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Article source: Pharmaceutical Guanlan

On December 16, according to the latest announcement on the official website of China's National Medical Products Administration (NMPA), the new drug application for omadacycline tosylate (omadacycline, trade name: Nuzyra) declared by Zai Lab has been approved

Image source: Screenshot of NMPA official website

Omacycline tosylate is a new type of tetracycline designed to overcome tetracycline resistance and has a broad-spectrum antibacterial activity, including gram-positive bacteria, gram-negative bacteria, atypical pathogens and a variety of resistant strains

In April 2017, Zai Lab obtained the exclusive license for the development, production and promotion of the drug in Mainland China, Hong Kong, Macau and Taiwan from Paratek

Antibiotic resistance has become a major public health challenge, and the demand for highly effective and well-tolerated antibiotics is increasing

According to the results of the Phase 3 clinical trial OASIS-2 of Nuzyra (omadacycline) published in The Lancet Infectious Diseases in 2019, taking the drug once a day to treat adult patients with ABSSSI (including MRSA infection) has an effect equivalent to every Linezolid was taken orally twice a day; at the same time, the trial reached all primary and secondary clinical research endpoints and was proven to be safe and effective for the treatment of ABSSSI

Earlier, Zai Lab has successfully launched three anti-cancer products in Mainland China-Zele (Nilapali), Tumor Electric Field Therapy Optune and Qinlock (Repetinib)

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Reference materials:

[1] Information to be obtained for the drug approval certificate issued by the National Medical Products Administration of China on December 16.

[3]Paratek Pharmaceuticals and Zai Lab Announce Collaboration, Development and License Agreement for Omadacycline in China.