Shanghai Junshi Biosciences Co.Ltd(688180) may 23 announcement, The product of oral nucleoside anti sars-cov-2 drug vv116 tablets (project code: jt001/vv116, hereinafter referred to as “vv116”) jointly developed by the holding subsidiary Shanghai juntuo Biomedical Technology Co., Ltd. (hereinafter referred to as “juntuo biomedical”) and Suzhou Wangshan wangshui biomedical Co., Ltd. (hereinafter referred to as “Wangshan wangshui”) is used for the treatment of mild to moderate novel coronavirus pneumonia (hereinafter referred to as “covid-19”) with binematavir tablets / ritonavir tablets (paxlovid) The phase III registered clinical study of early treatment (nct05341609) reached the primary endpoint preset by the protocol. The company will communicate with the regulatory authorities on the submission of new drug listing applications in the near future.
Nct05341609 study is a multicenter, single blind, randomized, controlled phase III clinical study to evaluate the efficacy and safety of vv116 in the early treatment of patients with mild to moderate covid-19. Ning Guang, academician of Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University, served as the main investigator of the study. 822 patients were actually enrolled. The primary endpoint was “time to continuous clinical recovery”, and the secondary endpoint included “percentage of subjects with covid-19 progression (defined as severe / critical covid-19 or all-cause death) by the 28th day”. The results of this clinical study showed that vv116 for the early treatment of mild to moderate covid-19 reached the primary endpoint preset by the clinical protocol.
