CSPC Group (01093): The second marketing license application for simeglutide injection was accepted by the State Drug Administration

Zhitong Finance App News, Shiyao Group (01093) announced that the second marketing license application for the simeglutide injection developed by the company's subsidiary Shiyao Group Baike (Shandong) Biopharmaceutical Co., Ltd. has been accepted by the State Drug Administration of the People's Republic of China. The indication for this report is long-term weight management for adult overweight/obese patients based on diet control and increased physical activity. Previously, the marketing license application for this product intended for use in adult type 2 diabetes blood sugar control was accepted by the State Drug Administration in August 2025.

This product is a simeglutide preparation prepared by chemical synthesis. It is declared as a Class 2.2 new drug according to chemical registration classification. It is a drug with a new prescription process containing known active ingredients and has obvious clinical advantages. This product not only avoids immunogenic substances such as host proteins introduced during biological fermentation, but also ensures that the impurity level is not higher than that of simeglutide prepared by DNA recombination technology. The product works by binding to GLP-1 receptors, and can achieve comprehensive benefits in weight loss, sugar reduction, and cardiovascular and kidney protection through multiple mechanisms.

This application is based on a phase III clinical trial. The clinical trial results showed that in non-diabetic obese adult subjects, the product can significantly reduce body weight and waist circumference and improve blood sugar, blood fat and liver enzyme levels; compared with the simeglutide developed by Novo Nordisk, its efficacy is highly consistent, the safety characteristics are similar, and the incidence of adverse events is slightly lower. Based on its advantages in efficacy, safety and formulation, the product has significant clinical application value.