Junshi Biosciences Announces Lancet Infectious Diseases Publication of Results from the 2nd Phase 3 Study of VV116 for Treating COVID-19

SHANGHAI, China, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced a new publication in the Lancet Infectious Diseases. The paper presents final analysis results from a multicenter, double-blind, phase 3, randomized controlled study (NCT05582629) evaluating the efficacy and safety of VV116 (mindeudesivir hydrobromide tablets, product code: VV116/JT001) in patients with mild-to-moderate COVID-19. This study demonstrated that VV116 significantly reduced the time to sustained clinical symptom resolution compared to placebo, with no observed safety concerns.

During the study, academician Lanjuan LI, Director of the State Key Laboratory for Diagnosis & Treatment of Infectious Diseases (Zhejiang University), served as the primary investigator and corresponding author. Co-first authors include Prof. Xiaohong FAN and Prof. Yun Ling from Shanghai Public Health Clinical Center, Prof. Xiahong DAI, Prof. Lihua WU and Prof. Lingling TANG from Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University Shulan International Medical College.

Efficacy analyses were conducted on 1296 enrolled adult patients (646 in the VV116 group and 650 in the placebo group), with a median age of 35.0 years, of whom about 43.1% carried high-risk factors for progression to severe COVID-19. According to the SARS-CoV-2 genetic variation evaluated at enrollment, BA.5.2.48 and BF.7.14 were the leading subvariants.

At the interim analysis, VV116 was superior to placebo in reducing the time to sustained clinical symptom resolution among 1229 patients (hazard ratio [HR] 1.21, 95% CI 1.04–1.40; p=0.0023). In the final analysis of the study, a substantial reduction in the time to sustained clinical symptom resolution was observed with VV116 compared to placebo (median: 10.9 vs.12.9 days; HR=1.17; 95% CI: 1.04 - 1.33; p=0.0009), consistent with the interim analysis. For the elderly patient subgroup (≥60 years old), the time to sustained clinical symptom resolution was also shorter in the VV116 group compared to the placebo group, with an HR of 1.22 (95% CI: 0.74-2.01), which is consistent with the overall population.