CSPC PHARMA(01093)
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石药集团涨超4% 帕妥珠单抗注射液上市申请获国家药监局受理
Zhi Tong Cai Jing· 2025-11-13 02:39
石药集团(01093)涨超4%,截至发稿,涨4.05%,报7.96港元,成交额3.73亿港元。 本次申请主要基于一项Ⅲ期等效性临床试验,其入组对象为早期或局部晚期HER2阳性乳腺癌患者。临 床试验结果显示,该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药具有等效 性。同时,该产品的安全性和耐受性良好,与原研参照药相当。 消息面上,11月12日,石药集团发布公告,本公司附属公司石药集团巨石生物制药有限公司开发的帕妥 珠单抗注射液(该产品)的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用生 物制品3.3 类申报,其适应症为HER2阳性乳腺癌。 该产品为一款重组人源化抗HER2单克隆抗体注射液,患者每3周需使用一次。该产品通过特异性结合 HER2的细胞外二聚化结构域II,阻断HER2与HER2或其他HER家族成员之间的配体之间的二聚化作 用,从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。 ...
港股异动 | 石药集团(01093)涨超4% 帕妥珠单抗注射液上市申请获国家药监局受理
智通财经网· 2025-11-13 02:29
该产品为一款重组人源化抗HER2单克隆抗体注射液,患者每3周需使用一次。该产品通过特异性结合 HER2的细胞外二聚化结构域II,阻断HER2与HER2或其他HER家族成员之间的配体之间的二聚化作 用,从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。 本次申请主要基于一项Ⅲ期等效性临床试验,其入组对象为早期或局部晚期HER2阳性乳腺癌患者。临 床试验结果显示,该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药具有等效 性。同时,该产品的安全性和耐受性良好,与原研参照药相当。 智通财经APP获悉,石药集团(01093)涨超4%,截至发稿,涨4.05%,报7.96港元,成交额3.73亿港元。 消息面上,11月12日,石药集团发布公告,本公司附属公司石药集团巨石生物制药有限公司开发的帕妥 珠单抗注射液(该产品)的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用生 物制品3.3 类申报,其适应症为HER2阳性乳腺癌。 ...
公募基金港股持仓 聚焦高成长性资产
Zheng Quan Ri Bao· 2025-11-12 23:12
Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from 951.985 billion yuan at the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings in Hong Kong stocks indicates a structural transformation in asset allocation, driven by the attractiveness of technology and value stocks [1] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main reasons: valuation advantages compared to A-shares, the convenience and low cost of ETF trading, and risk diversification benefits [2] - The top Hong Kong stocks that public funds increased their holdings in include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [2]
公募基金港股持仓聚焦高成长性资产
Zheng Quan Ri Bao· 2025-11-12 16:15
Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings indicates a structural transformation in asset allocation, driven by the enhanced attractiveness of Hong Kong stocks, particularly in the technology and banking sectors [1][2] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main factors: valuation advantages compared to A-shares, trading convenience and low fees of ETFs, and risk diversification benefits [2] - The most favored Hong Kong stocks by public funds include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors, aligning with the constituents of the Hang Seng Technology Index and the Hong Kong Pharmaceutical Index [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [3] Group 3 - The acceleration of fund flows into ETFs is expected to enhance market liquidity and pricing efficiency, supporting the stable development of the Hong Kong stock market [4]
港股公告掘金 | 荣利营造:拟携手宁德时代共同开发高效储能系统及解决方案
Zhi Tong Cai Jing· 2025-11-12 15:19
Major Events - Hong Kong Stock Exchange (00388) plans to make a strategic investment in Xunqing Settlement Holdings Limited [1] - Lai Kai Pharmaceutical-B (02105) signs an exclusive licensing agreement with Qilu Pharmaceutical for LAE 002 (AFURESERTIB) in China [1] - TECHSTARACQ-Z (07855) is expected to inherit the company Tuda Tong's listing on the main board of the Stock Exchange on December 10 [1] - Superstar Legend (06683) intends to establish a joint venture with Yushu Technology to develop consumer-grade IP robots and IP derivative products [1] - Beijing Enterprises Holdings (00392) plans to acquire 100% equity of Beijing Beiran Special Equipment Inspection and Testing Co., Ltd. for 54.6 million yuan [1] - CSPC Pharmaceutical Group (01093) has its application for the marketing of Pertuzumab Injection accepted by the National Medical Products Administration [1] - Rongli Construction (09639) plans to collaborate with CATL to develop efficient energy storage systems and solutions [1] Operating Performance - BeiGene (06160) reports a net profit attributable to shareholders of 1.139 billion yuan for the first three quarters, turning from loss to profit year-on-year [1] - Tencent Music-SW (01698) reports a net profit attributable to equity holders of 2.15 billion yuan in the third quarter, a year-on-year increase of 36.0% [1] - Zhou Li Fu (06168) sees a 32% year-on-year increase in e-commerce revenue for the first ten months, with net profit rising 71% year-on-year [1] - China Resources Land (01109) reports a cumulative contract sales amount of approximately 169.6 billion yuan for the first ten months, a year-on-year decrease of 16.6% [1]
石药集团(01093):帕妥珠单抗注射液的上市申请获国家药品监督管理局受理
智通财经网· 2025-11-12 10:20
智通财经APP讯,石药集团(01093)发布公告,本公司附属公司石药集团巨石生物制药有限公司开发的帕 妥珠单抗注射液(该产品)的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用 生物制品3.3 类申报,其适应症为HER2阳性乳腺癌。 该产品为一款重组人源化抗HER2单克隆抗体注射液,患者每3周需使用一次。该产品通过特异性结合 HER2的细胞外二聚化结构域II,阻断HER2与HER2或其他HER家族成员之间的配体之间的二聚化作 用,从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作用。 本次申请主要基于一项Ⅲ期等效性临床试验,其入组对象为早期或局部晚期HER2阳性乳腺癌患者。临 床试验结果显示,该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药具有等效 性。同时,该产品的安全性和耐受性良好,与原研参照药相当。 该产品的研发遵循生物类似药相关研究指南,通过药学、非临床、人体药代动力学、临床有效性及安全 性等一系列逐步递进的研究,科学、严谨、完整地确证了其与原研参照药在质量、安全性和有效性方面 高度相似,且不存在具有临床意义的差异。 ...
石药集团:帕妥珠单抗注射液的上市申请获国家药品监督管理局受理
Mei Ri Jing Ji Xin Wen· 2025-11-12 10:17
每经AI快讯,石药集团晚间公告,本公司附属公司石药集团巨石生物制药有限公司开发的帕妥珠单抗 注射液的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用生物制品3.3类申 报,其适应症为HER2阳性乳腺癌。 ...
石药集团(01093.HK):附属“帕妥珠单抗注射液”上市申请获药监局受理
Ge Long Hui· 2025-11-12 10:05
本次申请主要基于一项Ⅲ期等效性临床试验,其入组对象为早期或局部晚期HER2阳性乳腺癌患者。临 床试验结果显示,该产品用于早期或局部晚期HER2阳性乳腺癌的新辅助治疗与原研参照药具有等效 性。同时,该产品的安全性和耐受性良好,与原研参照药相当。 该产品的研发遵循生物类似药相关研究指南,通过药学、非临床、人体药代动力学、临床有效性及安全 性等一系列逐步递进的研究,科学、严谨、完整地确证了其与原研参照药在质量、安全性和有效性方面 高度相似,且不存在具有临床意义的差异。 格隆汇11月12日丨石药集团(01093.HK)宣布,公司附属公司石药集团巨石生物制药有限公司开发的帕妥 珠单抗注射液的上市申请已获中华人民共和国国家药品监督管理局受理。该产品按照治疗用生物制品 3.3类申报,其适应症为HER2阳性乳腺癌。该产品为一款重组人源化抗HER2单克隆抗体注射液,患者 每3周需使用一次。 该产品通过特异性结合HER2的细胞外二聚化结构域II,阻断HER2与HER2或其他HER家族成员之间的 配体之间的二聚化作用,从而阻断细胞周期并诱导凋亡。该产品还可介导抗体依赖细胞介导的细胞毒作 用。 ...
石药集团(01093) - 自愿公告 - 帕妥珠单抗注射液的上市申请获国家药品监督管理局受理
2025-11-12 10:00
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) 代表董事會 石藥集團有限公司 主席 蔡東晨 香港,2025年11月12日 自願公告 帕妥珠單抗注射液的上市申請 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 布,本公司附屬公司石藥集團巨石生物製藥有限公司開發的帕妥珠單抗注射液(「該產品」) 的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3.3 類申報,其適應症為HER2陽性乳腺癌。 該產品為一款重組人源化抗HER2單克隆抗體注射液,患者每3周需使用一次。該產品通過 特異性結合HER2的細胞外二聚化結構域II,阻斷HER2與HER2或其他HER ...
港股创新药ETF(159567)跌0.48%,成交额8.54亿元
Xin Lang Cai Jing· 2025-11-11 10:04
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.48% on November 11, with a trading volume of 854 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 10, 2024, the fund's latest share count was 9.675 billion, with a total size of 8.015 billion yuan, reflecting a significant increase in both share count and size compared to the previous year [1] Fund Performance - The fund's share count increased by 2347.04% and its size increased by 2021.31% from 3.95 million shares and 378 million yuan on December 31, 2024 [1] - Over the past 20 trading days, the cumulative trading amount reached 24.964 billion yuan, with an average daily trading amount of 1.248 billion yuan [1] - Year-to-date, the cumulative trading amount for 207 trading days was 244.556 billion yuan, with an average daily trading amount of 1.181 billion yuan [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 65.68% during the management period [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant percentages of the portfolio allocated to these stocks [2] - The largest holdings by percentage include BeiGene at 10.62%, CanSino Biologics at 10.55%, and Innovent Biologics at 10.21% [2]