Core Viewpoint - The approval of the TaurusTrio transcatheter aortic valve (TAV) system by the National Medical Products Administration of China represents a significant advancement in treatment options for patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio TAV system received approval on December 11, 2025, for its registration application [1] - The system is developed and manufactured by the company based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy transcatheter heart valve (THV) system [1] - The TaurusTrio TAV system is specifically designed for treating patients with severe AR via the femoral artery approach, addressing a significant clinical need due to limited treatment options for AR patients [1] Group 2: Clinical Background and Market Potential - The Trilogy THV system, which serves as the basis for the TaurusTrio, 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 successful launch of the TaurusTrio TAV system in China will provide a safe and effective treatment option for patients suffering from severe AR, fulfilling a major unmet clinical demand [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China for the registration application of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The system is specifically designed for treating patients with severe aortic regurgitation via the transfemoral approach, addressing a significant unmet clinical need [1] Group 2: Technical Features - Unlike patients with aortic stenosis, AR patients typically lack calcified tissue for TAV anchoring, which limits treatment options [1] - The system utilizes proprietary positioning key technology to achieve stable anchoring even in the absence of calcified tissue, ensuring proper alignment of the valve [1] Group 3: Market Potential - The Trilogy™ THV system received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures in real-world clinical practice as of the announcement date [1] - The company anticipates that the successful launch of the TaurusTrio™ TAV system in China will provide a safe and effective treatment option for patients with severe AR [1]

Core Insights - The company announced the approval of the TaurusTrio™ transcatheter aortic valve (TAV) system by the National Medical Products Administration of China, effective December 11, 2025 [1] - The TaurusTrio™ TAV system is developed under an exclusive license from JenaValve Technology, Inc. and is designed specifically for treating patients with severe aortic regurgitation (AR) [1][2] - The system utilizes proprietary anchoring technology to ensure stable fixation even in the absence of calcified tissue, addressing a significant unmet clinical need for AR patients [1] Group 1 - The TaurusTrio™ TAV system is intended for patients with severe aortic regurgitation, which presents different challenges compared to aortic stenosis patients [1] - The JenaValve Trilogy™ THV system, which the TaurusTrio™ is based on, received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures [2] - The company anticipates that the successful launch of the TaurusTrio™ TAV system in China will provide a safe and effective treatment option for patients suffering from severe AR [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China for the registration application of the TaurusTrio Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1] 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 system is specifically designed for treating patients with severe aortic regurgitation via the transfemoral approach, addressing a significant unmet clinical need [1] Group 2: Technical Features - The TaurusTrio TAV system utilizes proprietary anchoring technology that allows for secure fixation even in the absence of calcified tissue, which is a common challenge in AR patients [1] - The system ensures proper alignment of the valve with the native leaflets, enhancing the effectiveness of the treatment [1] Group 3: Market Potential - The Trilogy THV system received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures in real-world clinical practice as of the date of the announcement [1] - The successful launch of the TaurusTrio TAV system in China is expected to provide a safe and effective treatment option for patients suffering from severe AR, fulfilling a significant clinical demand in the market [1]

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 ...

Group 1 - The core viewpoint of the article highlights that Peijia Medical-B (09996) has seen a stock price increase of over 3%, currently trading at HKD 5.92 with a transaction volume of HKD 8.93 million [1] - On December 5, Peijia Medical announced that its Executive Director, CEO, and Chairman, Dr. Zhang Yi, will begin purchasing company shares in the open market starting December 1, 2025, with a total investment not exceeding HKD 15 million [1] - Dr. Zhang does not rule out the possibility of further increasing his shareholding in the company at an appropriate time, in accordance with applicable laws and regulations [1] Group 2 - CITIC Securities released a report indicating that the company's TAVR products are experiencing continuous growth in volume and steadily increasing market share [1] - The GeminiOneTEER system, TaurusTrio aortic regurgitation valve, and TaurusNXT dry valve TAVR are expected to receive intensive approvals between the end of 2025 and 2026, driving accelerated growth in the valve business [1] - The MonarQ tricuspid valve system has initiated global clinical trials, and the cutting-edge technology business has secured external financing, indicating a clear path for innovation and international expansion [1]

Group 1 - The stock of Peijia Medical-B (09996.HK) experienced a rise of over 3% at one point, and as of the report, it increased by 2.6%, reaching HKD 5.92 [2] - The trading volume for Peijia Medical-B was HKD 8.9349 million [2]

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。 ...