CSPC PHARMA(01093)

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石药集团(01093):仑卡奈单抗注射液在中国获临床试验批准
智通财经网· 2025-09-25 10:33
Core Viewpoint - The approval of the recombinant anti-human beta-amyloid monoclonal antibody injection, Lunakanai, by the National Medical Products Administration of China marks a significant milestone for the company as it becomes the first biosimilar of Lunakanai to receive clinical trial permission in China [1] Company Summary - The product is a biosimilar to Leqembi, classified under Category 3.3 of therapeutic biological products, and is intended for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease [1] - The development of the product adheres to the relevant research guidelines for biosimilars, ensuring that it meets the necessary standards for quality, safety, and efficacy [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug, supporting the initiation of subsequent clinical studies [1]
石药集团(01093) - 自愿公告 - 仑卡奈单抗注射液在中国获临床试验批准
2025-09-25 10:27
(股份代號:1093) (於香港註冊成立之有限公司) 自願公告 侖卡奈單抗注射液在中國獲臨床試驗批准 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 佈,本集團開發的侖卡奈單抗注射液(「該產品」)已獲中華人民共和國國家藥品監督管理局 批 准 , 可 在 中 國 開 展 臨 床 試 驗 , 為 國 內 首 個 獲 得 臨 床 許 可 的 侖 卡 奈 單 抗 注 射 液 生 物 類 似 藥。 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 該產品是一種重組抗人b澱粉樣蛋白單克隆抗體,為樂意保®的生物類似藥,按照治療用生 物製品3.3類申報,適用於治療由阿爾茨海默病引起的輕度認知障礙和阿爾茨海默病輕度痴 呆。 該產品的研發遵循生物類似藥相關研究指南。藥學及非 ...
智通港股通资金流向统计(T+2)|9月25日
智通财经网· 2025-09-24 23:32
在净流出比方面,康基医疗(09997)、辽港股份(02880)、珍酒李渡(06979) 以-54.12%、-49.57%、-48.65%位列市场前三。 智通财经APP获悉,9月22日,盈富基金(02800)、阿里巴巴-W(09988)、恒生中国企业(02828)南 向资金净流入金额位列市场前三,分别净流入29.24 亿、26.10 亿、15.95 亿 美团-W(03690)、信达生物(01801)、石药集团(01093)南向资金净流出金额位列市场前三,分别 净流出-3.88 亿、-2.92 亿、-2.61 亿 在净流入比方面,大唐新能源(01798)、固生堂(02273)、安徽皖通高速公路(00995)以69.20%、 58.06%、55.69%位列市场前三。 备注:上面表格港股通资金净流向数据为港股通流入资金之和,由于港交所是T+2日结算,此数据为延 迟数据。 智通机器人根据港交所数据,经过人工智能运算后自动生成,并不保证数据100%准确。 | 高鑫零售(06808) | 53.37% | 1422.58 万 | 1.970(-3.43%) | | --- | --- | --- | --- | | 江苏宁 ...
港股创新药ETF(159567)涨1.50%,成交额12.63亿元
Xin Lang Cai Jing· 2025-09-22 11:50
Group 1 - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 1.50% on September 22, with a trading volume of 1.263 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1] - As of September 19, 2024, the fund's latest share count was 8.17 billion shares, with a total size of 7.676 billion yuan, reflecting a year-to-date increase of 1966.38% in shares and 1931.78% in size compared to December 31, 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 87.92% during the management period [2] - The top holdings of the fund include Innovent Biologics (9.52%), WuXi Biologics (9.47%), BeiGene (8.73%), and others, with their respective market values and share counts detailed [2] - The cumulative trading amount over the last 20 trading days reached 37.235 billion yuan, with an average daily trading amount of 1.862 billion yuan [1][2]
超60亿大单品丁苯酞:石药领航,复星折戟,改良仿制困局谁能破?
Ge Long Hui· 2025-09-22 11:41
长久以来,石药集团独占丁苯酞市场,其"攻防战"的艰难与突破口备受业界关注。 9月17日,NMPA发布药品通知件送达信息,复星集团子公司锦州奥鸿药业申报的备受关注的丁苯酞改良新药SBK010口服溶液赫然在列,其上市申报失败。 丁苯酞是石药集团旗下第一大单品,去年九月,石药旗下的丁苯酞品种在接连成功抵御五轮市场挑战后,现迎来了第六重、也是迄今为止最为猛烈的冲击 ——复星医药旗下子公司强势介入竞争。 截图来源:NMPA 丁苯酞(商品名恩必普),作为国家一类新药问世,为缺血性脑卒中患者带来了全新的希望。软胶囊剂型于2004年上市,注射液于2009年获批。该产品是继 青蒿素和双环醇之后,中国第三个拥有自主知识产权的国家1类新药。 | 中国国木以与y 19余 了及列吊用阵 | | | | | | | --- | --- | --- | --- | --- | --- | | 药品名称:丁苯酸 × | 可 试验分期:BE试验 × | | | | | | 试验数据 全局分析 | | | | | | | 按登记号浏览(19) | 按品种浏览(3) 按申办单位浏览(14) | 按临床机构浏览(11) | | | | | 登记号 ...
开源证券:首予石药集团“买入”评级 多项重磅出海交易即将达成
Zhi Tong Cai Jing· 2025-09-22 09:44
Core Viewpoint - The report from Open Source Securities highlights that CSPC Pharmaceutical Group (01093) is intensifying its focus on innovation, establishing eight major technology platforms, and has over 130 projects in its pipeline, indicating a period of concentrated value realization for its innovations [1] Financial Projections - The firm forecasts the net profit attributable to the parent company for 2025-2027 to be 4.915 billion, 5.272 billion, and 5.714 billion yuan respectively, with EPS projected at 0.4, 0.5, and 0.5 yuan, corresponding to PE ratios of 21.4, 20.0, and 18.4 times [1] Innovation and Collaborations - CSPC has achieved multiple external licensing agreements for several innovative products in recent years, including Lp(a), MAT2A, ROR1ADC, and irinotecan liposome, with expected revenue recognition from these licenses in 2025 [1] - The company is currently in discussions with international pharmaceutical firms regarding various innovative drug projects, including a collaboration with AstraZeneca in June to co-develop a new oral small molecule candidate using an AI-driven drug discovery platform [1] - In July, CSPC announced the global licensing of its small molecule GLP-1 receptor agonist SYH2086 to Madrigal Pharmaceuticals, which includes a $120 million upfront payment [1] R&D Platform and Growth Potential - The company's R&D platform is entering a realization phase, and the achievement of multiple licensing agreements is expected to become its second growth curve [1]
开源证券:首予石药集团(01093)“买入”评级 多项重磅出海交易即将达成
智通财经网· 2025-09-22 09:42
Core Viewpoint - The report from Kaiyuan Securities highlights that CSPC Pharmaceutical Group (01093) is intensifying its focus on innovation, establishing eight major technology platforms, and has over 130 projects in its pipeline, indicating that the value of its innovations is entering a concentrated realization phase [1] Financial Projections - The company is expected to achieve net profit attributable to shareholders of 4.915 billion, 5.272 billion, and 5.714 billion yuan for the years 2025 to 2027, respectively [1] - Earnings per share (EPS) are projected to be 0.4, 0.5, and 0.5 yuan for the same years, with corresponding price-to-earnings (PE) ratios of 21.4, 20.0, and 18.4 times [1] Innovation and Collaborations - CSPC has recently entered into multiple external licensing agreements for several innovative products, including Lp(a), MAT2A, ROR1 ADC, and irinotecan liposome, with expected revenue recognition from these licenses in 2025 [1] - The company is actively negotiating licensing agreements for various innovative drug projects with international pharmaceutical companies, including a collaboration with AstraZeneca in June to develop a new oral small molecule candidate driven by AI [1] - In July, CSPC announced the global licensing of its small molecule GLP-1 receptor agonist SYH2086 to Madrigal Pharmaceuticals, which includes a $120 million upfront payment [1] - The realization of revenue from multiple pipelines is anticipated to become a second growth curve for the company [1]
智通港股通资金流向统计(T+2)|9月22日
智通财经网· 2025-09-21 23:32
Key Points - The article highlights the net inflow and outflow of funds for various companies in the Hong Kong market, with Alibaba-W leading the inflow [1][2] - It provides detailed statistics on the top companies with the highest net inflows and outflows, indicating market trends [2][3] Group 1: Net Inflows - Alibaba-W (09988) recorded a net inflow of 5.042 billion, representing a 20.09% increase in its closing price to 161.600 [2] - Meituan-W (03690) saw a net inflow of 2.098 billion, with a 14.37% increase in its closing price to 105.200 [2] - Changfei Optical Fiber (06869) had a net inflow of 0.989 billion, with an 18.51% increase in its closing price to 54.150 [2] Group 2: Net Outflows - Xiaomi Group-W (01810) experienced the highest net outflow of -0.644 billion, with a -6.48% change in its closing price to 57.850 [2] - China Mobile (00941) had a net outflow of -0.514 billion, reflecting a -25.37% decrease in its closing price to 86.600 [2] - Stone Pharmaceutical Group (01093) faced a net outflow of -0.415 billion, with an -18.51% change in its closing price to 10.010 [2] Group 3: Net Inflow Ratios - The top net inflow ratio was recorded by Standard Chartered Hong Kong 100 (02825) at 100.00%, with a net inflow of 0.0187 million [3] - Datang New Energy (01798) had a net inflow ratio of 53.77%, with a net inflow of 0.03897 million [3] - Jiangsu Ninghu Highway (00177) reported a net inflow ratio of 53.56%, with a net inflow of 0.02301 million [3] Group 4: Net Outflow Ratios - China National Heavy Duty Truck Group (03808) had the highest net outflow ratio at -66.74%, with a net outflow of -0.06031 billion [3] - Q Technology (01478) recorded a net outflow ratio of -51.13%, with a net outflow of -0.03931 billion [3] - China State Construction International (03311) faced a net outflow ratio of -44.37%, with a net outflow of -0.05668 billion [3]
港股创新药ETF(159567)跌1.27%,成交额12.58亿元
Xin Lang Cai Jing· 2025-09-19 12:24
Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) has shown significant growth in both share volume and fund size since its inception, indicating strong investor interest in the innovative drug sector [1][2]. Fund Performance - As of September 18, 2024, the fund's share volume reached 8.17 billion shares, with a total size of 7.839 billion yuan, reflecting an increase of 1966.38% in share volume and 1974.81% in size compared to its initial figures on December 31, 2023 [1]. - The fund manager, Ma Jun, has achieved a return of 90.14% since taking over management on January 3, 2024 [2]. Trading Activity - The ETF recorded a trading volume of 12.58 billion yuan on September 19, 2024, with an average daily trading amount of 18.71 billion yuan over the last 20 trading days [1]. - Year-to-date, the ETF has accumulated a total trading amount of 206.404 billion yuan over 176 trading days, averaging 11.73 billion yuan per day [1]. Top Holdings - The ETF's major holdings include: - Innovent Biologics (9.52% holding, 263 million yuan market value) - WuXi Biologics (9.47% holding, 258 million yuan market value) - BeiGene (8.73% holding, 238 million yuan market value) - CanSino Biologics (7.62% holding, 208 million yuan market value) - China National Pharmaceutical Group (7.17% holding, 196 million yuan market value) [2].
石药集团授出合共900万份受限制股份
Zhi Tong Cai Jing· 2025-09-19 09:47
Core Viewpoint - The company, 石药集团 (Stone Group), announced the grant of 9 million restricted shares to an employee under its restricted share award plan, pending acceptance by the recipient [1] Group 1 - The grant involves a total of 9 million restricted shares [1] - The recipient of the shares is an employee who is not a director, CEO, or a major shareholder, nor connected to any of these individuals [1] - The grant will only be effective upon acceptance by the recipient [1]