Core Viewpoint - Peijia Medical-B (09996) experienced a nearly 7% increase in stock price following the approval of its TaurusTrio™ transcatheter aortic valve (TAV) system by the National Medical Products Administration of China [1] Group 1: Company Developments - Peijia Medical announced the approval of its TaurusTrio™ TAV system's registration application on December 11 [1] - 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 Trilogy™ THV system 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 [1] Group 2: Market Implications - 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 aortic regurgitation (AR), addressing a significant unmet clinical need [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]

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 ...