OF PREPARATION The interim condensed consolidated financial information for the six months ended 30 June 2026 has been prepared in accordance with IAS 34 Interim Financial Reporting . The interim condensed consolidated financial information does not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Group ’s annual consolidated financial statements for the year ended 31 December 2025. The Group had net current liabilities of RMB1,054,908,000 as at 30 June 2026. Having taken into account the unused banking facilities and the expected cash flows from operating, investing and financing activities, the directors of the Company consider that it is appropriate to prepare the financial information on a going concern basis. 1.2 CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES The accounting policies adopted in the preparation of the interim condensed consolidated financial information are consistent with those applied in the preparation of the Group ’s annual consolidated financial statements for the year ended 31 December 2025, except for the adoption of the following amended IFRS Accounting Standards for the first time for the current period ’s financial information. Amendments to IFRS 9 and IFRS 7 Amendments to the Classification and Measurement of Financial Instruments Amendments to IFRS 9 and IFRS 7 Contracts Referencing Nature-dependent Electricity Annual Improvements to IFRS Accounting Standards – Volume 11 Amendments to IFRS 1, IFRS 7, IFRS 9, IFRS 10 and IAS 7 The nature and impact of the amended IFRS Accounting Standards are described below: (a) Amendments to IFRS 9 and IFRS 7 Amendments to the Classification and Measurement of Financial Instruments clarify that a financial asset is derecognised when the entity ’s rights to the contractual cash flows expire or are transferred, while a financial liability is derecognised on the settlement date. The amendments introduce an accounting policy option to derecognise a financial liability that is settled through an electronic payment system before the settlement date if specified criteria are met. The amendments clarify how to assess the contractual cash flow characteristics of financial assets with environmental, social and governance and other similar contingent features. Moreover, the amendments clarify the requirements for classifying financial assets with non-recourse features and contractually linked instruments. The amendments also include additional disclosures for investments in equity instruments designated at fair value through other comprehensive income and financial instruments with contingent features. Since the Group ’s accounting policy for the derecognition of financial assets and liabilities in prior years aligned with the amendments and the Group did not have the financial assets that were addressed by the amendments, the amendments did not have any impact on the interim condensed consolidated financial information.
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63 (b) Amendments to IFRS 9 and IFRS 7 Contracts Referencing Nature-dependent Electricity clarify the application of the “own-use ” requirements for in-scope contracts and amend the designation requirements for a hedged item in a cash flow hedging relationship for in-scope contracts. The amendments also include additional disclosures that enable users of financial statements to understand the effects these contracts have on an entity ’s financial performance and future cash flows. As the Group did not have any contracts that are in the scope of the amendments, the amendments did not have any impact on the interim condensed consolidated financial information. (c) Annual Improvements to IFRS Accounting Standards – Volume 11 set out narrow scope amendments to IFRS 1, IFRS 7 (and the accompanying Guidance on implementing IFRS 7 ), IFRS 9, IFRS 10 and IAS 7. The amendments include clarifications, simplifications, corrections or changes to improve consistency in the corresponding IFRS Accounting Standards. The amendments did not have any impact on the interim condensed consolidated financial information. 2. OPERATING SEGMENT INFORMATION The Group is engaged in biopharmaceutical R&D, biopharmaceutical services and biopharmaceutical production and sales, which are regarded as a single reportable segment in a manner consistent with the way in which information is reported internally to the Group ’s senior management for purposes of resource allocation and performance assessment. Therefore, no analysis by operating segment is presented. Geographical information (a) Revenue from external customers For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Chinese mainland 2,904,356 2,627,840 Asia Pacific (excluding Chinese mainland) 472,733 28,037 North America 149,597 101,513 South America 2,403 16,327 Europe 59,139 45,475 Others – 348 Total 3,588,228 2,819,540 The geographical information above is based on the locations of customers. Seasonality of operations The Group ’s operations are not subject to seasonality.
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64 3. REVENUE An analysis of revenue is as follows: For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Revenue from contracts with customers 3,586,169 2,818,116 Revenue from other source Gross rental income 2,059 1,424 Total 3,588,228 2,819,540 Disaggregated revenue information for revenue from contracts with customers Types of goods or services Sales of biopharmaceutical products 2,885,800 2,556,783 Licensing revenue 528,260 74,441 Research and development services 167,409 185,418 Others 4,700 1,474 Total 3,586,169 2,818,116 Timing of revenue recognition Transferred at a point in time 3,389,674 2,619,814 Transferred over time 196,495 198,302 Total 3,586,169 2,818,116 4. OTHER INCOME AND GAINS An analysis of other income and gains is as follows: For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Government grants 45,653 10,615 Interest income 5,675 9,483 Others 2,019 28 Total 53,347 20,126
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65 5. PROFIT BEFORE TAX The Group ’s profit before tax is arrived at after charging/(crediting): For the six months ended 30 June 2026 2025 RMB’000 RMB’000 Note (Unaudited) (Unaudited) Cost of inventories sold 562,986 457,574 Cost of services provided 257,054 162,785 Depreciation of property, plant and equipment* 77,076 82,240 Depreciation of right-of-use assets* 42,160 36,594 Amortisation of intangible assets* 93,288 101,755 Research and development expenses: Current period expenditure 826,015 585,466 Foreign exchange losses, net 12,270 1,660 (Reversal)/write-down of inventories to net realisable value (5,398) 7,472 Bank interest income 4 (5,675) (9,483) Loss on disposal of items of property, plant and equipment 66 168 (Reversal of)/provision for impairment losses on trade receivables (4,748) 3,092 Reversal of impairment losses on other receivables (653) (89) Loss on disposal of intangible assets – 132 Gain on disposal of items of right-of-use assets – (41) Impairment of contract assets 4,816 – * The depreciation of property, plant and equipment, the depreciation of right-of-use assets and the amortisation of intangible assets are included in “Cost of sales ”, “Research and development expenses ”, “Selling and distribution expenses ” and “Administrative expenses ” in the condensed consolidated statement of profit or loss. 6. FINANCE COSTS An analysis of finance costs is as follows: For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Interest expense on bank and other borrowings 50,123 55,753 Interest expense on lease liabilities 4,220 5,117 Less: Interest capitalised (2,494) (6,533) Total 51,849 54,337
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66 7. INCOME TAX The provision for Chinese mainland current income tax is based on the statutory rate of 25% (six months ended 30 June 2025: 25%) of the assessable profits of the Group as determined in accordance with the PRC Corporate Income Tax Law which was approved and became effective on 1 January 2008, except for certain group entities in Chinese mainland, which are taxed at a preferential rate of 15%. Taxes on profits assessable elsewhere have been calculated at the tax rates prevailing in the jurisdictions in which the Group operates. For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Current 88,394 3,607 Deferred (21,013) – Total tax charge for the period 67,381 3,607 8. DIVIDENDS No dividend was paid or declared by the Company during the six months ended 30 June 2026 (six months ended 30 June 2025: Nil). 9. EARNINGS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT The calculation of the basic earnings per share amount is based on the profit for the period attributable to ordinary equity holders of the parent and the weighted average number of ordinary shares of 543,532,682 (six months ended 30 June 2025: 543,494,853) in issue during the period. The calculation of the diluted earnings per share amount is based on the profit for the period attributable to ordinary equity holders of the parent. The weighted average number of ordinary shares used in the calculation is the weighted average number of ordinary shares in issue during the period and the weighted average number of conversion of all dilutive potential ordinary shares into ordinary shares.
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67 The calculations of basic and diluted earnings per share are based on: For the six months ended 30 June 2026 2025 RMB’000 RMB’000 (Unaudited) (Unaudited) Earnings Profit attributable to ordinary equity holders of the parent used in the basic earnings per share calculation 430,436 390,127 Number of shares For the six months ended 30 June 2026 2025 (Unaudited) (Unaudited) Shares Weighted average number of ordinary shares outstanding during the period used in the basic earnings per share calculation 543,532,682 543,494,853 Effect of dilution – weighted average number of ordinary shares: – Share award scheme 3,615,276 – – Share option scheme 488,574 – Weighted average number of ordinary shares outstanding during the period used in the diluted earnings per share calculation 547,636,532 543,494,853 10. TRADE AND NOTES RECEIVABLES 30 June 2026 31 December 2025 RMB’000 RMB’000 (Unaudited) (Audited) Trade receivables 1,707,479 1,836,111 Notes receivable 7,714 – 1,715,193 1,836,111 Less: Impairment (15,506) (20,254) Net carrying amount 1,699,687 1,815,857 An ageing analysis of the trade receivables as at the end of the Reporting Period, based on the invoice date and net of loss allowance, is as follows: 30 June 2026 31 December 2025 RMB’000 RMB’000 (Unaudited) (Audited) Within 3 months 1,691,640 1,815,602 3 to 6 months 333 255 Total 1,691,973 1,815,857
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68 11. PREPAYMENTS, DEPOSITS AND OTHER RECEIVABLES 30 June 2026 31 December 2025 Note RMB’000 RMB’000 (Unaudited) (Audited) Prepayments 281,306 181,269 Value added tax to be deducted and certified 57,481 15,841 Deposits and other receivables 137,642 71,036 Due from AMTD (i) 451,978 466,438 928,407 734,584 Less: Impairment (i) (451,978) (466,438) Total 476,429 268,146 Note: (i) On 25 September 2019, the Company entered into an investment management agreement (the “IMA”) with AMTD Global Markets Limited ( “AMTD”, now renamed as oOo Securities (HK) Group Limited). Pursuant to the IMA, the Company deposited a total principal amount of USD117,000,000 into its investment portfolio account with AMTD (the “AMTD Account ”) and engaged AMTD to provide investment management services. The Company recovered in total of USD30,640,000 from AMTD during the years ended 31 December 2020, 2021 and 2022. During the year ended 31 December 2023, the Company further recovered an amount of USD20,000,000 from AMTD. As at 30 June 2026 and 31 December 2025, the outstanding balances of the investment principal in AMTD Account amounted to USD66,360,000 (equivalent to RMB451,978,000 and RMB466,438,000 respectively). Based on the analysis by the Company ’s management and with the assistance of the Company ’s external legal counsel, it is clarified that when the IMA was terminated on 25 September 2021, and the Company had the legal rights to recover all the outstanding investment amounts from AMTD. Therefore, the outstanding investment amount with AMTD is accounted for as an amount due from AMTD. Since the year of 2023, the Company has taken legal actions to recover the outstanding investment amount from AMTD. The Company assessed the expected credit losses based on all the facts and available information, including historical correspondence with AMTD and relevant analysis from the external legal counsel of the Company, etc. Impairment of the amount due from AMTD amounting to USD66,360,000 was provided for the amount due from AMTD as at 30 June 2026 and 31 December 2025. The deposits and other receivables included in the above balances relate to receivables for which there was no recent history of default and past due amounts. As at 30 June 2026 and 31 December 2025, the loss allowance was assessed to be minimal.
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69 12. TRADE PAYABLES An ageing analysis of the trade payables, as at the end of the reporting period, based on the invoice date, is as follows: 30 June 2026 31 December 2025 RMB’000 RMB’000 (Unaudited) (Audited) Within 1 year 730,394 791,462 1 to 2 years 5,519 38,291 2 to 3 years 27,360 1,259 Over 3 years 153 – Total 763,426 831,012 13. EVENTS AFTER THE REPORTING PERIOD On 17 July 2026, the board of directors resolved to grant a total of 4,130,000 options and 230,000 restricted share units, respectively, to certain participants of the Group under the 2025 H share option scheme and the 2025 H share restricted share units scheme. PUBLICATION OF INTERIM RESULTS AND INTERIM REPORT This announcement is published on the website of the Hong Kong Stock Exchange at www.hkexnews.hk and on the website of the Company at www.henlius.com. The 2026 Interim Report containing all the information required by the Listing Rules will be published on the websites of the Company and the Hong Kong Stock Exchange in due course. APPRECIATION The Group would like to express its appreciation to all the staff for their outstanding contribution towards the Group ’s development. The Board wishes to sincerely thank the management for their dedication and diligence, which are the key factors for the Group to continue its success in future. Also, the Group wishes to extend its gratitude for the continued support from its shareholders, customers, and business partners. The Group will continue to deliver sustainable business development, so as to create more value for all its shareholders. On behalf of the Board Shanghai Henlius Biotech, Inc. Wenjie Zhang Chairman Hong Kong, 21 August 2026 As at the date of this announcement, the Board of Directors of the Company comprises Mr. Wenjie Zhang as the chairman and non-executive director, Dr. Jun Zhu as the executive director, Mr. Qiyu Chen, Mr. Yuqing Chen, Ms. Xiaohui Guan, Dr. Yi Liu and Dr. Xingli Wang as the non-executive directors, and Mr. Tak Young So, Dr. Lik Yuen Chan, Dr. Ruilin Song and Mr. Yihao Zhang as the independent non-executive directors.