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康宁杰瑞制药-B(09966.HK):JSKN003再次获得CDE突破性疗法认定
Ge Long Hui· 2025-10-20 00:09
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (01093.HK), has led to the breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1 - JSKN003 has previously received breakthrough therapy designation from CDE in March 2025 for treating PROC, with no restrictions on HER2 expression levels [1]
智通港股股东权益披露|10月20日
智通财经网· 2025-10-20 00:06
Core Viewpoint - The latest shareholder equity disclosure for CSPC Pharmaceutical Group (01093) was conducted on October 20, 2025, indicating changes in shareholding among institutional investors [1]. Group 1: Shareholding Changes - Cai Dongchen increased his holdings in CSPC Pharmaceutical Group from 2.839 billion shares to 2.842 billion shares, representing a holding percentage of 24.67% in the latest disclosure compared to 24.64% previously [2].
石药集团(01093) - 自愿公告 - JSKN003於中国再次获授予突破性治疗认定用於治疗HER...
2025-10-20 00:00
自願公告 JSKN 003於中國再次獲授予突破性治療認定 用於治療HER2陽性晚期結直腸癌患者 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) 在 2025 年 美 國 臨 床 腫 瘤 學 會 (ASCO ) 年 會 上 , 一 項「 JSKN 003 單 藥 治 療 晚 期 HER2 高 表 達 ( IHC3 + )胃腸道腫瘤患者的兩項臨床研究匯總分析」被發表。該項匯總分析包括在澳大利亞 進行的I期臨床研究(JSKN 003 -101)和在中國進行的I / II期臨床研究(JSKN 003 -102)。截至2025 年2 月 28 日 ,兩項 研究 共入組 50 例 HER2高 表達 的晚期 胃腸道 腫瘤 患者( 其 中23 例為結 直腸 癌 ),其中38 %的患者既往接受過≥ 3線抗腫瘤治療。初 ...
石药集团(01093.HK)获执行董事兼主席蔡东晨增持300万股
Ge Long Hui· 2025-10-19 23:56
Core Points - The article reports that Cai Dongchen, the executive director and chairman of CSPC Pharmaceutical Group (01093.HK), increased his shareholding by purchasing 3 million shares at an average price of HKD 8.81 per share, totaling approximately HKD 26.43 million [1] - Following this transaction, Cai's total shareholding increased to 2,842,118,670 shares, raising his ownership percentage from 24.64% to 24.67% [1] Summary by Sections - **Share Purchase Details** - Cai Dongchen acquired 3 million shares at an average price of HKD 8.81 per share [1] - The total investment for this purchase was about HKD 26.43 million [1] - **Shareholding Changes** - After the purchase, Cai's total shares held reached 2,842,118,670 [1] - His ownership percentage increased from 24.64% to 24.67% [1]
康宁杰瑞&石药集团ESMO数据解读
2025-10-19 15:58
Summary of Conference Call on Corning Jereh & CSPC Pharmaceutical Group ESMO Data Interpretation Company and Industry Overview - The conference call discusses clinical data and future plans for GS-003, a drug developed by Corning Jereh and CSPC Pharmaceutical Group, focusing on its applications in oncology, specifically in platinum-resistant ovarian cancer (PROC), HER2-positive colorectal cancer, and HER2-positive breast cancer. Key Points and Arguments Clinical Efficacy of GS-003 - In PROC, GS-003 demonstrated an objective response rate (ORR) of 32%, a disease control rate (DCR) of 72%, a median progression-free survival (PFS) of 4.1 months, and a 9-month overall survival (OS) rate of 65.4% with a treatment-related adverse event (TRAE) rate of 15.4% [1][2] - In HER2-positive colorectal cancer, GS-003 showed an ORR of 68.8%, a DCR close to 97%, a median PFS of 11.4 months, and a median duration of response (DOR) of 9.9 months, outperforming existing treatments like DS8,201 and TQB2,102 [1][5] - The 026 project for HER2-positive gastric cancer showed significant PFS improvement (HR=0.25) compared to the control group, with a TRAE rate of 60% [1][9][10] Future Development Plans - GS-003 plans to submit a marketing application for HER2-positive breast cancer in 2026 and expects to report phase III clinical data for PROC in 2027 [1][6] - The company aims to explore additional indications and conduct clinical trials for gastric cancer and other cancers, with a focus on both high and low HER2 expression markets [1][7][11] Competitive Landscape - GS-003 is positioned as a best-in-class product in HER2-positive colorectal cancer, with superior efficacy compared to existing therapies [5][11] - The combination of GS-003 and 026 is expected to cover the entire lifecycle management of breast and gastric cancers, enhancing competitive positioning in both high and low HER2 expression markets [1][11] Safety and Tolerability - The safety profile of GS-003 in PROC and colorectal cancer shows a manageable TRAE rate, indicating a favorable risk-benefit ratio compared to other treatments [2][10] - The 026 project reported a higher TRAE rate due to longer chemotherapy cycles, which is considered normal given the treatment duration [10] Market Potential and Strategy - The combination of GS-003 and 026 is anticipated to fill unmet clinical needs in various cancer types, with a strategic focus on leveraging existing data to attract partnerships for overseas clinical development [1][19] - The company plans to utilize combination therapies to enhance treatment efficacy and patient outcomes, particularly in HER2-positive populations [14][19] Insights on Future Trials - The company is considering a segmented market strategy for HER2-positive gastric and breast cancer, aiming to maximize the advantages of both GS-003 and 026 [12][18] - Ongoing clinical trials are exploring various drug combinations for gastric cancer, with promising early results [19] Additional Important Insights - The conference highlighted the potential of dual antibodies and ADCs in improving treatment outcomes for HER2-positive cancers, suggesting a shift in therapeutic strategies [14][21] - The anticipated results from ongoing trials could significantly impact the market positioning of GS-003 and 026, with expectations of long-term survival benefits for patients [21]
主席兼执行董事蔡东晨增持石药集团300万股 每股作价8.81港元
Zhi Tong Cai Jing· 2025-10-17 11:34
Group 1 - The chairman and executive director of the company, Cai Dongchen, increased his stake in the company by purchasing 3 million shares at a price of HKD 8.81 per share, totaling HKD 26.43 million [1] - Following the purchase, the total number of shares held by Cai Dongchen is approximately 2.842 billion, representing a holding percentage of 24.67% [1]
主席兼执行董事蔡东晨增持石药集团(01093)300万股 每股作价8.81港元
智通财经网· 2025-10-17 11:25
Group 1 - The chairman and executive director of the company, Cai Dongchen, increased his stake in the company by purchasing 3 million shares at a price of HKD 8.81 per share, totaling HKD 26.43 million [1] - Following the purchase, the total number of shares held by Cai Dongchen is approximately 2.842 billion, representing a holding percentage of 24.67% [1]
石药集团:受托人根据股份奖励计划购买合共300万股
Zhi Tong Cai Jing· 2025-10-17 10:45
石药集团(01093)发布公告,于2025年10月17日,受托人根据该计划之条款及条件在市场上购买合共300 万股公司股份,并为获选参与者之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
2025-10-17 10:32
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。 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) CSPC PHARMACEUTICAL GROUP LIMITED 自願公告 根據本公司股份獎勵計劃 在市場上購買股份 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17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17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 | | --- ...
港股创新药ETF(159567)涨2.42%,成交额14.86亿元
Xin Lang Cai Jing· 2025-10-16 10:35
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 2.42% on October 16, with a trading volume of 1.486 billion 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 October 15, 2024, the fund's shares reached 8.213 billion, with a total size of 7.102 billion yuan, reflecting a significant increase of 1977.25% in shares and 1779.88% in size compared to December 31, 2023 [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 68.94% since taking over the fund on January 3, 2024 [2] - The ETF's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2] Trading Activity - Over the last 20 trading days, the ETF recorded a cumulative trading amount of 30.962 billion yuan, averaging 1.548 billion yuan per day [1] - Since the beginning of the year, the ETF has seen a total trading amount of 222.219 billion yuan over 189 trading days, averaging 1.176 billion yuan per day [1]