Posted by Michael Wonder on 30 Jan 2023
Junshi Biosciences announces approval for marketing of VV116 in China
30 January 2023 - Shanghai Junshi Biosciences announced today that the NMPA has conducted urgent review and approval under special examination and approval of drugs, and conditionally approved for marketing deuremidevir hydrobromide tablets (project code: JT001/VV116), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate COVID-19.
This approval is mainly based on a multi-center, double-blind, randomised, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of VV116 among mild to moderate COVID-19 patients with or without high risk of progression to severe COVID-19.
