（原标题：近期流感用药需求激增；国家药监局原副局长陈时飞被提起公诉） 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 上海：聚焦细胞与基因治疗、罕见病、高质量首仿药、人工智能医疗器械等重点领域和产品 建立在研重点品种服务清单 11月24日，上海市人民政府办公厅今日印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》的通知，其中提到， 聚焦细胞与基因治疗、罕见病、儿童用药、高质量首仿药、人工智能医疗器械、医用机器人、脑机接口、粒子治疗设备、创新中医诊疗设备等重 点领域和产品，建立在研重点品种服务清单，在临床试验、注册上市、检查检验、生产许可等环节跨前指导。夯实国家、市、区三级联动服务机 制，支持国家药监局药品审评检查长三角分中心、医疗器械技术审评检查长三角分中心能力提升，加快区生物医药产品注册指导服务工作站扩能 升级，开展在研创新产品信息收集、重点项目跨前指导和跟踪服务。 药械审批 一品红获得重酒石酸利斯的明口服溶液注册证书 11月24日，济川药业(600566.SH)公告称，公司计划使用自有资金以集中竞价交易方式回购部分公司股份，资 ...

新京报讯(记者陈琳)10月15日，位于北京经济技术开发区的国家药监局药品医疗器械审评检查京津冀分 中心办公区内，多家药企正与审评专家面对面交流。从研发难点到申报流程，企业代表问题不断，专家 一一细致解答。这一幕，正是该分中心挂牌运行后日常工作的缩影。 9月21日，京津冀分中心正式挂牌并投入运行，标志着国家药监局在优化区域审评服务布局上迈出关键 一步。该中心将依托国家药监局药品审评中心、医疗器械技术审评中心、食品药品审核查验中心"三大 中心"，串联北京已有的四家药械创新服务站，构建起"3+1+4+N"立体式服务网络，助力北京打造医药 创新高地，也为京津冀鲁区域医药产业协同发展注入新动力。 "我们将充分利用首都资源集聚优势、'两区'政策优势和'三医'协同机制优势，与企业需求精准对 接。"京津冀分中心主任许真玉表示，分中心将建立面对面咨询机制，开展事前事中指导，帮助企业提 高研发和申报质量。 北京市药监局医疗器械注册处处长高飞指出，分中心的运行将推动审评专家更早介入人工智能医疗器械 等前沿领域，提供"量体裁衣"式服务，优化申报质量与审评资源配置，同时促进京津冀鲁区域在研发、 生产与临床方面的深度融合。 未来，北京市 ...

Core Viewpoint - The Shanghai Municipal Government has released an action plan to promote the full-chain development of the high-end medical device industry, aiming for significant growth and international competitiveness by 2027 [1] Group 1: Key Development Goals - By 2027, Shanghai aims to add over 500 domestic third-class medical device registrations and over 100 medical device products approved in overseas markets [1] - The plan includes nurturing two leading enterprises with an annual output value exceeding 10 billion yuan and establishing three high-end medical device industry clusters [1] Group 2: Focused Product Categories - The action plan identifies eight key product categories for development, including high-end medical imaging products, high-end implantable intervention products, high-end surgical systems, high-end in vitro diagnostic products, high-end radiation therapy products, high-end rehabilitation treatment products, high-end artificial intelligence medical devices, and innovative future devices [2] - Specific advancements are targeted in high-end medical imaging, surgical systems, and radiation therapy products, with a focus on upgrading existing technologies and developing new products [2] Group 3: Key Tasks and Financial Support - The action plan outlines 20 key tasks across seven areas, including innovation, clinical empowerment, review and approval, enterprise cultivation, and international development [3] - Financial support will be enhanced through collaboration with industry funds and the establishment of innovative medical device insurance mechanisms [3] Group 4: International Development and Efficiency Improvements - The plan promotes internationalization by facilitating import/export processes and enhancing cooperation in international medical device training and promotion [4] - It aims to reduce the time required for clinical trials and regulatory approvals, with specific targets for ethical review and trial initiation timelines [4][5] Group 5: Industry Outlook - Analysts are optimistic about the medical device sector, anticipating a new development phase driven by improved internal policies and external market expansion [6][7] - The industry is expected to experience a recovery in performance and valuation, with a focus on innovation and globalization as key growth drivers [7]

Core Insights - The Shanghai Municipal Government has released an action plan to promote the development of the high-end medical device industry, aiming to achieve significant milestones by 2027, including over 500 new domestic Class III medical device registrations and over 100 new products approved in overseas markets [1] Focus on Key Product Categories - The action plan identifies eight key product categories for development: high-end medical imaging products, high-end implantable and interventional products, high-end surgical systems, high-end in vitro diagnostic products, high-end radiation therapy products, high-end rehabilitation products, high-end artificial intelligence medical devices, and innovative future devices [2] - Specific advancements in high-end medical imaging include accelerating the upgrade of positron emission tomography and X-ray computed tomography devices, as well as developing micro home ultrasound devices [2] - In high-end surgical systems, the plan emphasizes the upgrade of laparoscopic surgical robots and the development of flexible surgical robots [2] - For high-end radiation therapy products, the focus is on upgrading proton therapy systems and developing flash radiation therapy devices [2] - The plan also highlights the need for advancements in AI medical devices, including intelligent medical imaging diagnostic software and surgical navigation systems [2] Deployment of Key Tasks - The action plan outlines 20 key tasks across seven areas: innovation sourcing, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3] - Financial support initiatives include encouraging collaboration between leading industry funds and industrial clusters, supporting market-oriented medical device venture capital funds, and developing innovative medical device insurance mechanisms [3] Promoting International Development - The action plan aims to facilitate import and export processes, including optimizing customs measures for medical device R&D, production, and sales [4] - It also emphasizes international collaboration, providing comprehensive services for enterprises going global, and promoting medical device innovations through various platforms [4] - The plan seeks to reduce the time required for various processes, such as clinical research and ethical review, aiming to compress the overall ethical review process to within three weeks [4] Optimizing Review and Approval Services - The action plan supports pilot reforms that allow companies with medical device registrations to produce Class II and III devices in Shanghai [5] - It encourages pilot medical institutions to continue developing and filing self-researched reagents based on clinical needs [5] Industry Outlook - Analysts are optimistic about the medical device sector, anticipating a new development phase driven by improved internal policies and external market expansion [6][7] - The industry is expected to experience a recovery in performance and valuation, with core drivers being domestic policy optimization and accelerated globalization [7] - Future growth is projected to rely on technological platform development, AI diagnostics, and the expansion of consumer healthcare, indicating a shift towards higher-level industry development [7]

Core Viewpoint - The Shanghai Municipal Government has released an action plan to promote the development of the high-end medical device industry, aiming for significant growth in product approvals and the establishment of competitive enterprises by 2027 [1] Focus on Key Development Products - The action plan identifies eight key product categories for development, including high-end medical imaging, implantable devices, surgical systems, in vitro diagnostics, radiation therapy, rehabilitation devices, AI medical devices, and innovative future devices [2] - Specific advancements are targeted in high-end medical imaging, surgical systems, and radiation therapy products, with a focus on upgrading existing technologies and developing new systems [2] Deployment of Key Tasks - The action plan outlines 20 key tasks across seven areas: innovation, clinical empowerment, review and approval, hospital application, enterprise cultivation, industrial ecology, and international development [3] - Financial support initiatives include collaboration with venture capital and insurance products tailored for the medical device sector [3] Promotion of International Development - Measures to facilitate international trade include optimizing customs processes and enhancing international cooperation through various platforms and events [4] - The plan emphasizes reducing the time required for clinical trials and regulatory approvals, aiming to streamline processes significantly [4] Optimizing Review and Approval Services - The action plan supports pilot reforms for companies with medical device registrations to produce devices in Shanghai and encourages self-research reagent development [5] Industry Outlook - Analysts predict a new development phase for China's medical device industry, driven by improved internal policies and external market expansion [6] - The industry is expected to experience a recovery in performance and valuation, with a focus on innovation and globalization [6]

公司代码：600587 公司简称：新华医疗 山东新华医疗器械股份有限公司 二〇二五年八月二十九日 重要提示 一、 本公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容的真实性、准确 性、完整性，不存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 二、 公司全体董事出席董事会会议。 三、 本半年度报告未经审计。 四、 公司负责人王玉全、主管会计工作负责人周娟娟及会计机构负责人（会计主管人员）姚海 云声明：保证半年度报告中财务报告的真实、准确、完整。 五、 董事会决议通过的本报告期利润分配预案或公积金转增股本预案 无。 六、 前瞻性陈述的风险声明 √适用 □不适用 本报告中涉及的未来计划、发展战略等前瞻性陈述存在不确定性，不构成公司对投资者的实 质承诺，敬请投资者注意投资风险。 七、 是否存在被控股股东及其他关联方非经营性占用资金情况 否 八、 是否存在违反规定决策程序对外提供担保的情况 否 九、 是否存在半数以上董事无法保证公司所披露半年度报告的真实性、准确性和完整性 否 十、 重大风险提示 报告期内，不存在对公司生产经营产生实质性影响的特别重大风险。公司已在本报告中详细 描述可能存 ...

Core Insights - Shenzhen-based Ruixin Medical has launched a fully automated AI vascular interventional surgery robot, marking the entry into a "fully automated" intelligent phase in vascular interventional diagnosis and treatment [1] - This robot represents one of the first industrialized results in the key area of "medical robots + AI medical devices," enabling collaboration among doctors, intelligent systems, and execution terminals [1] - The robot allows doctors to issue clinical tasks through natural language interactions, which the intelligent system translates into executable operational goals, ultimately performed by the execution terminal [1] Product Development - The fully automated AI vascular interventional surgery robot has completed prototype production and simulation experiments, with expectations to finish AI automated animal surgeries in the second half of this year [1] - Ruixin Medical's founder and CEO, Zheng Lingxiao, indicated that in the future, simple and repetitive surgical procedures could be autonomously completed by AI surgical robots under the supervision of doctors [1] - For more complex surgeries, AI surgical robots are expected to provide stronger assistance to experts [1]

Core Viewpoint - The article discusses the upcoming Second Global Medical Technology Conference and Industry Awards Ceremony, highlighting its significance in the medical technology sector and the expected participation of industry leaders and experts [4][10]. Event Details - The conference will take place at the Zhongguancun Exhibition Center in Beijing on July 17, 2025, with an expected attendance of approximately 500 participants [4]. - The event is organized by Siyu MedTech and the Zhongguancun Alliance for New Biomedical Industry [4][14]. Agenda Highlights - The conference will feature a series of speeches and discussions, including topics such as the current status and future trends of medical device business development, the integration of hospital innovation ecosystems, and the role of artificial intelligence in medical devices [11][12]. - Notable speakers include experts from various institutions, such as Wang Haow, Director of the Technology Department at Beijing Tiantan Hospital, and Zuo Nianming, a researcher at the Chinese Academy of Sciences [11][12]. Key Topics - Discussions will cover a range of subjects, including the development of wearable brain-machine interfaces, AI applications in ultrasound, and innovations in liquid biopsy technologies for precision oncology [12]. - The event aims to foster collaboration and innovation within the medical technology industry, addressing both opportunities and challenges faced by the sector [10][12].

Core Viewpoint - The article discusses the upcoming Second Global Medical Technology Conference and Industry Awards Ceremony, highlighting its significance in the medical technology sector and the participation of various industry leaders and experts [4][14]. Event Details - The conference will take place at the Zhongguancun Exhibition Center in Beijing on July 17, 2025, with an expected attendance of approximately 500 participants [4]. - The event is organized by Siyu MedTech and the Zhongguancun Alliance for New Biomedical Industry [4][14]. Agenda Highlights - The conference will feature a series of speeches and discussions on topics such as the current status and future trends of medical devices, the integration of technology in hospitals, and the development of artificial intelligence in medical devices [11][12]. - Notable speakers include experts from various institutions, including the Chinese Academy of Sciences and leading medical technology companies [5][7]. Participation and Registration - Attendees can register for the event using a discount code to obtain free tickets, emphasizing the accessibility of the conference for industry professionals [16].

Core Points - The article discusses the upcoming Second Global Medical Technology Conference scheduled for July 17, 2025, in Beijing, which aims to gather around 500 participants [3]. - The conference will feature various sessions focusing on advancements in medical technology, including artificial intelligence in medical devices and innovations in imaging equipment [4][8]. Group 1: Conference Details - The conference will take place at the Zhongguancun Exhibition Center in Haidian District, Beijing [3]. - The event is organized by SYMedTech and the Zhongguancun Alliance for New Life Sciences [3]. - Previous successful events include the First Global Ophthalmology Conference, First Global Orthopedics Conference, First Global Cardiovascular Conference, and First Global Aesthetic Technology Conference [1][8]. Group 2: Agenda Highlights - Keynote topics include discussions on the development of AI in medical devices, wearable brain-machine interfaces, and trends in the medical device industry for 2025 [4]. - Notable speakers include experts from the China Academy of Sciences and CITIC Securities, focusing on investment strategies and innovations in the medical device sector [4]. - A roundtable session will cover multi-modal data infrastructure and the future of AI in healthcare [4].