普卢格列汀是一种二肽基肽酶-4(DPP-4)抑制剂，可通过抑制DPP-4，使内源性活性GLP-1水平升高，从 而增加葡萄糖刺激的胰岛素分泌，并增强葡萄糖对胰高血糖素分泌的抑制作用，进而改善高血糖。二甲 双胍是一种双胍类药物，可减少肝糖生成，抑制葡萄糖的肠道吸收，并通过增加外周组织对葡萄糖的摄 取和利用而提高胰岛素敏感性。 石药集团(01093)涨超4%，截至发稿，涨3.91%，报9.83港元，成交额8.99亿港元。 消息面上，1月12日，石药集团发布公告，集团开发的普卢格列汀二甲双胍缓释片的上市申请已获中国 国家药品监督管理局受理。目前，集团正积极推进由普卢格列汀、达格列净和盐酸二甲双胍组成的三药 联合复方制剂的临床开发进程，以期使更多患者从中获益。 ...

石药集团(01093)发布公告，集团开发的普卢格列汀二甲双胍缓释片的上市申请已获中国国家药品监督 管理局受理。 该产品为集团1类创新药普卢格列汀与盐酸二甲双胍的复方缓释制剂，按照化学药品注册分类2.3类申 报，拟定适应症为"适用于成人2型糖尿病(T2DM)患者：本品配合饮食和运动治疗，用于二甲双胍单药 治疗控制不佳或正在接受普卢格列汀与二甲双胍联合治疗"。普卢格列汀是一种二肽基肽酶-4(DPP-4)抑 制剂，可通过抑制DPP-4，使内源性活性GLP-1水平升高，从而增加葡萄糖刺激的胰岛素分泌，并增强 葡萄糖对胰高血糖素分泌的抑制作用，进而改善高血糖。二甲双胍是一种双胍类药物，可减少肝糖生 成，抑制葡萄糖的肠道吸收，并通过增加外周组织对葡萄糖的摄取和利用而提高胰岛素敏感性。 在初始治疗的T2DM患者以及二甲双胍单药治疗血糖控制不佳的T2DM患者中开展的Ⅲ期临床试验证 实，普卢格列汀具有良好的有效性和安全性。与二甲双胍单药治疗相比，普卢格列汀联合二甲双胍具有 显著且持久的降糖作用，低血糖发生率较低，且安全性良好。此外，该产品与其他药物发生相互作用的 可能性较低，轻中度肾功能不全患者服用该产品时无需调整剂量。与两种 ...

在初始治疗的T2DM患者以及二甲双胍单药治疗血糖控制不佳的T2DM患者中开展的Ⅲ期临床试验证 实，普卢格列汀具有良好的有效性和安全性。与二甲双胍单药治疗相比，普卢格列汀联合二甲双胍具有 显着且持久的降糖作用，低血糖发生率较低，且安全性良好。此外，该产品与其他药物发生相互作用的 可能性较低，轻中度肾功能不全患者服用该产品时无需调整剂量。与两种单方制剂联合应用相比，复方 制剂可简化治疗方案、显着提高患者依从性，从而更有效地控制血糖。 目前，集团正积极推进由普卢格列汀、达格列净和盐酸二甲双胍组成的三药联合复方制剂的临床开发进 程，以期使更多患者从中获益。 格隆汇1月12日丨石药集团(01093.HK)宣布，集团开发的普卢格列汀二甲双胍缓释片的上市申请已获中 华人民共和国国家药品监督管理局受理。 该产品为集团1类创新药普卢格列汀与盐酸二甲双胍的复方缓释制剂，按照化学药品注册分类2.3类申 报，拟定适应症为「适用于成人2型糖尿病(「T2DM」)患者：本品配合饮食和运动治疗，用于二甲双胍 单药治疗控制不佳或正在接受普卢格列汀与二甲双胍联合治疗」。普卢格列汀是一种二肽基肽 酶-4(「DPP-4」)抑制剂，可通过抑制DPP- ...

目前，集团正积极推进由普卢格列汀、达格列净和盐酸二甲双胍组成的叁药联合复方制剂的临床开发进 程，以期使更多患者从中获益。 在初始治疗的T2DM患者以及二甲双胍单药治疗血糖控制不佳的T2DM患者中开展的Ⅲ期临床试验证 实，普卢格列汀具有良好的有效性和安全性。与二甲双胍单药治疗相比，普卢格列汀联合二甲双胍具有 显著且持久的降糖作用，低血糖发生率较低，且安全性良好。此外，该产品与其他药物发生相互作用的 可能性较低，轻中度肾功能不全患者服用该产品时无需调整剂量。与两种单方制剂联合应用相比，复方 制剂可简化治疗方案、显著提高患者依从性，从而更有效地控制血糖。 智通财经APP讯，石药集团(01093)发布公告，集团开发的普卢格列汀二甲双胍缓释片的上市申请已获中 国国家药品监督管理局受理。 该产品为集团1类创新药普卢格列汀与盐酸二甲双胍的复方缓释制剂，按照化学药品注册分类2.3类申 报，拟定适应症为"适用于成人2型糖尿病(T2DM)患者：本品配合饮食和运动治疗，用于二甲双胍单药 治疗控制不佳或正在接受普卢格列汀与二甲双胍联合治疗"。普卢格列汀是一种二肽基肽酶-4(DPP-4)抑 制剂，可通过抑制DPP-4，使内源性活性GL ...

本次获批的临床适应症为："本品配合饮食运动，用于单独使用盐酸二甲双胍血糖控制不佳的成人2型糖 尿病患者。"三药联合复方制剂药物作用机制互补，覆盖糖尿病的多重病理生理机制，可有效控制血 糖，且安全性和耐受性良好;同时可减少服药数量、简化降糖方案、提高患者治疗依从性，具有较高的 临床开发价值。该产品将为2型糖尿病患者提供新的治疗选择，并进一步丰富集团在代谢疾病领域的产 品线。 智通财经APP讯，石药集团(01093)发布公告，集团开发的普卢格列汀达格列净二甲双胍缓释片(该产品) 已获中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 该产品为全球首款获批临床的由普卢格列汀、达格列净和盐酸二甲双胍组成的三药联合复方制剂。普卢 格列汀是一种二肽基肽酶-4(DPP-4)抑制剂，通过抑制DPP-4，使内源性活性胰高血糖素样肽-1(GLP-1) 水平升高，从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌，并增强葡萄糖 对胰高血糖素分泌的抑制作用，进而改善高血糖。达格列净是一种钠—葡萄糖协同转运蛋白 2(「SGLT2」)抑制剂，通过抑制SGLT2，减少滤过葡萄糖的重吸收，从而促进尿糖排泄。二甲双胍 ...

格隆汇12月9日丨科源制药(301281.SZ)在互动平台表示，公司产品聚焦慢病领域，三高和心血管原料药 均有布局，目前降糖类主要原料药为格列齐特和盐酸二甲双胍，心血管类主要原料药为单硝酸异山梨 酯，目前公司暂未布局保健品原料药。 ...

Group 1: Termination of Restructuring - The termination of the restructuring project was primarily due to changes in the overall market environment, which affected the expectations of the parties involved in the transaction [2][3][6] - The company decided to terminate the restructuring to protect the long-term interests of all shareholders after thorough discussions and analyses with relevant parties [2][6][8] Group 2: Market Environment and Strategic Focus - Recent changes in centralized procurement policies have altered the supply-demand relationship for drugs, impacting the expectations for the restructuring project [3] - The company remains focused on drug research, production, and sales, with a strong emphasis on developing new products and expanding its product range, including categories such as hypoglycemic, anesthetic, cardiovascular, and psychiatric drugs [3][5][7] Group 3: Financial Performance - For the period from January to September 2025, the company achieved a revenue of ¥302,688,076.14 and a net profit attributable to shareholders of ¥31,261,045.17 [5] - The company plans to continue investing in core products to enhance market share and profitability, especially in light of the upcoming procurement agreements [5][7] Group 4: Future Plans and Collaborations - The company is committed to exploring new product introductions and market development strategies following the termination of the restructuring [7][8] - Collaborations with research institutions and industry partners are planned to enhance technological cooperation and joint research efforts [4][8] Group 5: Market Position and Competitive Advantage - The company has established a strong market position with key products such as Glimepiride and Metformin, supported by advanced technology and mature production processes [7][8] - The company holds 31 active pharmaceutical ingredient (API) registration numbers and 44 approved chemical drug formulations, with many products included in national medical insurance directories [8]

Core Insights - The "2025 China Listed Companies Excellence Demonstration Case Selection" results were announced, with Koyuan Pharmaceutical (301281.SZ) Secretary Li Chunhua awarded the "Outstanding Secretary" title [1] - The selection aims to promote high-quality development in China's capital market and advocates for value and long-term investment [1] Company Overview - Koyuan Pharmaceutical is a leading company in the domestic chemical raw materials drug sector, focusing on chronic disease areas such as diabetes, anesthesia, cardiovascular, and central nervous system disorders [1] - The company specializes in the R&D, production, and sales of chemical raw materials and formulations, with all products certified by national GMP and core products holding EU CEP certification [1] Product Development and Strategy - The company is enhancing its product development capabilities and expanding its product range, currently offering various categories of drugs including diabetes, anesthesia, cardiovascular, and psychiatric medications [1] - Key products include mature raw materials such as Glimepiride, Metformin Hydrochloride, Ropivacaine Hydrochloride, and Isosorbide Mononitrate, contributing to stable revenue and profit [1] Mergers and Acquisitions - Koyuan Pharmaceutical is actively pursuing an integrated development strategy of "raw materials + formulations" through the acquisition of Lino Pharmaceutical, which adds new growth potential [2] - The company has successfully passed anti-monopoly review for the acquisition of 99.42% equity in Shandong Hongjitang Pharmaceutical Group [2] Management Team - The management team consists of high-quality experts with multidisciplinary backgrounds and extensive experience in the chemical raw materials drug industry [2] - The team emphasizes sustainable long-term development and core competitiveness, implementing effective management systems across R&D, procurement, production, marketing, and human resources [2] Future Outlook - Koyuan Pharmaceutical will continue to adhere to its values of "long-termism, productism, and altruism," focusing on chronic disease areas and diversifying into other niche markets [2] - The company aims to enhance R&D capabilities and expand its core competitiveness through integrated raw material and formulation strategies [2]

Core Viewpoint - The company Fu Yuan Pharmaceutical (601089.SH) has received a drug registration certificate from the National Medical Products Administration for its product, Pioglitazone Metformin Tablets (15mg/850mg), allowing for its production [1] Group 1: Product Approval - The National Medical Products Administration has issued a drug registration certificate for Pioglitazone Metformin Tablets (15mg/850mg) [1] - The product is indicated for type 2 diabetes patients who have inadequate blood sugar control with Metformin alone or those currently using a combination of Pioglitazone and Metformin [1] Group 2: Market Context - The original manufacturer of the drug is Takeda Pharmaceutical Company, which received approval for the product in the United States in August 2005 [1] - The original manufacturer's version of Pioglitazone Metformin Tablets has not yet been launched in China [1]

Core Insights - Shandong Fukun Group's project on "Key Technologies and Industrialization of Crystalline Hydrochloride Metformin and Lazol Series Drugs" won the 2024 Shandong Provincial Science and Technology Progress Second Prize, achieving international advanced levels in high-quality drug crystal production [1] - The company has developed a complete industrial chain for Metformin, increasing its annual production capacity from 5,000 tons to 20,000 tons, capturing 70% of the domestic market and nearly one-third of the global market share [1][2] Group 1 - The project addresses common challenges in the production of crystalline Hydrochloride Metformin and Lazol series drugs through multi-scale research from molecular level to industrialization [1] - The fully automated production line at Shandong Fukun Group operates at a speed of 200 boxes per minute, showcasing advanced intelligent control systems monitoring the entire production process [1] - The transformation of limestone, costing 70 yuan per ton, into diabetes treatment drugs valued at 600,000 yuan per ton illustrates the company's innovative production capabilities [1] Group 2 - The company identified high-quality limestone from the Helan Mountain region as a stable raw material for producing Dicyandiamide, which constitutes over 60% of the production cost of Metformin [2] - In 2021, Shandong Fukun Group established the world's largest Dicyandiamide production base in Alxa League, Inner Mongolia, enhancing its upstream supply chain [2] - The company has formed a complete industrial chain that includes pharmaceutical intermediates, specialty raw materials, and finished formulations, with leading global production and sales in the raw material drug sector [2]