Core Viewpoint - The new drug application for the injection of Idaglutide α developed by Stone Pharmaceutical Group has been accepted by the National Medical Products Administration of China, targeting long-term weight management in overweight or obese adults [1] Company Summary - Stone Pharmaceutical Group's subsidiary, Stone Pharmaceutical Group Baike (Shandong) Biopharmaceutical Co., Ltd., is responsible for the development of the new drug [1] - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] Product Details - The drug is classified as a Class 1 new drug for therapeutic biological products, aimed at weight management alongside diet control and increased physical activity [1] - It selectively binds and activates GLP-1 receptors, leading to appetite suppression and reduced food intake, while also lowering blood glucose levels in a glucose-dependent manner [1] - The product shows benefits in cardiovascular and metabolic indicators [1] Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results indicate that the product significantly reduces weight compared to a placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids [1] - The safety and tolerability of the product are reported to be good, with lower rates of gastrointestinal adverse events compared to similar marketed drugs [1] Dosing and Administration - The dosing regimen is noted to be quicker and simpler, achieving the target maintenance dose within just four weeks [1]
石药集团(01093.HK)：依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理