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海思科(002653) - 关于创新药HSK3486获得FDA上市许可申请受理通知的公告
2025-07-31 10:15
证券代码:002653 证券简称:海思科 公告编号:2025-087 海思科医药集团股份有限公司 关于创新药 HSK3486 获得 FDA 上市许可申请 受理通知的公告 二、 受理注册意义 FDA 本次受理 HSK3486 的上市许可申请,是公司创新药研发迈向 国际的关键一步,也是公司国际化战略的重大里程碑,若其成功上市, 将为全球患者带来更安全、更高效的麻醉镇静新选择。 三、 主要风险提示 本公司及董事会全体成员保证信息披露内容的真实、准确、完整, 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司(以下简称"公司")于 2025 年 7 月 30 日收到美国食品药品监督管理局(FDA)下发的受理通知。根 据 FDA 相关规定,经审查,HSK3486(环泊酚注射液)新药上市申请 (NDA)符合药品注册的有关要求,决定予以受理。 一、 研发项目简介 HSK3486(环泊酚注射液、思舒宁®)是公司开发的全新的具有自 主知识产权的 1 类静脉麻醉药物,于 2020 年 12 月国内获批上市,在 国内已获得"非气管插管手术/操作中的镇静和麻醉"、"全身麻醉 诱导和维持"、"重症监护期间的镇静"适应症的 ...
中国创新药:出海黄金时代,游到海水变蓝
2025-07-30 02:32
Summary of Key Points from the Conference Call Industry Overview - The Chinese innovative pharmaceutical industry is experiencing a significant enhancement in strength, with its share of global first-in-class drugs increasing to 19% [7] - Multinational corporations (MNCs) are facing a severe patent cliff, with major companies like Merck, AbbVie, and BMS having over 60%, 58%, and 69% of their 2024 revenues coming from drugs facing patent expiration within the next five years [8][9] - MNCs are actively seeking business development (BD) transactions to address these challenges, with strong cash reserves available for such activities [10] Business Development Trends - The trend of Chinese innovative drugs going global is robust, driven by the strengthening capabilities of Chinese companies and the impending patent cliffs faced by MNCs [2] - MNCs are expected to engage in more BD transactions, particularly in the second half of 2025 and into 2026, as they seek to replenish their pipelines [2] Oncology Sector Insights - The oncology field is shifting from PD-1 combined with chemotherapy to next-generation immuno-oncology (IO) and antibody-drug conjugates (ADC) [3] - Potential MNC buyers in this space include AstraZeneca, Pfizer, and Merck, all of which are looking to enhance their portfolios with next-generation IO and ADC assets [3] Metabolic Disease Developments - The metabolic field is evolving from merely focusing on weight loss to comprehensive metabolic management, including fat reduction and muscle preservation [4][5] - Companies like Novo Nordisk and AstraZeneca are exploring oral medications and multi-target approaches in this area [4] Immune and Inflammatory Disease Innovations - New directions in the immune and inflammation sector include novel targets and engineering innovations, with significant investments from companies like AbbVie and Sanofi [6] - Emerging targets such as TL1a are attracting substantial investments, indicating a strong interest in this area [20] Market Position of Chinese Innovative Drugs - Chinese innovative drug companies have made significant strides in global markets, with improved clinical data quality and increased academic recognition [7] - The presence of Chinese companies in the oncology sector is growing, with several projects in advanced stages of development [14] MNC Strategies for BD Transactions - MNCs are focusing on four main strategies for BD transactions: consolidating core areas, entering new fields, exploring opportunities, and investigating new technologies [11] - The willingness of MNCs to invest in promising assets at the preclinical stage is evident, particularly in high-potential areas like TL1a [20] ADC and TCE Technology Developments - The ADC field is characterized by a tiered approach, with MNCs diversifying their portfolios across various targets [15] - T-cell engagers (TCE) are being developed for blood cancers and autoimmune diseases, with ongoing clinical trials showing promising results [16] Conclusion - The ongoing trends in the Chinese pharmaceutical industry, coupled with the challenges faced by MNCs, are creating a fertile ground for increased collaboration and investment opportunities in the global market [29]
海思科57岁董事长王俊民年薪175万元,妻子申萍拟减持套现5亿元
Sou Hu Cai Jing· 2025-07-29 02:15
瑞财经 刘治颖 7月25日,海思科公告,公司控股股东之一致行动人申萍计划自本公告披露之日起十五个交易日后的三个月内,通过大宗交易或集中竞价方式 减持公司股份合计不超过1037.34万股,减持比例合计不超过公司总股本的0.926%。 以7月25日收盘价48.2元/股计算,此次减持套现金额约5亿元。截至公告披露日,海思科由控股股东王俊民持有35.68%股份,申萍持有4.43%股份,夫妻两人 合计持有40.11%股份。 | 一、本次减持主体及其一致行动人的持股情况 | | --- | | 股东名称 | 持有股份数量(股) | 占公司总股本比例 | | --- | --- | --- | | 田萍 | 49, 625, 894 | | | 王俊民(控股股东) | 399, 550, 400 | 35 | | 合计 | 449, 176, 294 | 4( | 资料显示,王俊民,男,1968年出生,中国国籍,有新加坡永久居留权,毕业于长江商学院,硕士学历。王俊民曾担任华西医科大学制药厂销售经理,2007 年11月至2019年3月历任海思科医药集团股份有限公司董事长、总经理,2019年3月起任公司董事长。 东方财富数据显 ...
7月28日工银前沿医疗股票A净值增长3.04%,近6个月累计上涨32.0%
Sou Hu Cai Jing· 2025-07-28 13:05
Group 1 - The core viewpoint of the news is the performance and holdings of the ICBC Frontier Medical Stock A fund, which has shown significant growth in recent months and has a diversified portfolio in the healthcare sector [1][3] - As of July 28, 2025, the latest net value of ICBC Frontier Medical Stock A is 3.4240 yuan, reflecting a growth of 3.04%. The fund's one-month return is 13.45%, six-month return is 32.00%, and year-to-date return is 30.14% [1] - The fund's top ten stock holdings account for a total of 59.44%, with significant investments in companies such as Heng Rui Pharmaceutical (9.51%), Kelun Pharmaceutical (9.16%), and others [1] Group 2 - The ICBC Frontier Medical Stock A fund was established on February 3, 2016, and as of June 30, 2025, it has a total scale of 9.33 billion yuan. The fund manager is Zhao Bei [1] - Zhao Bei has extensive experience in the healthcare sector, having served as the fund manager for various healthcare-related funds since 2014 and currently holds multiple managerial positions within ICBC Credit Suisse Asset Management [2]
7月28日工银医疗保健股票净值增长2.50%,近6个月累计上涨29.37%
Sou Hu Cai Jing· 2025-07-28 12:46
Group 1 - The core viewpoint of the news is the performance and holdings of the Industrial and Commercial Bank of China Medical Healthcare Stock Fund, which has shown significant growth in recent months and has a diversified portfolio in the healthcare sector [1][3] - The latest net value of the fund is 2.9160 yuan, reflecting a growth of 2.50%. The fund's return over the past month is 12.94%, ranking 280 out of 1035 in its category. Over the past six months, the return is 29.37%, ranking 125 out of 1001, and since the beginning of the year, the return is 27.95%, ranking 148 out of 991 [1] - The top ten holdings of the fund account for a total of 44.59%, with significant investments in companies such as Heng Rui Pharmaceutical (7.52%), Kelun Pharmaceutical (6.50%), and BeiGene (5.08%) [1] Group 2 - The fund was established on November 18, 2014, and as of June 30, 2025, it has a total scale of 2.797 billion yuan. The fund managers are Zhao Bei and Ding Yang [1] - Zhao Bei has extensive experience in the healthcare sector, having served as the fund manager for various healthcare-related funds since 2014, while Ding Yang joined the company in December 2017 and has been involved in managing healthcare investment funds [2]
7月28日汇添富医疗积极成长一年持有混合A净值增长4.14%,近6个月累计上涨64.72%
Sou Hu Cai Jing· 2025-07-28 11:56
Group 1 - The core viewpoint of the news is the performance and holdings of the Huatai-PineBridge Medical Active Growth One-Year Holding Mixed Fund A, which has shown significant growth in various time frames [1] - As of June 30, 2025, the fund's latest net value is 0.8101 yuan, reflecting a growth of 4.14% [1] - The fund has achieved a one-month return of 21.65%, a six-month return of 64.72%, and a year-to-date return of 63.33%, with respective rankings of 296 out of 4764, 63 out of 4579, and 72 out of 4542 in its category [1] Group 2 - The top ten stock holdings of the fund account for a total of 61.79%, with significant positions in companies such as Sanofi (10.07%), Innovent Biologics (8.94%), and Kelun-Biotech (8.71%) [1] - The fund was established on August 21, 2020, and as of June 30, 2025, it has a total scale of 1.922 billion yuan [1] - The fund manager is Zheng Lei, who has extensive experience in the medical and healthcare investment sector [2]
变盘!集体跌停
中国基金报· 2025-07-28 07:45
Market Overview - A-shares continued to rise, with the Shanghai Composite Index up 0.12%, the Shenzhen Component Index up 0.44%, and the ChiNext Index up 0.96% on July 28 [6][7] - A total of 2,781 stocks rose, while 2,438 stocks fell, with 62 stocks hitting the daily limit up [8][9] Commodity Market - Domestic commodity futures saw a collective decline, with coking coal, glass, coke, soda ash, industrial silicon, and lithium carbonate futures hitting the limit down [4] - Coking coal prices fell by 11% to 1,100.5 yuan/ton, while glass and soda ash dropped by 9% and 8.04% respectively [4] - The market sentiment weakened following new trading limits introduced by exchanges, leading to a significant withdrawal of long positions in coking coal [5] Policy Impact - The Shanghai Municipal Economic and Information Commission issued measures to expand AI applications, including a 600 million yuan subsidy for computing power and a maximum 30% rent subsidy for AI computing resources [10] - This policy is expected to support companies in the AI sector, leading to a surge in related stocks such as Dazhu CNC and Chip Microelectronics, which hit the daily limit up [10] Pharmaceutical Sector - Innovative drug concept stocks were active, with companies like Heng Rui Medicine and Lian Huan Pharmaceutical hitting the daily limit up [13] - Heng Rui Medicine announced a potential $12.5 billion licensing deal with GlaxoSmithKline, covering a clinical-stage respiratory drug and multiple candidates [13][14] Resource Sector - Resource stocks, particularly in coal and steel, experienced adjustments, with companies like Liu Steel and Shanxi Coking Coal seeing declines of over 5% [15][16]
今日656只个股突破五日均线
Market Overview - The Shanghai Composite Index is at 3597.22 points, above the five-day moving average, with a slight increase of 0.10% [1] - The total trading volume of A-shares today is 14,360.10 billion yuan [1] Stocks Performance - A total of 656 A-shares have surpassed the five-day moving average today [1] - Notable stocks with significant deviation rates include: - Tongguan Copper Foil (15.08%) - Defu Technology (9.48%) - *ST Huike (9.43%) [1] - Stocks with smaller deviation rates that have just crossed the five-day moving average include: - Yao Yigou - Ningde Times - SAIC Group [1] Top Stocks by Deviation Rate - The following stocks have the highest deviation rates from the five-day moving average: - Tongguan Copper Foil: 20.00% increase, trading at 25.08 yuan [1] - Defu Technology: 11.96% increase, trading at 30.99 yuan [1] - *ST Huike: 12.10% increase, trading at 12.88 yuan [1] - Other notable stocks include: - Chaojie Shares: 12.51% increase, trading at 42.08 yuan [1] - Zhongxin Fluorine: 10.00% increase, trading at 20.68 yuan [1] [2]
创新药企ETF(560900)高开上扬涨1.57%,最新规模创近半年新高,创新药产业发展动力持续强劲
Sou Hu Cai Jing· 2025-07-28 02:04
Group 1 - The core viewpoint is that the Chinese innovative drug sector is gaining global recognition, with increasing clinical data presence at international academic conferences and rising BD authorization amounts and numbers, indicating enhanced global market acceptance of Chinese innovative drugs [2] - The innovative drug ETF (560900) has shown a strong performance, with a 1.57% increase as of July 28, 2025, and a 7.04% increase over the past two weeks, reflecting positive market sentiment [1] - The latest scale of the innovative drug ETF reached 55.51 million yuan, marking a six-month high, with a significant increase in shares by 3 million, leading the comparable funds [1] Group 2 - The support from medical insurance policies for innovative drugs is characterized by a "full chain, high intensity" approach, which includes accelerated inclusion of new drugs into the medical insurance catalog and optimized payment methods, further promoting rapid clinical application [2] - The innovative drug ETF closely tracks the CSI Innovative Drug Industry Index, which selects up to 50 representative listed companies involved in innovative drug research and development to reflect the overall performance of the innovative drug industry [2] - The rise of AI-driven technology waves has prompted Morgan Asset Management to integrate its "Global Vision Investment Technology" product line, aiding investors in seizing investment opportunities in quality technology enterprises globally [2]
海思科: 关于控股股东之一致行动人股份减持计划的预披露公告
Zheng Quan Zhi Xing· 2025-07-25 16:25
证券代码:002653 证券简称:海思科 公告编号:2025-086 海思科医药集团股份有限公司 关于控股股东之一致行动人股份减持计划的 预披露公告 一、本次减持主体及其一致行动人的持股情况 | 股东名称 | 持有股份数量(股) | 占公司总股本比例(%) | | --- | --- | --- | | 申萍 | 49,625,894 | 4.43 | | 王俊民(控股股东) | 399,550,400 | 35.68 | | 合计 | 449,176,294 | 40.11 | 二、本次减持计划的主要内容 (一)本次减持基本情况 公司股份合计不超过 10,373,400 股,合计比例不超过公司总股本的 后的三个月内(根据中国证券监督管理委员会和深圳证券交易所相关 规定禁止减持的期间除外)。 股东申萍保证向公司提供的信息披露内容的真实、准确、完整,没 有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信 息一致。 特别提示: 截止本公告披露日,海思科医药集团股份有限公司(以下简称"公司")控 股股东之一致行动人申萍女士(控股股东王俊民之配偶)持有公司股份 申萍计划自本 ...