Earnings release
Page 1
zaiLǝb Zai Lab Announces Second Quarter 2021 Financial Results and Corporate Updates August 9 , 2021 Company to Host Conference Call and Webcast on August 10 , 2021 , at 8:00 a.m. EDT SHANGHAI and SAN FRANCISCO , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) -- Zai Lab Limited ( NASDAQ : ZLAB ; HKEX : 9688 ) , an innovative commercial - stage biopharmaceutical company , today announced financial results for the second quarter of 2021 , along with recent product highlights and corporate updates . " Consistent with our past track record , Zai Lab continued to execute with speed and quality across the organization during the second quarter , " said Dr. Samantha Du , Founder , Chairperson and Chief Executive Officer of Zai Lab . " We successfully launched QINLOCK , the first product in what we hope will become a world - class gastric cancer franchise , in China ; generated strong revenue growth from ZEJULA and Optune ; and entered into strategic collaborations with Mirati , MacroGenics and Schrödinger to further strengthen our disease strongholds in oncology and our global pipeline . " We anticipate achieving multiple regulatory milestones across our product pipeline throughout 2021 , including the potential approval of NUZYRA for community - acquired bacterial pneumonia ( CABP ) and acute bacterial skin and skin structure infections ( ABSSSI ) by the NMPA . We also continue to make progress in numerous regulatory activities , and we anticipate a discussion with the NMPA in the near future on the filing strategy for efgartigimod . In addition , we anticipate many important data readouts and updates in the remainder of this year , including for Tumor Treating Fields in ovarian cancer , for QINLOCK in second - line GIST , for margetuximab in gastric cancer , for CLN - 081 in non - small cell lung cancer ( NSCLC ) , for TPX - 0022 in NSCLC and gastric cancer , for adagrasib in NSCLC and colorectal cancer , and for other product candidates in our global pipeline . " We are focused more than ever on our mission to build a leading global biopharmaceutical company addressing the unmet medical needs of patients in China and around the world , " Dr. Du concluded . 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 once - daily PARP inhibitor approved in the United States , the European Union and mainland China ( hereinafter , " China " ) as a monotherapy maintenance treatment for patients with advanced epithelial ovarian , fallopian tube , or primary peritoneal cancer who are in a complete or partial response to first - line platinum - based chemotherapy , regardless of their biomarker status . Recent Product Highlight • Zai Lab has made significant progress in recent months in the number of hospitals that list ZEJULA as an approved medicine . From the date of National Reimbursement Drug List ( NRDL ) implementation on March 1 , 2021 to June 30 , 2021 , the number of hospitals listing ZEJULA has increased sevenfold to more than 800 . Anticipated 2021 Zai Milestones • Complete enrollment of the Phase 1b study of ZEJULA in combination with tebotelimab in gastric cancer . • Announce topline results of the Phase 3 PRIME study of ZEJULA in Chinese patients with first - line ovarian cancer . • Seek NRDL inclusion for a first - line ovarian cancer indication . • Continue to explore additional indications and combination opportunities . Tumor Treating Fields Tumor Treating Fields ( TTFields ) are electric fields tuned to specific frequencies to disrupt cell division . Recent Product Highlights • In July 2021 , Zai Lab partner Novocure announced the final results from its Phase 2 pilot HEPANOVA trial in liver cancer testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced hepatocellular cancer . In 21 evaluable patients , HEPANOVA showed a 76 % disease control rate , 9.5 % objective response rate and 5.8 months of progression free survival in a patient population with poor prognosis and limited exposure to study treatments . In patients