CSPC PHARMA(01093)
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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]
siRNA 药物行业深度报告:小核酸,大时代,靶向治疗新纪元
GUOTAI HAITONG SECURITIES· 2025-10-10 11:23
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]
智通港股股东权益披露|10月10日

智通财经网· 2025-10-10 00:06
| 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。 ...
协合新能源前9月光伏发电量增约3成 东方海外国际年内航线收入同比下滑
Xin Lang Cai Jing· 2025-10-09 11:58
Company News - Sunny Optical Technology (02382.HK) plans to transfer Shanghai Aolai for approximately 1.903 billion yuan and invest in GoerTek to jointly develop AI/AR optical business [2] - Orient Overseas International (00316.HK) reported a 8.3% decrease in shipping revenue for the first nine months, totaling approximately 6.696 billion USD, with an overall load factor down 1.5% and average revenue per standard container down 12.4% compared to the same period last year [2] - Xiehe New Energy (00182.HK) reported a 0.31% decrease in equity power generation for the first nine months, totaling 6,464.54 GWh, while solar equity power generation increased by 30.69% year-on-year [2] - Fast Retailing (06288.HK) announced annual results for the year ending August 31, 2025, with revenue of 3.400539 trillion yen, a year-on-year increase of 9.6%, and net profit of 433.009 billion yen, up 16.4% [3] - Dongfeng Motor Group (00489.HK) reported cumulative vehicle sales of 1.3168 million units for the first nine months, a year-on-year decline of approximately 3.6% [4] - Gemdale Property (00535.HK) reported a cumulative contract sales amount of approximately 8.533 billion yuan for the first nine months, a year-on-year decrease of 39.81% [4] - Baolong Real Estate (01238.HK) reported a contract sales total of approximately 5.431 billion yuan for the first nine months, down 43.64% year-on-year [4] - Zhengrong Real Estate (06158.HK) reported a cumulative contract sales amount of approximately 3.288 billion yuan for the first nine months, a year-on-year decrease of 32.8% [4] - JINGRUI Holdings (01862.HK) reported a contract sales amount of 740 million yuan for the first nine months, a year-on-year decrease of 49.52% [5] - China Wisdom Energy (01004) withdrew its liquidation petition [5] Shareholding Changes - Flat Glass Group (06865.HK) saw some shareholders and directors reduce their holdings by a total of 29.9803 million shares [6] - CNOOC Services (02883.HK) reported that its controlling shareholder, China National Offshore Oil Corporation, increased its holdings by 16.008 million H-shares over the past six months [6] - China National Offshore Oil Corporation (00883.HK) reported that its actual controller increased its holdings by 22.098 million shares in the past six months [6] - Tencent Holdings (00700.HK) repurchased 816,000 shares at a cost of 551 million HKD, with repurchase prices ranging from 666 to 680.5 HKD [6]
主席兼执行董事蔡东晨增持石药集团200万股 每股作价9.43港元
Zhi Tong Cai Jing· 2025-10-09 11:04
香港联交所最新资料显示,10月9日,主席兼执行董事蔡东晨增持石药集团(01093)200万股,每股作价 为9.43港元,总金额为1886万港元。增持后最新持股数目约为28.39亿股,最新持股比例为24.64%。 ...
石药集团:SYH2070注射液(双链小干扰RNA药物)在美国获临床试验批准
Zhi Tong Cai Jing· 2025-10-09 10:16
Core Insights - The company Shiyao Group (01093) has received FDA approval for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, allowing clinical trials in the United States [1] - The product has also been approved by the National Medical Products Administration of China to conduct clinical trials in China starting September 2025 [1] Product Details - SYH2070 is designed for liver-targeted delivery of siRNA through the conjugation of N-acetylgalactosamine (GalNAc), administered subcutaneously to target angiopoietin-like protein 3 (ANGPTL3), effectively lowering ANGPTL3 levels [1] - The drug aims to provide a long-lasting gene silencing effect, potentially serving as an ultra-long-acting siRNA drug for treating hypertriglyceridemia or mixed hyperlipidemia, with the ability to reduce the risk of elevated residual cholesterol levels [1] Clinical Research Findings - Preclinical studies indicate that SYH2070 demonstrates superior drug activity and efficacy duration compared to similar siRNA products, showcasing prolonged drug effects, good safety profiles, and high patient compliance, highlighting its significant clinical development value [1]
石药集团:SYH2070注射液在美国获临床试验批准
Zheng Quan Shi Bao Wang· 2025-10-09 10:16
Core Viewpoint - The company has received FDA approval for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, allowing it to conduct clinical trials in the United States [1] Group 1 - The drug SYH2070 injection has also been approved by the National Medical Products Administration (NMPA) of China to conduct clinical trials starting from September 2025 [1]