Declaration and listing of the first new drug "kangtazolamine" of mengke medicine

On January 4, the official CDE website showed that the application for the listing of the first antibacterial new drug, kangtazolamine tablets, was accepted by CDE 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 A critical phase III clinical study for the treatment of complex skin and soft tissue infections (cssti) showed that the clinical cure rate of contazolamine in the primary end-point cure test period (TOC, 7-14 days after the last administration) was not inferior to linezolid and showed lower drug-related hematological adverse events This double-blind trial was carried out in 50 clinical centers in China Patients with complex skin and soft tissue infection were randomly assigned to receive oral comtazolamine 800mg or linezolid 600mg twice a day for 7 to 14 days Of the 719 patients enrolled, 589 were clinically evaluable (CE) at the time of TOC visit In the CE population, the clinical cure rate of contazolamine was 93.0% and that of linezolid was 93.4% at TOC visit, respectively, reaching the non inferiority threshold of - 10% In addition, the lower limit of 95% confidence interval of the difference between the two groups was greater than - 10%, which further proved that the efficacy of conazolam and linezolid was equivalent.