Group 1 - The core point of the news is that the subsidiary of the company, Shijiazhuang Yiling Pharmaceutical Co., Ltd., has received acceptance from the National Medical Products Administration of China for the second marketing authorization application of semaglutide injection, aimed at long-term weight management in overweight/obese adults [1] - The product is classified as a new chemical drug under category 2.2, which contains known active ingredients and demonstrates significant clinical advantages, avoiding immunogenic substances introduced by biological fermentation processes [1] - The product works by binding to GLP-1 receptors, providing multiple benefits including weight loss, blood sugar reduction, and cardiovascular and renal protection [1] Group 2 - The application is based on a Phase III clinical trial, which showed significant weight and waist circumference reduction in non-diabetic obese adults, along with improvements in blood sugar, blood lipids, and liver enzyme levels [2] - The efficacy of the product is highly consistent with that of semaglutide developed by Novo Nordisk, with similar safety profiles and slightly lower incidence of adverse events, indicating good tolerability [2] - The product's advantages in efficacy, safety, and formulation suggest significant clinical application value [2]
石药集团(01093.HK)：司美格鲁肽注射液的第二项上市许可申请获国家药监局受理