【文/观察者网专栏作者 邓铂鋆】 7月10日，财政部发布《关于在政府采购活动中对自欧盟进口的医疗器械采取相关措施的通知》（以下简称《通知》），对于4500万元人民币以上的医疗器 械政府采购项目，应当排除欧盟企业参与，但是《通知》对欧洲企业在华生产的医疗器械不予限制。 事情起源于6月20日，欧盟委员会发布了一条令人匪夷所思的禁令："为纠正中欧医疗器械贸易的不均衡"，自2025年6月30日起，中国企业不得参与欧盟地区 数额500万欧元的医疗器械采购；中标的医疗器械合同中，中国产品的份额不得超过50%。 笔者对欧盟此番禁令的不解之处在于，当下正处于我国医药产业、医疗器械产业飞速发展的爆发点，先进药品与高端医疗器械的国产化水平不断提高，国产 品牌的市场占有率节节攀升。任何国家出台可能导致中方对等反制的贸易限制措施，都有可能让该国的相关产品永久告别广阔的中国市场。 中欧医疗贸易：东升西落 2024年，中欧医疗器械贸易规模370.4亿美元。其中，中国进口额280.4亿美元，同比减少6.09%，自2022年起连续三年下降；中国出口90亿美元，同比增长 12%。 从产品构成看，中国出口欧盟的高端设备增速显著。例如内窥镜四年出 ...

国家药监局日前发布十条举措，大力支持我国高端医疗器械创新发展。那么，最新出台的新政策，主要 聚焦哪些高端医疗器械？有哪些是国内首创或是国际领先的措施？我国高端医疗器械企业、患者和产业 将迎来哪些利好？本台记者独家采访国家药监局相关业务的负责人进行解读。 我国出台新政助推高端医疗器械万亿市场 国家药监局医疗器械注册司司长吕玲：这次的支持举措我们重点选取了医用机器人、高端医学影像设 备、新型生物材料医疗器械、人工智能医疗器械，因为它们就是高端医疗器械的典型代表性产品，也是 塑造医疗器械新质生产力的关键领域，也充分代表着当前医疗器械行业发展的方向。 国家药监局表示，当前出台这些重磅措施支持高端医疗器械发展，希望促进更多新技术、新材料、新工 艺和新方法应用于医疗健康领域。 国家药监局医疗器械注册司司长吕玲：比如基于脑机接口技术的医疗器械，还有腹腔内窥镜手术系统， 还有多病种大模型的人工智能医疗器械等等，这些都是我们目前聚焦的重点产品，我们就是要通过以点 带面，通过大力支持这些代表性的产品来努力抢占国际制高点，使得更多"中国造、全球新"的医疗器械 早日上市。 国家药监局医疗器械注册司司长吕玲：比如产品上市前我们将审评的 ...

国家药品监督管理局7月8日消息，心神宁胶囊经组织论证和审核，已由处方药转换为非处方药。相关药 品上市许可持有人须在2026年4月1日前，依据《药品注册管理办法》向省级药品监督管理部门备案说明 书修订事项，并通知医疗机构等单位；自补充申请备案日起生产的药品不得使用原说明书，非处方药说 明书范本内容外其他事项保留原批准证明文件。 药械审批 国家药品监督管理局7月8日消息，国家药监局综合司再次公开征求对《药品附条件批准上市申请审评审 批工作程序（试行）（修订稿征求意见稿）》及相关政策解读的意见，以进一步完善药品附条件批准上 市申请审评审批制度。 心神宁胶囊转换为非处方药 徐诺药业口服癌症新药艾贝司他拟纳入优先审评 近日，中国国家药监局药品审评中心（CDE）官网公示，徐诺药业申报的甲苯磺酸艾贝司他片拟纳入优 先审评，拟用于既往接受过至少两种系统性治疗的复发或难治滤泡性淋巴瘤成年患者。公开资料显示， 艾贝司他是一种新型有效的口服泛HDAC抑制剂。 鲁抗医药吉非替尼片获药品注册证书 政策动向 国家药监局再次公开征求药品附条件批准上市审批程序修订意见 7月8日，鲁抗医药公告，近日收到国家药品监督管理局颁发的关于吉非替尼片《 ...

东方红京东大数据混合A、东方红新动力混合A、东方红智华三年持有混合A基金经理分别为周云、刘中群。 7月8日，海泰新光连续6个交易日下跌，区间累计跌幅-2.20%。青岛海泰新光科技股份有限公司是成立于2003年的中外合资企业,主要从事医用内窥镜器械和 光学产品的研发、生产和销售。 财报显示，东方红资产管理旗下3只基金进入海泰新光前十大股东。其中东方红京东大数据混合A今年一季度增持，东方红新动力混合A今年一季度不变，东 方红智华三年持有混合A今年一季度增持。 其中，东方红京东大数据混合A今年以来收益率6.48%，同类排名708(总2301)，东方红新动力混合A今年以来收益率5.68%，同类排名794(总2301)，东方红智 华三年持有混合A今年以来收益率3.66%，同类排名2850(总4529)。 简历显示，周云先生:生于1982年,清华大学生物学博士。上海东方证券资产管理有限公司公募权益投资一部总经理、基金经理,2015年9月至今任东方红京东 大数据灵活配置混合型证券投资基金基金经理、2015年9月至今任东方红新动力灵活配置混合型证券投资基金基金经理、2016年6月至2018年8月任东方红睿 满沪港深灵活配置混 ...

NO.3 以岭药业G201-Na胶囊临床试验申请获批 NO.2 中外制药与一家新加坡公司达成授权合作 7月7日，中外制药与Gero PTE公司宣布，双方已签署联合研究与许可协议，共同开发与年龄相关疾病 的新型疗法，中外制药将向Gero支付高达约2.5亿美元的首付款和里程碑付款。Gero PTE总部位于新加 坡，是一家处于临床前阶段的人工智能驱动型生物技术公司，其AI平台旨在识别驱动多种与年龄相关 的疾病以及可能对抗衰老本身的治疗靶点。 点评：此次合作涉及高达2.5亿美元的首付款和里程碑付款，反映出市场对衰老相关疾病治疗领域的高 度关注与投资潜力。Gero PTE作为临床前阶段的AI驱动型生物技术公司，其技术平台的创新性与中外 制药的产业资源相结合，有望加速新型疗法的研发进程，为投资者带来长期价值。同时，这也体现了全 球药企在抗衰老赛道的布局加速。 每经记者｜林姿辰 每经编辑｜陈俊杰 丨 2025年7月8日 星期二 丨 NO.1 新华医疗子公司产品获得二类医疗器械注册证 7月7日，新华医疗发布公告，称子公司新华手术器械有限公司于近日收到山东省药品监督管理局颁发的 《中华人民共和国医疗器械注册证》，产品名称为胸腹 ...

Group 1: Medical Device Regulations - The National Medical Products Administration (NMPA) announced measures to support the innovation and development of high-end medical devices, including special reviews for domestic and internationally leading products with significant clinical value [1][2] - The NMPA aims to scientifically establish evaluation requirements for high-end medical devices and expedite the revision of technical review guidelines for various medical systems and materials [2] - The NMPA will support post-market evidence-based research for medical device registrants and enhance the management of high-end active medical devices [3] Group 2: Metaverse Initiatives - Four departments, including the Ministry of Industry and Information Technology, are organizing the recommendation of typical cases for the Metaverse in 2025, covering digital human cases, product cases, park cases, and standard cases [4] Group 3: Space Exploration - China successfully launched the Experimental Satellite No. 28 B01 using the Long March 4B rocket, marking the 583rd flight of the Long March series, with the satellite intended for space environment detection and related technology experiments [5] Group 4: Second-Hand Vehicle Exports - The Ministry of Commerce is enhancing guidance on second-hand vehicle exports to promote healthy and orderly development, having initiated the export business in February 2024 [6] Group 5: Tax Refund Policies - Shanghai and six other departments have implemented an action plan to optimize the environment for tax refunds for departing travelers, lowering the minimum purchase amount for tax refunds to 200 RMB and increasing the cash refund limit to 20,000 RMB [7][8] Group 6: Industrial Internet Development - Sichuan Province has released an action plan for the Industrial Internet, aiming to establish a distinctive identification and resolution system by 2027, with over 30 secondary nodes and service for more than 11,000 enterprises [9] Group 7: Service Trade Growth - From January to May 2025, China's service trade reached 32,543.6 billion RMB, a year-on-year increase of 7.7%, with exports growing by 15.1% and imports by 2.7% [10] Group 8: AI Regulation Concerns - Nearly 50 European companies, including Airbus and Mercedes-Benz, are calling for a delay in the implementation of the EU AI Act, citing concerns that it may jeopardize the region's ambitions in the AI sector [11]

此外，科学制定高端医疗器械审评要求，完善高端医疗器械注册审查体系。加快制修订腹腔内窥镜手术 系统、医用磁共振成像系统、种植用口腔骨填充材料和镍钛合金血管内植介入等相关产品技术审查指导 原则。研究制定多病种、大模型人工智能领域相关技术指导原则或者审评要点；简化核心算法不变而算 法性能优化人工智能医疗器械产品变更注册要求；探索完善采用测评数据库开展人工智能医疗器械性能 评价要求；对在不同平台注册的同一人工智能软件功能，若能证明平台的等同性，简化审评要求。研究 人工智能、生物芯片等技术在生物材料医疗器械性能及安全性评价中应用。修订高端有源医疗器械使用 期限注册技术审查指导原则。探索高端医疗器械使用电子说明书的路径和要求。 其中提到，强化标准引领创新，进一步完善高端医疗器械标准体系。加快发布医用外骨骼机器人、放射 性核素成像设备等相关标准。加快推进医用机器人、人工智能医疗器械、高端医学影像设备等领域的基 础、通用标准和方法标准等制修订工作，积极筹建医用机器人、人工智能医疗器械标准化技术组织。加 强增材制造用医用材料、脑机接口柔性电极、基因工程合成生物材料等新型生物材料标准化研究。开展 人工智能医疗器械标准数据集研究。 ...

Core Viewpoint - The National Medical Products Administration (NMPA) is optimizing the regulatory framework for high-end medical devices to support innovation and improve the registration review system [1] Group 1: Regulatory Enhancements - The NMPA is formulating scientific review requirements for high-end medical devices and enhancing the registration review system [1] - There is a focus on expediting the revision of technical review guidelines for various medical devices, including laparoscopic surgical systems and medical MRI systems [1] - The agency aims to develop technical guidelines for multi-disease and large model artificial intelligence applications [1] Group 2: Artificial Intelligence and Performance Evaluation - The NMPA plans to simplify registration requirements for AI medical devices that optimize core algorithms without changing their fundamental functions [1] - There is an exploration of using evaluation databases for assessing the performance of AI medical devices [1] - The agency will simplify review requirements for AI software functions that demonstrate equivalence across different platforms [1] Group 3: Safety and Performance Standards - Research will be conducted on the application of technologies like AI and biochips in evaluating the performance and safety of biomaterials in medical devices [1] - The NMPA is revising technical review guidelines for the usage period of high-end active medical devices [1] - There is an exploration of pathways and requirements for using electronic instructions for high-end medical devices [1]

Core Viewpoint - The announcement of share reduction plans by shareholders of Anjiasi (688581.SH) indicates a strategic adjustment in their investment positions, with both shareholders planning to reduce their stakes by a total of 1,622,700 shares each, representing 2.0039% of the company's total shares [1][2] Group 1: Shareholder Reduction Plans - Shareholder Suzhou Yuansheng plans to reduce its holdings by up to 1,622,700 shares, with a maximum of 809,700 shares through centralized bidding and 813,000 shares through block trading [1] - Shareholder Hangzhou Tiantang Silicon Valley also plans to reduce its holdings by up to 1,622,700 shares, with the same distribution between centralized bidding and block trading [1] - The reduction period for centralized bidding is 90 natural days starting from 15 trading days after the announcement, while for block trading, it is 90 natural days starting from 3 trading days after the announcement [1] Group 2: Shareholding Structure - As of the announcement date, shareholder Suzhou Yuansheng holds 3,233,835 shares, accounting for 3.9934% of the total shares, with 2,309,882 shares from pre-IPO and 923,953 shares from the 2023 annual bonus shares [2] - Shareholder Hangzhou Tiantang Silicon Valley holds 1,622,700 shares, representing 2.0039% of the total shares, with 1,159,071 shares from pre-IPO and 463,629 shares from the 2023 annual bonus shares [2] - The pre-IPO shares held by these shareholders were released from restrictions and became tradable on May 20, 2024 [2] Group 3: IPO and Fundraising Details - Anjiasi raised a total of 182,032.60 million yuan from its IPO, with a net amount of 165,101.28 million yuan after deducting issuance costs, exceeding the original plan by 88,031.28 million yuan [3] - The funds raised are intended for projects including the production of 10 million medical endoscope devices, marketing network upgrades, and a minimally invasive medical device R&D center [3] - The total issuance costs amounted to 16,931.32 million yuan, with the lead underwriter, CITIC Securities, receiving 12,887.91 million yuan in fees [3] Group 4: Dividend Distribution - Anjiasi announced a cash dividend of 14.5 yuan (including tax) per 10 shares and a distribution of 4 bonus shares per 10 shares for the 2023 fiscal year, with the record date set for June 20 [4]

戴维医疗（300314）公告，全资子公司维尔凯迪近日取得浙江省药品监督管理局颁发的3项《受理通知 书》。受理号分别为械受20254019912、械受20254019913、械受20254019722。产品包括一次性使用肺 结节定位穿刺针、一次性使用电子输尿管肾盂内窥镜导管、便携式电子内窥镜图像处理器，注册分类均 为II类。上述品种注册申请受理对公司近期业绩不会产生影响。 ...