Core Viewpoint - The article discusses the recent acceptance of the new drug application for Idaglutide α injection by the China NMPA, developed by Shiyao Group's subsidiary, aimed at long-term weight management for overweight or obese adults [2][4]. Group 1: Drug Details - Idaglutide α injection is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein that requires weekly administration [2]. - The drug works by selectively binding and activating GLP-1 receptors, leading to appetite suppression and reduced food intake, thereby aiding in weight loss [4]. - It also lowers blood glucose levels in a glucose-dependent manner and improves cardiovascular and metabolic indicators [4]. Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase 3 clinical trial involving overweight adults with at least one weight-related comorbidity [4]. - Results showed that Idaglutide α significantly reduced body weight compared to a placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [4]. - The drug demonstrated good safety and tolerability, with lower rates of gastrointestinal adverse events and treatment interruptions due to adverse events, and a quicker, simpler dose escalation scheme that reaches the target maintenance dose in just four weeks [4].
速递｜石药集团GLP-1新药依达格鲁肽α，减重适应症提交上市申请