Core Viewpoint - The approval of SYH2072, a novel class I chemical drug developed by the company, by the National Medical Products Administration of China for clinical trials signifies a significant advancement in the treatment of uncontrolled hypertension and primary aldosteronism [1] Group 1: Product Development - SYH2072 is a highly selective and potent aldosterone synthase inhibitor (ASI) that effectively lowers plasma aldosterone levels without affecting cortisol levels [1] - The approved clinical indications for SYH2072 include uncontrolled hypertension and primary aldosteronism, addressing a broad clinical need [1] - Preclinical studies demonstrate that SYH2072 selectively inhibits aldosterone synthase activity, significantly reducing plasma aldosterone levels in animal disease models and dose-dependently lowering blood pressure in hypertension models [1] Group 2: Drug Characteristics - The product exhibits favorable pharmacokinetic (PK) properties and safety, positioning it as a potential best-in-class drug [1] - The company has submitted multiple patent applications for SYH2072 both domestically and internationally, indicating a strong commitment to protecting its intellectual property [1] Group 3: Market Potential - Given the extensive clinical demand for aldosterone synthase inhibitors, SYH2072 holds high clinical development value and is expected to provide new treatment options for patients with uncontrolled hypertension and primary aldosteronism [1]

石药集团(01093)发布公告，集团开发的化药1类新药强效醛固酮合成酶抑制剂(SYH2072片)已获得中华 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。 鉴于醛固酮合成酶抑制剂的临床需求广阔，该产品具有较高的临床开发价值，有望为未控制高血压和原 发性醛固酮增多症患者提供新的治疗选择。 该产品是一种高选择性强效醛固酮合成酶抑制剂(ASI)，可有效降低血浆醛固酮水平，且不影响皮质醇 水平。本次获批的临床适应症为未控制高血压和原发性醛固酮增多症。临床前研究显示，该产品可选择 性抑制醛固酮合成酶活性，在动物疾病模型中显著降低血浆醛固酮水平，并剂量依赖性地降低高血压模 型的血压，同时不影响皮质醇水平。该产品具有良好的药代动力学(PK)特性和安全性，使其具备成为一 款同类最优(best-in-class)药物的潜力。目前，集团已在国内外提交了该产品的多项专利申请。 ...

Core Viewpoint - The approval of SYH2069 injection by the National Medical Products Administration of China marks a significant milestone for the company, as it is expected to be the first GLP-1/GIP receptor dual agonist to enter clinical trials in China, following its prior approval by the FDA for trials in the United States [1] Group 1: Product Development - SYH2069 injection is designed to selectively activate the cAMP pathway while significantly reducing β-arrestin recruitment, which minimizes receptor internalization and desensitization, thereby enhancing efficacy and duration of effect [1] - The product utilizes a long half-life modification platform technology, aiming for deeper and more sustained weight loss effects [1] Group 2: Clinical Research Findings - In studies involving diet-induced obesity (DIO) mice and non-human primates, SYH2069 demonstrated significantly superior weight loss and metabolic improvement compared to existing market products [1] - Toxicology studies in non-human primates indicated good tolerability of the product, with no observed vomiting or gastrointestinal adverse reactions [1] Group 3: Clinical Application and Value - The approved clinical indication for SYH2069 is weight management in obese or overweight individuals with at least one weight-related comorbidity [1] - The product also shows potential for improving blood glucose control in adults with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1]

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]

智通财经APP讯，石药集团(01093)发布公告，集团开发的GLP -1 / GIP受体双偏向性激动多肽注射液( SYH2069注射液 )已获得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。此前，该 产品亦已获得美国食品药品监督管理局(FDA)批准在美国开展临床试验。 本 次 获 批 的 临 床 适 应 症 为 肥 胖 或 超 重 合 并 至 少 一 种 体 重 相 关 合 并 症 人 群 的 体 重 管 理 。 此外，该产品亦具备用于改善成人2型糖尿病(T2DM)患者的血糖控制的潜力，具有较高的临床开发 价值。 该 产 品 有 望 成 为 中 国 首 款 进 入 临 床 阶 段 的 GLP -1 / GIP 受 体 双 偏 向 激 动 剂 ， 可 选 择 性 激 活 c AMP通路，显著降低b-arrestin募集，从而减少受体内吞及脱敏，提高药效和效果持续性。同 时，结合长半衰期修饰平台技术，该产品能实现更深度、更持久的减重效果。在饮食诱导肥胖(DIO)小 鼠和非人灵长类的研究中，该产品在减重及代谢改善方面的效果均显著优于同类上市产品。非人灵长类 重复给药毒理研究显示，该产品耐受性良好，未观 ...

该产品是一种高选择性强效醛固酮合成酶抑制剂(ASI)，可有效降低血浆醛固酮水平，且不影响皮质醇 水平。本次获批的临床适应症为未控制高血压和原发性醛固酮增多症。临床前研究显示，该产品可选择 性抑制醛固酮合成酶活性，在动物疾病模型中显著降低血浆醛固酮水平，并剂量依赖性地降低高血压模 型的血压，同时不影响皮质醇水平。该产品具有良好的药代动力学(PK)特性和安全性，使其具备成为一 款同类最优(best-in-class)药物的潜力。目前，集团已在国内外提交了该产品的多项专利申请。 智通财经APP讯，石药集团(01093)发布公告，集团开发的化药1类新药强效醛固酮合成酶抑制剂( SYH2072片 )已获得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。 鉴于醛固酮合成酶抑制剂的临床需求广阔，该产品具有较高的临床开发价值，有望为未控制高血压和原 发性醛固酮增多症患者提供新的治疗选择。 ...

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].

Core Viewpoint - The approval of SYH2069 injection by the National Medical Products Administration of China marks a significant milestone for the company, as it is set to be the first GLP-1/GIP receptor dual agonist to enter clinical trials in China, following its prior approval by the FDA for trials in the United States [1][1]. Group 1: Product Development - SYH2069 injection is designed to selectively activate the cAMP pathway, significantly reducing b-arrestin recruitment, which in turn minimizes receptor internalization and desensitization, enhancing drug efficacy and duration of effect [1][1]. - The product incorporates a long half-life modification platform technology, enabling deeper and more sustained weight loss effects compared to existing products [1][1]. Group 2: Clinical Research Findings - In studies involving diet-induced obesity (DIO) mice and non-human primates, SYH2069 demonstrated significantly superior weight loss and metabolic improvement effects compared to similar marketed products [1][1]. - Toxicology studies in non-human primates indicated good tolerability of the product, with no observed vomiting or gastrointestinal adverse reactions [1][1]. Group 3: Clinical Application and Potential - The approved clinical indication for SYH2069 is weight management in individuals who are overweight or obese with at least one weight-related comorbidity [1][1]. - The product also shows potential for improving blood glucose control in adults with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1][1].

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。 該產品是一種高選擇性強效醛固酮合成酶抑制劑(ASI)，可有效降低血漿醛固酮水平，且不 影響皮質醇水平。本次獲批的臨床適應症為未控制高血壓和原發性醛固酮增多症。臨床前 研究顯示，該產品可選擇性抑制醛固酮合成酶活性，在動物疾病模型中顯著降低血漿醛固 酮水平，並劑量依賴性地降低高血壓模型的血壓，同時不影響皮質醇水平。該產品具有良 好的藥代動力學(PK)特性和安全性，使其具備成為一款同類最優(best-in-class)藥物的潛力。 目前，本集團已在國內外提交了該產品的多項專利申請。 鑒於醛固酮合成酶抑制劑的臨床需求廣闊，該產品具有較高的臨床開發價值，有望為未控 制高血壓和原發性醛固酮增多症患者提供新的治療選擇。 承董事會命 石藥集團有限公司 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 強效醛 ...