石药百克生物发力:依达格鲁肽α注射液获受理,肥胖及代谢疾病有新招
Ge Long Hui·2025-10-15 20:03

Core Viewpoint - The announcement by the company regarding the acceptance of the new drug application for the injection of Idaglutide α by the NMPA in China marks a significant step in the management of obesity and overweight in adults, emphasizing its potential benefits in weight management and metabolic health [1][3]. Group 1: Product Details - Idaglutide α injection is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein that requires weekly administration [3]. - The drug selectively binds and activates GLP-1 receptors, leading to appetite suppression and reduced food intake, which contributes to weight loss [3]. - It also lowers blood glucose levels in a glucose-dependent manner and improves cardiovascular and metabolic indicators [3]. Group 2: Clinical Trial Results - The new drug application is primarily based on a key Phase 3 clinical trial involving overweight adults with at least one weight-related comorbidity [4]. - Results indicated that the product significantly reduced patient weight, waist circumference, blood glucose, blood pressure, and blood lipids compared to a placebo, providing cardiovascular and metabolic benefits [4]. - The safety and tolerability of the product were found to be good, with lower rates of gastrointestinal adverse events and treatment discontinuation due to adverse events [4]. - The dose escalation regimen can reach the target maintenance dose within just four weeks, making it a quick and convenient option for patients [4]. - Currently, two Phase 3 clinical trials for the product in patients with type 2 diabetes are actively progressing, potentially benefiting a larger patient population [4].