该产品为化学合成法制备的司美格鲁肽制剂，按照化药注册分类2.2类新药申报，属于含有已知活性成 份的新处方工艺且具有明显临床优势的药品。该产品既避免生物发酵过程引入的宿主蛋白等免疫原性物 质，又保证杂质水平不高于DNA重组技术制备的司美格鲁肽。该产品可通过与GLP-1受体结合而发挥作 用，并可通过多重机制实现减重、降糖以及心血管和肾臟保护等方面的综合获益。 本次申请基于一项Ⅲ期临床试验。该临床试验结果表明，在非糖尿病的肥胖成人受试者中，该产品可显 著降低体重及腰围，改善血糖、血脂及肝酶水平;与诺和诺德开发的司美格鲁肽相比，其有效性高度一 致，安全性特徵相似，且耐受性良好，不良事件发生率略低。基于在疗效、安全性、制剂方面的优势， 该产品具有显著的临床应用价值。 石药集团(01093)公布，公司附属公司石药集团百克(山东)生物制药股份有限公司开发的司美格鲁肽注射 液的第二项上市许可申请已获中华人民共和国国家药品监督管理局受理。本次申报的适应症为在控制饮 食和增加体力活动的基础上对成人超重╱肥胖患者的长期体重管理。此前，该产品拟用于成人2型糖尿 病血糖控制的适应症上市许可申请已于2025年8月获国家药监局受理。 ...

本次申请基于一项Ⅲ期临床试验。该临床试验结果表明，在非糖尿病的肥胖成人受试者中，该产品可显 著降低体重及腰围，改善血糖、血脂及肝酶水平；与诺和诺德开发的司美格鲁肽相比，其有效性高度一 致，安全性特征相似，且耐受性良好，不良事件发生率略低。基于在疗效、安全性、制剂方面的优势， 该产品具有显著的临床应用价值。 该产品为化学合成法制备的司美格鲁肽制剂，按照化药注册分类2.2类新药申报，属于含有已知活性成 份的新处方工艺且具有明显临床优势的药品。该产品既避免生物发酵过程引入的宿主蛋白等免疫原性物 质，又保证杂质水平不高于DNA重组技术制备的司美格鲁肽。该产品可通过与GLP-1受体结合而发挥作 用，并可通过多重机制实现减重、降糖以及心血管和肾脏保护等方面的综合获益。 格隆汇12月8日丨石药集团(01093.HK)宣布，公司附属公司石药集团百克(山东)生物制药股份有限公司 开发的司美格鲁肽注射液("该产品")的第二项上市许可申请已获中国国家药品监督管理局("国家药监 局")受理。本次申报的适应症为在控制饮食和增加体力活动的基础上对成人超重╱肥胖患者的长期体重 管理。此前，该产品拟用于成人2型糖尿病血糖控制的适应症上市许可 ...

自願公告 司美格魯肽注射液的第二項上市許可申請 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 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布，本公司附屬公司石藥集團百克（ 山東 ）生物製藥股份有限公司開發的司美格魯肽注射液 （「 該 產 品 」）的 第 二 項 上 市 許 可 申 請 已 獲 中 華 人 民 共 和 國 國 家 藥 品 監 督 管 理 局（「 國 家 藥 監 局」）受理。本次申報的適應症為在控制飲食和增加體力活動的基礎上對成人超重╱肥胖患 者 的 長 期 體 重 管 理 。 此 前 ， 該 產 品 擬 用 於 成 人 2 型 糖 尿 病 血 糖 控 制 的 適 應 症 上 市 許 可 申 請 已於2025年8月獲國家藥監局受理。 該產品為化學合成法製備的司美格魯肽製劑，按照化藥註冊分類2.2類新藥申報，屬於含有 已知活性成份的新處方工藝且具有明顯臨床優勢的藥品。該產品既避免生物發酵過程引入 的宿主蛋白等免疫原性物質，又保證雜質水平不高於DNA重組技術製備的司美格魯肽。該 產品可通過與GLP -1 受體結合而發揮作用 ...

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Core Viewpoint - The approval of SYH2069 injection by the FDA 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, offering potential for effective weight management and treatment of metabolic diseases [1]. Group 1: Product Development - The SYH2069 injection has received FDA approval to conduct clinical trials in the U.S. [1] - This product selectively activates 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 is designed to achieve deeper and more sustained weight loss effects due to its long half-life modification technology [1]. Group 2: Clinical Research Findings - In studies involving diet-induced obesity (DIO) mice and non-human primates, SYH2069 demonstrated significantly better weight loss and metabolic improvement compared to existing products on the market [1]. - Toxicology studies in non-human primates indicated good tolerability, with no observed vomiting or gastrointestinal adverse reactions [1]. Group 3: Clinical Application and Value - The approved clinical indication is for weight management in individuals who are obese or overweight with at least one weight-related comorbidity [1]. - The product also shows potential for improving blood glucose control in adult patients with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1].

Core Insights - The company Shiyao Group (01093) has received FDA approval for its GLP-1/GIP receptor dual agonist peptide injection (SYH2069), allowing clinical trials to commence in the United States [1] - This product is expected to be the first GLP-1/GIP dual agonist to enter clinical stages in China, with a mechanism that selectively activates the cAMP pathway while significantly reducing β-arrestin recruitment, leading to improved efficacy and sustained effects [1] - The product demonstrates superior weight loss and metabolic improvement in studies involving diet-induced obesity (DIO) mice and non-human primates compared to existing products [1] - Toxicology studies in non-human primates indicate good tolerability with no observed vomiting or gastrointestinal adverse reactions, suggesting excellent efficacy and safety [1] - The approved clinical indication focuses on weight management for obese or overweight individuals with at least one weight-related comorbidity, and it also shows potential for improving blood glucose control in adults with type 2 diabetes mellitus (T2DM), indicating high clinical development value [1]

Core Viewpoint - The approval of SYH2069 injection by the FDA 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, potentially offering a new treatment for obesity and metabolic diseases [1] Group 1: Product Development - The product 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 long half-life modification technology allows 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 better weight loss and metabolic improvement compared to existing products on the market [1] - Toxicology studies in non-human primates indicated good tolerability, with no observed vomiting or gastrointestinal adverse reactions [1] Group 3: Clinical Application and Value - The approved clinical indication is for weight management in individuals who are overweight or obese 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]

（股份代號：1093） （於香港註冊成立之有限公司） 自願公告 GLP -1 / GIP受體雙偏向性激動多肽注射液（SYH2069注射液） 在美國獲臨床試驗批准 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GLP -1 / GIP受體雙偏向性激動多肽注射液（ SYH2069注射液 ）（「該產品」）已 獲得美國食品藥品監督管理局(FDA)批准，可在美國開展臨床試驗。 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 – 1 – 本 次 獲 批 的 臨 床 適 應 症 為 肥 胖 或 超 重 合 併 至 少 一 種 體 重 相 關 合 併 症 人 群 的 體 重 管 理 。 此 外，該產品亦具備用於改善成人2型糖尿病(T2DM)患者的血 ...

Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for its Class 1 chemical drug, a selective 5-HT2A receptor agonist (SYH2056 tablets) [1] Group 1 - The product has also been approved by the National Medical Products Administration (NMPA) in China to conduct clinical trials starting from November 2025 [1]

Core Viewpoint - The approval of SYH2056 by the FDA for clinical trials in the U.S. marks a significant milestone for the company, indicating potential growth in the treatment of depression [1] Company Summary - The company, Shijiazhuang Yiling Pharmaceutical, has developed a new chemical drug, SYH2056, which is a selective 5-HT2A receptor agonist aimed at improving the condition of patients with depressive disorders [1] - SYH2056 has also received approval from the National Medical Products Administration in China to conduct clinical trials starting November 2025 [1] Product Details - SYH2056 is designed to provide rapid onset of action with lasting effects and does not carry the risk of inducing hallucinations [1] - The clinical indication for SYH2056 is specifically for the treatment of depression [1]