Instant Report

Date: 04-Jun-2021

China NMPA Approves MicuRxs Contezolid For Treatment Of Drug Resistant Bacterial Infection

June 3, 2021 /PRNewswire/ -- MicuRx Pharmaceuticals Co., Ltd. (MicuRx), a leading biopharmaceutical company focused on the discovery, development and commercialization of antibacterial agents against drug-resistant bacterial infection, announced that China National Medical Products Administration (NMPA) has approved its new drug application for contezolid as the treatment of complicated skin and soft tissue infection. Contezolid, designed and developed by MicuRx's China and US R&D team, is the next-generation oxazolidinone agent against multi-drug resistant (MDR) Gram-positive bacterial infection. Contezolid is the exciting product resulting from the company's 12 years' effort, which represents a major breakthrough for the new drug discovery to combat infectious diseases in China.

By leveraging the proprietary technology platform built for drug discovery and screening, MicuRx R&D team discovered the next-generation oxazolidinone candidate contezolid (formerly named MRX-I) for the treatment of infections caused by Gram-positive bacteria (including multidrug-resistant bacteria) in 2008. Backed by a massive amount of data, the team has confirmed that contezolid has great efficacy in treating infections caused by MDR Gram-positive bacteria, in the meantime significantly reducing the side effects associated with myelosuppression frequently encountered with the type of antibiotics and the tendency to induce drug resistance. MicuRx has successfully completed nine clinical trials of contezolid both in and outside of China. The approval from NMPA is based on the efficacy and safety result obtained from a multi-center, randomized, double-blind, double-dummy Phase III clinical trial involving 719 patients with complicated skin and soft tissue infections.