Earnings release
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zailǝb Zai Lab Announces Third Quarter 2021 Financial Results and Corporate Updates November 9 , 2021 -- Broad Product Pipeline Expands Both Vertically and Horizontally with Three New Potential First - in - Class or Best - in - Class Medicines · Company to Host Conference Call and Webcast on November 10 , 2021 , at 8:00 a.m. EST SHANGHAI and SAN FRANCISCO and CAMBRIDGE , Mass . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- Zai Lab Limited ( NASDAQ : ZLAB ; HKEX : 9688 ) , a patient - focused , innovative , commercial - stage , global biopharmaceutical company , today announced financial results for the third quarter of 2021 , along with recent product highlights and corporate updates . " In the third quarter of 2021 , we continued to deliver strong growth and performance , " said Dr. Samantha Du , Founder , Chairperson and Chief Executive Officer of Zai Lab . " We made important advances across our broad , innovative product portfolio and recently added three new potentially transformative medicines . Our agreement with Blueprint Medicines for two promising lung cancer drug candidates presents opportunities to further deepen our potentially world - class lung cancer franchise . Our partnership with Karuna Therapeutics allows us to expand into neuroscience with an exciting anchor asset . Neuroscience is a disease area with a large patient population and significant unmet medical needs . ” Notable updates across our business in the quarter included : • Our three marketed products - ZEJULA , OPTUNE , and QINLOCK - achieved solid revenue growth , driven by strong demand and commercial execution . • ZEJULA received approval and was launched for first - line ovarian cancer in Hong Kong . • QINLOCK received approval and was launched for fourth - line GIST in Taiwan . • Positive Phase 1/2 results for adagrasib in colorectal cancer and potentially registration - enabling Phase 2 topline results in non - small - cell lung cancer were announced . • Encouraging updated Phase 2 data for repotrectinib and Phase 1 data for elzovantinib ( TPX - 0022 ) in advanced cancer patients with relevant genomic alterations were announced . • Enrollment of our clinical trial of Tumor Treating Fields in gastric cancer was completed ; a topline data readout of this Phase 2 pilot trial is expected in the first half of 2022 . • Regulatory filings are being prepared for Tumor Treating Fields in malignant pleural mesothelioma and for margetuximab in HER2 - positive breast cancer . • A positive meeting with the NMPA on efgartigimod suggests the potential for an accelerated pathway for regulatory approval for generalized myasthenia gravis ( gMG ) in China . Subject to United States Food and Drug Administration ( FDA ) approval and further discussion with the NMPA , we expect to file the New Drug Application ( NDA ) in China by the first half of 2022. Our partner argenx anticipates a decision by the FDA on their regulatory filing of efgartigimod for gMG during the fourth quarter . • ZL - 1102 , Zai Lab's internally developed anti - IL - 17A Humabody Ⓡ for plaque psoriasis , achieved proof of concept and will now advance into global clinical development . • Positive topline results were announced for sulbactam - durlobactam ( SUL - DUR ) in Acinetobacter infections from the global Phase 3 ATTACK trial . " We have had a very productive year and built a stronger pipeline with depth and breadth , " Dr. Du concluded . " With 28 products in our innovative pipeline , we expect our fourth quarter and 2022 to be rich in milestones to unlock significant value in our business . " Recent Product Highlights and Anticipated Milestones Oncology ZEJULAⓇ ( niraparib ) ZEJULA is an oral , once - daily small - molecule poly ADP - ribose polymerase ( PARP ) 1/2 inhibitor . It is the only PARP inhibitor approved in the United States , the European Union and mainland China ( hereinafter , " China " ) as a monotherapy for patients with advanced ovarian cancer , regardless of their biomarker status .