Core Viewpoint - The company has received approval from the National Medical Products Administration of China for the registration of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The approval date for the TaurusTrio™ TAV system is set for December 11, 2025 [1] - The system is specifically designed for treating patients with severe aortic regurgitation, which presents unique challenges compared to aortic stenosis patients [1] Group 2: Clinical Significance and Market Potential - The Trilogy™ THV system has received CE mark certification in May 2021 and has been used in over 1,000 commercial surgeries in real-world clinical practice as of the announcement date [2] - The company anticipates that the TaurusTrio™ TAV system will provide a safe and effective treatment option for patients with severe AR in China, addressing a significant unmet clinical need [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 Peijia Medical Limited 沛嘉醫療有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股 份 代 號：9996） 自願公告 國家藥監局批准TaurusTrio™經導管主動脈瓣系統的註冊申請 本公告乃由沛嘉醫療有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，為本公司股東及潛在投資者提供有關本集團最新業務發展及新產品 研發進度的最新資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年12月11日，本公司收到 中華人民共和國國家藥品監督管理局（「國家藥監局」）就TaurusTrio™經導管主 動脈瓣（「TAV」）系統（「該系統」）的註冊申請發出的批准。 茲提述本公司日期為2022年1月14日的公告。TaurusTrio™ TAV系統由本公司 基於自JenaValve Technology, Inc.（「JenaValve」）獲得的Tr ...

本文源自：智通财经网 消息面上，12月5日，沛嘉医疗公告称，公司执行董事、首席执行官兼董事会董事长张一博士自2025年 12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港元。根据公告，张 一博士将不排除根据适用法律及法规于适当时候进一步增加其于公司持股的可能性。 中信建投发布研报称，公司TAVR产品持续放量，市场份额稳步提升；GeminiOneTEER系统、 TaurusTrio主动脉反流瓣及TaurusNXT干瓣TAVR预计2025年底至2026年密集获批，驱动瓣膜业务加速增 长；MonarQ三尖瓣系统启动全球临床，前沿技术业务已获外部融资，创新出海路径清晰。 智通财经获悉，沛嘉医疗-B(09996)现涨超3%，截至发稿，涨2.6%，报5.92港元，成交额893.49万港 元。 ...

（文章来源：每日经济新闻） 每经AI快讯，沛嘉医疗-B(09996.HK)一度涨超3%，截至发稿涨2.6%，报5.92港元，成交额893.49万港 元。 ...

沛嘉医疗-B(09996)现涨超3%，截至发稿，涨2.6%，报5.92港元，成交额893.49万港元。 消息面上，12月5日，沛嘉医疗公告称，公司执行董事、首席执行官兼董事会董事长张一博士自2025年 12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港元。根据公告，张 一博士将不排除根据适用法律及法规于适当时候进一步增加其于公司持股的可能性。 中信建投（601066）发布研报称，公司TAVR产品持续放量，市场份额稳步提升；GeminiOneTEER系 统、TaurusTrio主动脉反流瓣及TaurusNXT干瓣TAVR预计2025年底至2026年密集获批，驱动瓣膜业务加 速增长；MonarQ三尖瓣系统启动全球临床，前沿技术业务已获外部融资，创新出海路径清晰。 ...

中信建投发布研报称，公司TAVR产品持续放量，市场份额稳步提升；GeminiOneTEER系统、 TaurusTrio主动脉反流瓣及TaurusNXT干瓣TAVR预计2025年底至2026年密集获批，驱动瓣膜业务加速增 长；MonarQ三尖瓣系统启动全球临床，前沿技术业务已获外部融资，创新出海路径清晰。 消息面上，12月5日，沛嘉医疗公告称，公司执行董事、首席执行官兼董事会董事长张一博士自2025年 12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港元。根据公告，张 一博士将不排除根据适用法律及法规于适当时候进一步增加其于公司持股的可能性。 智通财经APP获悉，沛嘉医疗-B(09996)现涨超3%，截至发稿，涨2.6%，报5.92港元，成交额893.49万港 元。 ...

Core Viewpoints - The company holds a leading position in the domestic heart valve intervention field, with TAVR products showing positive clinical feedback and rapid market share growth since commercialization [1][6] - The company has a comprehensive product pipeline in aortic, mitral, and tricuspid valve treatments, which continues to strengthen its leadership in the heart valve sector [1][6] - The company anticipates three major products to be approved and commercialized in China between the end of 2025 and 2026, contributing to a rapid recovery in overall performance [1][6] Event Summary - On December 5, 2025, the company announced that Chairman Dr. Zhang Yi plans to invest up to HKD 15 million in purchasing company shares on the open market [1] - This share buyback reflects Dr. Zhang's confidence in the company's long-term development potential and intrinsic value [1] Product Development and Pipeline - The company has made significant progress in its product pipeline, with multiple innovative products expected to achieve commercialization, including the GeminiOne transcatheter edge-to-edge repair system and the ReachTactile robotic-assisted TAVR system [2][3] - The TaurusTrio aortic valve replacement system, GeminiOne, and the non-glutaraldehyde cross-linked TAVR product TaurusNXT are expected to be approved and commercialized between late 2025 and 2026, driving revenue growth [2][3] Neurointervention Business - The company has successfully launched the YonFlow mesh stent and has entered multiple provincial markets, indicating strong commercialization potential [4] - The neurointervention business is expected to maintain rapid growth, with a profit margin exceeding 20% and ongoing product development [4] Financial Outlook - The company projects revenues of CNY 758 million, CNY 1.035 billion, and CNY 1.385 billion for 2025, 2026, and 2027, respectively, with year-on-year growth rates of 23.17%, 36.46%, and 33.88% [6] - The net profit attributable to the parent company is expected to improve significantly, with projections of CNY -114 million, CNY 14 million, and CNY 129 million for the same years, reflecting substantial growth [6]

Core Viewpoint - The demand for neurointerventional medical devices in China is increasing due to the rising incidence of cerebrovascular diseases, with stroke being the leading cause of death among Chinese residents. The market for neurointerventional consumables is projected to grow significantly in the coming years [1][5]. Industry Definition and Classification - Neurointerventional devices are medical consumables required for neurointerventional surgeries, primarily used to diagnose and treat cerebrovascular diseases through minimally invasive techniques [2][3]. Industry Development Status - The global market for neurointerventional consumables is expected to reach $3.292 billion in 2024, with North America holding a 43.04% market share. The Chinese market for these consumables is projected to grow from 3.504 billion yuan in 2024 to 4.879 billion yuan in 2025 [5][6]. Industry Chain - The upstream of the neurointerventional device industry consists of raw material suppliers, while the midstream includes manufacturers like Medtronic and Johnson & Johnson. The downstream consists of medical institutions that utilize these devices [7]. Industry Development History - The neurointerventional device industry in China has evolved through three stages: the embryonic stage (1980-1999), the initiation stage (2000-2010), and the rapid development stage (2011-present) [8]. Competitive Landscape - The market is primarily dominated by multinational companies such as Medtronic and Johnson & Johnson, while domestic companies like Guichuang Tongqiao and Micron Brain Science are gaining ground through competitive pricing and localized channels [9][10]. Key Enterprises - The leading companies in the Chinese neurointerventional market include Medtronic, Stryker, and Johnson & Johnson, with a significant presence of domestic players like Guichuang Tongqiao and Micron Brain Science [10][11]. Technological Breakthroughs - Domestic companies are achieving technological advancements in core products, allowing them to compete more effectively with international standards while benefiting from cost advantages [12]. Application Scenario Expansion - The application of new technologies such as AI-assisted navigation systems and biodegradable materials is expected to enhance the efficiency and scope of neurointerventional procedures, supported by favorable government policies [13].

责任编辑：卢昱君 沛嘉医疗-B（09996）盘中涨超6%，截至发稿，股价上涨5.60%，现报5.85港元，成交额217.68万港元。 12月7日晚，沛嘉医疗发布公告称，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，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，沛嘉医疗公布，董事会获悉，执行董事、首席执行官兼公司董事会董事长张一博士透过其所控制 的公司，自2025年12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港 元。经张博士告知，持股增加反映其对公司内在价值的认可，以及其对公司发展前景及增长潜力的坚定 信心。 此外，沛嘉医疗公布，董事会获悉，执行董事、首席执行官兼公司董事会董事长张一博士透过其所控制 的公司，自2025年12月1日起开始于公开市场上购买公司股份。持股增加合共代价预期不超过1500万港 元。经张博士告知，持股增加反映其对公司内在价值的认可，以及其 ...

每经AI快讯，沛嘉医疗-B(09996.HK)涨超6%，截至发稿涨6.32%，报5.89港元，成交额198.95万港元。 （文章来源：每日经济新闻） ...