The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that the phase III clinical study (NCT05341609, the JT001-010 Study) of VV116 tablet (project code: JT001/VV116, VV116), an oral nucleoside analog anti-SARS-CoV-2 drug jointly developed by Shanghai JunTop Biosciences Co., Ltd. (JunTop Biosciences) and Vigonvita Life Sciences Co., Ltd. (Vigonvita), versus nirmatrelvir tablet/ritonavir tablet (namely PAXLOVID) for the early treatment of patients with mild to moderate coronavirus disease 2019 (COVID-19) who are at high risk for progression to severe COVID-19, including death, has been completed. In addition, several international multi-center phase III clinical studies of VV116 are concurrently carried out on different populations globally. About Progress Of Clinical Studies: JT001-010 study: a multi-center, single-blind (observers remain blinded), randomized, controlled phase III clinical study (NCT05341609) led by Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine and the first "head-to-head" phase III clinical study on small-molecule oral antiviral drug for COVID-19 patients in China during the prevalence of the Omicron mutant.

According to the final analysis results of the study, among full analysis set (FAS) populations, VV116 versus PAXLOVID achieved non-inferiority (HR=1.17, 95%CI:1.02~1.36) in "time to sustained clinical recovery" and the median time to sustained clinical recovery was shorter in the VV116 group than that in the PAXLOVID group (four days vs. five days). Both the VV116 and PAXLOVID groups exhibited similar results in respect of "time to sustained resolution of all target symptoms" and "time to a first negative SARS-CoV-2 test", with a median time of seven days.

At each preset time point (day 5, 7, 10, 14 and 28), the proportion of patients with clinical recovery was larger in the VV116 group than that in the PAXLOVID group. No patients in either group had progression to severe/critical COVID-19 or had died. In addition, about 3/4 of the patients in the study had vaccinated against SARS-CoV-2, and such patients have been excluded from most trials, and subgroup analysis showed that there was no statistically significant difference in the treatment results between VV116 and PAXLOVID in the vaccinated or unvaccinated population.

In terms of safety, VV116 shows fewer safety concerns than PAXLOVID. The incidence of adverse events in the VV116 group was lower than that in the PAXLOVID group (all-grade adverse events: 67.4% vs. 77.3%, Grade 3 or 4 adverse events: 2.6% vs.

5.7%). It is notable that while PAXLOVID has drug-drug interaction, VV116 does not inhibit or induce major drug metabolizing enzymes or inhibit major drug transporters and is therefore less likely to interact with the drugs for combination therapy. The above research results were recently published online in the global authoritative journal The New England Journal of Medicine (NEJM) (impact factor: 176.079).

It is the first time that NEJM published the clinical trial results of China-developed anti-SARS-CoV-2 drug. II. JT001-015 study: a multi-center, double-blind, randomized, placebo-controlled phase III clinical study (NCT05582629) to evaluate the efficacy and safety of VV116 among mild to moderate COVID-19 subjects with or without high risk.

The study has completed the first patient enrollment and drug administration in October 2022 and the company is striving to promote patient enrollment and drug administration evaluation in multiple clinical research centers in China. III. JT001-004 study: an international, multi-center, double-blind, randomized, placebo-controlled phase III clinical study (NCT05242042) to evaluate the efficacy, safety and pharmacokinetics of VV116 for early treatment of mild to moderate COVID-19 patients with high risk of progression.

The study has completed the first patient enrollment and drug administration in Shanghai Public Health Clinical Center in March 2022 and has established clinical research centers in several regions, including multiple cities in mainland China; Hong Kong, China; and the Philippines, of which patient enrollment and drug administration evaluation are progressing smoothly.