Securities code: Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) Announcement No.: 2022056
Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317)
About the holding subsidiary’s class I innovative drug ray1216 tablets
Announcement on the completion of phase I clinical trial and the enrollment of the first subject
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Recently, Guangdong Zhongsheng RuiChuang Biotechnology Co., Ltd. (hereinafter referred to as “Zhongsheng RuiChuang”), a holding subsidiary of Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) company (hereinafter referred to as “the company”), took the oral anti novel coronavirus 3CL protease inhibitor ray1216 tablets for phase I clinical trial, which was approved by the ethics committee of the first medical College of Jilin University, and completed the enrollment of the first subject. The details are as follows:
1、 Phase I clinical trial of ray1216 tablets
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 impact 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.
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 virus precursor protein by acting on the novel coronavirus main protease (MAI nprotease, MPRO, 3clpro), and then block virus replication to achieve the anti covid-19 virus effect.
After the clinical trial of ray1216 tablets was approved by the State Drug Administration, zhongshengruichuang immediately organized the phase I clinical study according to the requirements of the notice of approval of drug clinical trial, and obtained the consent of the ethics committee of the first hospital of Jilin University. Recently, zhongshengruichuang completed the enrollment and administration of the first subject. Zhongsheng RuiChuang will continue to promote clinical research with high quality and speed according to relevant requirements.
2、 Risks and implications for the company
Securities code: Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) Announcement No.: 2022056
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 view of the long cycle and large investment of clinical trial research, the rapid mutation of covid-19 virus, the uncertain epidemic area, and the increased prevention and control of covid-19, there is a risk that the promotion of R & D projects and the effect of R & D do not meet the expectations. The clinical trial progress, review and approval results and future product market competition pattern of ray1216 project are uncertain.
Whether the drugs can be approved for listing, the time of approval for listing, and the production and sales after listing are uncertain. The time when ray1216 project will have an impact on the company’s performance is uncertain. The company will perform the obligation of information disclosure for the follow-up progress as required. Please pay attention to the investment risks.
It is hereby announced.
May 22, 2002 board of directors
