Slides
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2025.8
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2 Disclaimer This presentation has been delivered to interested parties for information purposes only and upon the express understanding that such parties will use it only for the purposes set forth above, and it is not intended to form the basis of any investment decision or any decision to purchase securities of Akeso, Inc. (the “Company”). This presentation does not constitute or contain an offer or invitation to sell, or any solicitation of any offer to subscribe for or purchase any securities in any jurisdiction in which the making of such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction or would not otherwise be in compliance with the laws and regulations of such jurisdiction, and neither this presentation nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. 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Business Highlights
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5 5 Leading Global IO 2.0 through Innovation and Clinical Advancement IO 2.0+ADC 2.0 strategic synergies 13 Phase III/registrational trials of ivonescimab covering lung cancer and expanding to cold tumors • The final analysis of HARMONI-A OS showed that ivonescimab achieved clinical endpoints and clinically meaningful and statistically significant OS benefits • Global Phase III MRCT Harmoni trial Global clinical data are highly consistent with Chinese clinical data • Newly approved 1L lung cancer indication, sNDA of 1L sq-NSCLC accepted by the CDE Autoimmune innovation enters a new stage of commercialization 10 phase III clinical studies of cadonilimab across lung cancer, gastric cancer, liver cancer and cervical cancer • Newly approved 1L cervical cancer indication • Initiated a global multicenter registrational clinical study: IO resistant HCC • Included in more than 20 clinical treatment guidelines and consensus Penpulimab receives FDA approval in the United States Ligufalimab (CD47) is conducting trials in both solid tumors and hematological malignancies Pulocimab (VEGFR-2) is targeting various IO- resistant indications
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6 6 • Commercial sales revenue in 2025H1 reached 1.402 billion, a year-on-year increase of 49% • 2 core bispecific antibodies included in the NRDL, on goal towards 2000 hospitals by year end. Achieved dual-channel / access in ~85% of hospitals • New Commercial Launch in 2 metabolic and autoimmune therapeutics • Two drivers of growth: commercial improvements in the Oncology Division and the Non-Oncology Division, with over 1,200 sales staff • Improving patient access through active participation in national medical insurance programs and expanding coverage by commercial insurance programs Achieving the core strategic goal of commercialization and beginning new journey Strong Financial Performance • 1H 2025 Revenue 1.412 billion, a 33.7% growth from 1H in 2024 • Cash and short-term financial assets of approximately 7.14 billion • Continued improvement in Sales and Marketing Efficiency, with S&M expense as a percentage of sales decreased; R&D and administration expense as a percentage of sales decreased
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7 2025 H1 Akeso’s New Drug Approval and Commercialization Milestones 2 Cadonilimab (PD-1/CTLA-4) • 1L Cervical cancer New Drug Marketing Authorization applications approved 2 new Supplemental Indication Applications ( sNDA ) for Marketed Drugs approved by CDE Ivonescimab (PD-1/VEGF) • 1L locally advanced squamous NSCLC • 1L advanced nasopharyngeal carcinoma • 2L nasopharyngeal carcinoma Penpulimab (PD-1) • Moderate to severe psoriasis Ebdarokimab (IL-12/IL-23) 3sNDA applications under review • Moderate to severe psoriasis Gumokimab (IL-17) 4 Commercialized products Ivonescimab ( PD-1/VEGF ) Cadonilimab (PD-1/CTLA-4) Ivonescimab ( PD-1/VEGF ) • 1L PD-L1(+) non-small cell lung cancer US FDA approval • 1L liver cancer Penpulimab (PD-1) Ebdarokimab (IL-12/IL-23) Ebronucimab ( PCSK9) China NMPA approval First in the World to beat pembro, and the world's best therapy for NSCLC The only approved IO drug for 1L cervical cancer for all patient types
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8 2025 H1 Highlights of Akeso’s Pipeline Clinical Development Milestones AK138D1 (HER3 ADC) 9 Newly initiated Phase III / registrational trials 3 Blockbuster new drug candidates entered clinical stage 4 Products Ivonescimab • 1L CRC • 1L PD-L1(-) TNBC • 2L NSCLC (PD-(L)1 resistant) • Post CCRT LS-SCLC consolidation therapy • 1L PDAC Cadonilimab • CCRT/SCRT progressed NSCLC • Perioperative G/GEJ • 2L IO-resistant HCC( global ) • Atopic dermatitis in adolescents Manfidokimab (IL-4Rα) AK146D1 (TROP-2/ Nectin-4 ADC) The world's first TROP2/Nectin-4 bispecific antibody ADC Ivonescimab + Ligufalimab (CD47) AK139 (IL4 R/ST2 ) The world's first IL4R/ST2 autoimmune bispecific antibody 6 Phase III clinical trial reached the primary endpoint • ankylosing spondylitis Gumokimab (IL-17) • Moderate to severe atopic dermatitis Manfidokimab (IL-4Rα) Ivonescimab • 1L advanced sq-NSCLC • 1L PD-(L)1 + NSCLC • EGFR-TKI progressed NSCLC (China) • 3rd gen. EGFR-TKI resistant NSCLC ( global ) First global Phase III results readout First Phase III OS readout - clinically meaningful and statistically significant OS benefits A new generation differentiated ADC
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9 Two Cornerstone I/O Bispecific Drives Sustainable Competitive Advantage in R&D strategy Consolidating IO 2.0's leading position Leveraging two commercial bispecific, Exploring combinations with ICIs, ADCs, mRNA, TME, other platforms IO2.0+ADC 2.0 Advancing through both internal and external collaborations ADC 2.0 platform advancement Combination with external drugs Combination with self-developed drugs In-house ADC and bispecific ADC entered global Phase I through combo with Cadonilimab and Ivonescimab Explore combo use with leading ADC around the world ADC 2.0 Platform (bispecific ADC, dual payload, blood stability) Multiple targets + + + Trispecific antibody Explore new mechanisms Key Innovator in Global Rx Trends Accelerate development of new therapeutic platform New MOA
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10 Next Stage in Commercialization : 2 Bispecific Antibodies Entered NRDL, and 2 Non-oncology Launched Commercially (PD-1/CTLA-4) (PD-1/VEGF) Commercial Team Upgrade to Systematic Organization, Professional Sales Force to Drive Access Across Diversified Healthcare Provider ( IL-12/IL-23 ) Aidaluo® ( PCSK9 ) Yixining® Commercial team: 1,200+ commercial sales team, covering oncology and non-oncology medicine Systematic operations: business units separation, market segmentation, professional management, and effective resource allocation Broad access and coverage: Both bispecific have achieved coverage in over 2,000 hospitals , with ~85% access in hospital / dual-channel Active preparation for next year's NRDL, including: Oncology: Three 1L indications for two bispecific antibodies Cadonilimab cervical cancer, Cadonilimab gastric cancer, Ivonescimab PD-L1 positive non-small cell lung cancer Non-oncology: Ebdarokimab for moderate to severe psoriasis, Ebronucimab for hypercholesterolemia Simultaneously promote access to local commercial insurance (“Hui Min Bao”) ”Patient care as core priority ”, with focus on "academic promotion" Drive business and market share growth through evidence-based clinical data Global value proposition through therapeutic innovation and broad clinical benefits The company's commercial sales revenue RMB 1.402 billion in the first half of 2025, an increase of 49% from 1H 2024 Systematic Sales Organization Diversified access Specialized market
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11 Cervical cancer: 1L treatment received Category 1 recommendation from multiple authoritative guidelines ; 2L+ immune checkpoint inhibitors received the highest level recommendation • Chinese Medical Association Guidelines for the Clinical Application of Immune Checkpoint Inhibitors in Gynecological Tumors ( 2025 Edition ): CC 1L is the only Category 1 recommendation; CC 2L+ Category 2A recommendation • CSCO Guidelines for the Clinical Application of Immune Checkpoint Inhibitors ( 2025 Edition): CC 1L Class I recommendation; CC 2L+ Class 2A recommendation • CACA Brachytherapy Committee Guidelines for the Diagnosis and Treatment of Recurrent and Metastatic Cervical Cancer ( 2025 Edition ): CC 1L is the only category 1 recommendation regardless of PD-L1 expression status ; CC 2L+ is a category 2A recommendation The highest level of recommendation for 1L Gastric cancer, regardless of PD-L1 expression • CSCO Gastric Cancer Diagnosis and Treatment Guidelines ( 2025 Edition) regardless of PD-L1 expression Catogory I recommendation • CSCO Guidelines for the Clinical Application of Immune Checkpoint Inhibitors ( 2025 Edition) regardless of PD-L1 expression Catogory I recommendation • CACA Chinese Guidelines for Integrated Diagnosis and Treatment of Oncology - Gastric Cancer ( 2025 Edition), regardless of PD-L1 expression, priority recommended Continued recommendation for other therapeutic areas • The Chinese Medical Association's Guidelines for the Clinical Application of Immune Checkpoint Inhibitors in Gynecological Tumors ( 2025 Edition) recommends Cadonilimab for the initial treatment • CACA Guidelines for Integrated Diagnosis and Treatment of Tumors in China – Nasopharyngeal Carcinoma ( 2025 Edition) • Chinese Expert Consensus on Immune Checkpoint Inhibitors for Biliary Tract Malignancies ( 2025 Edition) • Chinese Expert Consensus on Transformative Treatment of Biliary Tract Malignancies ( 2025 Edition) • China CSCO Esophageal Cancer Diagnosis and Treatment Guidelines ( 2024 Edition) • China CSCO Nasopharyngeal Carcinoma Diagnosis and Treatment Guidelines (2024 Edition ) • Targeted immunotherapy combined with local treatment for advanced hepatocellular carcinoma Chinese Expert Consensus Included in more than 20 clinical treatment guidelines and consensus, covering gynecological cancer, gastric cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, biliary tract cancer Cadoinlimab has been recommended in more than 20 authoritative clinical treatment guidelines NRDL indications Approved indications 2L + cervical cancer 1L gastric cancer 1L Cervical cancer 2L + cervical cancer The only immune checkpoint inhibitor approved in China for the first- line indication of persistent, recurrent or metastatic cervical cancer • Widely covered and reimbursed by NRDL • Expanding adoption and access in 1L treatments • Active engagement with payers and private insurers
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12 Cadonilimab continues to expand clinical presence – higher incidence cancers, multi-line coverage, and combination therapies … Next Generation Cornerstone Immunotherapy broad-spectrum, high-efficacy, low-toxicity, and differentiated • Conducted 28+ clinical studies • Covering 20+ indications • Global clinical studies initiated... 10 Phase III / registration clinical trials ongoing, 3 Phase III reached clinical endpoints • More China and global clinical trials under preparation • Multiple combination therapy explorations are underway : including combination with self- developed / external ADCs , oncolytic viruses, targeted small molecules, and other novel platforms
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13 28+ clinical trials in progress, covering 20+ indications 10 Phase III / registrational clinical studies covering gastric cancer, lung cancer, liver cancer, and cervical cancer 2L+: Approved for marketing and included in NRDL COMPASSION-13 1L : Approved for marketing in May 2025 COMPASSION-16 (+ chemotherapy ± bevacizumab ) 1L : Approved for marketing in September 2024 COMPASSION-15 (+ chemotherapy ) 2L IO resistance: enrollment ongoing COMPLUS-5 (+ pulocimab + chemotherapy ) Perioperative treatment: Newly initiated COMPASSION-33 (+ chemotherapy ) 1L PD-L1(-) : enrollment ongoing COMPASSION-28 (+ chemotherapy vs PD-1+ chemotherapy ) Unresectable NSCLC after concurrent sequential chemoradiotherapy: enrollment ongoing COMPASSION-30 ( + chemotherapy vs PD-L1+ chemotherapy) 2L IO- resistant squamous NSCLC : Under preparation Postoperative adjuvant therapy: enrollment completed COMPASSION-22 Intermediate stage HCC: enrollment ongoing COMPASSION-29 (+ Lenvatinib +TACE) 2L IO resistance: Global registrational Phase II, newly initiated COMPASSION-36 (+ Lenvatinib ) Cervical cancer (new cases: ~110,000-130,000 / year) Gastric cancer (new cases: ~450,000-500,000 / year ) Lung cancer (new cases: ~ 1-1.1 million / year ) Liver cancer (new cases: ~ 400,000-450,000 / year) Epidemiological data source: Based on National Cancer Center database and Frost & Sullivan forecasts Cadonilimab continues to expand clinical presence – broader indications, all line coverage, and extensive combination
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14 Global First in Class Redefining Standard of Care NSCLC after EGFR-TKI Progression: Included in First Category Recommendation CSCO Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2025): Level I Recommendation CACA Guidelines for Integrative Diagnosis and Treatment of Tumors in China (2025) - Lung Cancer: Consensus Recommendation Chinese Guidelines for the Treatment of Stage IV Primary Lung Cancer (2024): Level I Recommendation Chinese Guidelines for the Standardized Application of Immunotherapy in Lung Cancer (2024): Class I Evidence Driver gene-negative 1L NSCLC: Newly Added to Guidelines CSCO Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2025): TPS ≥ 1%, Squamous & Non-Squamous Cell Carcinoma Level II recommendation CACA Guidelines for Integrative Diagnosis and Treatment of Tumors in China (2025) - Lung Cancer: Recommendation Biliary Tract Cancer: First Inclusion in Expert Consensus • Chinese Expert Consensus on Immune Checkpoint Inhibitors for Biliary Tract Malignancies (2025) • Chinese Expert Consensus on Transformative Treatment of Biliary Tract Malignancies (2025) 8 Authoritative Guidelines Recommendations, Covering Lung Cancer, Biliary Tract Cancer, Etc. Ivonescimab reshapes lung cancer treatment landscape, accelerating commercial adoption and NRDL access Included in NRDL NSCLC after EGFR- TKI-progression 1L PD-L1(+) NSCLC • Full market coverage for NRDL indication • Expanding access for first- line indication • Establish and improve insurance coverage and diversified payment systems Newly approved indication in 2025 H1 New indication submitted in 2025, under NDA review 1L locally advanced squamous NSCLC
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15 Ivonescimab can Upgrade Standard of Care Across Multiple Cancers, Leading IO 2.0 in China and the World 30+ clinical trials, 30*+ indications Next Generation Cornerstone Immunotherapy broad-spectrum, high-efficacy, low-toxicity, and differentiated Broaden & solidify leadership in lung cancer markets, expand benefit to multiple types of cancer , and upgrade current best-in-class or standard-of-care 13 phase III registrational trials ongoing, 4 achieved primary endpoints 6 head-to-head phase III trials vs. PD-(L)1 therapies • Additional Phase III Global and China trials ongoing • Combination studies* with ADCs, bispecific ADCs, small molecules, mRNA vaccines * Includes indications and studies from collaborations with external partners
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16 Ivonescimab Leadership in IO 2.0, Full Coverage of Global Lung Cancer Markets across Different Treatment Lines 8 phase III trials on lung cancer, 4 achieved positive results First phase III MRCT delivers positive results, showing high consistency in the data across global and Chinese studies 1L 1L PD-L1-positive / high-expression NSCLC 1L sqNSCLC + nsqNSCLC Harmoni-2/AK112-303 1L PD-L1 positive (TPS≥1%) NSCLC Ivonescimab vs pembrolizumab Approved in April 2025 Harmoni-6/AK112-306 1L locally advanced sqNSCLC Ivonescimab + chemo vs tislelizumab + chemo Positive PFS read-out in April 2025, sNDA in July 2025 Harmoni-7/AK112-3007 1L PD-L1 high (TPS≥50%) NSCLC Ivonescimab vs pembrolizumab Enrollment ongoing Harmoni-3/AK112-3003 1L metastatic sqNSCLC+nsqNSCLC Ivonescimab + chemo vs pembro + chemo Enrollment ongoing 2L Post EGFR-TKI progression (Chinese population: ~45%) Post PD-1/L1 resistance(est. new market > $ 19 billion) Harmoni-a/AK112-301 Ivonescimab + chemo vs chemo Approved, in NRDL, PFS & OS dual endpoints reached Harmoni-8a/AK112-305 sqNSCLC+nsqNSCLC Ivonescimab plus chemo vs chemo Enrollment ongoing NSCLC after 3rd-gen EGFR-TKI progression (US/EU population ~15%) Post cCRT Limited Stage-SCLC consolidation therapy Harmoni Ivonescimab plus chemo vs chemo Global and Chinese data highly consistent AK112-311 Post cCRT LS-SCLC consolidation therapy Ivonescimab vs. placebo Enrollment ongoing China Global China Global China China Global cCRT: concurrent chemoradiotherapy; SCLC: small cell lung cancer China
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17 Ivonescimab Expands into “Cold Tumors”, Broadening Benefit Across Multiple First Line Indications Broad indication layout, 5 phase III trials ongoing Epidemiological data source: Research Nester，Modor Intelligence, Global Market Insights，Data Bridge Market AK112-309/Harmoni-GI1 Ivonescimab + chemo vs. durvalumab + chemo Enrollment completed 1L biliary tract cancer (~ $5.7 billion market) AK117-302/Harmoni-HN1 Ivonescimab + ligufalimab vs Keytruda Enrollment ongoing 1L PD-L1(+) Head and Neck* (~ $3 billion market) AK112-308/Harmoni-BC1 Ivonescimab + chemo vs. chemo Enrollment ongoing 1L PD-L1(-) TNBC (~ $2 billion market) AK112-312/Harmoni-GI3 Ivonescimab + chemo vs bevacizumab + chemo Enrollment ongoing 1L colorectal cancer (~ $18 billion market) AK112-310/Harmoni-GI2 Ivonescimab + chemo ± ligufalimab vs chemo Enrollment ongoing 1L pancreatic cancer (~ $9 billion market) Phase III global/China clinical trials in preparation Additional tumor types HNSCC: head and neck squamous cell carcinoma
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18 Penpulimab Approved by US FDA for Two Indications: Key Milestone in International Development and Approval In April 2025, Penpulimab approved by US FDA for 1L nasopharyngeal carcinoma 2L+ nasopharyngeal carcinoma Akeso’s first self-developed innovative biologic approved by US FDA The First US FDA-approved innovative biologic fully independently led by a Chinese company throughout the entire process (R&D, clinical trials, manufacturing, supply, and regulatory filing) Global Phase III data published in April 2025 Approved indications 2L+ classical Hodgkin Lymphoma 1L squamous non- small cell lung cancer Newly approved in 2025 H1 Under NDA review 1L nasopharyngeal carcinoma 1L liver cancer 2L+ nasopharyngeal carcinoma 1L nasopharyngeal carcinoma 2L+ nasopharyngeal carcinoma US FDA approval
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19 Commercial Expansion into Non-Oncology Medicine: Ebdarokimab (IL-12/IL-23) Approved and Launched for Plaque Psoriasis 爱达罗 ® ( Ebdarokimab , IL - 12/IL - 23) China’s first and only self - developed innovative IL - 12/IL - 23 dual - target monoclonal antibody Approved in April 2025 Indication: Moderate to severe plaque psoriasis Strong & sustained long-term efficacy Quality of life improvement Excellent short-term efficacy Significant improvement after 2 doses Strong and durable efficacy Short-term and potent skin lesion cleareance Long-term high response Only four doses per year for safety and convenience Better outcomes in patients with comorbidities (cardiovascular, metabolic diseases) 6.7 million Chinese psoriasis patients USD 9.5bn Chinese market size* * Data source: Frost & Sullivan, 2017-2030 China Psoriasis Drug Market Ebdarokimab: AK101-302 Phase III (52-week) data published in 2024 EADV 1 – PHONEX 1
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20 Ebronucimab (PCSK9) Expands Non-Oncology Franchise Approved in Sept. 2024 Indications: • Primary hypercholesterolemia and mixed hyperlipidemia • Heterozygous familial hypercholesterolemia (HeFH) 伊喜宁 ® ( ebronucimab , PCSK9) The only mAb focus on ultra - high - risk cardiovascular populations High Rate in LDL-C reduction: > 90% Rapid Onset: Peak concentration reached in 2 days Potent Effect: 66% LDL-C Reduction at Week 12 Comprehensive Benefits: Significantly reduction in non-HDL-C, Lp(a), ApoB and TC levels Sustained Response: Long-term and stable reduction of LDL-C, with maximum reduction > 70% Key Benefits Guidelines / Expert Consensus Chinese Expert Consensus on Comprehensive Management of Lipid-Related Cardiovascular Risk (2025) County-level Guidelines for Rational Medication Use and Comprehensive Management of Dyslipidemia (2025) Benefit across all Patients: regardless of stratification (ultra-high, very high, high, or mediate-low risk), and regardless of LDL-C level or other indicators 110 million Chinese hypercholesterolemia patients USD1.34bn Chinese market value* * Data source: Frost & Sullivan, Estimated PCSK9 Chinese market in 2023 Ebronucimab AK102-301 Phase III data published in Pharmacological Research 2– LAPLACE-2, ODYSSEY
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21 Psoriasis NDA accepted by CDE in Jan 2025 Indication: • Moderate to severe plaque psoriasis Ankylosing Spondylitis • Primary and secondary efficacy endpoints reached, with clinically meaningful and statistically significant improvements • Plan to present data at an academic conference Phase III Positive Results Regulatory Filing Plan NDA planned in 2026 At W12 and W52, both PASI90 and PASI100 response rates outperform secukinumab Best-in-class efficacy Convenient dosing and durable efficacy Gumokimab (IL-17): NDA Under Review for Psoriasis, and Primary Endpoints Reached for Ankylosing Spondylitis 6.7 million Chinese psoriasis patients USD 9.5bn Chinese market value* * Data source: Frost & Sullivan, 2017-2030 China Psoriasis Drug Market ~4 million Chinese ankylosing spondylitis patients USD 90bn Chinese market value** ** Data source: Frost & Sullivan and epidemiological data, estimated market size in 2030
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Core R&D progress
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24 Cadonilimab Approved in First-Line Treatment of Cervical Cancer, Reshaping the Treatment Landscape COMPASSION-13 Cadonilimab monotherapy 2L+ Cervical cancer Phase II registrational clinical data published Approved by NMPA in June 2022 Included in NRDL in January 2025 • The world's first approved dual checkpoint inhibitor for cancer treatment • Filling the gap in IO drugs for advanced cervical cancer in China COMPASSION-16 Cadonilimab + chemotherapy ± bevacizumab 1L cervical cancer Phase III data published at New indication approved in May 2025 • The only approved IO drug for 1L CC in China • Significant efficacy across entire population, filling treatment gap for cervical cancer with low or negative PD-L1 expression PFS data cutoff : Sep 2023 OS data cutoff : April 2024 Data cutoff : August 2021 CR 35.6% vs 22.9%; ORR 82.9% vs 68.6% mPFS 13.3m vs 8.2m, HR 0.62 mOS NR vs 22.8m, HR 0.64 CR 13.4%, ORR 33%, mPFS 3.75m, mOS 17.5m
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25 Cadonilimab is Advancing for Lung Cancer, Targeting the PD-1 Market COMPASSION-28 Cadonilimab + chemotherapy 1L PD-L1(-) NSCLC Phase II/III clinical trial enrollment ongoing vs PD-1 + chemotherapy Continue the unique and differentiated treatment benefit in PD-L1 negative population IIT study data published at COMPASSION-30 Cadonilimab concurrent sequential chemoradiotherapy for NSCLC COMPLUS-6 Cadonilimab + Pulocimab IO-resistant squamous NSCLC Breakthrough Therapy Designation in April 2025 Cadonlimab + Pulocimab Phase II data will be published at Chemo-freeThe current standard of care has limited effect on improving overall survival, and there is still a huge unmet clinical need mPFS 7.1m , mOS 16.7m Data cutoff: January 2025Data cutoff: March 2025 Cadonilimab + chemotherapy 1L PD-L1(-) NSCLC (N=47) Cadonilimab + Pulocimab IO-resistant squamous NSCLC (N=26) Phase II/III clinical trial enrollment ongoing vs PD-L1 + chemotherapy ORR 66.0% (sq 87.0%/ nsq 45.8%) DCR 100% Cadonilimab + ivonescimab NSCLC Phase II data demonstrated Superior efficacy and safety profile Phase III trial in planning
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26 Cadonilimab Reshape 1L Treatment of Gastric Cancer and has Broad Coverage of Gastric Cancer with Multiple Indications COMPASSION-15 Cadonilimab + chemotherapy 1L G/GEJ adenocarcinoma Bringing a new and effective treatment option to all patients, addressing the huge unmet clinical needs of patients with low or negative PD-L1 expression COMPLUS-5 Cadonilimab+ Pulocimab + chemo IO-resistant G/GEJ adenocarcinoma Significant market potential for entire population of patients with resectable gastric cancer COMPASSION-33 Cadonilimab + chemo perioperative G/GEJ adenocarcinoma Significant clinical unmet need Expected to become the best solution to overcome IO resistance in gastric cancer Phase II data will be presented at an upcoming academic conference Approved in September 2024 Phase III clinical trial enrollment ongoing Phase III clinical trial enrollment ongoing COMPASSION-15 Cadonilimab + chemotherapy 1L G/GEJ adenocarcinoma ITT mPFS 7.0m vs 5.3m, HR 0.53 mOS 15.0 vs 10.8m, HR 0.62 CPS<5 PFS HR 0.6 vs 0.93(1)/0.83(2)/ 0.82(3) OS HR 0.7 vs 0.94(1) /0.85(2) / 0.89(3) CPS<1 PFS HR 0.6 vs 0.93(1) /0.9(2) / 0.8(3) OS HR 0.84 vs 0.92(1)/0.92(2)/1.01(3) Phase III data published at COMPLUS-5 Cadonilimab+Pulocimab+chemo IO-resistant G/GEJ adenocarcinoma Note: 1- Checkmate-649, 2-Keynote-859, 3-Rationale-305 Note: 1. RAINBOW, Paclitaxel ORR 48%/ 16%(1) , DCR 96%/ 64%(1) mPFS 6.8m/ 2.9m(1) , mOS 13.0m/ 7.4m(1) Phase II data published at Update data cutoff: Feb 2025Data cutoff: April 2023
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27 Advancing Three Registrational Trials of Cadonilimab for Liver Cancer Initiating First Global Registrational Study COMPASSION-22 Cadonilimab HCC postoperative adjuvant therapy Phase III clinical trial enrollment has been completed Data cut-off: February 2023, median follow-up: 27.4 months 6mg/kg Q2W: mPFS 8.61m, mOS 27.1m 15mg/kg Q3W: mPFS 9.82m, mOS NR COMPASSION-29 Cadonilimab + Lenvatinib + TACE Intermediate-stage HCC Phase III clinical trial enrollment ongoing 6-month recurrence-free survival rate ~75.6% 9-month recurrence-free survival rate ~60.4% Data cutoff: August 2023 COMPASSION-36 Cadonilimab + Lenvatinib IO- resistant HCC Approved by US FDA to start the global multi- center registrational trial Expanding global clinical and commercial value Addressing high heterogeneity of liver cancer, angiogenesis and liver function damage caused by liver cancer embolization Potential to effectively control tumor progression and bring durable survival benefits Currently, no IO drug is approved in this indication globally, demonstrating significant unmet clinical need Cadonilimab + Lenvatinib 1L HCC Cadonilimab + Lenvatinib + TACE Intermediate-stage HCC Phase II data published at Phase II data published at
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28 AK112-301 / HARMONi-A: Ivonescimab+ chemotherapy EGFR-TKI resistant NSCLC mPFS 7.1m vs 4.8m , HR 0.46 Subgroup with prior use of third- generation TKI PFS HR: 0.48 Data cutoff: March 2023 Significant PFS benefit Significant OS benefit • Final OS analysis showed ivonescimab reached clinical endpoint, demonstrating clinical benefit and statistical OS benefit Data cutoff: July, 2025 Ivonescimab‘s First Global Phase III Trial Received Positive Results Consistency Across Global Data to be Released at WCLC 2025 HARMONi: Ivonescimab + chemotherapy 3rd Gen EGFR-TKI resistant NSCLC PFS HR 0.52 (P < 0.0001) Statistically significant, significant clinical benefit Global data consistency • Harmoni and Harmoni-A results are consistent , demonstrating the consistent clinical efficacy of Ivonescimab across regions and ethnic groups • ~38% of patients were from Europe and USA, consistent with the patient distribution of previous similar global Phase III studies. PFS Dual significance OS Benefit Trend OS HR 0.79 Clear trend of OS benefit Data announcement date: May 30, 2025 The first indication approved in May 2024 Successful inclusion in NRDL in 2025 Data will be presented at the Plenary Chair's Symposium and officially released as an oral report
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29 AK112-303 / HARMONi-2 : Ivonescimab monotherapy vs. Pembrolizumab monotherapy 1L PD-L1(+) NSCLC • Squamous 0.48 , Non-squamous 0.54 • With / without liver metastasis 0.47 / 0.53 • With / without brain metastasis 0.55 / 0.53 • PD-L1 TPS 1-49% 0.54 • PD-L1 TPS ≥ 50% 0.46 The primary clinical endpoint of PFS showed statistically significant and substantial clinical benefit PFS HR 0.51, Ivonescimab group mPFS 11.14m compared to the Pembrolizumab group 5.82m, significant improved PFS for 5.3m Good overall safety profile, with no new safety signals PFS subgroups All showed positive results Good safety Ushering the Era of Global IO 2.0 - Ivonescimab Approved for First-Line Monotherapy of PD-L1 Positive NSCLC Data cutoff: January 29, 2024 PFS HR Ivonescimab vs. Keytruda 1L PD-L1 TPS ≥ 50% NSCLC Global Phase III enrollment ongoing Significant clinical benefit OS analysis results at (39% event maturity): OS HR 0.777 Indication approved in April 2025 Entering 1L treatment of lung cancer, providing patients with a better chemo-free treatment AK112-3007 Data release time: 2025.4 • Overcomes clinical contra- indication • Synergistic effect of IO + anti- angiogenesis delivers superior anti-tumor treatment
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30 Ivonescimab + chemo (vs Keytruda + chemo) 1L non-small cell lung cancer (squamous + non-squamous) Global Phase III enrollment is ongoing Overcomes Anti-Angiogenesis’ Clinical Contra-Indication Ivonescimab: 1L Sq NSCLC Achieved Strong Positive Phase III Results AK112-3003 AK112-306 / HARMONi-6: Ivonescimab + chemo vs. Tislelizumab + chemo 1L squamous NSCLC Significant benefits in all subgroups Good safety • Incidence of treatment-related serious adverse reactions and ≥3 grade bleeding events similar to those in the control group • Further validating safety of Ivo over VEGF targeting therapies • Ivonescimab treatment demonstrated clinically significant PFS benefits regardless of PD-L1 positive or PD-L1 negative population HARMONi-6 data will be published at • The primary endpoint of PFS was achieved , with statistically significance and substantial clinical benefit, OS data is not yet matured • Central squamous cell carcinoma accounts for ~63% which is consistent with the real-world patient distribution Decisively positive result sNDA submission accepted by NMPA in July 2025 Superior treatment option that overcomes clinical contra-indications and achieves synergistic anti-tumor effects of IO + anti-angiogenesis
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31 Expanding Coverage of the Lung Cancer market: New Phase III Trials for IO-resistant NSCLC and post cCRT LS-SCLC Initiated AK112-305 / HARMONi-8A: Ivonescimab + chemotherapy IO-resistant NSCLC (sq & nsq) • The only bispecific IO therapy currently in registrational Phase III clinical trial for this indication • Most patients face recurrence or drug resistance • Significant and critical unmet need since current standard treatment is still chemotherapy Phase III clinical trial enrollment ongoing Phase II data published at AK112-311 / HARMONi-9: Monotherapy LS-SCLC that has not progressed after cCRT • The first Phase III registrational clinical trial in SCLC for Ivonescimab, further expanding coverage in lung cancer market USD ~ 19 bn global market * Phase II data will be published in a future academic conference * Data source: Credence Research, estimated market size of 2030-2032 USD ~ 5.6 b n global market * Phase III clinical trial enrollment ongoing
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32 Ivonescimab Targets Cold Tumors: Enrollment for New Phase III Trials in 1L Colorectal Cancer and 1L Pancreatic Cancer AK112-312 : Ivonescimab + chemo 1L MSS/pMMR1 mCRC Enrollment ongoing for the phase III trial Phase II data published • 1L MSS/pMMR mCRC (~95% of patients) • Current standard of care is chemo±bevacizumab or targeted therapy, with immunotherapy showing limited efficacy • Significant and critical unmet clinical need AK112-310 : Ivonescimab + chemo ± ligufalimab 1L metastasis pancreatic cancer Phase II data to be presented at upcoming academic conferences • Chemo is currently the standard of care, and immunotherapy has yet to make a breakthrough in pancreatic cancer • Significant and critical unmet clinical need USD ~18bn global market2 Enrollment ongoing for phase III trial USD ~9bn global market3 1. Microsatelitte stability/mismatch repair proficient 2. Data source: Mordor Intelligence, estimated market size in 2030 3. Data source: Global Market Insights, estimated market size in 2030
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33 AK112-309: Ivonescimab + chemo vs durvalumab + chemo 1L biliary tract cancer Enrollment completed for the phase III trial AK117-302: Ivonescimab + AK117 vs pembrolizumab 1L PD-L1(+) Head and Neck* AK112-308: Ivonescimab + chemo vs chemo 1L PD-L1(-) TNBC* • No IO agents approved to date • Differentiated focus on PD-L1 negative populations Ivonescimab: Multiple Phase III Trials for 1L indications Challenge global standard of care Enrollment ongoing for the phase III trial Enrollment ongoing for the phase III trial *TNBC: Triple-negative breast cancer; Head and neck squamous cell carcinoma Phase II data published Phase II data published Phase II data published Challenge global standard of care
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34 Ligufalimab (AK117, CD47): Two Phase III Trials in Solid Tumors Ongoingand Enrollment Completed for a Global Phase II Trial in Hematologic Cancer Solid tumor: The world’s only CD47 mAb in phase III clinical trials Hematologic cancer: Enrollment completed for a MRCT phase II randomized double-blind trial AK117-302 Ligufalimab + Ivonescimab (vs Keytruda) Phase III, enrollment ongoing 1L PD-L1+ HNSCC 1L pancreatic cancer AK112-310 Ivonescimab + chemo ± Ligufalimab (vs chemo) Phase III, enrollment ongoing 1L MDS Ligufalimab + Azacitidine MRCT phase II randomized double-blind Enrollment completed 1L AML 1L PD-(L)1 resistant cHL Ligufalimab + Azacitidine + Venetoclax Phase II randomized double-blind Enrollment completed Ligufalimab + AK129 (PD-1/LAG-3) Phase I/II Enrollment ongoing Combined with Cadonilimab or Ivonescimab in solid tumors 10 clinical trials initiated, covering 8 indications Enrollment ongoing for 2 registrational phase III trials … Multiple phase II trials in hematologic cancer progressing efficiently globally and in China HNSCC: Head and neck squamous cell carcinoma MDS: High-risk myelodysplastic syndrome AML: Acute myeloid leukemia cHL: Classical hodgkin lymphoma
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35 Pulocimab (VEGFR2): Targeting IO-resistant indications COMPLUS-5 Pulocimab + Cadonilimab + chemo IO-resistant G/GEJ adenocarcinoma Enrollment completed for phase III trial For second-line treatment of patients progressed on IO + chemo Significant critical unmet need due to no effective standard of care ORR 48%/ 16%(1) , DCR 96%/ 64%(1) mPFS 6.8m/ 2.9m(1) , mOS 13.0m/ 7.4m(1) Updated data cut-off date: 2025.2 Note: 1. RAINBOW, paclitaxel Pulocimab + Cadonilimab IO-resistant squamous NSCLC Granted breakthrough therapy designation in April 2025 Phase III trial in planning Focus on multiple lines of therapy in lung cancer, advancing into IO-resistant space Complete Phase II data to be published mPFS 7.1m, mOS 16.7m (N=26) Data cut-off date: 2025.1 Phase II data published
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36 Manfidokimab (IL-4Rα) Reached Endpoints in the Registrational Phase III Trial for Atopic Dermatitis Manfidokimab (AK120, IL - 4Rα) Positive efficacy in atopic dermatitis, with promising clinical potential Phase III Positive Results • Achieved positive outcomes in the Phase III trial. The study met all primary endpoints, key secondary endpoints, several pre-specified secondary endpoints, and demonstrated statistically significant and clinically relevant improvements in patients. • Better efficacy than Dupi. Regulatory Filing Plan NDA planned in 2026 H1 70 million Chinese atopic dermatitis patients ~USD 5bn Chinese market value* * Data source: Frost & Sullivan’s forecast about China's moderate to severe atopic dermatitis drug market in 2030 Phase I/II clinical study results published in Phase III results will be published at an upcoming academic conference Adolescent atopic dermatitis • Phase II / pivotal Phase III enrollment ongoing
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37 Autoimmune Bispecific Antibody AK139 (IL-4Ra/ST2): Phase I AK139 (IL - 4R α /ST2 ) World’s first clinical IL - 4Rα/ST2 bispecific Overcome limitation of single cytokines, and benefit a broader patient population Target both IL-4R and ST2, inhibiting multiple cytokines in both Th2 and non-Th2 inflammatory pathways Extended half-life for better patient compliance 20% EOS high 80% EOS low 40% EOS high60% EOS low 33% Clear skin66% Incomplete reversal EOS high defined here as ≥300 eosinophil cells per microliter of blood. 1. Lancet Respir Med. 2025 Jan;13(1):47-58. 2. N Engl J Med 2021;384:1800-1809. 3. The Lancet, Volume 405, Issue 10478, 2025, Pages 583-596, ISSN 0140-6736 COPD Asthma Atopic dermatitis Focus on significant unmet medical needs in treatment of respiratory and dermatological autoimmune diseases • Phase I dose escalation ongoing with good safety profile • Phase I enrollment expected to complete in 2025 Q3 • Options for non-eosinophilic COPD and asthma are very limited, yet they account for 60%-80%1,2 of the market • Currently approved biologics in atopic dermatitis all target type 2 cytokines, which lead to clear skin only in up to a third of patients3 ~USD 8.4bn Chinese COPD market value** ~USD 5bn Chinese atopic dermatitis market value* * Data source: Frost & Sullivan’s forecast about China's moderate to severe atopic dermatitis drug market in 2030 ** Data source: Frost & Sullivan’s forecast about China's COPD drug market in 2030
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38 Guided by medical needs and clinical value Improve R&D success rate for more effective, safer, and accessible innovative therapies Discovery Strategies and Therapeutic Platform Development Focus on Unmet Medical Need Targeting multiple targets, cell engagers Improvements: dual payloads, blood stability Tumor vaccines, siRNA, in vivo CAR Targeting diseased cells/tissues Oncology Autoimmune diseases Allergic diseases CNS diseases Metabolic diseases Aging-related diseases …… Multi-specific Ab ADC Gene therapy Targeted drug delivery First-in-class Best-in-class Differentiation Deep knowledge of disease biology Prioritize high-potential targets Continuously optimize & expand technology platforms Forward looking investments into broad disease areas, unmet medical needs Select the best drug types and platforms based on molecular mechanisms and treatment approach
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39 “IO 2.0 + ADC” advances into clinical development stage AK138D1 (HER3 ADC) AK146D1 (Trop2/Nectin4 ADC ) Global Phase I dose escalation ongoing in AUS China Phase I ongoing Global Phase I dose escalation ongoing in AUS China Phase I to be initiated IO 2.0 + ADC Phase II trials for combination with cadonilimab or ivonescimab in preparation IO 2.0 + ADC 2.0 Phase II trials for combination with cadonilimab or ivonescimab to be initiated • Novel cleavable linker with improved plasma stability • High DAR enables potent cell killing activity and good homogeneity • Potent cytotoxicity against tumor cells positive for multiple tumor-specific antigens • Unique CMC process, exploring new ADC R&D directions Key Features Clinical Development Development Plan Key Features • Topoisomerase I inhibitor as payload and novel cleavable linker with improved stability • Bispecific antibody structure and high DAR deliver stronger antitumor activity, compared with Trop2 ADC or Nectin4 ADC monotherapy Clinical Development Development Plan
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40 Key Milestones in 2025 Milestones Assets & Indications 2025H1 2025H2 NDA/sNDA Approval Ivonescimab 1L PD-L1(+) NSCLC (vs. vs. pembro) ✔ Cadonilimab + chemo ± beva 1L CC ✔ Ebdarokimab (IL-12/IL-23) Moderate to severe plaque psoriasis ✔ Penpulimab + chemo 1L NPC & 2L+ NPC 🌏 ✔ Penpulimab + Anlotinib 1L HCC ⚪ Phase III Data Readout / NDA Filing Ivonescimab + chemo 1L sq-NSCLC (vs. tislelizumab + chemo) ✔ Ivonescimab + chemo NSCLC after 3rd-gen EGFR-TKI progression 🌏 ✔ Penpulimab + Anlotinib 1L advanced HCC ✔ Gumokimab (IL-17) Ankylosing spondylitis * ✔ Manfidokimab (IL-4R) Moderate to Severe atopic dermatitis ✔ Phase III Enrollment Complete Cadonilimab + Pulocimab PD-(L)1 resistant G/GEJ ⚪ Ivonescimab + chemo 1L BTC (vs durvalumab + chemo) ✔ Phase II Enrollment Complete Ligufalimab + Azacitidine 1L MDS 🌏 ✔ Ligufalimab + Azacitidine + Venetoclax. 1L AML ✔ * New milestone completed outside the development plan🌏 global trial/ BLA ✔ completed ⚪ expect to be completed
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41 Milestones Assets & Indications 2025H1 2025H2 Phase III Initiation Cadonilimab Consolidation therapy for NSCLC after CRT ✔ Cadonilimab Perioperative treatment for resectable G/GEJ* ✔ Cadonilimab IO resistant HCC* 🌏 ✔ Ivonescimab + chemo 1L CRC (vs beva + chemo) ✔ Ivonescimab + chemo PD-(L)1 resistant NSCLC ✔ Ivonescimab ± ligufalimab + chemo 1L PDAC ✔ Ivonescimab Consolidation therapy for LS-SCLC* ✔ Ivonescimab 1L PD-1 TPS≥50%NSCLC 🌏 ✔ Ivonescimab 1L HNSCC 🌏 ✔ Manfidokimab adolescent AD ✔ Entry into Phase II AK129 (PD-1/LAG-3) ✔ AK130 (TIGIT/TGF-β) ✔ AK131 (PD-1/CD73) ✔ AK132 (Claudin18.2/CD47) ⚪ AK137 (CD73/LAG3) ⚪ Entry into Phase I/ IND Application AK135 (IL-1RAP) ✔ AK138D1 (HER3 ADC) 🌏 ✔ AK139 (IL4R/ST2) ✔ AK146D1 (Trop2/Nectin4 ADC) 🌏 ✔ AK150 (ILT2/ILT4/CSF1R) ⚪ Key Milestones in 2025 * Milestone completed outside the plan🌏 global trial/ BLA ✔ completed ⚪ expect to be completed
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Financial Highlights
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43 2025H1 Revenue of RMB1.412 billion. Commercial sales of RMB1.402 billion, +49% y-o-y increase from 2024H1 Total of cash and cash equivalent, other short-term financial asset as of 2025.6.30: RMB7.138 billion Improvements in Expense Ratios: Sales and Marketing: 2025 H1 S&M expenses decrease to 48% of Commercial Sales from 55% in 2024H1 R&D: 2025H1 R&D expense decrease to 52% of Commercial Sales from 63% in 2024H1 Key Expense in 2025 H1 compared to 2024 H1: Accounting loss in 2025H1 recognized by the Group from its long-term equity investment in Summit Therapeutics was RMB191.7 million, compared to RMB32.6 million in 2024H1 R&D expenses increased by RMB137 million in 2025H1 compared to 2024H1 (23% YoY increase), mainly attributed to additional Phase III studies and the development of new pipeline and therapeutic platforms ESOP and RSU expense 2025 H1 was RMB27 million, an increase of RMB22 million over 1H 2024 2025H1 Adjusted EBITDA RMB -178.3million RMB million 2025H1 2024H1 Change % Revenue1 1,411.54 1,055.99 33.67% Commercial Sales （less distribution cost) 1,401.62 939.43 49.20% Gross Profit* 1,110.78 889.10 24.93% R&D 731.24 594.39 Sales and Market 669.94 515.98 S&M % ** 47.80% 54.93% Profit/Loss (588.28) (249.35) Adjusted EBITDA (178.33) (37.4) 2025H1 Financial Highlights 1. including commercial sales + license income-distribution expense *Gross Profit* = commercial sales – cost of sales **Sales and Market %: Sales and marketing expenses/Commercial sales× 100%
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44 758 939 1,402 442 516 670 2023H1 2024H1 2025H1 commercial sales sales expenses 758 939 1,402 2023H1 2024H1 2025H1 Commercial Sales Growth Sales Expenses to Commercial Sales Ratio1 Sustained Growth in Sales while Controlling S&M Expenses RMB million +24% +49% 58% 55% RMB million 48% 1. Sales Expenses to Commercial Sales ratio：Sales Expense / Commercial Sales × 100%
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45 R&D Expenses to Commercial Sales Ratio1 Steady Decline of Expense Ratios G&A Expenses to Commercial Sales Ratio2 758 939 1,402 575 594 731 - 200 400 600 800 1,000 1,200 1,400 1,600 2023H1 2024H1 2025H1 commercial sales R&D expenses RMB million 758 939 1,402 100 100 134 - 200 400 600 800 1,000 1,200 1,400 1,600 2023H1 2024H1 2025H1 commercial sales admin expenses 76% 63% 52% 13% 11% 10%RMB million 1. R&D Expenses to Commercial Sales ratio：R&D Expense / Commercial Sales × 100% 2. G&A expenses to Commercial Sales ratio：G&A expenses / Commercial Sales × 100%
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Q&A CONTACT US: ir@akesobio.com