By Fineline Cube 
China-based Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373) announced that a New Drug Application (NDA) for its contezolid sodium for injection (MRX-4 for injection) as a treatment for adult patients with complex skin and soft tissue infections (cSSTI) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development and potential market entry of this innovative antibiotic.
Contezolid Background
Contezolid, a potent oxazolidinone antibiotic effective against Gram-positive pathogens, was approved in China in June 2021 for the treatment of cSSTI. Contezolid sodium, the water-soluble prodrug version of contezolid, has demonstrated robust clinical efficacy and safety.
Clinical Trial Results
In its Phase III clinical study in China, contezolid sodium met the primary efficacy endpoint, demonstrating that MRX-4/contezolid were non-inferior to the linezolid group in terms of clinical efficacy. The study also highlighted a good overall safety and tolerability profile, positioning contezolid sodium as a promising treatment option for cSSTI.-Fineline Info & Tech