The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that the product 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), a subsidiary controlled by the Company, and Vigonvita Life Sciences Co., Ltd. (Vigonvita), reached its primary endpoint in a phase III registrational clinical study (NCT05341609) of VV116 versus nirmatrelvir tablet/ritonavir tablet (namely PAXLOVID) for early treatment of mild to moderate coronavirus disease 2019 ("COVID-19"). The Company will communicate with the regulatory authority in respect of the submission of new drug application ("NDA") in the near future. ABOUT VV116: In September 2021, JunTop Biosciences entered into a cooperative development agreement with Vigonvita to jointly undertake the clinical development and commercialization of VV116 in the cooperation territory, being the whole world except for the following four territories, namely the five Central Asian countries (Kazakhstan, Uzbekistan, Kyrgyzstan, Tajikistan and Turkmenistan), Russia, North Africa (Egypt, Libya, Tunisia, Algeria, Morocco and Sudan), and the Middle East (19 countries including Saudi Arabia, Iran, Iraq, Turkey, Israel, etc.).

VV116 showed good safety, tolerability and pharmacokinetics in healthy subjects, and the three phase I clinical study results have been published online in Acta Pharmacologica Sinica, a renowned journal in the pharmaceutical field. Currently, VV116 is under the stage of international multi-center phase III clinical studies, and several clinical studies for patients with mild to moderate and moderate to severe COVID-19 are in progress. About Progress of The Clinical Study (Nct05341609): The NCT05341609 study is a multi-center, single-blind, randomized, controlled phase III clinical study to evaluate the efficacy and safety of VV116 versus nirmatrelvir tablet/ritonavir tablet (namely PAXLOVID) for early treatment of patients with mild to moderate COVID-19.

The principal investigator of the study is academician Ning Guang of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, and 822 patients have been actually enrolled. Its primary endpoint is "time to sustained clinical recovery", and its secondary endpoints include, among other things, "percentage of participants who have progression of COVID-19 (defined as progression to severe and/or critical COVID-19 or death from any cause) by Day 28". The results of the clinical study showed that VV116 for the early treatment of mild to moderate COVID-19 reached the primary endpoint in the clinical study.

According to the laws and regulations in relation to drug registration of the PRC, the drug shall be subject to clinical research, and review and approval from the National Medical Products Administration before its production and marketing. The Company will communicate with the drug regulatory authority in respect of the submission of NDA in the near future.