Welcome to our dedicated page for Zai Lab news (Ticker: ZLAB), a resource for investors and traders seeking the latest updates and insights on Zai Lab stock.
Zai Lab Limited reports developments for a commercial-stage biopharmaceutical company with American depositary shares traded under ZLAB and ordinary shares listed in Hong Kong. The company discovers, develops, licenses and commercializes therapies for oncology, immunology, neuroscience and infectious disease, with operations based in China and the United States.
Recurring company updates include financial results, regulatory designations, clinical and preclinical data, collaborations and product updates across programs such as zocilurtatug pelitecan, ZL-1503, ZL-6201 and ZL-1222. Updates also address regional commercial products and pipeline assets including ZEJULA, VYVGART, KarXT and TIVDAK.
Zai Lab will present significant findings from the NORA Phase 3 study of ZEJULA (niraparib) at the ESMO Gynaecological Cancers Congress on February 23-24, 2023. Preliminary results show that niraparib maintenance therapy improved overall survival in platinum-sensitive recurrent ovarian cancer patients. The median overall survival was 46.3 months versus 43.4 months for placebo (HR=0.82). Additionally, a post hoc analysis from the Phase 3 PRIME trial revealed enhanced progression-free survival with niraparib compared to placebo across various surgical statuses. The presentations highlight the ongoing commitment to improving treatment options for ovarian cancer patients in China.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced the acceptance of their New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR) by China's National Medical Products Administration (NMPA). This investigational drug targets Acinetobacter baumannii infections, particularly multidrug-resistant and carbapenem-resistant strains, addressing a significant medical need. The drug shows promise in reducing mortality and renal toxicity over standard colistin therapy. SUL-DUR has also received priority review status in both China and the U.S. Zai Lab holds exclusive development rights for SUL-DUR in multiple countries across Asia and Oceania.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced it will report financial results for the twelve months ended December 31, 2022, after U.S. market closure on March 1, 2023. A live conference call and webcast will take place on March 2, 2023, at 8:00 a.m. ET. Investors can access the webcast via the company's website, and advance registration is required. This event will highlight the company's progress and future direction in the biopharmaceutical sector, particularly in oncology, autoimmune disorders, infectious diseases, and neurological disorders.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in several investor conferences in February 2023. Key events include a fireside chat at the Guggenheim Oncology Conference on February 8, and two chats on February 14 at the SVB Securities Global Biopharma Conference and the Citi Biotech C-Suite Fireside Chat Series. Interested parties can access the webcast links in the Investor Relations section of Zai Lab's website. The company aims to deliver transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders globally.
Zai Lab Limited (NASDAQ: ZLAB) announced that China's Center for Drug Evaluation (CDE) has granted priority review status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR). This investigational drug targets infections by Acinetobacter baumannii, especially multidrug-resistant strains. The grant emphasizes the urgent need for new treatments in light of the high mortality rates associated with these infections in ICU settings. The FDA has also accepted the NDA for SUL-DUR for priority review, with an action date of May 29, 2023. Zai Lab holds exclusive commercialization rights for SUL-DUR in multiple Asia-Pacific regions.
Zai Lab Limited (NASDAQ: ZLAB) announced that its drugs QINLOCK® (ripretinib) and NUZYRA® (omadacycline) have been added to China's National Reimbursement Drug List (NRDL). This inclusion is significant for patients with advanced gastrointestinal stromal tumors and community-acquired bacterial pneumonia. William Liang, Zai Lab's Chief Commercial Officer, emphasized that NHSA reimbursement will expand patient access to these treatments. Both drugs previously received regulatory approval in China, with NUZYRA launched in 2019. GIST affects approximately 30,000 new patients annually in China, highlighting a critical need for effective treatments.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced the appointment of Michel Vounatsos to its Board of Directors, effective January 7, 2023. Vounatsos has over 25 years of experience in the biopharmaceutical sector, including leadership roles at Biogen and Merck. His extensive commercial background, particularly in neuroscience and operations in China, is expected to enhance Zai Lab's growth and product commercialization efforts. The company currently has four drugs on the market and plans to launch three more, aiming to improve patient care in China and globally.
The LUNAR study by Zai Lab and Novocure has achieved its primary endpoint, showing a statistically significant improvement in overall survival for stage 4 non-small cell lung cancer (NSCLC) patients.
The study demonstrated enhanced survival rates for patients receiving Tumor Treating Fields (TTFields) alongside standard treatments compared to those receiving standard treatments alone. Notably, results indicated a positive trend in survival with TTFields combined with docetaxel. Novocure plans to present the complete findings at an upcoming medical conference and file for FDA approval in late 2023.
Zai Lab Limited (NASDAQ: ZLAB) announced the appointment of Dr. Rafael G. Amado as President and Head of Global Oncology Research and Development, effective December 30, 2022. Dr. Amado, with extensive oncology expertise, previously held leadership roles at Allogene Therapeutics and Adaptimmune. His appointment aims to enhance Zai Lab's oncology R&D capabilities, supporting the company's goal of becoming a leading global biopharmaceutical entity. Dr. Amado's focus will be on accelerating existing and future oncology programs to address unmet medical needs in China and globally.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in key investor conferences in January 2023. The company will be present at the Morgan Stanley Virtual China Opportunity Conference from January 4-6, and will present at the J.P. Morgan 41st Annual Healthcare Conference on January 10 at 9:00 a.m. PST in San Francisco. The webcast for the J.P. Morgan conference will be accessible on Zai Lab’s Investor Relations site, with an archived replay available for 30 days. Zai Lab focuses on developing transformative medicines in oncology, autoimmune disorders, infectious diseases, and neurological disorders.