GuSen Pharma's Subsidiary Guangzhou GuSen Pharmaceutical Receives NMPA Clinical Approval for Oral Anti-COVID-19 Drug GS-00202

VCBeat News learned that on September 6, Gusen Pharmaceutical received clinical trial approval from the National Medical Products Administration (NMPA) for GS-00202, an innovative small-molecule oral anti-COVID-19 drug.

It is reported that the Phase I clinical trial for this project will commence immediately and rapidly advance to Phase III, with the aim of achieving market approval as quickly as possible. Notably, the Phase III clinical program plans to conduct a head-to-head, double-blind, multicenter trial comparing GS-00202 with Pfizer’s nirmatrelvir, to further validate the best-in-class therapeutic potential of GS-00202 among drugs targeting the same mechanism.

To accelerate industrialization, Gushen has established strategic partnerships with two pharmaceutical companies to produce high-quality GS-00202 active pharmaceutical ingredient (API) and finished drug products in manufacturing facilities compliant with domestic and US/EU cGMP requirements, under the Marketing Authorization Holder (MAH) framework.