Group 1 - The core product developed by the company, a combination of Ploglitazone, Dapagliflozin, and Metformin, has been approved for clinical trials in China by the National Medical Products Administration [1] - This product is the world's first clinically approved three-drug combination formulation for diabetes management [1] - The mechanism of action of the components is complementary, addressing multiple pathophysiological mechanisms of diabetes, which can effectively control blood sugar levels [2] Group 2 - The approved clinical indication is for adult patients with type 2 diabetes who have inadequate blood sugar control with Metformin alone, in conjunction with diet and exercise [2] - The combination therapy aims to reduce the number of medications needed, simplify the treatment regimen, and improve patient adherence to therapy [2] - This product will provide a new treatment option for type 2 diabetes patients and further enrich the company's product line in the metabolic disease sector [2]

Core Viewpoint - The approval of the combination drug consisting of Ploglitazone, Dapagliflozin, and Metformin by the National Medical Products Administration of China marks a significant advancement in diabetes treatment, providing a new therapeutic option for type 2 diabetes patients [1][2] Group 1: Product Approval and Composition - The product is the first globally approved clinical combination formulation of Ploglitazone, Dapagliflozin, and Metformin [1] - Ploglitazone is a DPP-4 inhibitor that enhances insulin secretion and improves blood glucose control [1] - Dapagliflozin is an SGLT2 inhibitor that promotes urinary glucose excretion by reducing glucose reabsorption [1] - Metformin is a biguanide that improves glucose tolerance and lowers both fasting and postprandial blood glucose levels [1] Group 2: Clinical Application and Benefits - The approved clinical indication is for use in adults with type 2 diabetes who have inadequate blood glucose control with Metformin alone, in conjunction with diet and exercise [2] - The combination drug's complementary mechanisms address multiple pathophysiological aspects of diabetes, effectively controlling blood sugar levels [2] - The formulation simplifies the treatment regimen, reduces the number of medications needed, and enhances patient adherence to therapy, indicating high clinical development value [2] - This product will provide new treatment options for type 2 diabetes patients and expand the company's product line in the metabolic disease sector [2]

Core Viewpoint - The approval of the combination drug by the National Medical Products Administration of China marks a significant advancement in diabetes treatment, providing a new therapeutic option for patients with type 2 diabetes [1][2]. Group 1: Product Approval and Composition - The product, a combination of Ploglitazone, Dapagliflozin, and Metformin, is the first of its kind globally to receive clinical trial approval [1]. - Ploglitazone is a DPP-4 inhibitor that enhances insulin secretion and improves glucose sensitivity [1]. - Dapagliflozin is an SGLT2 inhibitor that promotes urinary glucose excretion by reducing glucose reabsorption [1]. - Metformin is a biguanide that improves glucose tolerance and lowers both fasting and postprandial blood glucose levels [1]. Group 2: Clinical Application and Benefits - The approved clinical indication is for use in adults with type 2 diabetes who have inadequate blood sugar control with Metformin alone, in conjunction with diet and exercise [2]. - The complementary mechanisms of the three-drug combination effectively address multiple pathophysiological aspects of diabetes, enhancing blood sugar control [2]. - The product is expected to simplify treatment regimens, reduce the number of medications needed, and improve patient adherence to therapy, indicating high clinical development value [2].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布，本集團開發的普盧格列汀達格列淨二甲雙胍緩釋片（「該產品」）已獲中華人民共和國國 家藥品監督管理局批准，可在中國開展臨床試驗。 該產品為全球首款獲批臨床的由普盧格列汀、達格列淨和鹽酸二甲雙胍組成的三藥聯合複 方製劑。普盧格列汀是一種二肽基肽酶-4（「DPP -4」）抑制劑，通過抑制DPP -4，使內源性活 性胰高血糖素樣肽-1 (GLP -1)水平升高，從而增強β細胞和α細胞對葡萄糖的敏感性，增加 葡 萄 糖 刺 激 的 胰 島 素 分 泌 ， 並 增 強 葡 萄 糖 對 胰 高 血 糖 素 分 泌 的 抑 制 作 用 ， 進 而 改 善 高 血 糖。達格列淨是一種鈉—葡萄糖協同轉運蛋 ...