Shanghai Junshi Biosciences Co., Ltd. announced that the National Medical Products Administration 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, "VV116"), an oral nucleoside analog anti-SARS-CoV-2 drug, for the treatment of adult patients with mild to moderate coronavirus disease 2019 ("COVID-19"). VV116 is a new oral nucleoside analog antiviral drug, which can be non-covalently bound to the active center of RNA-dependent RNA polymerase of SARS-CoV-2 in the form of nucleoside triphosphate, directly inhibiting the activity of RdRp of the virus and blocking the replication of virus, thus realizing the antiviral effect. Preclinical studies have shown that VV116 exhibited significant antiviral effects against both the original COVID-19 strain and mutant strains, including Omicron, and exhibited no genetic toxicity.

VV116 was jointly developed by the Shanghai Institute of Materia Medica at the Chinese Academy of Sciences, Wuhan Institute of Virology at the Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry at the Chinese Academy of Sciences, Central Asian Center of Drug Discovery and Development of Chinese Academy of Sciences) /China-Uzbekistan Medicine Technical Park, Lingang Laboratory, Vigonvita Life Sciences Co., Ltd. and Junshi Biosciences This approval is mainly based on a multi-center, double-blind, randomized, placebo-controlled phase III clinical study (NCT05582629) 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. The study was led by academician Lanjuan LI, Director of the State Key Laboratory for Diagnosis & Treatment of Infectious Diseases (Zhejiang University) as primary investigator. The primary endpoint of the study was the time to sustained clinical symptoms resolution, while the secondary endpoints included the time to sustained clinical symptoms alleviation, percentage of participants with disease progression to severe or critical COVID-19 or death by any cause by day 28, changes in SARS-CoV-2 nucleic acid and viral load, safety, and etc.

The study results showed that as of the data cut-off date of the interim analysis, among 1,277 randomized and treated subjects, the primary endpoint, or the time from first administration to sustained clinical symptoms resolution (The score of 11 COVID-19 related clinical symptom =0 and lasted for 2 days) of the VV116 group was significantly shortened when compared with that of the placebo group, and the median time difference was 2 days; similarly, the time to sustained clinical symptoms alleviation was also significantly shortened, and the change of viral load from baseline and other virological indicators were better than those of the placebo group.