Zai Lab Announces CTA Approval to Initiate a Phase 3 Clinical Trial of ETX2514SUL for the Treatment of Carbapenem-Resistant Acinetobacter Infections
Zai Lab Limited - American Depositary Shares (ZLAB)
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Source: GlobeNewswire
Approval allows Zai Lab to enroll patients in a global Phase 3 clinical trial in collaboration with Entasis Therapeutics More than 200,000 cases of A. baumannii infections in China annually - Approximately 60% are carbapenem-resistant - High mortality rate (30-60%) highlights serious medical need SHANGHAI, China, May 16, 2019 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted the Company’s Clinical Trial Application (CTA) to allow for the initiation of a Phase 3 clinical trial to evaluate the safety and efficacy of ETX2514SUL, a fixed-dosed combination of a broad spectrum ß-lactamase inhibitor with sulbactam, for the treatment of patients with pneumonia and blood stream infections caused by carbapenem-resistant A. baumannii. “Carbapenem-resistant A. baumannii infections are a very serious public health problem
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- 4/29/24 - Form ARS
- 4/29/24 - Form DEFA14A
- 4/29/24 - Form DEF
- ZLAB's page on the SEC website