ZLAB - Zai Lab's bacterial infection drug gets priority review in China
- China's National Medical Products Administration (NMPA) granted priority review to Zai Lab's ( NASDAQ: ZLAB ) new drug application seeking approval of sulbactam-durlobactam (SUL-DUR) to treat infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains.
- Acinetobacter baumannii-calcoaceticus are a type of Gram-negative bacteria.
- Zai said SUL-DUR is an intravenous drug developed by Entasis Therapeutics that is a combination of sulbactam, an IV ?-lactam antibiotic, and durlobactam, broad-spectrum IV ?-lactamase inhibitor.
- "CRAB infections are among the worst bacterial infections, and safe and effective treatment options are limited," said Harald Reinhart, president and head of Global Development, Neuroscience, Autoimmune and Infectious Diseases, Zai.
- The drug is also under priority review , which provides a shortened review period, in the U.S. based on an application filed by Innoviva ( NASDAQ: INVA ).
- ZLAB -1.96% to $44 premarket Jan. 30
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Zai Lab's bacterial infection drug gets priority review in China