该系统已获国家药监局创新医疗器械特别审批程序受理，后续将优先评估及审批。 智通财经APP讯，沛嘉医疗-B(09996)发布公告，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，消除了 瓣膜钙化的根本原因，而瓣膜钙化是人工瓣膜退化的主因。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，与使用甘油的传统乾燥组织技术相比，该系统采用超低温真空冷冻乾燥技术。此方法 帮助保持瓣膜组织的物理完整性，同时亦可将人工主动脉瓣预装到输送器上 。 TaurusNXT®的输送器 亦进行了升级，使其具备可回收及可调弯的特性，有助于医生更加容易将人工主动脉瓣引导至目标植入 位置，从而进一步提高手术的安全性。 ...

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 國家藥監局受理TaurusNXT® 「非醛交聯」幹瓣經導管 主動脈瓣置換系統的註冊申請 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 研發進度的更新資料。 – 1 – 該系統已獲國家藥監局創新醫療器械特別審批程序受理，後續將優先評估及 審批。 本公司可能最終無法成功銷售TaurusNXT® 「非醛交聯」幹瓣TAVR系統。本公司 股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 沛嘉醫療有限公司 董事長兼執行董事 張一博士 香港，2025年12月7日 於本公告日期，董事會包括執行董事張一博士、張葉萍太太及葉紅女士；非執行董事關繼 峰先 ...

Core Viewpoint - Peijia Medical-B (09996.HK) announced that its CEO and Chairman, Dr. Zhang Yi, will start purchasing company shares in the open market from December 1, 2025, with a total expenditure not exceeding HKD 15 million [1] Group 1: Company Actions - The CEO will begin share purchases on December 1, 2025 [1] - The total cost of the share buyback is expected to be no more than HKD 15 million [1] Group 2: Stock Performance - As of December 5, 2025, Peijia Medical-B closed at HKD 5.54, an increase of 0.73% [1] - The trading volume was 1.0137 million shares, with a total transaction value of HKD 5.6187 million [1] Group 3: Analyst Ratings - The stock has a predominant buy rating from investment banks, with one bank issuing a buy rating in the last 90 days [1] - CITIC Securities recently provided a buy rating for Peijia Medical-B [1] Group 4: Market Position and Financial Metrics - Peijia Medical-B has a market capitalization of HKD 3.693 billion, ranking 11th in the medical device II industry [1] - Key financial metrics include: - ROE: -10.75% (industry average: -4.03%, ranking: 24th) [1] - Market capitalization: HKD 3.693 billion (industry average: HKD 5.177 billion, ranking: 11th) [1] - Revenue: HKD 668 million (industry average: HKD 1.195 billion, ranking: 15th) [1] - Net profit margin: -20.14% (industry average: -16.5%, ranking: 25th) [1] - Gross margin: 70.07% (industry average: 54.89%, ranking: 62nd) [1] - Debt ratio: 23.63% (industry average: 29.03%, ranking: 15th) [1]

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。张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。 沛嘉医疗-B(09996)发布公告，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。 ...

沛嘉医疗-B(09996.HK)获首席执行官兼董事长张一增持不超过1500万港元公司股份 沛嘉医疗- B(09996.HK)：国家药监局受理GeminiOne®经导管缘对缘修复系统的注册申请 相关事件 格隆汇12月5日丨沛嘉医疗-B(09996.HK)公告，董事会获悉，张一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」)。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。张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讯，沛嘉医疗-B(09996)发布公告，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。 ...

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分內容而產生或 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 執行董事、首席執行官兼董事會董事長的持股增加 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，以告知本公司股東及潛在投資者有關執行董事、首席執行官兼本公司 董事會（「董事會」）董事長張一博士（「張博士」）於本公司持股增加的事宜。 董事會獲悉，張博士透過其所控制的公司，自2025年12月1日起開始於公開市 場上購買本公司股份（「持股增加」）。持股增加合共代價預期不超過15,000,000 港元。 經張博士告知，持股增加反映其對本公司內在價值的認可，以及其對本公司發 展前景及增長潛力的堅定信心。張博士將不排除根據適用法律及法規於適當 時候進一步增加其於本公司持股的可能性。 根據本公司可獲得的資料及就董事會所知 ...

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11月30日 狀態: 新提交 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」)（於開曼群島註冊成立的有限公司） 呈交日期: 2025年12月2日 本月底法定/註冊股本總額： USD 100,000 FF301 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 (-) | | | | 0 | | 0 | | | | 本月 ...

Core Insights - The neurovascular intervention medical consumables market in China is rapidly growing, with a projected market size of 132.56 billion yuan in 2024 and an expected increase to 197.22 billion yuan by 2025, indicating a significant growth trajectory in this sector [1][3]. Market Overview - The neurovascular intervention medical consumables market is categorized into three main segments: hemorrhagic intervention consumables (71.36 billion yuan, 53.83%), ischemic intervention consumables (35.04 billion yuan, 26.43%), and access intervention consumables (26.16 billion yuan, 19.73%) for 2024 [1][4]. - By 2025, the market shares are expected to shift slightly, with hemorrhagic intervention consumables projected to reach 109.95 billion yuan (55.75%), ischemic intervention consumables at 48.79 billion yuan (24.74%), and access intervention consumables at 38.48 billion yuan (19.51%) [1][4]. Industry Development - The neurovascular intervention field is recognized as a revolutionary advancement in neuroscience, providing less invasive treatment options compared to traditional open surgeries [3]. - The market has grown from 32.25 billion yuan in 2017 to 132.56 billion yuan in 2024, showcasing a robust annual growth rate [3]. Competitive Landscape - The market has historically been dominated by international giants such as Medtronic and Stryker, which held over 60% of the market share [5]. - Domestic companies like MicroPort NeuroScience, Xinwei Medical, Guichuang Tongqiao, and Peijia Medical have made significant advancements in product development, particularly in thrombectomy stents and embolization coils, enhancing their market competitiveness [5]. Industry Trends - The neurovascular intervention medical consumables industry is experiencing rapid growth driven by increased healthcare investment, rising consumer payment capabilities, and an aging population [7]. - There is a notable trend towards domestic companies achieving breakthroughs in lower-tech areas, with expectations for expansion into more advanced fields such as flow-directed devices and intracranial drug balloons [7].

Core Insights - The endovascular neurointervention for cerebral infarction has experienced explosive growth in China, driven by an aging population and lifestyle changes, leading to a continuous rise in the incidence of cerebral infarction [1][4][12] - The number of endovascular neurointervention procedures is projected to increase significantly, reaching 182,500 in 2024 and 266,600 in 2025 [1][5][4] Industry Definition and Barriers - Cerebral infarction, or acute ischemic stroke (AIS), accounts for approximately 80% of all strokes, primarily affecting individuals aged 45 to 70, with an increasing proportion of younger patients [2][4] - The industry has significant talent and brand barriers, as it requires specialized medical knowledge and substantial funding for product development and market entry [3][4] Current Industry Development - The endovascular neurointervention market has seen a rise from 24,100 procedures in 2017 to 182,500 in 2024, with expectations to reach 266,600 by 2025 [4][5] - The breakdown of procedures in 2024 includes intracranial stent retrieval (84,400 procedures, 46.25%), intracranial thrombectomy (66,500 procedures, 36.44%), and other procedures (31,600 procedures, 17.32%) [5] Industry Chain Structure - The industry chain includes upstream raw materials, production and diagnostic equipment, and professional support services, which influence the overall operation of the midstream device manufacturing and downstream clinical treatment [4][6] Major Companies - Key players in the market include Weikang Medical, Xinyi Medical, and Guichuang Tongqiao, among others, with increasing competition as demand grows [8][9] - Microinvasive Brain Science has established a comprehensive product line for stroke intervention, achieving significant revenue growth from 80 million yuan in 2019 to 402 million yuan in 2024 [9] - Guichuang Tongqiao reported a revenue of 780 million yuan in 2024, a 48.3% increase year-on-year, with a gross profit of 560 million yuan [9][10] Industry Development Trends - The market is expected to grow due to rising economic levels, lifestyle changes, and an aging population, with significant opportunities for domestic device manufacturers [12][13] - The industry is expanding its application range, moving beyond ischemic and hemorrhagic strokes to include complex lesions and combinations with other treatment methods [12][13]