Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) may 22 announced that the phase I clinical trial scheme of Zhongsheng RuiChuang oral anti novel coronavirus 3CL protease inhibitor ray1216 tablets, a holding subsidiary of Zhongsheng RuiChuang, was approved by the ethics committee of the first hospital of Jilin University, and the first subject was enrolled.
Ray1216 is a powerful, broad-spectrum anti covid-19 virus 3CL protease inhibitor developed by Zhongsheng RuiChuang and with global independent intellectual property rights. It can inhibit the cleavage of the virus precursor protein by acting on the novel coronavirus main protease (MPRO, 3clpro), and then block the virus replication to achieve the anti covid-19 virus effect.
The phase I clinical trial of ray1216 tablets is a randomized, double-blind, placebo-controlled, single / multiple dose escalation study, which mainly evaluates the safety, tolerance, pharmacokinetic characteristics and the effect of food on pharmacokinetics of ray1216 tablets in healthy subjects, so as to provide a basis for the determination of the administration scheme of subsequent phase II / III clinical trials of ray1216 tablets.
Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) said that the first subject was enrolled in the phase I clinical study of ray1216 project, which did not have a significant impact on the company’s short-term financial status and operating performance. In addition, due to the long research and development cycle and uncertain clinical effect of cod-19 mutation, vid-19 research and development projects have not reached the expected level, and vid-19 mutation prevention and control projects have uncertain regional risk. The clinical trial progress, review and approval results and future product market competition pattern of ray1216 project are uncertain.
