目前，糖尿病已经成为继肿瘤、心脑血管病之后第三位严重危害人类健康的慢性疾病。国际糖尿病联盟 (IDF)第11版数据显示，中国成人(20-79岁)糖尿病患病率达13.79%，患者数量达1.48亿，已经成为糖尿 病第一大国，其中2型糖尿病(T2DM)患者临床用药依从性不佳，血糖控制率仅有50.1%。HR20031片是 脯氨酸恒格列净、磷酸瑞格列汀和盐酸二甲双胍的固定复方制剂，有望通过三种不同作用机制达到降血 糖作用，拟每日一次口服用于治疗经二甲双胍治疗血糖控制不佳的成人2型糖尿病患者，可通过减少服 药数量简化降糖方案，提高患者的治疗依从性。经查询，国外已上市的同类三药联合固定复方制剂有勃 林格殷格翰-礼来糖尿病联盟的TRIJARDY XR(恩格列净/利格列汀/盐酸二甲双胍缓释片)，国内尚无同 类产品获批上市。截至目前，HR20031片相关项目累计研发投入约18,924万元。 恒瑞医药（600276）(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公司山东 盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")的通知，批准公司恒格列净瑞格列 汀二甲双胍缓释片(Ⅰ)、(Ⅱ)(HR ...

Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for its subsidiary Shandong Shengdi Medicine to launch HR20031 tablets, a fixed-dose combination of three oral hypoglycemic agents, marking a significant advancement in diabetes treatment in China [1] Product Details - HR20031 tablets are the first self-developed oral hypoglycemic combination product in China, available in specifications of 5/50/750mg and 10/100/1000mg [1] - The product is classified as a chemical drug category 2.3 and is a prescription medication [1] - It is indicated for adults with type 2 diabetes who have inadequate blood sugar control despite treatment with metformin, in conjunction with diet and exercise [1] Mechanism and Market Position - The product utilizes three different mechanisms to lower blood sugar, simplifying the medication regimen and potentially improving patient adherence [1] - There are currently no similar products approved in China, while the international equivalent is TRIJARDY XR [1] R&D Investment - The cumulative research and development investment for HR20031 tablets has reached approximately 189.24 million yuan [1] Production and Sales Uncertainty - The company has indicated that there are uncertainties associated with the production and sales of the drug, advising investors to be cautious [1]