Core Viewpoint - The announcement highlights the acceptance of a new drug application for the product Icodextrin α injection by the National Medical Products Administration of China, aimed at long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered weekly [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss while also lowering blood glucose levels and improving cardiovascular and metabolic indicators [1] Group 2: 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 showed significant weight reduction compared to placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit a larger patient population [2]
石药集团：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