神经介入所有三大产品线均录得稳健的收入增长，反映其各自核心产品的强劲表现。主要驱动因素为血 管通路产品录得收入增长，主要受惠于高性能DCwire微导丝销量持续扩大，带动市场份额迅速提升;出 血性产品受惠于YonFlow血流导向密网支架的成功上市，推动该产品线的收入增长;缺血性产品的收入增 长主要归功于Syphonet取栓支架及Tethys AS血栓抽吸导管的销量增长。于缺血性产品组合中，自2025年 下半年实施带量采购后，尽管球囊扩张导管的销售价格有所下调，但其销量大幅上升，尤其是Fastunnel 输送型球囊扩张导管，令球囊扩张导管整体收入较2024年保持稳定。 沛嘉医疗-B(09996)发布截至2025年12月31日止(报告期间)年度业绩，集团报告期间实现收入约人民币7 亿元-7.2亿元，同比增长约13.7–17.0%。 本集团的持续收入增长主要归功于神经介入业务所有叁大产品线的强劲表现;及中国经导管主动脉瓣置 换(TAVR)市场的市场份额持续扩大，主要受成功推出高端TaurusMax3D可调弯TAVR系统所推动。 于报告期间，本集团已商业化的TAVR产品组合(包括在全国用于治疗主动脉瓣狭窄的Taurus ...

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]

Core Viewpoint - The Hong Kong innovative medical device sector has seen significant growth this year, with the Hang Seng Healthcare Index rising over 50% year-to-date, driven by profit recovery and valuation adjustments [1][3]. Group 1: Market Dynamics - The National Medical Products Administration (NMPA) has announced ten measures to support the innovation and development of high-end medical devices, further enhancing long-term investment expectations for innovative medical device companies [1][3]. - The current investment environment is warming, leading to increased focus on the validation of innovative technologies and their commercial potential [3][9]. Group 2: Company Performance - Peijia Medical (09996) has experienced a stock price increase of over 95% year-to-date, significantly outperforming the index and bringing its market capitalization to around HKD 5 billion [1][3]. - The company has established itself as a leading brand in the Chinese transcatheter aortic valve replacement (TAVR) market, with a market share increase from 5% in 2021 to over 25% currently [4][10]. Group 3: Product Development and Innovation - Peijia Medical is advancing its product pipeline, with its second-generation TAVI product nearing market approval and its third-generation product expected to enter the market in the first half of next year [4][10]. - The company has a robust pipeline that includes innovative technologies such as non-glutaraldehyde cross-linked valves and shockwave calcification reconstruction technology, positioning it well against competitors [10][12]. Group 4: Market Potential - The TAVR market in China is projected to grow significantly, with an expected compound annual growth rate (CAGR) of 36.6% from 2021 to 2030, reaching approximately 109.5 billion yuan by 2030 [9][11]. - The current TAVR penetration rate in China is only 5.7% of the global total, indicating substantial growth potential for the market [11]. Group 5: Future Outlook - Peijia Medical aims to solidify its position as the leading TAVR brand in China by expanding its product offerings and increasing market share to 25-30% by 2025 [4][12]. - The company is also pursuing international expansion, with plans to apply for CE certification for its products and engage in global clinical studies [12][13].