The China National Medical Products Administration (NMPA) has approved Zai Lab Limited's (NASDAQ:ZLAB) Nuzyra (omadacycline), a novel antibiotic with both oral and intravenous (IV) formulations.
- The approval covers the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
- Nuzyra is Zai Lab's fourth new product approval and the first outside oncology.
- FDA approved Nuzyra for both CABP and ABSSSI based on comprehensive clinical trial programs involving more than 2,000 patients. Since 2019, it has been marketed in the U.S by Paratek Pharmaceuticals Inc (NASDAQ:PRTK)
- In 2017, Zai Lab in-licensed the rights to Nuzyra for the Greater China region (mainland China, Hong Kong, Macau, and Taiwan).
- Price Action: ZLAB shares are up 4.74% at $57.50 during the premarket session on the last check Thursday.
