Securities code: 002294 securities abbreviation: Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) No.: 2022-013
Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Announcement on the progress of sal0107 clinical trial
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without falsehood
False records, misleading statements or material omissions.
Recently, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) (hereinafter referred to as “the company”) alisartan axetil amlodipine tablets (project code: sal0107) have completed the enrollment of all subjects according to the phase III clinical protocol. The details are as follows:
1、 Clinical progress
Sal0107 shall organize and implement clinical trials according to relevant national requirements after obtaining clinical approval. As of the disclosure date of this announcement, all clinical enrollment of phase III clinic has been completed, and clinical follow-up will continue to be carried out in the follow-up. 2、 Other relevant information
Sal0107 is ARB / CCB compound preparation, and its indication is essential hypertension. After the product is listed, it will form a strategic synergy with the company’s listed class 1.1 antihypertensive drug xinlitan (alisartan ester tablets), expand the application scope of xinlitan, further prolong the product life cycle of xinlitan, and enrich the company’s innovative product pipeline in the field of cardio cerebrovascular.
The current clinical trial is a randomized, double-blind trial. At present, in order to complete the enrollment of subjects, the clinical trial results can be judged only after the statistical analysis is completed, and there is some uncertainty. The company will carry out clinical trials in accordance with the relevant provisions and requirements of the national drug registration, and apply for production according to the procedures after the clinical trials are successful. According to the general industry characteristics, the listing of drugs is uncertain. The R & D cycle is affected by several factors. The cycle is long and the risk is high. It will not have a significant impact on the company’s performance in the short term. The company will timely perform the obligation of information disclosure on relevant follow-up progress as required. Please invest rationally and pay attention to risks.
It is hereby announced
Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) board of directors
February 7, 2002
