1月7日，据心玮医疗官微消息，其全资子公司上海玮脑智联科技有限公司（以下简称"玮脑智联"）完成 工商注册登记，正式落户上海脑机接口未来产业集聚区。此举标志着心玮医疗在脑机接口赛道的战略布 局迈入实质化落地阶段。 对于此次子公司成立，心玮医疗表示，标志着公司脑机接口业务布局进入独立化、专业化运营的新阶 段。未来，公司将依托入选国家人工智能医疗器械创新任务"揭榜挂帅"课题的优势，在主管部门的统筹 指导与政策赋能下，稳步推进脑机接口项目落地，推动前沿技术向实用化产品转化。（厉平） 值得关注的是，此前的2025年12月，心玮医疗申报的"面向运动功能障碍的介入式脑机接口系统"项目成 功入选2025年人工智能医疗器械创新任务揭榜挂帅名单，成为介入式脑机领域唯一入选的代表企业。此 次"揭榜挂帅"核心目标为遴选具备较强创新实力与技术转化能力的单位开展集中攻关，推动人工智能医 疗器械领域的技术突破与产品落地应用，共有16个脑机接口项目入选。 据悉，心玮医疗申报项目采用创新性介入式脑机接口技术路线，相较于传统的侵入式和非侵入式脑机接 口，该技术路线采用微创介入手术将电极支架植入脑部血管，无需开颅操作，大幅降低手术创伤，有效 规避 ...

（来源：中国经济导报） "十四五"期间，高新区以科技创新引领发展新质生产力、带动生物医药产业"量质齐升"。构建国家重点 实验室-海河实验室-市级重点实验室创新矩阵，推动国家现代中药创新中心落地高新区，细胞海河实验 室建成GMP、前沿技术中心、孵化器等多个功能平台。截至目前，高新区在生物医药领域共有国家级 创新平台近20个，市级创新平台60余个。生物医药领域累计获国家和天津市科学奖奖项近30项。聚集细 胞及基因治疗产业链上下游企业100余家，形成从细胞提取制备-细胞存储-冷链物流-创新研发-小试中 试-审评审批-临床应用全产业链。多家企业入选工信部"人工智能医疗器械创新任务揭榜挂帅"单位。设 立高新区首只生物医药产业母基金及两只子基金，促进生物医药技术的研发、转化与应用。 转自：中国经济导报 展望"十五五"，刘宪明表示，高新区将锚定"全国领先的生物科技与生物制造产业高地"目标，统筹推进 华苑科创先导区与渤龙湖先进制造业承载区联动发展，建强京津冀特色"细胞谷"和"中国脑机谷"两大科 创和产业高地，聚焦创新药物、医疗器械、细胞治疗、脑机交互、医药服务五大核心产业，前瞻布局生 物制造、医疗康养、大健康等多个潜力产业领 ...

根据公告，公司副总裁、首席财务官、首席运营官兼联席公司董秘张涵总作为认购方已与公司签订认购 协议，通过自有资金以每股45.00 港元的价格认购公司特别发行的100 万股内资股。该交易还需要通过 股东大会授权董事会处理相关事宜，并修订公司章程细则。预计交易完成之后，张涵总持股比例达到 2.54%，同时可为公司带来约4325 万港元（约3926 万元）的净现金，进一步增厚公司的流动现金储 备，该笔现金预计在2028 年底前全部使用，用于在医疗器械行业的投资/并购，有望扩大公司产品组 合，助力公司长期可持续增长。 2025 年12 月12 日，公司公告拟折价1.10%向张涵配售100 万股内资股，净筹4325 万港元 根据公告，董事会决议建议根据特别授权发行认购股份，公司副总裁、首席财务官、首席运营官兼联席 公司董秘张涵作为认购方已与公司签订认购协议。根据协议，公司有条件同意定向发行100万股内资 股，认购价为45.00 港元，较认购协议签订日期前的交易日联交所所报每股H 股收盘价（即45.50 港元） 折价约1.10%。 简评 高管增持彰显信心，目前公司已经启动A 股IPO 计划 机构：中信建投证券 研究员：袁清 ...

近日，工业和信息化部、国家药品监督管理局联合组织的2025年人工智能医疗器械创新任务揭榜挂帅入围单位公布，阿里达摩院牵头研发的"急性主动脉综 合征CT图像智能辅助分诊软件"iAorta从1000余个申报项目中脱颖而出，成功入选。该AI模型已在全国十余家医院落地，帮助减少急性主动脉综合征的漏 诊、误诊。 人工智能技术与医疗器械正在加速融合发展。这是工信部、国家药监局自2021年首次联合开展人工智能医疗器械创新任务揭榜挂帅工作以来的第二次揭榜， 旨在征集并遴选一批具备较强创新能力的单位集中攻关，加速新技术、新产品落地应用，更好地服务和保障人民群众生命健康。 iAorta是阿里达摩院基于在"平扫CT+AI"方面的领先技术，联合浙江大学医学院附属第一医院（下简称"浙大一院"）历时三年多研发出的AI模型，攻克了急 性主动脉综合征（AAS）的漏诊、误诊频发的国际难题。据悉，包括主动脉夹层在内的急性主动脉综合征是一类危急的心血管疾病，发病24小时内死亡率可 达30%，但难以第一时间确诊。iAorta模型能在常规平扫CT上快速勾画出主动脉及其血管腔，判断血管壁有无结构变化，从而精准识别AAS。 在20万人的大规模临床试验中， ...

Investment Rating - The report maintains a "Recommended" rating for the humanoid robot industry, indicating a positive outlook for the sector [10]. Core Insights - The humanoid robot industry is experiencing accelerated financing activities, with companies like Zhongqing Robotics and Yunshe Technology successfully completing multiple funding rounds to enhance R&D and commercialize products [1][2][6]. - The report highlights the potential for humanoid robots to create a market space broader than that of automobiles, marking a significant investment opportunity as the industry transitions from 0 to 1 [10]. - The report emphasizes the importance of companies with core component capabilities and active involvement in humanoid robotics, suggesting a focus on specific stocks within this sector [10]. Summary by Sections Recent Developments - Zhongqing Robotics completed A1+ and A2 funding rounds, attracting investments from various institutional investors [1]. - Yunshe Technology announced over 500 million RMB in C round financing, aimed at enhancing R&D for humanoid and quadruped robots [2]. - Luming Robotics secured Pre-A1 and Pre-A2 funding rounds, focusing on investments in intelligent data and hardware [2]. - Yuanzhi Intelligent was recognized in the national AI medical device initiative, showcasing its advancements in surgical robotics [3]. Industry Performance - The humanoid robot industry is positioned to benefit from the ongoing electrification and intelligence trends, with significant product iterations and business collaborations underway [10]. - The report notes that the humanoid robot sector may be on the verge of a transformative moment akin to the "ChatGPT moment" [10]. Key Companies to Watch - The report suggests monitoring companies with established core components and active engagement in humanoid robotics, including Sanhua Intelligent Controls, Top Group, and Zhejiang Rongtai, among others [10].

12 月 8 日，工业和信息化部与国家药品监督管理局联合公示了 " 2025 年人工智能医疗器械创新任务揭榜挂 帅 " 入围单位名单。元化智能科技（深圳）有限公司全资子公司 —— 骨圣元化机器人（深圳）有限公司，凭 借其自主研发的 " 智能骨肿瘤手术辅助导航定位系统 " 成功入围，标志着该公司在人工智能与骨科手术机器 人领域的创新实力获得国家级连续认可。 | 100 首页 | | --- | | 组织机构 | | 新闻发布 | | 政务公开 | | 政务服务 | | 互动交流 | | 工信数据 | 本次 " 揭榜挂帅 " 由工业和信息化部科技司、国家药品监督管理局医疗器械注册管理司共同组织，旨在遴选 并推动人工智能医疗器械领域的突破性创新。经过严格评审，骨圣元化机器人公司的 " 智能骨肿瘤手术辅助 导航定位系统 " 在激烈竞争中脱颖而出。 据了解，该系统属于 " 智能手术机器人产品 " 方向，专注于骨肿瘤手术的精准辅助。它深度融合人工智能、 机器人控制与实时导航技术，能够为外科医生提供高精度的手术规划与术中引导，有望显著提升手术的精准 度、安全性及效率，从而减轻患者创伤，是应对临床迫切需求的创新解决方案。 | ...

12月8日，工业和信息化部与国家药品监督管理局联合公示了"2025年人工智能医疗器械创新任务揭榜挂 帅"入围单位名单。元化智能科技（深圳）有限公司全资子公司——骨圣元化机器人（深圳）有限公 司，凭借其自主研发的"智能骨肿瘤手术辅助导航定位系统"成功入围，标志着该企业在人工智能与骨科 手术机器人领域的创新实力获得国家级连续认可。 本次"揭榜挂帅"由工业和信息化部科技司、国家药品监督管理局医疗器械注册管理司共同组织，旨在遴 选并推动人工智能医疗器械领域的突破性创新。经过严格评审，骨圣元化机器人公司的"智能骨肿瘤手 术辅助导航定位系统"（项目编号：2025-AIFZZL-01001）在激烈竞争中脱颖而出。 作为骨圣元化机器人的全资母公司，元化智能科技（深圳）有限公司是一家专注于智能医疗装备研发与 精密智造的国家级高新技术企业，致力于推动前沿科技与临床医学的深度协同，打造具有全球竞争力的 创新医疗（002173）解决方案。该企业相关负责人表示，作为元化智能科技在骨科领域的重要战略载 体，骨圣元化机器人公司长期专注于骨科手术机器人的研发与产业化。此次再次入选国家级"揭榜挂 帅"项目，不仅是对公司核心技术攻关能力的持续认 ...

Policy Developments - Shanghai government issued measures to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, high-quality first generic drugs, and AI medical devices [2] Drug Approvals - Yipinhong received a drug registration certificate for Levodopa oral solution, aimed at treating mild to moderate Alzheimer's symptoms, with an estimated sales scale of approximately 100.21 million RMB in 2024 [4] - Prolo Pharma obtained a drug registration certificate for Cefdinir dry suspension, which is the first generic drug approved in China for this formulation, with a projected market size of 760 million RMB in 2024 [5] - Haichuang Pharma's HP518 tablet, a PROTAC drug for advanced prostate cancer, received clinical trial approval, with no similar products currently approved in the market [6] Market Activity - Dae Oriental announced plans to transfer 80% of its subsidiary Jinhua Lianji's equity for 1 RMB and related debts for approximately 5.8 million RMB [8] - Jichuan Pharma plans to repurchase shares worth between 25 million and 50 million RMB, with a maximum repurchase price of 38 RMB per share [9] Industry Trends - JD's data indicated a 22-fold year-on-year increase in sales of flu medications during the current flu season, with significant spikes in demand for specific drugs like Oseltamivir and Sufentanil [11] - The respiratory virus testing orders on JD's platform increased by 66%, with a positivity rate of 68.2% [11] Tax Compliance - Shenqi Pharma's subsidiary paid approximately 16.67 million RMB in overdue corporate income tax and penalties [13] Regulatory Issues - Former deputy director of the National Medical Products Administration, Chen Shifei, was arrested for bribery, highlighting ongoing regulatory scrutiny in the pharmaceutical sector [15]

Core Points - The establishment of the Beijing-Tianjin-Hebei Center marks a significant step in optimizing regional drug and medical device review services by the National Medical Products Administration [1][2] - The center aims to enhance collaboration in the pharmaceutical industry across the Beijing-Tianjin-Hebei region, leveraging existing resources and services to support innovation [2][3] Group 1: Center Operations - The Beijing-Tianjin-Hebei Center will provide comprehensive technical services including research guidance, consultation acceptance, and review communication for drug and medical device evaluations [2] - The center will connect the review and approval functions of Beijing with existing service institutions, creating a collaborative service network [2] Group 2: Industry Impact - The center aims to improve the efficiency and success rate of research and development for pharmaceutical companies by facilitating direct communication with experts [2] - Beijing's pharmaceutical and health industry has surpassed one trillion yuan, supported by numerous national research institutions and clinical resources [2] Group 3: Future Development - The center plans to establish a face-to-face consultation mechanism to assist companies in enhancing the quality of their research and applications [3] - Future collaboration between Beijing and the National Medical Products Administration will focus on creating a high-quality integrated development platform for the pharmaceutical industry [3]

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]