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。 消息面上，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。 沛嘉医疗-B(09996)涨超6%，截至发稿，涨6.32%，报5.89港元，成交额198.95万港元。 ...

Core Viewpoint - Peijia Medical-B (09996) experienced a significant increase of over 6%, currently trading at 5.89 HKD, with a transaction volume of 1.9895 million HKD, following the announcement of the acceptance of its TAVR system registration application by the National Medical Products Administration of China [1] Group 1: Company Developments - Peijia Medical announced the receipt of an acceptance notice for the registration application of its TaurusNXT® "non-glutaraldehyde cross-linked" transcatheter aortic valve replacement (TAVR) system [1] - The TaurusNXT® is a third-generation TAVR system developed in-house, utilizing patented non-glutaraldehyde biological tissue cross-linking technology aimed at enhancing the durability and biocompatibility of artificial aortic valves [1] Group 2: Executive Actions - The board of directors has been informed that Dr. Zhang Yi, the executive director, CEO, and chairman of the board, will begin purchasing company shares in the open market starting December 1, 2025, with a total investment not exceeding 15 million HKD [1] - Dr. Zhang's planned share acquisition reflects his recognition of the company's intrinsic value and his strong confidence in the company's development prospects and growth potential [1]

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

沛嘉医疗-B(09996.HK)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。 | 指标 | 沛嘉医疗-B | 医疗器械II 行业平均 | 行业排名 | | --- | --- | --- | --- | | ROE | -10.75% | -4.03% | 24 29 | | 港股流通市值 | 36.93亿 | 51.77亿 | 11 29 | | 营业收入 | 6.68亿 | 11.95亿 | 15 29 | | 净利率 | -20.14% | -16.5% | 25 29 | | 毛利率 | 70.07% | 54.89% | 62 16 | | 员债率 | 23.63% | 29.03% | 15 29 | 以上内容为证券之星据公开信息整理，由AI算法生成（网信算备310104345710301240019号），不构成 投资建议。 投行对该股的评级以买入为主，近90天内共有1家投行给出买入评级。中信建投最新一份研报给予沛嘉 医疗-B买入评级。 机构评级详情见下表： | 股票代码 股 ...

格隆汇12月7日丨沛嘉医疗-B(09996.HK)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 ("国家药监局")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 ("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("人工主动脉 瓣")的耐用性及生物相容性。此外，与使用甘油的传统干燥组织技术相比，该系统采用超低温真空冷冻 干燥技术。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("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。 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。 ...

该系统已获国家药监局创新医疗（002173）器械特别审批程序受理，后续将优先评估及审批。 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。 ...

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。 ...