By Fineline Cube 
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the conditional approval in China for its COVID-19 therapy Mindewei (deuremidevir) has been converted to full approval by the National Medical Products Administration (NMPA). This approval is for the treatment of adult patients with mild to moderate COVID-19 infection, marking a significant step in the availability of effective treatments for the ongoing pandemic.
Development and Efficacy of Deuremidevir
Deuremidevir, a nucleoside antiviral drug, emerged from co-development between the Shanghai Institute of Materia Medica (SIMM), the Wuhan Institute of Virology, and other research institutes. The drug has demonstrated significant antiviral activity against both the original SARS-CoV-2 strain and various mutant strains, including Omicron XBB.1.16, EG.5, and JN.1. Importantly, deuremidevir has shown no genetic toxicity in relevant studies, further enhancing its safety profile.
Clinical Trial Support
The full approval of deuremidevir was supported by results from a multi-center, double-blinded, randomized, placebo-controlled Phase III study. This study evaluated the drug’s efficacy and safety in patients with mild to moderate COVID-19, with or without progression to severe high-risk factors. The positive outcomes from this study, which led to the initial conditional approval in January 2023, have now been confirmed, resulting in the conversion to full approval.
Future Prospects
The conversion of the conditional approval to full approval for Mindewei (deuremidevir) by the NMPA is a significant achievement for Shanghai Junshi Biosciences. This approval ensures that deuremidevir is now widely available for the treatment of COVID-19, providing healthcare providers with an additional effective option to manage the disease. As the pandemic continues to evolve, the availability of therapies like deuremidevir remains crucial in the global effort to control and treat COVID-19.