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健世科技-B涨超6% LuX-Valve Plus已正式获准进入港澳药械通
Zhi Tong Cai Jing· 2025-10-09 02:48
Core Viewpoint - Jenscare Scientific's product LuX-Valve Plus has been approved for commercialization in designated medical institutions in the Greater Bay Area, which is expected to enhance the company's market penetration and revenue growth [1] Group 1: Company Developments - Jenscare Scientific's LuX-Valve Plus has received approval to enter the Hong Kong and Macau Medical Device Directory, allowing its use in mainland China [1] - The approval is part of the "Hong Kong and Macau Medical Device Pass" policy aimed at facilitating the use of urgently needed medical devices in the Greater Bay Area [1] - The company plans to leverage this policy opportunity to accelerate the commercialization of LuX-Valve Plus and address unmet clinical needs [1] Group 2: Market Context - The "Hong Kong and Macau Medical Device Pass" policy is designed to provide a more efficient access channel for innovative medical devices in the Greater Bay Area [1] - This initiative aims to meet patients' urgent demand for advanced medical technologies and offer diverse treatment options [1] - The company anticipates that the experience gained from this initiative will support its future expansion in domestic and international markets [1]
港股异动 | 健世科技-B(09877)涨超6% LuX-Valve Plus已正式获准进入港澳药械通
智通财经网· 2025-10-09 02:42
Core Viewpoint - Jenscare Scientific's product LuX-Valve Plus has been approved for commercialization in the Greater Bay Area, enhancing the company's market penetration and growth potential [1] Group 1: Company Developments - Jenscare Scientific (Netherlands) B.V. has received approval for its LuX-Valve Plus product to enter the Hong Kong and Macau medical device directory [1] - The approval allows for commercial clinical use in designated medical institutions within the Greater Bay Area [1] - The company aims to leverage the "Hong Kong and Macau Medical Device Pass" policy to accelerate the market penetration of LuX-Valve Plus [1] Group 2: Industry Context - The "Hong Kong and Macau Medical Device Pass" is a medical innovation policy implemented in the Guangdong-Hong Kong-Macao Greater Bay Area [1] - This policy facilitates the use of urgently needed drugs or medical devices in mainland clinical settings after approval, addressing patient needs for advanced medical technologies [1] - The initiative aims to provide diverse treatment options for patients and create an efficient access channel for innovative medical devices [1]
健世科技-B(09877):LuX-Valve Plus获准进入港澳药械通
智通财经网· 2025-10-09 00:57
Core Viewpoint - Jenscare Scientific (Netherlands) B.V., a wholly-owned subsidiary of Jian Shi Technology-B (09877), has received approval for its product LuX-Valve Plus to enter the Hong Kong and Macau medical device market, enabling commercial clinical use in designated medical institutions within the Greater Bay Area [1] Group 1: Product Approval and Market Entry - LuX-Valve Plus has successfully passed the "Hong Kong and Macau Medical Device Pass" approval due to its extensive successful clinical application experience across major regions including Asia-Pacific, North America, Europe, South America, and the Middle East [1] - The product is expected to address the urgent treatment needs of numerous patients suffering from tricuspid regurgitation in the Greater Bay Area [1] Group 2: Strategic Plans and Market Expansion - The company aims to leverage the "Hong Kong and Macau Medical Device Pass" policy opportunity to actively promote the commercialization of LuX-Valve Plus in the Greater Bay Area, accelerating market penetration [1] - This initiative is expected to help the company accumulate critical experience for further expansion into domestic and overseas markets, driving long-term sustainable revenue growth [1]
健世科技-B(09877):LUX-VALVE PLUS获准进入港澳药械通
智通财经网· 2025-10-08 23:47
Core Viewpoint - The approval of LuX-Valve Plus for commercial clinical use in the Greater Bay Area marks a significant advancement in addressing the unmet clinical needs of patients with severe tricuspid regurgitation, particularly in high-risk surgical cases [1][2] Group 1: Product Approval and Market Entry - Jenscare Scientific's LuX-Valve Plus has been officially approved to enter the Hong Kong-Macao Medical Device Directory, allowing its use in designated medical institutions in the Greater Bay Area [1] - The "Hong Kong-Macao Medical Device Pass" policy aims to facilitate the entry of urgently needed medical devices and drugs into the mainland, enhancing patient access to advanced medical technologies [1] Group 2: Product Features and Clinical Performance - LuX-Valve Plus is designed specifically for patients with severe tricuspid regurgitation and complex anatomical structures, offering a solution where few effective treatments exist [2] - The product features innovative design elements such as inter-ventricular anchoring and adaptive anti-leak rings, available in seven sizes from 40mm to 70mm, demonstrating excellent clinical performance and safety [2] Group 3: Strategic Market Expansion - The company plans to leverage the "Hong Kong-Macao Medical Device Pass" policy to accelerate the commercialization of LuX-Valve Plus in the Greater Bay Area, aiming to meet the significant clinical demand [2] - Successful implantation and follow-up results globally have established LuX-Valve Plus's clinical value and advanced technology, which will support the company's long-term revenue growth and market expansion [2]
健世科技-B:LUX-VALVE PLUS获准进入港澳药械通
Zhi Tong Cai Jing· 2025-10-08 23:47
此外,公司将充分把握"港澳药械通"政策机遇,积极推动LuX-Valve Plus在大湾区的商业化植入,加快 市场渗透,积极服务广大患者未满足的临床需求,亦为后续国内及海外市场全面拓展进一步积累关键经 验,推动集团收入实现长期可持续增长。 LuX-Valve Plus凭借其全球范围内包括亚太、北美、欧洲、南美、中东等重要国家地区大量成功临床应 用经验、优异的临床表现,以及独特先进的产品设计,成功通过"港澳药械通"批准,得以在粤港澳大湾 区内地进行商业化临床应用,有望先行满足区域内大量三尖瓣反流患者急迫的治疗需求。 LuX-Valve Plus是一款自主研发的专为重度三尖瓣反流且手术高风险的患者设计的经导管三尖瓣置换系 统。三尖瓣反流存在大量未满足的临床需求,尤其是对于三尖瓣瓣环严重扩张且解剖结构复杂的患者, 长期缺乏安全、有效的治疗手段。LuX-Valve Plus通过全球创新的室间隔锚定和可自适应防漏环的瓣膜 设计,配合经颈静脉入路方式,并提供40mm-70mm的七个尺寸型号,适用于各类解剖结构挑战且几乎 并无其他治疗选择的三尖瓣反流患者,并显示出优异的临床表现。该产品已在全球范围内成功完成大量 植入,随访结 ...
健世科技-B(09877.HK):LUX-VALVE PLUS获准进入港澳药械通
Ge Long Hui· 2025-10-08 23:42
Core Viewpoint - Jenscare Scientific (Netherlands) B.V., a subsidiary of the company, has received approval for its LuX-Valve Plus product to enter the Hong Kong and Macau Medical Device Directory, allowing for commercial clinical use in designated medical institutions within the Greater Bay Area [1] Group 1 - The "Hong Kong and Macau Medical Device Pass" is a medical innovation policy implemented in the Guangdong-Hong Kong-Macau Greater Bay Area, facilitating the use of urgently needed drugs or medical devices in public hospitals after approval [1] - The policy aims to meet patients' urgent needs for advanced medical technologies and provide a wider range of treatment options [1] - It also offers an efficient access channel for innovative medical devices [1]
健世科技(09877) - 自愿公告LUX-VALVE PLUS获准进入港澳药械通
2025-10-08 23:30
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。 – 1 – 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獲准進入港澳藥械通 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」)按 自 願 基 準 作 出,以 向 本 公 司 股 東 及 潛 在 投 資 者 提 供 有 關 本 集 團 最 新 業 務 及 新 產 品 開 發 的 最 新 資 料。 本公司董事(「董 事」)會(「董事會」)欣 然 宣 布,近 日,本 集 團 附 屬 公 司Jenscare Scientific (Netherlands) B.V.產 品LuX-Valve Plus經頸靜脈三尖瓣置換系統已 ...
健世科技(09877) - 截至2025年9月30日止月份之股份发行人的证券变动月报表
2025-10-08 09:08
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: 寧波健世科技股份有限公司 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10月8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 | | 310,306,209 | | 2. 股份分 ...
健世科技(09877) - 补充公告有关取消暂停办理股份过户登记期间
2025-09-29 13:00
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依賴該等內容而引致的任何損失承擔任何責任。 Jenscare Scientific Co., Ltd. 承董事會命 寧波健世科技股份有限公司 執行董事兼首席執行官 補充公告 有關取消暫停辦理股份過戶登記期間 茲提述寧波健世科技股份有限公司(「本公司」)日期為二零二五年九月二十六 日的通函(「通 函」),內 容 有 關 本 公 司 將 於 二 零 二 五 年 十 月 十 五 日 召 開 股 東 特 別 大 會(「股東特別大會」)及相應的股東特別大會通告(「股東特別大會通告」)。除 另 有 定 義 者 外,本 公 告 所 用 詞 彙 與 通 函 所 界 定 者 具 有 相 同 涵 義。 通 函 及 股 東 特 別 大 會 通 告 載 明,本 公 司 將 於 二 零 二 五 年 十 月 十 一 日(星 期 六)至 二零二五年十月十五日(星 期 三)(包 括 首 尾 兩 天)暫停辦理H股 股 份 過 ...
心血管疾病相关医疗器械行业报告:心血管行业空间广阔,集采助力国产替代
Western Securities· 2025-09-27 11:33
Investment Rating - The industry investment rating is "Overweight" [4] Core Insights - The cardiovascular medical device market, particularly for arrhythmia-related devices, is substantial, with the Chinese market for cardiac electrophysiology devices expected to grow from 6.58 billion RMB in 2021 to 15.73 billion RMB by 2025, and further to 41.97 billion RMB by 2032 [15][18] - The global market for cardiac rhythm management devices has seen a compound annual growth rate (CAGR) of 1.8% from 2016 to 2021, with expectations to reach 12.8 billion USD by 2030 [19] - The aortic stent market in China is also expanding, with the number of aortic interventions projected to increase significantly by 2030 [28] Summary by Sections 1. Cardiovascular Disease Market Outlook - Cardiovascular diseases are a leading cause of death globally, with a significant increase in intervention procedures expected due to rising health awareness and government policies promoting domestic products [13][14] - The Chinese market for cardiac electrophysiology devices is projected to grow at a CAGR of 24.34% from 2021 to 2025 [15] 2. Arrhythmia Market - The market for cardiac electrophysiology devices in China reached 6.58 billion RMB in 2021, with expectations to grow to 15.73 billion RMB by 2025 [15] - The global cardiac electrophysiology market is expected to reach 32.45 billion USD by 2032, with a CAGR of 12.21% from 2025 to 2032 [18] 3. Coronary Artery Disease Market - The number of patients with coronary artery disease in China is projected to reach 31.67 million by 2030, with a CAGR of 2.0% from 2026 to 2030 [24] - The market for coronary artery interventions is expected to grow significantly, driven by increasing patient numbers and intervention rates [24] 4. Aortic Stent Market - The aortic stent market in China was valued at 2.4 billion RMB in 2021, with projections to reach 4.31 billion RMB by 2030 [28] - The number of aortic interventions is expected to increase to 180,400 by 2030, indicating strong growth potential in this segment [28] 5. Heart Valve Market - The market for transcatheter aortic valve replacement (TAVR) in China is expected to grow from 911.5 million RMB in 2021 to 4.86 billion RMB by 2025, with a CAGR of 52.0% [35] - The number of transcatheter mitral valve interventions is projected to increase significantly, indicating a growing market for heart valve treatments [38][41] 6. Key Companies to Watch - Microelectrophysiology (688351.SH) is highlighted as a leading manufacturer in the cardiac electrophysiology sector [3] - Bairen Medical (688198.SH) is recognized for its excellence in surgical and interventional valve products [3] - Jianxi Technology (09877.HK) is noted for its advancements in transcatheter valve technologies [3]