Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has risen over 4%, currently trading at HKD 9.83 with a transaction volume of HKD 899 million, following the acceptance of its上市申请 for the Ploglitazone Metformin Sustained Release Tablets by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group is actively advancing the clinical development of a combination therapy consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [1] - Ploglitazone is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion in response to glucose and improving hyperglycemia [1] - Metformin is a biguanide that reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases insulin sensitivity by enhancing peripheral glucose uptake and utilization [1]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has risen over 4%, currently trading at HKD 9.83 with a transaction volume of HKD 899 million, following the acceptance of its上市申请 for the Ploglitazone Metformin Sustained Release Tablets by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group is actively advancing the clinical development of a combination therapy consisting of Ploglitazone, Dapagliflozin, and Metformin, aiming to benefit more patients [1] - Ploglitazone is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion in response to glucose and improving hyperglycemia [1] - Metformin is a biguanide that reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases insulin sensitivity by enhancing peripheral glucose uptake and utilization [1]

Core Viewpoint - The announcement indicates that the application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets has been accepted by the National Medical Products Administration of China, representing a significant step in the company's innovative drug development [1] Group 1: Product Development - The product is a Class 1 innovative drug combining Ploglitazone and Metformin in an extended-release formulation, aimed at treating adult patients with Type 2 Diabetes Mellitus (T2DM) [1] - The intended indication is for patients with inadequate blood sugar control on Metformin monotherapy or those currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have demonstrated that Ploglitazone shows good efficacy and safety in initial treatment of T2DM patients and those with inadequate control on Metformin monotherapy [2] - The combination of Ploglitazone and Metformin has shown significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia compared to Metformin alone [2] - The product has a low potential for drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] Group 3: Market Strategy - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]

Core Viewpoint - The application for the上市 of Shijiazhuang Pharmaceutical Group's innovative drug, Ploglitazone Metformin Sustained-Release Tablets, has been accepted by the National Medical Products Administration of the People's Republic of China, indicating a significant step in the company's product development pipeline [1] Group 1 - The product is a combination of the innovative drug Ploglitazone and Metformin, classified as a type 2.3 chemical drug registration, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - Ploglitazone is a DPP-4 inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion and suppressing glucagon secretion to improve hyperglycemia [1] - Metformin reduces hepatic glucose production and intestinal glucose absorption while increasing peripheral tissue sensitivity to insulin [1] Group 2 - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in T2DM patients, showing significant and sustained blood sugar reduction compared to Metformin monotherapy, with a lower incidence of hypoglycemia [2] - The combination of Ploglitazone and Metformin has a lower likelihood of drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]

Core Viewpoint - The application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets developed by the company has been accepted by the National Medical Products Administration of China [1] Group 1: Product Information - The product is a first-class innovative drug combining Ploglitazone and Metformin in a sustained-release formulation, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - The proposed indication is for use in T2DM patients who have inadequate blood sugar control with Metformin monotherapy or are currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in initial treatment of T2DM patients and those with inadequate blood sugar control on Metformin monotherapy [2] - Compared to Metformin monotherapy, the combination of Ploglitazone and Metformin shows significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia [2] - The product has a low potential for drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] Group 3: Treatment Simplification - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control compared to the use of two separate formulations [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]

在初始治療的T2DM患者以及二甲雙胍單藥治療血糖控制不佳的T2DM患者中開展的Ⅲ期臨 床試驗證實，普盧格列汀具有良好的有效性和安全性。與二甲雙胍單藥治療相比，普盧格 列 汀 聯 合 二 甲 雙 胍 具 有 顯 著 且 持 久 的 降 糖 作 用 ， 低 血 糖 發 生 率 較 低 ， 且 安 全 性 良 好 。 此 外，該產品與其他藥物發生相互作用的可能性較低，輕中度腎功能不全患者服用該產品時 無需調整劑量。與兩種單方製劑聯合應用相比，複方製劑可簡化治療方案、顯著提高患者 依從性，從而更有效地控制血糖。 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 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 普盧格列汀二甲雙胍緩釋片的上市申請 獲國家藥監局受理 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 ...