信达生物(01801)：玛仕度肽高剂量9mg上市申请获国家药品监督管理局受理

Core Viewpoint - The application for the high-dose 9mg of Xinermy® (Mastudipeptide injection) for long-term weight control in adults with moderate to severe obesity has been accepted by the National Medical Products Administration (NMPA) in China, providing a new effective and safe treatment option beyond weight loss surgery for this population [1][2]. Group 1: Clinical Study Results - The application is based on the outstanding results of the Phase III clinical study GLORY-2, where the 9mg group showed an average weight reduction of 18.55% at week 60, compared to 3.02% in the placebo group, with 44.0% of participants achieving a weight loss of 20% or more [1][2]. - In participants without type 2 diabetes, the 9mg group achieved an average weight reduction of 20.08% at week 60, while the placebo group had a reduction of 2.81%, with 48.7% of the 9mg group achieving a weight loss of 20% or more [2]. - The study also noted a significant reduction in liver fat content, with an average percentage decrease of 71.9% from baseline, along with improvements in key cardiovascular metabolic indicators such as blood pressure, blood lipids, blood uric acid, and waist circumference [2]. Group 2: Safety and Regulatory Aspects - The safety profile of the 9mg dosage is favorable, with no new safety signals identified [2]. - The company plans to collaborate closely with regulatory authorities to expedite the approval of this important therapy to serve a broad patient population [3]. Group 3: Market Positioning - Xinermy® (Mastudipeptide injection) 9mg is currently the only GLP-1 class drug that can achieve over 20% weight loss in one year through a two-step dosing titration, providing evidence-based medicine for effective weight management in moderate to severe obesity patients [3]. - The development strategy has evolved from targeting a broad overweight/obese population with 2-4-6mg dosages to now focusing on moderate to severe obesity with 3-6-9mg dosages, reflecting deep scientific insights and clear market demand for personalized treatment solutions [3].