1月21日，浙商证券在最新研报中称，随着医保局收费目录政策落地和海外市场加速拓展，行业有望从早 期发展期步入快速增长期。如果说过去五年是技术追赶期，那么未来五年将是商业化兑现期。 2024年中国手术机器人市场规模约为72亿元人民币。根据预测，到2032年，这一数字将暴涨至767亿 元。这意味着在未来8年间，年复合增长率（CAGR）高达约34%。 这种增速在当前的宏观环境下极为罕 见。 2026年1月20日，国家医保局发布《手术和治疗类辅助操作类立项指南（试行）》，明确手术机器人收费 框架，这将显著降低产品入院门槛。同时，头部企业海外订单快速增长，微创机器人全球订单突破160 台，精锋医疗海外订单达72台，出海正成为新的增长引擎。 市场空间：超700亿规模，年增长34% 研报指出，根据Frost&Sullivan数据，2024-2032年中国手术机器人市场规模将从72亿元增长至767亿元 人民币，年复合增长率约34%。 相比之下，全球市场同期将从212亿美元增长至750亿美元，年复合增长率约17%，中国市场增速显著高 于全球平均水平。 国产手术机器人行业正处于从"概念验证"迈向"规模化盈利"的关键转折点。 研报 ...

Investment Rating - The industry investment rating is "Increase Holding" [2][5] Core Insights - The recent release of the "Guidelines for the Pricing of Surgical and Treatment Auxiliary Medical Services" by the National Medical Insurance Administration aims to standardize pricing for innovative medical technologies, including surgical robots, which is expected to accelerate clinical application [4] - The guidelines introduce a tiered pricing model based on the level of participation and clinical value of surgical robots, allowing for higher fees for more advanced functionalities [4] - The establishment of a new pricing project for "Remote Surgical Assistance" facilitates the practical application of remote surgery, enhancing access to quality medical resources across regions [4] - The guidelines clarify the boundaries between consumable costs and technical service fees, promoting transparency and reducing unreasonable price increases in the industry [4] - The inclusion of medical data storage and device operation records in the pricing structure is expected to support future technological iterations and application expansions [4] Summary by Sections Industry Overview - The industry comprises 133 listed companies with a total market value of 14,628.56 billion and a circulating market value of 13,032.75 billion [2] Policy Impact - The new pricing guidelines are anticipated to break the commercialization bottleneck of surgical robots, emphasizing the need for continuous innovation among companies [4] - Companies with technological accumulation and high product maturity, such as Tianzhihang-U, Jingfeng Medical-B, and others, are expected to benefit from the inclusion of robotic-assisted surgery projects in local medical insurance directories [4]

Group 1 - The "Shockwave Valve Treatment System" developed by Zhejiang University School of Medicine and Peijia Medical has been selected for the National Medical Products Administration's innovative medical device special review procedure, marking a significant breakthrough in the treatment of aortic valve calcification in China [1][3] - This system represents a shift from "artificial valve replacement" to "autologous valve repair," addressing the durability issues of implants for younger patients and the surgical challenges for complex calcified cases [1][2] - The technology utilizes advanced imaging guidance and energy control to precisely focus shockwave energy, effectively loosening calcified lesions while protecting surrounding healthy tissue, thus avoiding long-term complications associated with traditional implants [2] Group 2 - The inclusion of the Shockwave Valve Treatment System in the innovative channel reflects regulatory recognition of its originality and clinical value, which will accelerate its clinical trial and registration process [3] - Peijia Medical aims to expedite the clinical transformation of this technology to benefit a wide range of patients, especially in the context of the growing global population suffering from heart valve diseases [3] - The breakthrough signifies a new height in China's medical device innovation and indicates a shift towards more precise, minimally invasive, and personalized treatment for heart valve diseases [3]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 本月底法定/註冊股本總額： USD 100,000 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | | 股份類別 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09996 | 說明 | | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 671,438,159 | | 0 | | 671,438,159 | | 增加 / 減少 (-) | | | 622,500 | | 0 | | | | 本月底結存 | | | 672,060,659 | | 0 | | 672,060,659 | 致：香港交易及結算所有限公司 公司名稱: 沛嘉醫療有限公司 (「本公司 ...

（原标题：港股异动 | 沛嘉医疗-B(09996)再涨超6% 董事长增持彰显信心 旗下TaurusTrio近日获批上 市） 消息面上，12月5日，沛嘉医疗公告称董事长张一博士拟斥资不超过1500万港元于公开市场增持公司股 份。12月11日，沛嘉医疗公布，旗下TaurusTrio经导管主动脉瓣系统正式获得国家药品监督管理局上市 批准，成为国内首款获批的一体化定位键经股入路主动脉瓣反流(AR)专用介入治疗器械。 中信建投此前发布研报称，公司在国内心脏瓣膜介入领域居于领先地位，TAVR产品自商业化以来临床 反馈良好，产品快速放量，市场份额持续提升；另外公司在主动脉瓣、二尖瓣和三尖瓣治疗领域具有全 面深入的产品研发布局，持续巩固公司在心脏瓣膜领域的领先地位；公司预计在25年底至26年有三款重 磅产品在国内获批并实现商业化，助力公司整体业绩恢复快速增长趋势。公司神经介入业务居于国产公 司前列，随着在研产品管线的持续丰富、获证产品商业化的不断推进，公司神经介入业务有望保持快速 发展的趋势。 智通财经APP获悉，沛嘉医疗-B(09996)再涨超6%，月内累涨逾22%。截至发稿，涨5.31%，报6.35港 元，成交额1090 ...

沛嘉医疗-B(09996)再涨超6%，月内累涨逾22%。截至发稿，涨5.31%，报6.35港元，成交额1090.7万港 元。 消息面上，12月5日，沛嘉医疗公告称董事长张一博士拟斥资不超过1500万港元于公开市场增持公司股 份。12月11日，沛嘉医疗公布，旗下TaurusTrio经导管主动脉瓣系统正式获得国家药品监督管理局上市 批准，成为国内首款获批的一体化定位键经股入路主动脉瓣反流(AR)专用介入治疗器械。 中信建投（601066）此前发布研报称，公司在国内心脏瓣膜介入领域居于领先地位，TAVR产品自商业 化以来临床反馈良好，产品快速放量，市场份额持续提升；另外公司在主动脉瓣、二尖瓣和三尖瓣治疗 领域具有全面深入的产品研发布局，持续巩固公司在心脏瓣膜领域的领先地位；公司预计在25年底至26 年有三款重磅产品在国内获批并实现商业化，助力公司整体业绩恢复快速增长趋势。公司神经介入业务 居于国产公司前列，随着在研产品管线的持续丰富、获证产品商业化的不断推进，公司神经介入业务有 望保持快速发展的趋势。 ...

Core Viewpoint - The demand for cerebrovascular interventional devices in China is increasing due to the rising incidence of cerebrovascular diseases, which are among the top three causes of death in the country, with stroke being the leading cause [1][10]. Industry Definition and Classification - Cerebrovascular diseases are conditions affecting blood vessels in the brain, primarily including ischemic and hemorrhagic strokes. Cerebrovascular interventional surgery involves minimally invasive techniques for diagnosing and treating these conditions [2]. - Cerebrovascular interventional devices include medical consumables required for these surgeries, such as embolization coils, thrombectomy stents, and aspiration catheters [2]. Industry Characteristics - The cerebrovascular interventional device industry is characterized by high technical barriers, continuous technological innovation, and favorable industry policies [4]. Current Industry Status Global Market - The global market for cerebrovascular interventional devices is projected to reach USD 3.292 billion in 2024, with North America accounting for 43.04% of the market, Europe 26.56%, and Asia-Pacific 25.27%. The market is expected to grow to USD 3.974 billion by 2025 [7]. Chinese Market - In China, the market for cerebrovascular interventional devices is expected to reach CNY 3.504 billion in 2024, with specific segments such as intracranial thrombectomy stents at CNY 1.584 billion and aspiration catheters at CNY 0.272 billion. By 2025, the market is projected to grow to CNY 4.879 billion [10][13]. Industry Supply Chain - The upstream of the cerebrovascular interventional device industry consists of raw material suppliers, including tubing and alloy materials. The midstream includes manufacturers like Medtronic and Johnson & Johnson, while the downstream consists of distribution channels and end customers, primarily medical institutions [15].

Core Viewpoint - The article discusses the recent approval of innovative medical devices by the National Medical Products Administration (NMPA) in China, highlighting the advancements in the field of interventional cardiology and urology [2][3]. Group 1: TaurusTrio Transcatheter Aortic Valve System - The TaurusTrio system, developed by Peijia Medical Technology (Suzhou) Co., Ltd., addresses the challenges of aortic regurgitation (AR) in transcatheter aortic valve replacement (TAVR) procedures, particularly the difficulties in anchoring due to minimal calcification [7][12]. - The system features an integrated positioning key that allows for stable contact with the native valve leaflets, providing a structural solution to the anchoring issue faced by AR patients [12]. - TaurusTrio enhances operational controllability with adjustable bending and rotational capabilities, which significantly reduces the risk of complications and improves release accuracy during procedures [13]. - The design includes a large mesh outlet that preserves future coronary access for patients, reflecting a growing trend in clinical evaluations of TAVR systems [14]. - Peijia Medical, established in 2012, has positioned itself as a key player in the domestic structural heart disease intervention market, with the approval of TaurusTrio expanding its product offerings from stenosis to regurgitation treatments [16]. Group 2: Disposable Sterile Urinary Catheter - The disposable sterile urinary catheter, developed by Taizhou Dubomai Medical Devices Co., Ltd., includes single, double, and triple lumen models tailored for various clinical scenarios, with a core innovation being a polylysine coating that inhibits bacterial growth [18]. - This coating mechanism reduces bacterial adhesion and biofilm formation, representing a significant advancement over traditional sterile catheters that rely solely on standard sterilization methods [18]. - Taizhou Dubomai focuses on innovation in urinary and urological devices, and the approval of this catheter signifies a breakthrough in medical consumables, showcasing a shift towards functional improvements in domestic products [19].

Core Insights - The article highlights the acceleration of business development (BD) activities in the medical device sector from September to November 2025, with a total of 58 transactions identified across various subfields, including cardiovascular, nuclear medicine, and AI-enabled devices [2][3][4]. Group 1: Mergers and Acquisitions - Mergers and acquisitions have become a prominent form of BD, with companies leveraging capital control and product integration for rapid market positioning [7][8]. - Notable acquisitions include HeartLink's $680 million all-stock acquisition of Micro-Invasive Cardiology, enhancing its structural heart disease and rhythm management capabilities [7]. - Hua'an Zhonghui's acquisition of Bangni Medical marks its entry into the absorbable suture market, indicating a shift in surgical instrument competition towards material innovation [7]. Group 2: Strategic Collaborations - Strategic partnerships have been formed during the China International Import Expo, with companies like Shanghai Pharmaceuticals collaborating with international giants such as Boston Scientific and Medtronic to enhance their supply chain and academic promotion systems [7][8]. - The collaboration between GuoYao Medical and BDI Medical aims to deepen market penetration in the biomedicine and medical device sectors, focusing on compliance and distribution channel construction [13]. Group 3: Cross-Border Cooperation - Cross-border transactions have become more active, with foreign companies establishing local R&D and production systems in China, while domestic firms are exporting their solutions globally [9][10]. - The partnership between Trasis SA and Beijing Pait Biotechnology to establish a joint venture reflects a trend towards localized production and phased integration in the Chinese market [12]. Group 4: Ecosystem Building and Channel Expansion - The integration of supply chains and ecosystem building is a key theme, with companies focusing on collaborative agreements to enhance their market presence [11][15]. - The collaboration between Baxter and Neusoft Medical aims to create a comprehensive surgical solution by integrating their respective technologies [12]. Group 5: AI and Smart Healthcare - AI and data-driven approaches are becoming central to BD collaborations, with companies increasingly focusing on smart healthcare solutions [16][17]. - The partnership between Kefu Medical and Tencent Cloud to develop AI-powered hearing aids exemplifies the trend of integrating technology into healthcare products [21]. Group 6: Research and Diagnostic Synergy - The frequency of research-oriented collaborations is rising, indicating a shift from manufacturing-driven to research-driven industry dynamics [18][19]. - The collaboration between BGI and Infinera to enhance clinical applications of sequencing technology highlights the growing importance of research in driving innovation in the medical device sector [21].

Core Insights - Peijia Medical-B (9996.HK) experienced a stock price increase of 8.26% to HKD 6.29, reaching a nearly two-month high since October 21 [1] - The company announced the approval of its TaurusTrio™ Transcatheter Aortic Valve (TAV) system by the National Medical Products Administration of China, with expectations for a successful market launch in China by December 11, 2025 [1] - The TaurusTrio™ TAV system aims to provide a safe and effective treatment option for Chinese patients suffering from severe aortic regurgitation (AR), addressing a significant unmet clinical need [1] - CEO and Chairman Zhang Yi has begun purchasing company shares in the open market since December 1, 2025, with a total investment not exceeding HKD 15 million, reflecting confidence in the company's intrinsic value and growth potential [1] Company Developments - The approval of the TaurusTrio™ TAV system is a significant milestone for Peijia Medical, as it seeks to fulfill a critical demand in the Chinese healthcare market [1] - Zhang Yi's share purchase indicates a strong belief in the company's future prospects and may signal potential further investments in the company [1]