Core Viewpoint - The announcement by Haishi Science (002653.SZ) regarding the acceptance of its new drug application (NDA) for HSK3486 by the FDA marks a significant step in the company's international drug development efforts, potentially offering a safer and more efficient anesthetic option for global patients [2]. Company Summary - Haishi Science received a notice from the FDA on July 30, indicating that the NDA for HSK3486 (环泊酚注射液) meets the necessary requirements for drug registration [2]. - HSK3486 is a first-class intravenous anesthetic developed independently by the company, which was approved for domestic market entry in December 2020 [2]. - The successful launch of HSK3486 in the international market could enhance the company's position in the global pharmaceutical industry [2]. Industry Summary - The acceptance of HSK3486 by the FDA represents a critical advancement in the field of anesthetics, potentially providing healthcare professionals with a new option for patient care [2]. - The development of innovative anesthetic drugs like HSK3486 aligns with the industry's ongoing efforts to improve patient safety and treatment efficacy [2].

人民财讯7月31日电，海思科（002653）7月31日晚间公告，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。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。 ...

格隆汇7月31日丨海思科(002653.SZ)公布，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。 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"适应症的药品注册证书。公司于2024年完成所有临床研究，并完成与FDA 的Pre-NDA沟通，就申报内容达成一致，获得FDA同意进行NDA申报，于近日获得上市许可申请受理。 ...

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 ...

海思科公告，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。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"适应症的药品注册证书。HSK3486于2021年1月获得FDA的IND 申请批准，在美国免除Ⅱ期，直接进入关键Ⅲ期临床试验。海内外临床研究结果表明，HSK3486起效 快、恢复快，麻醉成功率高，有更稳定的血压控制，低血压、呼吸抑制和注射痛等不良反应发生率大幅 降低，患者及医生满意度更优。公司于2024年完成所有临床研究，并完成与FDA的Pre-NDA沟通，就申 报内容达成一致，获得FDA同意进行NDA申报，于近日获得上市许可申请受理。 ...

Group 1 - The core point of the article highlights the performance and holdings of the Industrial Bank's Frontier Medical Stock C fund, which has shown significant returns over various time frames [1] - As of July 30, 2025, the latest net value of the fund is 3.3890 yuan, reflecting a decrease of 0.73%. The fund's one-month return is 14.49%, six-month return is 33.90%, and year-to-date return is 31.97% [1] - The top ten holdings of the fund account for a total of 59.44%, with significant positions in companies such as Heng Rui Pharmaceutical (9.51%), Kelun Pharmaceutical (9.16%), and Xinli Tai (6.70%) [1] Group 2 - The Industrial Bank's Frontier Medical Stock C fund was established on November 23, 2020, and as of June 30, 2025, it has a total scale of 1.26 billion yuan [1] - Zhao Bei serves as the fund manager and has extensive experience in the healthcare sector, having held various positions within the Industrial Bank since 2010 [2]

Group 1 - The core point of the article highlights the performance and holdings of the Industrial and Commercial Bank of China (ICBC) Healthcare Stock Fund, which has shown significant returns over various time frames [1] - As of July 30, 2025, the latest net value of the ICBC Healthcare Stock Fund is 2.9710 yuan, reflecting a decrease of 0.74% [1] - The fund's one-month return is 13.74%, ranking 90 out of 725 in its category; the six-month return is 31.81%, ranking 76 out of 709; and the year-to-date return is 30.36%, ranking 91 out of 705 [1] Group 2 - The top ten holdings of the ICBC Healthcare Stock Fund account for a total of 44.59%, with significant positions in companies such as Heng Rui Pharmaceutical (7.52%), Kelun Pharmaceutical (6.50%), and BeiGene (5.08%) [1] - The fund was established on November 18, 2014, and as of June 30, 2025, it has a total scale of 2.797 billion yuan [1] - The fund is managed by Zhao Bei and Ding Yang, both of whom have extensive experience in the healthcare sector [2]

创新药彻底火了！ 截至7月29日，基金市场涌现16只"翻倍基"，全部都与创新药主题相关，其中汇添富基金的张韡管理的汇添富香港优势精选A以138.9%的傲人涨幅问鼎冠 军，长城基金的梁福睿管理的长城医药产业精选A以129.35%的涨幅拿下亚军。中银基金的郑宁管理的中银港股通医药A以119.64%涨幅排名第三名。 汇添富国证港股通创新药ETF、万家中证港股通创新药ETF、广发中证香港创新药ETF和华泰柏瑞恒生创新药ETF分别涨107.67%、106.87%、106.39%、 106.36%。 | 序号 | 证券代码 | 证券简称 | 今年净值增长率% | 合并规模(亿元) | | --- | --- | --- | --- | --- | | 1 | 470888.OF | 汇添富香港优势精选A | 138.90 | 2.19 | | 2 | 022286.OF | 长城医药产业精选A | 129.35 | 11.32 | | ਤੋ | 020397.OF | 中银港股通医药A | 119.64 | 7.40 | | 4 | 015915.OF | 永赢医药创新智选A | 114.79 | 30.43 | | 5 ...

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]

Summary of Key Points Core Viewpoint - The company, Haishike, announced a plan for a major shareholder to reduce their stake in the company, which may impact the stock price and investor sentiment. The company is also in the process of raising funds for new drug development and working capital through a specific stock issuance. Group 1: Shareholder Actions - The controlling shareholder's associate, Shen Ping, plans to reduce their holdings by up to 10.37 million shares, representing a maximum of 0.926% of the total share capital within three months after the announcement [1] - The estimated cash amount from this reduction, based on the closing price of 48.2 yuan per share, is approximately 500 million yuan [1] - As of the announcement date, the controlling shareholder, Wang Junmin, holds 35.68% of the shares, while Shen Ping holds 4.43%, totaling 40.11% for the couple [1] Group 2: Financial Performance and Projections - In 2024, Haishike's revenue is projected to be 3.721 billion yuan, reflecting a year-on-year growth of 10.92%, with a net profit attributable to shareholders of 395 million yuan, up 34% [4] - For the first quarter of 2025, the company reported revenue of 892 million yuan, an increase of 18.6% year-on-year, but the net profit attributable to shareholders decreased by 49.31% to 46.61 million yuan [5] Group 3: Fundraising and Investment Plans - The company plans to raise up to 1.365 billion yuan through a specific stock issuance, with funds allocated for new drug research and development and to supplement working capital [3] - The total investment for the new drug development project is approximately 965.26 million yuan, while 400 million yuan is earmarked for working capital [4]