日前，信达生物制药企业生产负责人表示全球首个且唯一获批上市的双靶点减重药物玛仕度肽，从去年 2月提交减重适应症上市申请，到今年6月获批上市，凭借其独特的双靶点设计，成为搅动国际减重药物 市场的"破局者"。 传统的药品上市审评审批标准与企业实际需求之间的差距仍然存在。"我们希望实现多肽类化药与生物 制品共线生产，但常规审批难以支持这一创新需求。"殷则阳回忆说。 有别于一般医疗器械生产、检验和出厂放行过程，超大型有源医疗设备需要在医疗机构现场组装调试和 检验。此类产品尚无现场检查指导原则，企业对注册质量体系核查模式和流程不甚了解，省药监局与企 业一路"摸着石头过河"。 药品上市后表现"炸场"，成为企业重要的营收增长极。而快速上市的背后，得益于江苏健全完善的体制 机制，着力实现全链条突破与赋能，促进各类先进生产要素向发展新质生产力集聚。 接到企业诉求后，省核查中心积极向国家药监局核查机构汇报，向外省检查机构同行交流请教，学习掌 握同类产品检查方式方法和关注的风险点，安排工作小组对接和跟踪服务，以"行业专家"为目标，参与 相关检查核查规范性文件的制定，积极提升专业水平，为检查争取有利条件，一路助推实现"零的突 破"。 ...

Core Insights - The global weight loss drug market has entered a "dual-target era" with the approval of the first GCG/GLP-1 dual receptor agonist, Mazdutide, by China's National Medical Products Administration (NMPA) [1][6][15] - Novo Nordisk also presented its new GLP-1/insulin receptor dual agonist, Amycretin, at the 85th American Diabetes Association (ADA) Scientific Sessions [4][11] Group 1: Mazdutide - Mazdutide is the first approved GCG/GLP-1 dual receptor agonist, utilizing a unique mechanism to achieve metabolic regulation through dual pathways [8][10] - In the Phase III GLORY-1 study, the 6mg dose group achieved an average weight loss of 14.8% after 48 weeks, with nearly half of the patients losing over 15% of their body weight [9][10] - The drug also significantly improved metabolic indicators, with an 80.24% average reduction in liver fat content (LFC) in the 6mg group, and 77.3% of patients achieving liver fat resolution [10][14] Group 2: Amycretin - Amycretin, developed by Novo Nordisk, is a long-acting GLP-1 and insulin receptor dual agonist that shows significant weight loss effects in clinical trials [11][13] - In the Phase Ib/IIa study, the high-dose group (60mg) achieved an average weight loss of 24.3% after 36 weeks, significantly outperforming existing GLP-1 drugs [13] - The safety profile of Amycretin is favorable, with most adverse reactions being mild to moderate gastrointestinal symptoms, and a low discontinuation rate of less than 5% [13][14] Group 3: Market Implications - The approval of Mazdutide and Amycretin provides safer and more effective treatment options for the approximately 500 million adults in China who are overweight or obese [14] - Despite the presence of 14 other tri-target weight loss drugs in clinical development, Mazdutide and Amycretin are expected to maintain a leading advantage in the next 3-5 years due to their first-in-class status and validated clinical efficacy [14][15] - The competition between these two drugs reflects the growing demand for healthier living among millions of obese patients, indicating a shift towards comprehensive management of metabolic syndromes beyond just weight loss [15]