Core Viewpoint - The announcement highlights the acceptance of a new drug application for the product Icodextrin α injection by the National Medical Products Administration of China, aimed at long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered weekly [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss while also lowering blood glucose levels and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit a larger patient population [2]

Core Viewpoint - The application for the new drug, Idaglutide α injection, developed by the subsidiary of the company, has been accepted by the National Medical Products Administration of China for long-term weight management in overweight or obese adults [1] Group 1: Product Details - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] - It selectively binds and activates GLP-1 receptors to suppress appetite and reduce food intake, leading to weight loss, while also lowering blood glucose levels in a glucose-dependent manner and improving cardiovascular and metabolic indicators [1] Group 2: Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results showed significant weight reduction compared to placebo, along with notable decreases in waist circumference, blood glucose, blood pressure, and blood lipids, providing cardiovascular and metabolic benefits [1] - The product demonstrated good safety and tolerability, with lower incidence rates of gastrointestinal adverse events compared to similar marketed drugs, and a quicker, simpler dose escalation regimen that reaches the target maintenance dose in just four weeks [1] Group 3: Ongoing Research - Currently, two Phase III clinical trials are actively progressing for the product in patients with type 2 diabetes, aiming to benefit more patients [2]

石药集团(01093)发布公告，集团开发的他克莫司缓释胶囊(0.5mg、1mg)已获得中华人民共和国国家药 品监督管理局颁发的药品注册批件，并视同通过仿制药质量和疗效一致性评价。 他克莫司是一种大环内酯类免疫抑制剂，属于钙调神经磷酸霉抑制剂。体内外研究均证实，他克莫司具 有强效的免疫抑制作用，能抑制引起移植物排斥反应的细胞毒淋巴细胞的形成，其作用机制主要包括抑 制T细胞的活化和T辅助细胞依赖型B细胞的增殖，并抑制淋巴因子的形成(如白介素-2，白介素-3及γ-干 扰素)和白介素-2受体的表达。该产品适用于预防肾脏移植术后的移植物排斥反应，预防肝脏移植术后 维持期的移植物排斥反应，以及治疗肾脏或肝脏移植术后应用其他免疫抑制药物无法控制的移植物排斥 反应。 该产品的获批将进一步丰富集团在免疫排斥治疗领域的产品线。 ...

Core Viewpoint - The new drug application for the injection of Idaglutide α developed by Stone Pharmaceutical Group has been accepted by the National Medical Products Administration of China, targeting long-term weight management in overweight or obese adults [1] Company Summary - Stone Pharmaceutical Group's subsidiary, Stone Pharmaceutical Group Baike (Shandong) Biopharmaceutical Co., Ltd., is responsible for the development of the new drug [1] - The product is a recombinant human glucagon-like peptide-1 (hGLP-1) Fc fusion protein injection, administered once a week [1] Product Details - The drug is classified as a Class 1 new drug for therapeutic biological products, aimed at weight management alongside diet control and increased physical activity [1] - It selectively binds and activates GLP-1 receptors, leading to appetite suppression and reduced food intake, while also lowering blood glucose levels in a glucose-dependent manner [1] - The product shows benefits in cardiovascular and metabolic indicators [1] Clinical Trial Results - The new drug application is based on a pivotal Phase III clinical trial involving overweight adults with at least one weight-related comorbidity [1] - Results indicate that the product significantly reduces weight compared to a placebo, along with reductions in waist circumference, blood glucose, blood pressure, and blood lipids [1] - The safety and tolerability of the product are reported to be good, with lower rates of gastrointestinal adverse events compared to similar marketed drugs [1] Dosing and Administration - The dosing regimen is noted to be quicker and simpler, achieving the target maintenance dose within just four weeks [1]

该产品的获批将进一步丰富集团在免疫排斥治疗领域的产品线。 他克莫司是一种大环内酯类免疫抑制剂，属于钙调神经磷酸霉抑制剂。体内外研究均证实，他克莫司具 有强效的免疫抑制作用，能抑制引起移植物排斥反应的细胞毒淋巴细胞的形成，其作用机制主要包括抑 制T细胞的活化和T辅助细胞依赖型B细胞的增殖，并抑制淋巴因子的形成(如白介素-2，白介素-3及γ-干 扰素)和白介素-2受体的表达。该产品适用于预防肾脏移植术后的移植物排斥反应，预防肝脏移植术后 维持期的移植物排斥反应，以及治疗肾脏或肝脏移植术后应用其他免疫抑制药物无法控制的移植物排斥 反应。 智通财经APP讯，石药集团(01093)发布公告，集团开发的他克莫司缓释胶囊(0.5mg、1mg)已获得中华人 民共和国国家药品监督管理局颁发的药品注册批件，并视同通过仿制药质量和疗效一致性评价。 ...

自願公告 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份內容而產 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） 他克莫司緩釋膠囊獲藥品註冊批件 主席 蔡東晨 香港，2025年10月13日 – 1 – 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 佈，本集團開發的他克莫司緩釋膠囊（ 0.5 mg、1mg ）（「該產品」）已獲得中華人民共和國國家 藥品監督管理局頒發的藥品註冊批件，並視同通過仿製藥質量和療效一致性評價。 他 克 莫 司 是 一 種 大 環 內 酯 類 免 疫 抑 制 劑 ， 屬 於 鈣 調 神 經 磷 酸 霉 抑 制 劑 。 體 內 外 研 究 均 證 實，他克莫司具有強效的免疫抑制作用，能抑制引起移植物排斥反應的細胞毒淋巴細胞的 形成， ...

自願公告 依達格魯肽α注射液的新藥上市申請 獲國家藥品監督管理局受理 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 佈，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依達格魯肽α注射 液（「該產品」）的新藥上市申請已獲中華人民共和國國家藥品監督管理局受理。該產品按照 治 療 用 生 物 製 品 1 類 新 藥 申 報 ， 其 適 應 症 為 在 控 制 飲 食 和 增 加 運 動 的 基 礎 上 ， 用 於 超 重 或 肥胖成人的長期體重管理。 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的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的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） 主席 蔡東晨 香港，2025年10月13日 該產品為一款重組人源胰高血糖素樣肽-1 (h ...

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Views - The in vivo CAR-T technology is emerging as a new hotspot in cell therapy, with significant investment opportunities in the domestic market. Major pharmaceutical companies are actively entering this field, with multiple high-value transactions occurring in 2025 [5][14] - Compared to traditional CAR-T, in vivo CAR-T offers advantages such as reduced manufacturing costs, shortened processing times, and improved accessibility for patients, making it applicable in various diseases including B-cell malignancies and autoimmune diseases [6][15] - The report highlights the performance of various sub-sectors within the pharmaceutical industry, noting that the hospital sector showed the highest increase, while the medical R&D outsourcing sector experienced the largest decline [7][24] Summary by Sections Section 1: In Vivo CAR-T Transactions - Numerous significant transactions in the in vivo CAR-T space have occurred in 2025, indicating strong interest and investment potential. Notable deals include AstraZeneca's acquisition of EsoBiotech for $1 billion and BMS's agreement to acquire Orbital Therapeutics for $1.5 billion [5][14] Section 2: Market Performance - In the second week of October 2025, the pharmaceutical sector declined by 1.20%, underperforming the CSI 300 index by 0.69 percentage points, ranking 25th among 31 sub-industries. The hospital sector saw the largest increase at 1.79% [7][18] - The report provides a detailed analysis of sub-sector performance, with the hospital sector leading gains and the medical R&D outsourcing sector facing the most significant losses [24][28] Section 3: Recommended Stocks - The report recommends several stocks for investment, including Shiyao Group, Sunshine Nuohuo, and Yuekang Pharmaceutical, among others [8][16]

Investment Rating - The report rates the industry as "Overweight" [4] Core Insights - The siRNA drug industry is entering a new era with the maturation of technology platforms and the expansion of indications, focusing on the commercial value of siRNA drugs for common diseases [2][3] - siRNA drugs have transitioned from rare diseases to common diseases, showcasing strong target expansion capabilities, robust research and development extensibility, long-lasting effects, and low resistance [4][12] - The industry is witnessing a surge in business development (BD) transactions, particularly among multinational corporations (MNCs), indicating a vibrant market for siRNA technology [4][31] Summary by Sections 1. Dawn of a New Era for Small Nucleic Acid Drugs - Small nucleic acid drugs, including siRNA and ASO, are becoming a significant path for drug development, with a focus on their ability to regulate protein production [7] - The global approval of small nucleic acid drugs has reached 23, with siRNA drugs leading the way in rare disease applications [12][13] - Alnylam and other leading companies have demonstrated significant market capitalization differences due to their innovative drug development technologies [14][16] 2. Platform Characteristics and Focus on Indications - The siRNA drug industry is characterized by high barriers in modification and delivery, with a focus on breakthroughs in extrahepatic delivery systems [6][29] - The commercialization of siRNA drugs is accelerating, with multiple common diseases nearing market readiness [6][29] - The GalNAc delivery system has become the mainstream strategy for liver-targeted siRNA delivery, while breakthroughs in extrahepatic delivery are still needed [6][29] 3. Related Companies - Listed companies in the siRNA space include Yuyuan Pharmaceutical, Hengrui Medicine, and others, while unlisted companies include Bewang Pharmaceutical and others [4][12]

| 股票名称 | 机构名称 | 性质 | 变动前持股 | 变动后持股 | 持股比 | | --- | --- | --- | --- | --- | --- | | 石四药集团 (02005) | China Pharmaceutical Company Limited | 好仓 | 8.85 亿股 | 8.86 亿股 | 30.03%(最新) 29.99%(前次) | | 石药集团(01093) | | | | | 24.62%(前次) | | 石四药集团 (02005) | 曲继广 | 好仓 | 12.10 亿股 | 12.11 亿股 | 41.03%(最新) 40.99%(前次) | | | 蔡东晨 | 好仓 | 28.37 亿股 | 28.39 亿股 | 24.64%(最新) | 智通财经APP获悉，石四药集团(02005)、石药集团(01093)于2025年10月10日进行了最新股东权益披 露。 备注：持股数变动有可能因供股、合股、拆股等情况引起，请注意对照实际情况进行辨别。 ...