NMPA approves Zai Lab's NUZYRA as Category 1 innovative drug for CABP and ABSSSI

Zai Lab Ltd

NMPA approved NUZYRA (omadacycline) for community-acquired bacterial pneumonia and acute bacterial skin infections.
Approved as Category 1 innovative drug; locally manufactured in China; Zai Lab's fourth product approval in 24 months.
NUZYRA offers IV and oral formulations, targeting multi-drug-resistant bacteria; first Zai Lab product outside oncology.
Approval based on three Phase 3 studies in Chinese patients; NUZYRA previously FDA-approved and marketed by Paratek in US.

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