By Fineline Cube 
China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) recently announced that its New Drug Application (NDA) for GR2001, an in-house developed Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). The application seeks approval for GR2001 as a passive immunization against tetanus.
GR2001 Monoclonal Antibody
GR2001 is a monoclonal antibody (mAb) targeting tetanus neurotoxin (TeNT). It has demonstrated significant promise in addressing tetanus through passive immunization. The drug has reached the primary efficacy endpoint in a Phase III clinical trial, underscoring its potential as an effective treatment option.
Market Landscape
Currently, there is only one similar drug approved in China for passive immunization against tetanus. The acceptance of the NDA for GR2001 marks a step forward in expanding treatment options in this space.-Fineline Info & Tech