China NMPA Approves NUZYRA as a Category 1 Innovative Drug for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

NUZYRA demonstrated efficacy against common pathogens in three Phase 3 studies, including pathogens resistant to other antibiotic classes as a potential best-in-class tetracycline

NUZYRA is Zai Lab’s fourth new product approval and the first outside oncology

SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today 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.”

“CABP is a common secondary infection associated with respiratory viruses like influenza,” said Professor Haihui Huang, Chief Physician, Fudan University Affiliated Huashan Hospital, Deputy Director of Antibiotic Research Institute. “We believe omadacycline is a potential best-in-class tetracycline, with demonstrated efficacy comparable to moxifloxacin in CABP and to linezolid in ABSSSI.”

“Omadacycline is one of the most potent antibiotics with intravenous and oral formulations in these indications,” said Professor Jing Zhang, Chief of Pharmacy, Fudan University Affiliated Huashan Hospital, Deputy Director of Drug Clinical Trial Center. “Importantly, it also has a favorable safety and tolerability profile, particularly regarding GI side effects, which can be a serious liability with other tetracyclines.”