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10月31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11月5日 I. 法定/註冊股本變動 | 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 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | 本月 ...

Major Events - Yuan Da Zhu Gong (02163) plans to apply for bankruptcy reorganization at Changsha Intermediate People's Court [1] - Yi Li Holdings (00076) subsidiary intends to issue blockchain vouchers V76, redeemable for bulk commodities on the platform [1] - Peijia Medical-B (09996): National Medical Products Administration accepts registration application for GeminiOne® transcatheter edge-to-edge repair system [1] - Paggen Biopharmaceutical-B (02565) proposes to grant exclusive license for VISEPEGENATIDE (PB-119) in the Middle East and Africa [1] - Beijing Enterprises Environment Group (00154) bids for Hong Kong I·PARK 2 project [1] - Fangda Holdings (01521) plans to acquire Shanghai Guanhua Medical Technology Co., Ltd. for 270 million yuan to enhance global laboratory service capabilities [1] - Lianzhong (06899) focuses on female user value, driving new entertainment through content [1] - Global New Materials International (06616) increases stake in CQV to 50.75%, strengthening global business collaboration [1] - Qianxin Biotechnology-B (02509): Qianxin's industrialization base successfully passes EU QP audit [1] - China Energy Construction (03996) subsidiary signs three new energy general contracting agreements, totaling approximately 19.554 billion yuan [1] - Yongyi International (01218) plans to sell all issued shares of Zhuoyi to Gaoshan (00616) [1] - Bohai Bank (09668) plans to list high capital-occupying debt assets for sale, with an initial pricing of no less than 48.883 billion yuan [1] - Chuangsheng Holdings (02680) plans to receive a premium of about 6% for full acquisition offer, resuming trading on October 13 [1] - Kelun-Botai Biopharmaceutical (06990): Core product TROP2ADC, Lukan-Satuzi (SAC-TMT) approved by National Medical Products Administration for third indication, treating EGFR mutation non-small cell lung cancer after EGFR-TKI progression [1] Operating Performance - Zhaojin Mining (01818) reports net profit of approximately 2.117 billion yuan for the first three quarters, a year-on-year increase of 140.43% [2] - Sunny Optical Technology (02382): September mobile phone camera module shipments reach 48.524 million units, a month-on-month increase of 15.3% and a year-on-year increase of 32% [2] - Yuexiu Property (00123) reports cumulative contract sales of approximately 79.812 billion yuan for the first nine months, a year-on-year increase of about 2.8% [2] - Qiu Tai Technology (01478) reports September camera module sales of 46.654 million units, a month-on-month decrease of 7.6% but a year-on-year increase of 45.1% [2]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration regarding the acceptance of its registration application for the GeminiOne® transcatheter edge-to-edge repair (TEER) system [1] Group 1: Product Innovation - GeminiOne® is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - The device includes innovative features such as an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) system [1] Company Summary - GeminiOne® is an innovative TEER device developed in-house by the company [1] - The device features a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - Additional innovations include an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne transcatheter edge-to-edge repair (TEER) system [1] Group 1: Product Innovation - GeminiOne is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - The device includes innovative features such as an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) system [1] Group 1: Product Innovation - GeminiOne® is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a small implant size and delivery system while achieving a longer grasping arm length [1] - The device includes an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

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 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。 – 1 – 本公司可能最終無法成功開發及營銷GeminiOne®TEER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10月10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 峰先生、陳飛先生及楊俊先生；及獨立非執行董事Stephen Newman OESTERLE博士、Robert Ralph PARKS先生、葉偉明先生及衛華誠先生。 國家藥監局受理GeminiOne®經導管緣對緣修復系統的註冊申請 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 ...

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9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10月2日 I. 法定/註冊股本變動 | 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 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | 本月底 ...

Core Viewpoint - The company has initiated the first patient enrollment for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system, marking a significant milestone in its clinical trial process [1] Group 1: Clinical Trial Details - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital [1] Group 2: System Features and Innovations - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - Its modular and mobile design is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The system features a force sensing mechanism that provides real-time tactile feedback, aiding in instrument navigation under complex vascular conditions [1] - The master-slave control layout effectively reduces the operator's radiation exposure and associated occupational health risks [1] - The Ethernet-based remote control functionality enables cross-regional surgical operations and training [1]

Group 1 - The company Peijia Medical-B (09996) has announced the enrollment of the first patient in the clinical trial for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital, implanting a TaurusElite transcatheter aortic valve in a patient with severe aortic stenosis [1] - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] Group 2 - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - The system features a modular mobile design that fits traditional vascular intervention catheter rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The force sensing mechanism provides immediate tactile feedback, aiding in instrument navigation under complex vascular conditions, while the master-slave control layout effectively reduces radiation exposure risks for the operator [1]