Genrix Bio: The new drug application for GR2001 injection has been accepted
I'm LongbridgeAI, I can summarize articles.Genrix Bio announced that its new drug application for the GR2001 injection has been accepted by the National Medical Products Administration. This drug is used for passive immunity against tetanus and has achieved the primary efficacy endpoint in Phase III clinical trials. GR2001 is a recombinant humanized monoclonal antibody against tetanus toxin that can specifically bind to TeNT-Hc, blocking its entry into neuronal cells and exerting passive immunity
According to the Zhitong Finance APP, Genrix Bio (688443.SH) announced that its GR2001 injection for passive immunity against tetanus has reached the primary efficacy endpoint in the Phase III clinical trial. The company has submitted a new drug application to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), which has been accepted.
The GR2001 injection is a monoclonal antibody of recombinant humanized anti-tetanus neurotoxin (Tetanus Neurotoxin, TeNT) independently developed by the company, classified as a Class 1 therapeutic biological product, with the target action site being the C-terminal of TeNT heavy chain (TeNT-Hc). This product can exert passive immunity by specifically binding to TeNT-Hc and blocking its entry into neuronal cells