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先健科技:G-iliacTM Pro髂动脉覆膜支架系统获得中国国家药品监督管理局的正式注册批准
Zhi Tong Cai Jing· 2026-01-08 11:25
Core Viewpoint - The approval of the G-iliacTM Pro iliac artery covered stent system marks a significant advancement in the company's product offerings, enhancing solutions for endovascular treatment of iliac artery aneurysms and improving patient outcomes [1][3]. Group 1: Product Approval and Features - The G-iliacTM Pro received formal registration approval from the National Medical Products Administration of China on January 7, 2026, for the treatment of abdominal aortic aneurysms combined with iliac artery aneurysms [1]. - The product is designed to ensure pelvic blood supply by reconstructing the internal iliac artery, providing a more mature and comprehensive solution compared to existing treatment options [1]. - The G-iliacTM Pro consists of the G-iliacTM Pro covered stent and the SilverFlowTM Pro covered stent, featuring a low-profile delivery system and ergonomic design for improved usability and precision during procedures [2]. Group 2: Clinical Significance and Market Position - The G-iliacTM system, previously approved in 2021, was the first commercialized iliac artery bifurcation device in China, addressing a long-standing market gap in endovascular reconstruction of the internal iliac artery [2]. - Clinical applications and real-world studies have demonstrated the G-iliacTM's excellent safety, patency rates, and operational stability, enabling physicians to perform complex reconstructions more confidently [2]. - The company aims to provide a complete solution for minimally invasive treatment of aortic diseases, pushing towards a more systematic, standardized, and efficient development phase in the medical device sector [3].
先健科技(01302):G-iliacTM Pro髂动脉覆膜支架系统获得中国国家药品监督管理局的正式注册批准
智通财经网· 2026-01-08 11:23
Core Viewpoint - The approval of the G-iliacTM Pro iliac artery stent system marks a significant advancement in the company's product offerings, enhancing its position in the minimally invasive treatment of aortic diseases and providing improved solutions for iliac artery reconstruction [1][3]. Group 1: Product Approval and Features - The G-iliacTM Pro stent system received formal registration approval from the National Medical Products Administration of China on January 7, 2026, and is designed for endovascular treatment of abdominal aortic aneurysms combined with iliac artery aneurysms or isolated common iliac artery aneurysms [1]. - The G-iliacTM Pro consists of the G-iliacTM Pro stent and SilverFlowTM Pro stent, maintaining a two-piece combination for safety and convenience, with a low-profile delivery system and ergonomic design for improved operation [2]. Group 2: Clinical Significance and Market Impact - The G-iliacTM system, approved in 2021, was the first commercialized iliac artery bifurcation device in China, addressing a long-standing market gap in endovascular reconstruction of the internal iliac artery [2]. - The company aims to provide a comprehensive solution for aortic minimally invasive treatments, pushing for a more systematic, standardized, and efficient development phase in treating complex aortic diseases [3].
先健科技(01302.HK):G-iliac™Pro髂动脉覆膜支架系统获药监局正式注册批准
Ge Long Hui· 2026-01-08 11:19
格隆汇1月8日丨先健科技(01302.HK)宣布,于2026年1月7日,公司自主研发的G-iliac™Pro髂动脉覆膜 支架系统(「G-iliac™Pro」)获中国国家药品监督管理局正式注册批准。该产品适用于腹主动脉瘤合并髂 动脉瘤或孤立髂总动脉瘤的腔内治疗,通过重建髂内动脉确保盆腔供血,为临床提供了更成熟、更完善 的解决方案,实现了对既有治疗方案的系统性升级。 髂内动脉为髂总动脉的重要分支,承担着盆腔脏器、臀肌及脊髓的重要供血功能。早期腹主动脉瘤腔内 修复术(「EVAR」)中,为了防止内漏往往会栓塞一侧或双侧髂内动脉,从而引发臀肌跛行、性功能障 碍、结肠缺血、直肠坏死、脊髓缺陷甚至截瘫等一系列并发症,严重影响患者长期生活质量。国内外大 量指南及共识已明确:EVAR术中,至少保留一侧髂内动脉,可使患者获得良好的预後。髂动脉分支支 架(「IBD」)技术,因其更符合生理解剖、内漏发生率低、远期通畅率高等优势,逐渐成为腔内重建髂 内动脉的理想选择。 ...
先健科技(01302) - 自愿性公佈 - G-iliac TM Pro髂动脉覆膜支架系统获得中国国...
2026-01-08 11:13
(股份代號:1302) 自願性公佈 香港交易及結算所有限公司與香港聯合交易所有限公司對本公佈的內容概不負責,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佈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。 LifeTech Scientific Corporation 先健科技公司 (在開曼群島註冊成立的有限公司) – 2 – G-iliacTM Pro髂動脈覆膜支架系統 獲得中國國家藥品監督管理局的正式註冊批准 本公佈乃由先健科技公司(「本公司」,連同其附屬公司稱為「本集團」)自願作出,旨 在向其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情況的資料。 本公司董事(「董事」)會(「董事會」)欣然宣佈,於二零二六年一月七日,本公司自主 研發的G-iliacTM Pro髂動脈覆膜支架系統(「G-iliacTM Pro」或「該產品」)獲中國國家 藥品監督管理局(「國家藥品監督管理局」)正式註冊批准。該產品適用於腹主動脈瘤 合併髂動脈瘤或孤立髂總動脈瘤的腔內治療,通過重建髂內動脈確保盆腔供血,為 臨床提供了更成熟、更完善的解決方案,實現了對既有治療方案的系統性升級。 髂內 ...
先健科技(01302) - 截至2025年12月31日之股份发行人的证券变动月报表
2026-01-06 08:16
FF301 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12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: 先健科技公司 (在開曼群島註冊成立的有限公司) 呈交日期: 2026年1月6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) | 01302 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 ...
医疗器械行业研究:政策推动创新器械应用,脑机接口加速商业落地
SINOLINK SECURITIES· 2025-12-27 15:39
Investment Rating - The report suggests a positive investment outlook for the medical device sector, particularly in brain-computer interface devices, which are expected to see accelerated commercialization due to supportive policies [1][3]. Core Insights - Recent policies have significantly increased support for innovation in medical devices, with the National Medical Products Administration actively promoting faster market entry for brain-computer interface devices, indicating a diverse application landscape and substantial future potential [1][3]. - The pharmaceutical sector is witnessing positive developments, such as GSK's approval of mepolizumab for a new indication in COPD patients, marking it as the first monthly administered biologic in China, which is expected to reduce the annual incidence of severe exacerbations significantly [1][32]. - The report highlights the approval of Wegovy® tablets in the U.S. for weight management, emphasizing its potential impact on the market as the first oral GLP-1 receptor agonist for this purpose [37][40]. Summary by Sections Pharmaceutical Sector - Mepolizumab has been approved for COPD treatment in China, with a monthly dosing schedule, targeting a significant patient population [1][32]. - The A/H share innovation drug sector maintains high activity levels, with new drug approvals and cross-border transactions remaining robust [16][28]. Biologics - Wegovy® tablets have been approved in the U.S. for weight management, showing similar weight loss efficacy to its injectable counterpart, with a significant portion of participants achieving substantial weight loss [37][40]. CXO and Pharmaceutical Supply Chain - The CXO sector continues to show upward momentum, supported by a stable order backlog, with November financing levels slightly above the annual average [44][46]. Medical Devices - The centralized procurement process for high-value medical consumables is progressing steadily, with high selection rates in multiple rounds of bidding, indicating a favorable environment for leading domestic companies [2][52]. Retail Pharmacy - The industry is undergoing a consolidation phase, with leading companies expected to benefit from increased market share through mergers and acquisitions [2][3]. Medical Services and Consumer Healthcare - Aier Eye Hospital's acquisition of 39 institutions for 960 million yuan strengthens its market position, with the acquired entities showing signs of financial recovery [2][3].
先健科技股东将股票由建银国际证券转入富途证券国际香港 转仓市值4.07亿港元
Zhi Tong Cai Jing· 2025-12-15 05:25
此前先健科技发布公告,于2025年12月9日,信托人富途信托有限公司、卖方Xianjian Advanced Technology Limited及公司订立该协议,据此,就股份奖励计划而言,信托人(经公司指示)同意购买(由 公司提供资金)且卖方同意销售2.3亿股股份。 香港联交所最新资料显示,12月12日,先健科技(01302)股东将股票由建银国际证券转入富途证券国际 香港,转仓市值4.07亿港元,占比5.74%。 ...
先健科技(01302)股东将股票由建银国际证券转入富途证券国际香港 转仓市值4.07亿港元
智通财经网· 2025-12-15 00:24
此前先健科技发布公告,于2025年12月9日,信托人富途信托有限公司、卖方Xianjian Advanced Technology Limited及公司订立该协议,据此,就股份奖励计划而言,信托人(经公司指示)同意购买(由 公司提供资金)且卖方同意销售2.3亿股股份。 智通财经APP获悉,香港联交所最新资料显示,12月12日,先健科技(01302)股东将股票由建银国际证券 转入富途证券国际香港,转仓市值4.07亿港元,占比5.74%。 ...
12月10日深港通医疗(港币)(983036)指数跌0.28%,成份股先健科技(01302)领跌
Sou Hu Cai Jing· 2025-12-10 11:19
Core Points - The Shenzhen-Hong Kong Stock Connect Medical Index (983036) closed at 4327.65 points, down 0.28%, with a trading volume of HKD 7.682 billion and a turnover rate of 0.9% [1] - Among the index constituents, 21 stocks rose while 36 stocks fell, with Kewei Medical leading the gainers at a 4.14% increase and Xianjian Technology leading the decliners at a 9.14% decrease [1] Index Constituents Summary - The top ten constituents of the Shenzhen-Hong Kong Stock Connect Medical Index include: - Mindray Medical (sz300760) with a weight of 14.56%, latest price at HKD 198.00, and a market cap of HKD 240.063 billion, down 0.36% [1] - Yier Eye Hospital (sz300015) with a weight of 11.62%, latest price at HKD 11.23, and a market cap of HKD 104.724 billion, down 0.62% [1] - Lejin Medical (sz300003) with a weight of 4.85%, latest price at HKD 15.64, and a market cap of HKD 28.831 billion, down 0.64% [1] - Aimeike (sz300896) with a weight of 4.80%, latest price at HKD 143.25, and a market cap of HKD 43.346 billion, up 1.47% [1] - Yuyue Medical (sz002223) with a weight of 4.66%, latest price at HKD 35.68, and a market cap of HKD 35.768 billion, up 0.17% [1] - Yingke Medical (sz300677) with a weight of 3.64%, latest price at HKD 41.76, and a market cap of HKD 27.360 billion, down 0.17% [1] - Furuijia (sz300049) with a weight of 3.59%, latest price at HKD 69.33, and a market cap of HKD 18.371 billion, down 0.82% [1] - Meinian Health (sz002044) with a weight of 3.58%, latest price at HKD 5.09, and a market cap of HKD 19.924 billion, up 0.39% [1] - Sinopharm Holdings (hk01099) with a weight of 3.35%, latest price at HKD 18.15, and a market cap of HKD 56.638 billion, down 0.40% [1] - Ping An Good Doctor (hk01833) with a weight of 2.63%, latest price at HKD 12.23, and a market cap of HKD 26.434 billion, down 3.24% [1] Capital Flow Analysis - The index constituents experienced a net outflow of HKD 382 million from institutional investors, while retail investors saw a net inflow of HKD 329 million [1] - Notable individual stock capital flows include: - Meinian Health (sz002044) with a net inflow of HKD 23.6308 million from institutional investors [2] - Aimeike (sz300896) with a net inflow of HKD 5.8353 million from institutional investors [2] - Yier Eye Hospital (sz300015) with a net outflow of HKD 20.7620 million from retail investors [2]
12月10日深港通医疗(983035)指数跌0.41%,成份股先健科技(01302)领跌
Sou Hu Cai Jing· 2025-12-10 11:19
Core Viewpoint - The Shenzhen-Hong Kong Medical Index (983035) experienced a slight decline of 0.41%, closing at 4415.21 points on December 10, with a trading volume of 6.972 billion yuan and a turnover rate of 0.9% [1] Group 1: Index Performance - The Shenzhen-Hong Kong Medical Index closed at 4415.21 points, down 0.41% [1] - The index had a trading volume of 6.972 billion yuan and a turnover rate of 0.9% [1] - Among the constituent stocks, 21 companies saw an increase, with Kewei Medical leading at a 4.14% rise, while 36 companies declined, with Xianjian Technology leading the drop at 9.14% [1] Group 2: Capital Flow - The net outflow of main funds from the Shenzhen-Hong Kong Medical Index constituent stocks totaled 382 million yuan [2] - Retail investors contributed a net inflow of 329 million yuan, while speculative funds saw a net inflow of 53.373 million yuan [2] - Detailed capital flow information for the constituent stocks is available in the accompanying table [2]