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zaiLǝb Zai Lab Announces First Quarter 2021 Financial Results May 10 , 2021 Company to Host Conference Call and Webcast Today at 8:00 a.m. EDT SHANGHAI and SAN FRANCISCO , May 10 , 2021 ( GLOBE NEWSWIRE ) -- Zai Lab Limited ( NASDAQ : ZLAB ; HKEX : 9688 ) , an innovative commercial - stage biopharmaceutical company , today announced financial results for the first quarter of 2021 , along with recent product highlights and corporate updates . " Zai Lab continued to execute well in all aspects of the business during the first quarter , " said Dr. Samantha Du , Founder , Chairperson and Chief Executive Officer of Zai Lab . " We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds ; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod , a pipeline - in - a - product opportunity ; advanced numerous clinical programs toward key data readouts ; gained approval of QINLOCK by the National Medical Products Administration ( NMPA ) , our third innovative oncology product approval in the last 15 months in China and the first commercial product in what we expect to become a world - class gastric cancer franchise ; and generated solid revenue growth , in part from increased volume of ZEJULA driven by its recent inclusion on the National Reimbursement Drug List ( NRDL ) . In addition , we recently received encouraging news on several key assets from our partners . The Biologics License Application ( BLA ) filing of efgartigimod in generalized myasthenia gravis ( gMG ) was accepted by the U.S. Food and Drug Administration ( FDA ) . The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non - small cell lung cancer ( NSCLC ) was recommended to continue with reduced sample size based on an accelerated interim analysis . Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first - line treatment for gastric cancer patients who overexpress FGFR2b . " With the completion of our recent global public offering with gross proceeds of nearly $ 860 million , we significantly strengthened our capital position . This new capital will allow us to accelerate our growth by entering into additional strategic partnerships , advancing our clinical development pipeline , and scaling our commercial and R & D organizations to drive strong revenue growth and enhance our global pipeline . " We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval of Nuzyra for community- acquired bacterial pneumonia ( CABP ) and acute bacterial skin and skin structure infections ( ABSSSI ) by the NMPA . We plan to file margetuximab for Her2 - positive breast cancer , Tumor Treating Fields for mesothelioma and ZEJULA for late - line ovarian cancer in China . We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China . And we anticipate numerous data readouts , including for Tumor Treating Fields in liver cancer and ovarian cancer , for QINLOCK in second - line GIST , for margetuximab in gastric cancer , for CLN - 081 in NSCLC and for TPX - 0022 in NSCLC and gastric cancer . " In our mission to address serious unmet medical needs for patients in China and around the world , we believe that we have built a sustainable platform that we can leverage , " Dr. Du concluded . “ Our team continues to deliver on our aggressive growth objectives . I believe that the future of Zai Lab has never been brighter . " 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 . Anticipated 2021 Zai Milestones • Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab ( PD - 1 x LAG - 3 ) in gastric cancer . • Announce topline results of the Phase 3 PRIME study of ZEJULA in patients with first - line ovarian cancer in China in the second half . • Submit the supplemental New Drug Application ( SNDA ) for late - line ovarian cancer treatment in the second half . • Continue to explore additional indications and combination opportunities . Tumor Treating Fields Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division , inhibiting tumor growth and potentially causing cancer cell death . Recent Product Highlights