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China NMPA approves Nuzyra as a Category 1 innovative drug.

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Published:17th Dec 2021
Zai Lab Limited announced that the China National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Nuzyra (omadacycline), a novel antibiotic with both oral and intravenous (IV) formulations, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Nuzyra was approved as a Category 1 innovative drug by the NMPA and is locally manufactured in China. It is the fourth Zai Lab product approved over the last 24 months.

"In the face of ever-increasing antibiotic resistance, the NMPA’s approval of Nuzyra brings an important new treatment option for CABP and ABSSSI to millions of patients in China,” said Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases at Zai Lab. “We believe Nuzyra is particularly well positioned due to its broad activity against a wide spectrum of pathogens, including multi-drug-resistant (MDR) bacteria, associated with these serious infections. In addition, Nuzyra offers clinicians the ability to treat patients in the hospital with the intravenous formulation and transition them to complete treatment at home with the oral formulation. This flexible treatment regimen potentially helps reduce exposure to hospital pathogens and the costs associated with hospital stays.”

Condition: Infectious Diseases/ABSSSI
Type: drug

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