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口服降糖三药联合固定复方制剂
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恒瑞医药:恒格列净瑞格列汀二甲双胍缓释片(Ⅰ)、(Ⅱ)(HR20031 片)获批上市
Zhi Tong Cai Jing· 2025-10-24 09:59
Group 1 - Company announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the launch of HR20031 tablets, which is China's first self-developed oral hypoglycemic combination fixed-dose formulation [1] - HR20031 tablets consist of three active ingredients: Prandial Glucose Regulators, Regaglitin, and Metformin, and are intended for adult patients with type 2 diabetes who have inadequate blood sugar control after Metformin treatment [2] - The product aims to simplify the treatment regimen by reducing the number of medications taken, thereby improving patient adherence to therapy [2] Group 2 - Diabetes has become the third most serious chronic disease affecting human health, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The blood sugar control rate among type 2 diabetes patients is only 50.1%, indicating a significant need for effective treatment options [2] - The total research and development investment for HR20031 tablets has reached approximately 189.24 million yuan [2]
恒瑞医药:子公司山东盛迪医药获批首个自主研发口服降糖三药联合制剂上市
Hua Er Jie Jian Wen· 2025-10-24 09:13
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]