Gusen Pharmaceuticals Receives IND Acceptance for Oral Anti-COVID-19 Small Molecule Drug GS-00202

VCBeat News has learned that Gushen Pharmaceutical recently received a Clinical Trial Application Acceptance Notice from the National Medical Products Administration (NMPA) for GS-00202, an innovative small-molecule oral drug for the treatment of COVID-19.

GS-00202 is a 3CLpro inhibitor benchmarked against Pfizer’s nirmatrelvir, clinically intended for the treatment of mild-to-moderate COVID-19. It demonstrates best-in-class potential among drugs targeting the same mechanism, effectively inhibiting SARS-CoV-2, reducing viral shedding and post-infection sequelae, and contributing to a comprehensive prevention and control closed loop integrating testing, vaccination, management measures, and specific therapeutics.

This project has received full support from the national and Guangdong Provincial science and technology departments’ emergency task forces for COVID-19, and has entered the rolling rapid review channel of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA). It is poised to obtain clinical trial approval and initiate Phase I clinical trials.