The first class 1 new drug of mengke medicine was accepted in Huashen newspaper!

The latest announcement by the drug evaluation center (CDE) of the State Food and Drug Administration of China shows that the class 1 innovative drug, contezolid (also known as mrx-i), which was declared by mengke pharmaceutical and Huahai pharmaceutical, has submitted an application for listing and has been accepted by CDE (acceptance No.: cxhs1900044) This is the first antibacterial new drug that has been applied for market since its establishment In September 2018, the drug obtained the fast track qualification granted by the US FDA for the treatment of acute bacterial skin and skin tissue infections Contazolamine is an oral oxazolidinone antibiotic designed to treat infections caused by resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE), providing doctors and patients with a safer and more tolerable treatment option than the existing oxazolidinone drugs According to the public information, Mercer pharmaceutical has successfully completed two independent phase 2 studies of mrx-i in the United States and China in 2015, and completed phase 3 studies of complex skin and soft tissue infection (cssti) in China in 2019 The results showed that the clinical cure rate of conazolamide (93.0%) was the same as that of linezolid (93.4%) The overall incidence of adverse events (teaes) after treatment was comparable in the two groups of contazolamine and linezolid According to the researchers, the teaes related to the study drug were similar, most of them were mild or moderate However, the incidence of study drug-related teaes was lower in the comtazolamine group than in the linezolid group in hematology Since its establishment in 2007, micurx has set up R & D laboratories in China and the United States The president and CEO of the company is Dr yuan Zhengyu The company focuses on the discovery, development and commercialization of new antibiotics for the treatment of multidrug resistance (MDR) "superbug" infections Since its establishment, the company has constructed R & D pipelines for four kinds of antibacterial drugs (contezolid, contezolid acefosamil, mrx-8 and mrx-10), aiming at multiple pathogens listed on the who "super bacteria" list ▲ the R & D pipeline of mengke (picture source: Official Website of mengke) In addition to kangtazolamine tablets, another drug under research of mengke medicine, kangtazolamine phosphate (mrx-4, contezolid acefosamil), is the prodrug of kangtazolamine It has two dosage forms, oral and injection It plans to carry out global development for multi drug resistant Gram-positive bacterial infection At present, the same kind of new drugs approved for marketing are linezolid and tertiazem Linezolid generic drugs are on the market Mengmeng's article is the integrated content of yaozhi.com, and the copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.