Zaiding Pharmaceutical's new antibiotic Class 1 new drug New Zaile was approved for listing

On December 16, the reporter learned from Zaiding Pharmaceutical that the company's new drug application for New Zaile (omacycline toluenesulfonate) was approved by the State Drug Administration. Nunzale is a new antibiotic, available in both oral and intravenous dosage forms, approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Neurero is approved by the State Food and Drug Administration as a Class 1 new drug and is produced in China. This is also the fourth product approved by Zaiding Pharmaceutical in the past 24 months.

Ren Hairui, chief medical officer of Zaiding Pharmaceutical's autoimmune and anti-infection field, said that the problem of antibacterial drug resistance is becoming increasingly serious, and the approval of the State Food and Drug Administration has brought a new treatment option to millions of CABP and ABSSSI patients in China. Nunzale has a particular advantage based on its broad-spectrum antimicrobial activity against a wide range of pathogens associated with these serious infections, including multidrug-resistant bacteria. In addition, Nunzale offers physicians both intravenous infusion in the hospital and switching to oral dosage forms after discharge, a flexible way of administration that will help reduce potential hospital-like risks and reduce associated hospitalization costs.

According to publicly available information, based on a number of comprehensive clinical studies enrolling more than 2,000 patients, the U.S. Food and Drug Administration (FDA) approved Neuzaile's marketing applications for CABP and ABSSSI. Since 2019, Nunzale has been sold in the United States by Palatik Pharmaceuticals, Inc. Since 2017, Zaiding Pharmaceutical and Paletek have cooperated to develop, produce and conduct three clinical studies in China to support the registration and listing of Nunzale in Chinese mainland. In 2020, Zaiding Pharmaceutical awarded the exclusive promotion right of Nunzale (Omacycline toluenesulfonate) in China to Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Hanhui Pharmaceutical Co., Ltd. As the holder of the drug marketing authorization of Nunzale, Zaiding Pharma has all the rights to manufacture, import, sell and distribute Nunzale in China.