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石药集团(01093):受托人根据股份奖励计划购买300万股公司股份
智通财经网· 2025-10-13 12:10
智通财经APP讯,石药集团(01093)公布,于2025年10月13日,受托人根据股份奖励计划的条款及条件在 市场上购买合共300万股公司股份,并为获选参与者的利益以信托方式持有该等股份。 ...
石药集团(01093) - 自愿公告 - 根据本公司股份奖励计划在市场上购买股份
2025-10-13 12:00
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 謹此 提述 石藥 集團 有限 公司(「本 公司」)於 2018 年8 月 20 日 有關 刊發 採納 本公 司限 制性 股份 獎勵計劃(「該計劃」)之公告(「該公告」)。誠如本公司日期為2024年5月21日之自願公告所披 露,該計劃之條款其後已作出修訂。除本公告另有界定外,本公告所用詞彙與該公告所界 定者具有相同涵義。 於2025年10月13日,受託人根據該計劃之條款及條件在市場上購買合共3,000,000股本公司 股份,並為獲選參與者之利益以信託方式持有該等股份。受託人於2025年10月13日所購買 及以信託方式持有之股份詳情如下: | 所購買股份總數: | 3,000,000股股份 | | --- | --- | | 所購買股份佔目前已發行股份總數百分比: | 約0.026 % | | 每股平均價格: | 約9.3251港元 | | ...
石药集团:依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-10-13 11:05
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]
石药集团(01093):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
智通财经网· 2025-10-13 11:03
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:他克莫司缓释胶囊获药品注册批件
Zhi Tong Cai Jing· 2025-10-13 10:58
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。 ...
石药集团(01093.HK):依达格鲁肽α注射液的新药上市申请获国家药品监督管理局受理
Ge Long Hui· 2025-10-13 10:58
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]
石药集团(01093):他克莫司缓释胶囊获药品注册批件
智通财经网· 2025-10-13 10:57
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。 ...
石药集团(01093) - 自愿公告 - 他克莫司缓释胶囊获药品註册批件
2025-10-13 10:49
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, ...
石药集团(01093) - 自愿公告 - 依达格鲁肽注射液的新药上市申请获国家药品监督管理局受理
2025-10-13 10:47
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 ...
行业周报:体内CAR-T交易迭起,关注国内投资机会-20251012
KAIYUAN SECURITIES· 2025-10-12 09:41
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]