Core Viewpoint - The recent clinical trial results for LuX-Valve Plus and Ken-Valve demonstrate significant safety and efficacy in treating patients with large annuli, addressing a substantial unmet clinical need in severe tricuspid regurgitation and aortic regurgitation patients. Group 1: LuX-Valve Plus TRINITY Study - The TRINITY study is a global, prospective, multi-center, single-arm clinical trial assessing the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation and high surgical risk, involving 161 patients across 20 centers [1] - Over 75% of patients in the TRINITY study used valve sizes of 55mm, 60mm, 65mm, and 70mm, with an average age of 77 years and a Tri-Score of 13.5% [2] - The 6-month follow-up results indicate excellent efficacy and safety of LuX-Valve Plus in large annuli patients, with significant improvements in tricuspid regurgitation levels and quality of life [3] Group 2: Ken-Valve Study - The Ken-Valve study is a prospective, multi-center, single-arm clinical trial evaluating the safety and efficacy of Ken-Valve in symptomatic aortic regurgitation (or combined stenosis) patients, including 142 patients from 15 centers in China [4] - More than 45% of patients used valve sizes of 29mm, 31mm, and 33mm, with an average age of 72 years and an average STS score of 5.60% [4] - The 1-year follow-up results show that Ken-Valve maintains excellent safety and efficacy in large annuli patients, with significant improvements in aortic regurgitation levels and quality of life, addressing a considerable unmet clinical need [4]

Core Insights - The company has announced promising clinical trial results for its products, LuX-Valve Plus and Ken-Valve, which address significant unmet clinical needs in patients with large annuli [1][2][4] Group 1: LuX-Valve Plus TRINITY Study - The TRINITY study is a global, prospective, multi-center, single-arm clinical trial assessing the safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation and high surgical risk [2] - The study included 161 patients from 20 centers, primarily in France, Germany, Spain, Denmark, and the UK, with over 75% using valve sizes of 55mm, 60mm, 65mm, and 70mm [2] - The 6-month follow-up results demonstrated excellent efficacy and safety of LuX-Valve Plus in large annulus patients, with significant improvements in tricuspid regurgitation levels and quality of life [3] Group 2: Ken-Valve Study - The Ken-Valve study is a prospective, multi-center, single-arm clinical trial evaluating the safety and efficacy of Ken-Valve in symptomatic aortic regurgitation (or combined stenosis) patients at high surgical risk [4] - The study involved 142 patients from 15 centers in China, with over 45% using valve sizes of 29mm, 31mm, and 33mm [4] - The 1-year follow-up results indicated that Ken-Valve showed excellent safety and efficacy in large annulus patients, with significant improvements in aortic regurgitation levels and quality of life [4]

Core Viewpoint - The announcement highlights the positive clinical trial results for LuX-Valve Plus and Ken-Valve, indicating the potential of these products to meet significant unmet clinical needs in the market [1] Group 1: Clinical Trial Results - The global multicenter clinical trial ("TRINITY") for LuX-Valve Plus has shown promising 6-month follow-up results for patients with large annuli [1] - Ken-Valve has demonstrated 1-year follow-up results in large annuli patients, further supporting the efficacy of the company's products [1] Group 2: Market Implications - The results are expected to showcase the advantages of the company's products in addressing a wide range of unmet clinical needs, potentially expanding their market reach [1]

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 就 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。 Jenscare Scientific Co., Ltd. 寧波健世科技股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：9877） 自願公告 LuX-Valve Plus TRINITY研究大瓣環患者6個月期 臨床隨訪結果及Ken-Valve大瓣環患者臨床應用效果 於2025年 倫 敦 瓣 膜 會 發 佈，展 現 產 品 獨 特 大 尺 寸 優 勢 LuX-Valve Plus TRINITY研 究：大 瓣 環 患 者6個月期臨床隨訪結果 －由 來 自 法 國 波 爾 多 大 學 醫 院 的Thomas Modine教授發佈 TRINITY是 一 項 全 球 前 瞻 性、多 中 心、單 臂 臨 床 試 驗，主 要 用 於 評 估LuX-Valve Plus於 重 度 三 尖 瓣 反 流 ...

Core Viewpoint - Recently, JianShi Technology (09877) has been awarded the "2025 Excellent Domestic Medical Device Consumables Selection" for its transcatheter aortic valve replacement system, highlighting its recognition in the medical device industry [1] Group 1: Product Features - The Ken-Valve transcatheter intervention replacement system is designed for severe aortic regurgitation (or combined stenosis), featuring an original design that adapts to a wide range of complex anatomical structures [1] - The device enhances operational safety and flexibility during procedures, significantly reducing instrument operation time, which has gained broad recognition from practitioners and the market [1] - The availability of large sizes (29mm, 31mm, and 33mm) addresses the treatment needs of patients with large annuli that are currently unmet in the market [1] Group 2: Market Position and Strategy - The device is also applicable for patients with complex anatomical challenges, such as those with extreme angulation [1] - The company is actively promoting the commercialization of this product, aiming to meet the urgent clinical needs of a wide range of underserved patients [1]

Core Viewpoint - Recently, JianShi Technology (09877) has received recognition for its transcatheter aortic valve replacement system, Ken-Valve, as a recommended product in the "2025 Yangtze River Delta Excellent Domestic Medical Equipment and Consumables Selection" for medical consumables [1] Group 1: Product Features - The Ken-Valve system is designed for severe aortic regurgitation (or combined stenosis) and features an original design that adapts to a wide range of complex anatomical structures [1] - The device enhances operational safety and flexibility during procedures, significantly reducing instrument operation time, which has gained broad recognition from practitioners and the market [1] - The availability of large sizes (29mm, 31mm, and 33mm) addresses the treatment needs of patients with large annuli that are currently unmet in the market [1] Group 2: Market Position and Strategy - The device is also applicable for patients with complex anatomical challenges, such as those with extreme angulation [1] - The company is actively promoting the commercialization of this product, aiming to meet the urgent clinical needs of a wide range of underserved patients [1]

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: 寧波健世科技股份有限公司 FF301 非上市股份包括本公司的內資股和非上市外資股。 呈交日期: 2025年11月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09877 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 310,306,209 | RMB | | 1 | RMB | | 310,306,209 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 310,306,209 | RMB | | 1 | RMB | ...

澄清公告 茲提述本公司日期為二零二五年十月二十八日的公告（「十月二十八日公告」） 及二零二五年十月二十九日的公告（「十月二十九日公告」，連 同 十 月 二 十 八 日 公 告，統 稱「先前公告」）。本 公 告 乃 由 寧 波 健 世 科 技 股 份 有 限 公 司（「本公司」， 連 同 其 附 屬 公 司，統 稱「本集團」）就 先 前 公 告 作 出 澄 清，以 澄 清 先 前 公 告 中 為 糾 正 十 月 二 十 八 日 公 告 中 的 一 項 無 心 之 失 而 作 出 的 修 訂。除 另 有 界 定 者 外，本 公 告 所 用 中 詞 彙 與 先 前 公 告 中 所 用 詞 彙 具 有 相 同 涵 義。 本 公 司 謹 此 澄 清，十 月 二 十 八 日 公 告 中 第 二 頁 所 載 的 有 關 安 全 性 結 果 隨 訪 期 間 的 兩 處 內 容 已 於 十 月 二 十 九 日 公 告 中 修 訂，而 所 有 安 全 性 結 果 已 準 確 呈 列 且 未 做 修 訂，為 方 便 參 考，兩 份 公 告 之 間 所 作 的 更 改 如 下 註 釋： 香港交易及結算所有限公司及香港聯合交易所有限公 ...

Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 highlight significant advancements in the treatment of heart valve diseases, showcasing their safety, efficacy, and innovative designs [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study demonstrated LuX-ValvePlus's excellent safety and efficacy, with a stable low incidence of adverse events and improved patient quality of life over six months [2] - Over 75% of patients in the TRINITY study used larger valve sizes (55mm to 70mm), indicating its broad application, especially for patients with severe tricuspid regurgitation [2] - The device has achieved a 100% procedural success rate in the FDA IDE-EFS study, with pivotal clinical research set to commence soon [2] Group 2: JensClip - JensClip, designed for severe mitral regurgitation, showed a one-year follow-up result with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients exhibited no moderate or severe regurgitation, with significant improvements in various quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation, demonstrated excellent one-year follow-up results, maintaining stable effective orifice area and low rates of adverse events [4] - The device is available in multiple sizes (23mm to 33mm) and is designed to address complex anatomical challenges, fulfilling the needs of patients with limited treatment options [4] Group 4: Overall Company Positioning - The comprehensive research outcomes across tricuspid, mitral, and aortic valves garnered significant attention and praise from global experts at TCT2025 [4] - The company plans to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio [4]

Core Insights - The recent clinical trial results for LuX-ValvePlus, JensClip, and Ken-Valve presented at TCT2025 demonstrate significant advancements in the treatment of heart valve diseases, showcasing their safety and efficacy in various patient populations [1][2][3][4] Group 1: LuX-ValvePlus - The TRINITY study's 6-month follow-up results indicate that LuX-ValvePlus exhibits good safety and efficacy, with a stable low incidence of adverse events compared to the 30-day follow-up [2] - Over 75% of enrolled patients in the TRINITY study used larger valve sizes (55mm, 60mm, 65mm, and 70mm), highlighting its broad application, especially for patients with severe tricuspid regurgitation [2] - The FDA IDE-EFS for LuX-ValvePlus has completed all enrollments with a 100% procedural success rate, and a pivotal study is set to commence [2] Group 2: JensClip - JensClip, designed for treating severe mitral regurgitation, shows excellent one-year follow-up results, with an all-cause mortality rate of only 1.8% and minimal device-related complications [3] - 96.3% of patients demonstrated no moderate or severe regurgitation, with significant improvements in quality of life metrics [3] Group 3: Ken-Valve - Ken-Valve, aimed at high-risk surgical patients with severe aortic regurgitation or mixed aortic stenosis, also shows promising one-year follow-up results, with stable effective orifice area and low rates of adverse events [4] - The device is available in multiple sizes (23mm to 33mm) and is designed to accommodate complex anatomical challenges, addressing the limited treatment options for large annulus patients [4] Group 4: Overall Company and Industry Impact - The comprehensive research outcomes for tricuspid, mitral, and aortic valves have garnered significant attention and praise from global experts at TCT2025 [4] - The company aims to leverage its extensive clinical experience and innovative product designs to advance the global application and commercialization of its product portfolio across various regions [4]