Core Viewpoint - The approval of the second indication for the drug Masitide injection by the National Medical Products Administration marks a significant advancement for the company in the treatment of type 2 diabetes, following its earlier approval for weight management [2][3]. Group 1: Product Approval and Features - Masitide injection has received approval for blood sugar control in adult patients with type 2 diabetes, following its earlier approval for weight loss in June [2]. - The injection pen features a hidden needle design and is a single-use device, utilizing X-cut technology to reduce injection pain [2]. Group 2: Clinical Research and Efficacy - Masitide is the world's first approved dual receptor agonist for GCG/GLP-1, improving insulin secretion and insulin resistance [2]. - The approval is based on two phase III clinical studies conducted in China, demonstrating that Masitide outperforms placebo and Dulaglutide 1.5mg in blood sugar control and weight management for adult type 2 diabetes patients [2]. - The drug also shows improvements in various cardiovascular, liver, and kidney-related metabolic indicators [2]. Group 3: Weight Management Results - In weight management, clinical studies indicate that patients treated with Masitide experienced an average weight loss of 21%, over 80% reduction in liver fat content, and reductions in waist and neck circumference [3]. - Multiple health indicators, including blood sugar, blood pressure, blood lipids, uric acid, and transaminases, have also shown improvement [3]. Group 4: Ongoing Research - Currently, there are four ongoing phase III clinical studies for Masitide, targeting populations with moderate to severe obesity, metabolic-related fatty liver disease (MAFLD), and obstructive sleep apnea (OSA) associated with obesity [3]. - A head-to-head comparison study with Semaglutide is being conducted among obese type 2 diabetes patients [3].
信达生物：减肥药玛仕度肽获批糖尿病适应症 为全球首个GCG/GLP-1双受体激动降糖药