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2型糖尿病综合管理
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信达生物:玛仕度肽获中国国家药品监督管理局批准用于成人2型糖尿病患者的血糖控制
Zhi Tong Cai Jing· 2025-09-19 09:35
Core Viewpoint - The approval of the new drug application (NDA) for Masitide injection, a dual receptor agonist for glucagon (GCG) and glucagon-like peptide-1 (GLP-1), marks a significant advancement in the treatment of type 2 diabetes in China, addressing the urgent need for effective blood sugar control and weight management among the country's large diabetic population [1][2][5] Industry Overview - China has the highest number of adult diabetes patients globally, with approximately 140 million individuals, accounting for about one-quarter of the world's diabetic population [2] - The management of diabetes is evolving from mere blood sugar control to a more comprehensive approach that includes patient-centered strategies focusing on blood sugar, weight management, and the prevention of cardiovascular and renal complications [2] Product Details - Masitide is the first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, expected to provide multiple benefits including blood sugar control, weight loss, and improvements in cardiovascular, liver, and kidney health [1][3][5] - The approval is based on two Phase III clinical studies demonstrating that Masitide outperforms placebo and dulaglutide 1.5mg in terms of blood sugar control and weight loss, while also improving various metabolic indicators [3][4] Safety and Efficacy - The safety profile of Masitide is consistent with previous studies of other GLP-1 receptor agonists, with no new safety risks identified [4] - The innovative injection pen for Masitide enhances convenience and safety, featuring a hidden needle design to reduce injection anxiety and a single-use mechanism to minimize contamination risks [4] Future Outlook - The successful launch of Masitide reflects the regulatory authority's recognition of its clinical value and safety, reinforcing the company's strength in metabolic treatment innovation [5] - The company aims to continue its focus on developing high-quality biopharmaceuticals across various therapeutic areas, including oncology, autoimmune diseases, metabolism, cardiovascular health, and ophthalmology, aligning with the goal of achieving "Healthy China 2030" [5]