格隆汇12月7日丨沛嘉医疗-B(09996.HK)公告，于近日，公司收到中华人民共和国国家药品监督管理局 ("国家药监局")的受理通知书，确认受理TaurusNXT"非醛交联"干瓣经导管主动脉瓣置换("TAVR")系统 ("系统")的注册申请。 TaurusNXT为公司内部研发的第三代TAVR系统，采用已获得专利的非醛生物组织交联技术，消除了瓣 膜钙化的根本原因，而瓣膜钙化是人工瓣膜退化的主因。该技术旨在提升人工主动脉瓣("人工主动脉 瓣")的耐用性及生物相容性。此外，与使用甘油的传统干燥组织技术相比，该系统采用超低温真空冷冻 干燥技术。此方法帮助保持瓣膜组织的物理完整性，同时亦可将人工主动脉瓣预装到输送器("输送器") 上。TaurusNXT的输送器亦进行了升级，使其具备可回收及可调弯的特性，有助于医生更加容易将人工 主动脉瓣引导至目标植入位置，从而进一步提高手术的安全性。 该系统已获国家药监局创新医疗器械特别审批程序受理，后续将优先评估及审批。 ...

该系统已获国家药监局创新医疗器械特别审批程序受理，后续将优先评估及审批。 智通财经APP讯，沛嘉医疗-B(09996)发布公告，于近日，公司收到中华人民共和国国家药品监督管理局 的受理通知书，确认受理TaurusNXT® "非醛交联"干瓣经导管主动脉瓣置换("TAVR")系统的注册申请。 TaurusNXT®为公司内部研发的第三代TAVR系统，采用已获得专利的非醛生物组织交联技术，消除了 瓣膜钙化的根本原因，而瓣膜钙化是人工瓣膜退化的主因。该技术旨在提升人工主动脉瓣的耐用性及生 物相容性。此外，与使用甘油的传统乾燥组织技术相比，该系统采用超低温真空冷冻乾燥技术。此方法 帮助保持瓣膜组织的物理完整性，同时亦可将人工主动脉瓣预装到输送器上 。 TaurusNXT®的输送器 亦进行了升级，使其具备可回收及可调弯的特性，有助于医生更加容易将人工主动脉瓣引导至目标植入 位置，从而进一步提高手术的安全性。 ...

Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Views - The pharmaceutical and biotechnology sector saw a weekly increase of 2.67%, underperforming the Wind All A index (2.9%) but outperforming the CSI 300 index (1.64%). The raw material drug sector experienced a decline of 4.27%, while chemical preparations and pharmaceutical circulation products increased by 4.18% and 3.71%, respectively [3][8] - Recent policies in Shanghai and Beijing aim to support the high-quality development of the medical device industry, indicating a shift towards innovation and global competitiveness in this sector. The report suggests monitoring the transformation progress of leading companies in the medical device field [3][12] - Flu activity is on the rise, with the percentage of flu-like cases reported by sentinel hospitals in southern provinces reaching 7.8%, up from 6.8% the previous week, and higher than the same period in 2022 and 2024 [3][11] Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector increased by 2.67% from November 24 to November 28, 2025, with raw material drugs declining by 4.27% and chemical preparations increasing by 4.18% [8][9] - Individual stock performances included significant gains for Haiwang Biological (38.2%), Yue Wannianqing (36.2%), and Guangji Pharmaceutical (31.7%), while *ST Changyao (-15.3%), Huitai Medical (-9.6%), and Kangwei Century (-8.8%) saw notable declines [11] Industry News and Key Company Announcements Important Industry Events - The report highlights the increase in flu-like illness percentages in both southern (7.8%) and northern (8.6%) provinces, indicating a significant rise in flu activity compared to previous years [11][12] Industry News - Significant approvals were noted, including the NMPA's approval of Xinmeiyue® for treating moderate to severe plaque psoriasis and the FDA's accelerated approval of Sibeprenlimab for IgAN treatment [12][14] Company Announcements - Notable announcements include the FDA approval of a generic injectable drug by Jianyou Co. and the successful completion of a Phase III trial for JS001sc, a subcutaneous PD-1 monoclonal antibody for non-small cell lung cancer [15][16]

Core Insights - Recent measures have been implemented in cities like Beijing and Shanghai to support the high-quality development of the medical device industry, focusing on various aspects such as clinical research, registration, production, application, cluster development, digital empowerment, and international expansion [1] - The support policies for innovative medical devices from national and local governments are expected to strengthen, leading to an acceleration in medical device innovation [1] - The company remains optimistic about structural investment opportunities in the medical device sector by 2026, suggesting investors take advantage of performance and valuation recovery opportunities in companies expected to see growth in 2026 [1] - Long-term investment opportunities in the medical device industry are anticipated to arise from innovation, international expansion, and mergers and acquisitions, with the sector's innovation and international capabilities gaining recognition and valuation being restructured [1]

资金流入方面，医疗创新ETF最新资金净流入551.48万元。拉长时间看，近10个交易日内有7日资金净 流入，合计"吸金"3385.73万元，日均净流入达338.57万元。（数据来源：Wind） 医疗创新ETF(516820)精选30只医药白马股，覆盖创新药（34%）、CXO（17%）、医疗器械 （13%）、消费医疗（11%）等核心赛道龙头。短期看，当前医药板块内部分化明显，创新药估值高企 （历史88%分位），而CXO、器械、消费医疗等板块具备补涨潜力，医疗创新ETF聚焦低位医药核心资 产，可以用来把握"高低切"机会。 风险提示：基金有风险，投资需谨慎。基金管理人承诺以诚实信用、勤勉尽责的原则管理和运用基金资 产，但不保证本基金一定盈利，也不保证最低收益。基金管理人提醒投资人基金投资的"买者自负"原 则，在做出投资决策后，基金运营状况与基金净值变化引致的投资风险，由投资人自行负担。基金的过 往业绩及其净值高低并不预示其未来业绩表现，基金管理人管理的其他基金的业绩不构成对本基金业绩 表现的保证。投资人购买基金，既可能按其持有份额分享基金投资所产生的收益，也可能承担基金投资 所带来的损失。投资人应当认真阅读《基金合 ...

Group 1 - The core viewpoint of the articles highlights the Chinese government's initiatives to promote the high-quality development of the medical device industry through various supportive measures and regulatory reforms [1][2]. - Beijing's measures include 15 supportive actions aimed at enhancing clinical research, registration, production, application, and international expansion of innovative medical devices [1]. - Shanghai's measures focus on expediting the registration process for innovative Class II medical devices, aiming to reduce the average registration cycle to within six months [1][2]. Group 2 - The "14th Five-Year Plan" emphasizes support for the development of innovative drugs and medical devices, indicating a robust growth trajectory for China's medical industry [2]. - The medical device market in China is projected to grow from 729.8 billion RMB in 2020 to 941.7 billion RMB by 2024, with a compound annual growth rate (CAGR) of 6.6%, and is expected to reach 1.81 trillion RMB by 2035 [2]. - The A-share market for medical devices has a total market capitalization of 1.38 trillion RMB, with major companies like Mindray Medical and United Imaging Healthcare leading the sector [3]. Group 3 - There are 45 medical device stocks with a rolling price-to-earnings (P/E) ratio below 40, including 12 stocks with a P/E ratio below 20, indicating potential undervaluation in the sector [4]. - As of November 25, 20 stocks have seen a price decline of over 20% from their yearly highs, with five stocks experiencing declines exceeding 30% [4]. - Aibo Medical, a leading manufacturer of high-end artificial lenses, reported a net profit of 290 million RMB for the first three quarters, a year-on-year decrease of 8.64%, but anticipates steady growth in sales by 2026 [4].

Core Insights - The Chinese medical device industry has entered a golden period of innovation, with more Chinese companies appearing in the global TOP 100 rankings and showing upward trends in their positions [2][4] - The overall market size of China's medical device industry is projected to reach 1.35 trillion yuan in 2024, making it the second-largest market globally [3] Group 1: Industry Growth and Innovation - Leading Chinese companies like Mindray, Weigao, and United Imaging have made significant strides, with 12 domestic firms entering the global TOP 100 list, and Mindray ranking 25th, up two spots from the previous year [4] - Over 50% of Mindray's profits now come from overseas markets, indicating a successful transition from a follower to a leader in specific segments [4] - The industry is experiencing a shift from imitation to innovation, driven by intense competition and the need for differentiation [4][5] Group 2: Collaborative Ecosystem - The collaboration between industry, hospitals, and research institutions is crucial for transforming innovative ideas into market-ready products [5] - The establishment of the Shanghai Clinical Innovation Transformation Research Institute exemplifies efforts to streamline the process from clinical needs to product development [5][6] Group 3: Regulatory and Institutional Innovations - The regulatory framework is evolving to support innovation, with a focus on adapting to new technologies like brain-computer interfaces and surgical robots [6] - Shanghai's Pudong New Area is leading in medical device regulatory reforms, aiming to transition from domestic replacement to global innovation standards [6][8] Group 4: Regional Development and Internationalization - Pudong has a solid medical device industry foundation, with over 500 R&D and manufacturing companies, accounting for 25% of the city's total [7] - The region has approved 38 innovative medical devices, representing about 10% of the national total, including several global firsts [7] - Pudong is also a hub for international collaboration, with over 200 foreign medical device companies and more than 60 local firms successfully entering international markets [7][8] Group 5: Future Plans and Strategic Initiatives - Pudong has launched a development plan for high-end medical devices from 2025 to 2027, focusing on innovation, park clustering, and ecosystem enhancement [8][9] - The area aims to become a global center for innovative medical devices and a preferred location for scientific entrepreneurship and regulatory reforms [9]

2025年杜塞尔多夫国际医疗器械设备展近日在德国开幕，大量中国企业参展，然而中国参展商遭遇大规 模食物中毒事件，大约200人食用一家中餐馆提供的盒饭后上吐下泄，有人甚至一晚上拉了40多次。 （文章来源：每日经济新闻） 记者在展会现场看到，10多个场馆几乎都有中国企业的身影，部分场馆还有特设的中国展区。 "中国参展企业不仅数量更多，产品质量也更好了。"长期参与组织中国企业参加展会的中国医疗器械行 业协会国际合作部副主任夏天表示，中国医疗器械产品的技术含量和覆盖品类逐年增加，中国企业正在 得到全球客户的认可。 本届展会为期4天，预计将吸引超过160个国家和地区的8万名专业人士参观。 每日经济新闻综合自第一财经、扬子晚报、新华网、公开资料等 江苏参展商小罗（化名）称，中国参展商组成30多个参展团参加这次活动，展会期间的餐食由地接联系 一家名为"兄弟烤吧"的当地中餐馆供应，一份盒饭20欧元（约合人民币164元），价格相当高。 该餐馆11月19日在社交媒体上发信道歉，声称食材是正规渠道采购，只是肉品未完全煮透熟所致，但未 提具体赔偿措施。 很多受影响者对此并不满意，认为该餐馆避重就轻，没有说明食物中毒的实质问题。多人表 ...

Core Insights - The stock price of United Imaging Healthcare (688271) closed at 136.88 CNY on November 14, 2025, reflecting a decrease of 0.57% from the previous week's closing price of 137.66 CNY [1] - The company's market capitalization is currently 112.81 billion CNY, ranking 2nd in the medical device sector out of 126 companies and 155th in the A-share market out of 5165 companies [1] Company Announcements - United Imaging Healthcare's wholly-owned subsidiary, Wuhan United Imaging Healthcare Technology Co., Ltd., obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system on November 11, 2025 [1] - The registered products include the uSONIQUE Pulse series, uSONIQUE Genesis series, and uSONIQUE Venus series, which cater to a wide range of markets from high-end to economical, applicable in various departments such as general, cardiac, obstetric, and vascular [1] - The product series is based on the uEDGETEC technology platform, integrating multiple innovative technologies to achieve intelligent imaging and applications [1] - The registration certificate is valid until November 10, 2030, and the company has cumulatively received approvals for over 140 products, entering more than 90 countries and regions [1] - This certification is expected to enhance the product line and strengthen core competitiveness, although the impact on future revenue remains uncertain [1]

Core Insights - The surgical robot market is highly competitive but not saturated, with significant growth potential in China [2] - Johnson & Johnson is accelerating its investment in the surgical robot sector in China, particularly through partnerships with local companies [2][7] - The Haishan I, developed by Chinese company RuLong Surgical, is a notable product showcased by Johnson & Johnson, representing a strategic collaboration [2][3] Market Dynamics - The surgical robot market is characterized by intense competition, with Intuitive Surgical's Da Vinci system holding a dominant market share of 53.8% as of Q2 2025 [3] - RuLong Surgical's Haishan I is the first modular surgical robot in China, offering flexibility and lower production costs compared to traditional integrated systems [3][4] - Johnson & Johnson's entry into the surgical robot market has been relatively late, but the company has made several acquisitions and is optimistic about future growth [4][5] Product Development - Johnson & Johnson currently has one approved surgical robot in China, the MONARCH, while aiming for a target installation of 500 units for the Haishan I within five years [4][5] - The Haishan I has received approvals for multiple surgical applications, unlike many competitors that require separate approvals for each application [3][4] Pricing and Cost Structure - The high cost of surgical robots has historically limited their adoption, with prices for leading models exceeding 20 million yuan [5][6] - Johnson & Johnson is focused on optimizing technology and supply chains to reduce costs and improve competitiveness in the market [6] Collaboration and Commercialization - Johnson & Johnson has engaged in several collaborations with local medical device companies to enhance commercialization efforts [7] - The company is also exploring international markets for its products, contingent on confirming quality and supply chain stability [8] Market Opportunities - The aging population in China presents a significant opportunity for the medical device market, driving demand for surgical interventions [8] - Johnson & Johnson showcased over 1,000 products at the China International Import Expo, indicating a strong commitment to integrating into China's innovation ecosystem [8]