Zai Lab Announces Acceptance of NDA Submission of Omadacycline in China by the NMPA
Zai Lab Limited - American Depositary Shares (ZLAB)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
SHANGHAI, China and SAN FRANCISCO, Feb. 10, 2020 (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 its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). “This is another important step in the development of Zai as a fully-integrated biopharmaceutical company,” said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. “This NDA is our third submission accepted for review by the China NMPA and our first anti-infective NDA and demonstrates our capabilities in therapeutic areas outside of oncology. The Chinese infectious disease market is significantly underserved, and innovation is desperately needed more than ever due to the rise in bacterial resistance.” Dr. Harald Reinhart, Ch
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- 11/7/23 - Beat
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Sec Filings
- 4/29/24 - Form ARS
- 4/29/24 - Form DEFA14A
- 4/29/24 - Form DEF
- ZLAB's page on the SEC website