CSPC PHARMA(01093)
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石药集团(01093) - 自愿公告 - KN026(安尼妥单抗注射液)的新药上市申请获国家药品监督...
2025-09-11 11:31
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。 該產品是一種抗HER2雙特異性抗體,可同時結合HER2的兩個非重疊表位,導致HER2信號 阻斷。在2024年歐洲腫瘤內科學會(ESMO)大會上,該產品的II期臨床研究結果首次公布。 該研究結果顯示,該產品聯合化療的客觀緩解率為40.0 %,經獨立評審委員會(IRC)評估的 中位無進展生存期為8.6個月,中位總生存期為13.2個月。本次上市申請主要是基於一項關 鍵II╱III期臨床試驗( KC -WISE )。III期臨床研究的首次期中分析結果顯示,與目前的標準 治療相比,該產品聯合化療可顯著提高臨床療效,延長無進展生存期和總生存期,且在安 全性方面無新發安全性風險,心臟毒性發生率低,免疫原性低。 該 產 品 本 次 按 照 治 療 用 生 物 製 品 1 類 新 藥 申 報 , 其 適 應 症 為 聯 合 化 療 用 於 至 少 接 受 過 一 種 系統性治療( 必須包含曲妥珠單抗聯合化療 )失敗,HER ...
智通港股通活跃成交|9月11日
智通财经网· 2025-09-11 11:05
Core Insights - On September 11, 2025, Alibaba-W (09988), Meituan-W (03690), and SMIC (00981) were the top three stocks by trading volume in the southbound trading of the Shanghai-Hong Kong Stock Connect, with trading amounts of 8.075 billion, 6.184 billion, and 4.910 billion respectively [1] - In the southbound trading of the Shenzhen-Hong Kong Stock Connect, Alibaba-W (09988), SMIC (00981), and Innovent Biologics (01801) led the trading volume, with amounts of 4.357 billion, 3.132 billion, and 2.538 billion respectively [1] Southbound Trading Highlights - **Shanghai-Hong Kong Stock Connect:** - Alibaba-W (09988): Trading amount of 8.075 billion, net buying of 2.946 billion - Meituan-W (03690): Trading amount of 6.184 billion, net selling of 0.936 billion - SMIC (00981): Trading amount of 4.910 billion, net buying of 0.417 billion - Other notable companies include Kangfang Biologics (09926) with a trading amount of 2.797 billion and net selling of 0.755 billion, and Tencent Holdings (00700) with a trading amount of 2.633 billion and net selling of 0.923 billion [2] - **Shenzhen-Hong Kong Stock Connect:** - Alibaba-W (09988): Trading amount of 4.357 billion, net buying of 0.784 billion - SMIC (00981): Trading amount of 3.132 billion, net buying of 0.515 billion - Innovent Biologics (01801): Trading amount of 2.538 billion, net buying of 0.847 billion - Other significant companies include Kangfang Biologics (09926) with a trading amount of 2.418 billion and net buying of 0.365 billion, and Meituan-W (03690) with a trading amount of 2.268 billion and net buying of 0.839 billion [2]
港股收评:止步4连涨!恒指险守26000点,创新药重挫!
Ge Long Hui· 2025-09-11 08:44
Market Overview - The Hong Kong stock market indices collectively declined, ending a four-day rally, with the Hang Seng Index dropping 0.43% to close just above 26,000 points [1] - The Hang Seng Index, the Hang Seng China Enterprises Index, and the Hang Seng Tech Index fell by 0.43%, 0.73%, and 0.24% respectively [2] Sector Performance - Large technology stocks generally fell, with Meituan dropping over 5%, and other major players like Bilibili and Baidu also experiencing declines [5] - Semiconductor stocks showed strong gains, with notable increases in Shanghai Fudan and SMIC, driven by robust demand in the AI sector [6][7] - The copper and aluminum sectors performed actively, supported by expectations of a Federal Reserve interest rate cut [3][9] Notable Stocks - Meituan's stock price fell to 96.55, down 5.06%, with a market capitalization of 590.03 billion [6] - Semiconductor stocks like Shanghai Fudan and Huahong Semiconductor saw increases of over 5% and 4% respectively, reflecting strong market interest [7] - Apple-related stocks surged, with Hongteng Precision rising over 12% following the launch of new iPhone models [8] Biopharmaceutical Sector - The biopharmaceutical sector faced significant declines, with companies like Gilead Sciences and Hansoh Pharmaceutical dropping nearly 20% and 9% respectively, amid reports of potential U.S. restrictions on Chinese pharmaceuticals [10][11] Investment Trends - Southbound funds recorded a net inflow of 18.99 billion HKD, indicating continued interest in Hong Kong stocks [12] - Analysts suggest that the Hong Kong market's low valuations and improving asset quality may attract more foreign investment, particularly in the internet sector [14]
港股医药股多数低开
Xin Lang Cai Jing· 2025-09-11 07:44
Group 1 - Hansoh Pharmaceutical experienced a decline of 14.98% [1] - Fuhong Hanlin saw a drop of 11.84% [1] - Other companies such as CSPC Pharmaceutical, WuXi Biologics, and BeiGene also opened lower [1]
港股生物医药股集体下挫,中国生物制药、石药集团跌超10%
Xin Lang Cai Jing· 2025-09-11 06:28
Group 1 - The Hong Kong stock market saw a collective decline in the biopharmaceutical sector, with China Biologic Products and CSPC Pharmaceutical Group dropping over 10% [1] - Fosun Pharma experienced a decline of over 7%, while WuXi Biologics and WuXi AppTec also followed suit with declines [1]
超3300只个股上涨
第一财经· 2025-09-11 03:50
Core Viewpoint - The A-share market shows a strong upward trend, with significant gains in sectors such as computing hardware, semiconductors, and liquid-cooled servers, while sports and precious metals sectors remain sluggish [3][4]. Market Performance - The Shanghai Composite Index rose by 1.12%, the Shenzhen Component Index increased by 2.63%, and the ChiNext Index surged by 4.31% [3]. - The total trading volume in the Shanghai and Shenzhen markets reached 1.48 trillion yuan, an increase of 193.8 billion yuan compared to the previous trading day, with over 3,300 stocks rising [4]. Sector Highlights - Notable sectors with significant gains include: - Components: +6.54% - Co-packaged optics (CPO): +6.13% - AI 50 Index: +4.83% - PCB concept: +4.40% - Fiber optic concept: +4.11% [4]. - Semiconductor stocks, particularly computing chips, experienced a notable surge, with companies like Haiguang Information nearing a 20% limit up [6][13]. Individual Stock Movements - Industrial Fulian reached a new historical high, increasing by 8.78% to 58.38 yuan [9]. - In the pork sector, stocks such as Bangji Technology and Lihua Shares saw significant increases, with Bangji Technology hitting the daily limit up [11][12]. International Market Influence - OpenAI reportedly signed a deal to purchase $300 billion worth of computing power from Oracle over five years, leading to a 36% surge in Oracle's stock, which added approximately $250 billion to its market capitalization in a single day [13].
港股创新药概念股大跌,翰森制药跌15%,科伦博泰生物跌12%,药明生物、百济神州跌9%!机构称行业整体业绩改善仍需时间
Ge Long Hui· 2025-09-11 02:06
Group 1 - The overall performance of the pharmaceutical industry is weak, with an average revenue growth of 1.6% and a decline in average net profit by 3.2% for the first half of 2025 compared to the full year of 2024 [2] - The industry is expected to take time for performance improvement, with ongoing support policies for innovative drugs and devices, as well as improvements in global biopharmaceutical financing driving recovery [2] - A significant drop in stock prices was observed among innovative drug concept stocks in the Hong Kong market, with Huaneng Pharmaceutical down nearly 15% and Kelun-Bio down over 12% [4] Group 2 - The report by CMB International analyzed the performance of 393 pharmaceutical companies listed in A-shares and Hong Kong stocks, indicating a deterioration in both revenue and profit compared to the previous year [2] - The domestic centralized procurement policy optimization and continuous support for innovative drugs and devices are seen as crucial for the industry's recovery [2] - The stock performance of various pharmaceutical companies reflects the overall market sentiment, with multiple companies experiencing declines exceeding 9% [4]
港股医药板块全线下挫,多股跌逾10%
Mei Ri Jing Ji Xin Wen· 2025-09-11 02:00
Group 1 - The Hong Kong pharmaceutical sector experienced a significant decline, with major stocks dropping sharply [1] - Gilead Sciences-B (01672.HK) fell nearly 15%, indicating a substantial loss in market value [1] - China Biopharmaceutical (01177.HK) saw a decline of over 10%, reflecting broader market trends affecting the industry [1] Group 2 - Other notable declines included CSPC Pharmaceutical Group (01093.HK), BeiGene (06160.HK), Hengrui Medicine (01276.HK), and WuXi AppTec (02359.HK), all of which experienced significant drops [1]
港股异动 | 医药板块全线重挫 多股早盘低开逾10% 报道称特朗普政府拟限制中国药品
智通财经网· 2025-09-11 01:33
Core Viewpoint - The pharmaceutical sector is experiencing a significant decline due to potential regulatory actions from the Trump administration aimed at restricting drug imports from China [1] Group 1: Market Impact - Major pharmaceutical companies have seen substantial stock price drops, with Hansoh Pharmaceutical down 14.98% to HKD 32.8, CSPC Pharmaceutical down 9.51% to HKD 9.9, Innovent Biologics down 8.63% to HKD 91, and 3SBio down 7.78% to HKD 30.34 [1] Group 2: Regulatory Developments - The Trump administration is drafting an executive order that may threaten to cut off supply channels for drug research from China [1] - The proposed order includes stricter scrutiny of transactions where U.S. pharmaceutical companies purchase drugs from Chinese firms, requiring mandatory reviews by the Committee on Foreign Investment in the United States (CFIUS) [1] - The draft calls for the FDA to conduct more rigorous reviews and impose higher regulatory fees, discouraging reliance on clinical trial data from Chinese patients [1] Group 3: Government Pressure - The U.S. government has been increasingly pressuring the pharmaceutical industry, with President Trump advocating for a stronger domestic pharmaceutical sector and lower drug prices [1] - Trump has indicated that tariffs could be a tool to achieve these goals, threatening to impose tariffs as high as 250% on imported drugs [1] - On July 31, Trump sent letters to the CEOs of 17 major pharmaceutical companies, demanding significant reductions in U.S. prescription drug prices and binding commitments by September 29 [1]
恒生指数开盘跌0.81%,恒生科技指数跌0.97%,医药股走低
Mei Ri Jing Ji Xin Wen· 2025-09-11 01:27
(文章来源:每日经济新闻) 每经AI快讯,9月11日,恒生指数开盘跌0.81%,恒生科技指数跌0.97%。医药股走低,翰森制药跌近 15%,药明生物、石药集团跌超9%,药明康德跌近7%。 ...