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先健科技午后涨近5% CSTM支架系统进入创新医疗器械特别审查程序
Zhi Tong Cai Jing· 2026-01-14 06:10
Core Viewpoint - Xianjian Technology (01302) has seen a stock price increase of nearly 5%, currently trading at 1.7 HKD, following the announcement of its product entering a special review process by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - The company received formal notification from the NMPA confirming that the Concave Supra integrated arch three-branch reconstruction system (CSTM stent system) has entered the NMPA's special review procedure for innovative medical devices [1] - This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, representing a global first in providing a no-brain ischemia integrated solution for arch reconstruction [1] - The company holds independent intellectual property rights for this product, which has successfully completed multiple clinical implants in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [1] Group 2: Market Impact and Future Prospects - The board believes that entering the special review procedure will shorten the registration process for the product, thereby accelerating its market launch [1] - The company anticipates that further evidence from clinical studies will confirm the safety and effectiveness of the product [1]
港股异动 | 先健科技(01302)午后涨近5% CSTM支架系统进入创新医疗器械特别审查程序
智通财经网· 2026-01-14 06:07
Core Viewpoint - Xianjian Technology (01302) has seen a nearly 5% increase in stock price following the announcement of its innovative medical device entering a special review process by the National Medical Products Administration of China [1] Group 1: Product Development - The company announced that its Concave Supra integrated arch three-branch reconstruction system (CSTM stent system) has entered the special review process for innovative medical devices by the National Medical Products Administration [1] - This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, representing a global first in providing a no-brain ischemia integrated solution for arch three-branch reconstruction [1] - The company holds independent intellectual property rights for this product, which has successfully completed multiple clinical implants in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [1] Group 2: Market Impact - The entry of the product into the special review process is expected to shorten the registration timeline, thereby accelerating its market launch [1] - The company anticipates that further evidence from clinical studies will confirm the safety and effectiveness of the product [1]
先健科技:Concave Supra 一体式弓部三分支重建系统进入创新医疗器械特别审查程序
Zhi Tong Cai Jing· 2026-01-12 10:11
Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices, marking a significant advancement in minimally invasive treatment for complex aortic arch aneurysms and penetrating ulcers [1][3]. Group 1: Product Development and Innovation - The CSTM stent system is the world's first integrated arch branch reconstruction solution designed for complex aortic arch pathologies, addressing the challenges of traditional endovascular techniques [1][2]. - The product features a unique groove design that fits the anatomy of the arch, significantly reducing the risk of cerebral ischemia, and employs an integrated structure to prevent endoleaks while ensuring high branch patency rates [2][3]. - The company holds independent intellectual property rights for the product, which has already been successfully implanted in multiple clinical cases across Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [3]. Group 2: Clinical Research and Results - The feasibility study (FIM study) led by Professor Shu Chang completed enrollment of 10 patients in June 2023, showing no endoleaks and high patency rates at 12-month follow-up, validating the safety and effectiveness of the CSTM stent system [2]. - A subsequent prospective, multi-center clinical trial aims to enroll 103 patients across 25 authoritative centers, with 52 patients enrolled as of August 31, 2025, demonstrating a 100% technical success rate and a 1.92% all-cause mortality rate at 30 days post-operation [2]. - The absence of severe complications such as permanent paralysis or retrograde type A aortic dissection further supports the clinical value and application prospects of the CSTM stent system in aortic arch reconstruction [2]. Group 3: Market Impact and Future Outlook - The entry of the CSTM stent system into the special review procedure is expected to shorten the registration process and accelerate its market launch, benefiting patients with aortic arch aneurysms and ulcers [3]. - The anticipated market introduction will expand the company's product offerings and establish a comprehensive minimally invasive treatment solution for aortic diseases, covering key technical areas such as endovascular reconstruction of the arch branches, visceral branch, and iliac arteries [3].
先健科技(01302):Concave Supra 一体式弓部三分支重建系统进入创新医疗器械特别审查程序
智通财经网· 2026-01-12 10:04
Core Viewpoint - The company has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices, marking a significant advancement in minimally invasive treatment for complex aortic arch aneurysms and penetrating ulcers [1][3]. Group 1: Product Development and Innovation - The CSTM stent system is the world's first integrated solution for aortic arch branch reconstruction without brain ischemia, designed specifically for the complex anatomy of the aortic arch [1][2]. - The product has been developed in collaboration with Professor Shu Chang from the National Cardiovascular Center and has become the company's 17th product to enter the special review procedure [1][3]. Group 2: Clinical Research and Results - A feasibility study (FIM study) led by Professor Shu Chang included 10 patients and showed no internal leakage or adverse events after 12 months, validating the safety and effectiveness of the CSTM stent system [2]. - A subsequent prospective, multi-center clinical trial has enrolled 103 patients across 25 centers, with 52 patients enrolled as of August 31, 2025, demonstrating a 100% immediate technical success rate and a 1.92% all-cause mortality rate within 30 days [2]. Group 3: Market Potential and Strategic Outlook - The company holds independent intellectual property rights for the CSTM stent system, which has been successfully implanted in multiple cases in Germany, Switzerland, Greece, and Hong Kong, receiving high recognition from international clinical experts [3]. - The entry into the special review procedure is expected to shorten the registration process and accelerate the product's market launch, benefiting patients with aortic arch aneurysms and ulcers while expanding the company's product range [3].
先健科技(01302.HK):Concave Supra 一体式弓部三分支重建系统进入创新医疗器械特别审查程序
Ge Long Hui· 2026-01-12 10:01
Core Viewpoint - The company, Xianjian Technology (01302.HK), has received formal notification from the National Medical Products Administration confirming that its Concave Supra integrated arch branch reconstruction system (CSTM stent system) has entered the special review procedure for innovative medical devices. This product is designed for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers, marking a significant advancement in the field [1]. Group 1 - The CSTM stent system is the world's first integrated arch branch reconstruction solution that does not require brain ischemia, addressing a critical need in vascular surgery and endovascular intervention [1]. - This product is the 17th to enter the special review procedure by the National Medical Products Administration, indicating the company's strong pipeline of innovative medical devices [1]. - The aortic arch region is known for its complex anatomy and unique hemodynamics, making it one of the most challenging areas in vascular surgery [1]. Group 2 - The CSTM stent system was developed in collaboration with Professor Shu Chang from the National Center for Cardiovascular Diseases and Fuwai Hospital, showcasing the company's commitment to partnerships in advancing medical technology [1]. - The system employs a unique groove and integrated structure, fundamentally addressing multiple technical challenges associated with traditional endovascular techniques in arch branch reconstruction [1]. - This innovation provides a systematic, minimally invasive, and safer solution for complex arch lesions, representing a significant leap forward in treatment options [1].
先健科技(01302) - 自愿性公佈 - Concave Supra一体式弓部三分支重建系统进入创...
2026-01-12 09:53
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) (股份代號:1302) 自願性公佈 Concave Supra 一體式弓部三分支重建 系統進入創新醫療器械特別審查程序 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。 本公司董事(「董事」)會(「董事會」)欣然宣佈,於二零二六年一月九日,本公司收到 國家藥品監督管理局(「國家藥品監督管理局」)的正式書面通知,確認由國家心血管 病中心中國醫學科學院阜外醫院舒暢教授與本集團聯合研發的Concave Supra一體 式弓部三分支重建系統(「CSTM支架系統」或「該產品」)進入國家藥品監督管理局創 新醫療器械特別審查程序(「該程序」)。該產品適用於複雜主動脈弓部動脈瘤及穿透 性潰瘍的微創治療,為全球首創無腦缺血一體式弓部三分支重建解決方案,為本公 司第十七個進入國家藥品監督 ...
港股收评:恒指涨0.32%、科指涨0.15%,黄金及影视娱乐股走高,光伏概念及茶饮股走低,MiniMax上市首日涨近110%
Jin Rong Jie· 2026-01-09 08:24
Market Performance - The Hong Kong stock market experienced a mixed performance with the Hang Seng Index rising by 82.48 points, or 0.32%, closing at 26,231.79 points [1] - The Hang Seng Tech Index increased by 8.8 points, or 0.15%, to 5,687.14 points, while the China Enterprises Index rose by 9.19 points, or 0.1%, to 9,048.53 points [1] - Major tech stocks showed varied movements, with Alibaba up 2.73%, Tencent down 0.81%, and JD.com up 2.6% [1] Company News - Fast Retailing (迅销) reported a revenue of 1,027.745 billion yen for the first quarter ending November 30, 2025, a year-on-year increase of 14.8%, and a net profit of 147.445 billion yen, up 11.7% year-on-year [2] - Baidu Cloud (百融云) repurchased 4.15 million shares for a total of 51.783 million HKD at a price range of 12.41-12.51 HKD [3] - Tencent Holdings (腾讯控股) repurchased 1.636 billion HKD worth of shares, buying back 1.034 million shares at a price range of 610.5-618.5 HKD [4] - Xiaomi Group (小米集团) repurchased 5 million shares for 191 million HKD at a price range of 38.04-38.16 HKD [5] - Vanke Enterprises (万科企业) announced the retirement of Yu Liang, who stepped down from his roles as director and executive vice president [7] Industry Insights - CITIC Securities forecasts that the Hong Kong stock market may see a second round of valuation recovery and performance revival in 2026, driven by internal and external economic factors [13] -招商证券 suggests that the market will enter a phase of structural differentiation, focusing on quality-driven growth, and recommends a dual strategy of focusing on both rebound opportunities and growth stocks [13] - Zheshang International maintains a cautiously optimistic outlook for the Hong Kong market, highlighting sectors benefiting from policy support such as new energy, innovative pharmaceuticals, and AI technology [14]
先健科技现涨超4% G-iliacPro髂动脉覆膜支架系统获药监局正式注册批准
Zhi Tong Cai Jing· 2026-01-09 06:23
Core Viewpoint - Xianjian Technology (01302) has seen a stock increase of over 4%, currently trading at 1.65 HKD, with a transaction volume of 43.52 million HKD following the announcement of regulatory approval for its G-iliacPro iliac artery stent system by the National Medical Products Administration of China [1] Group 1 - The G-iliacPro system is designed for endovascular treatment of abdominal aortic aneurysms combined with iliac artery aneurysms or isolated common iliac artery aneurysms [1] - The product aims to enhance pelvic blood supply by reconstructing the internal iliac artery, providing a more mature and comprehensive solution for clinical applications [1] - This approval represents a systematic upgrade over existing treatment options in the market [1]
港股异动 | 先健科技(01302)现涨超4% G-iliacPro髂动脉覆膜支架系统获药监局正式注册批准
智通财经网· 2026-01-09 06:17
消息面上,先健科技宣布,于2026年1月7日,公司自主研发的G-iliacPro髂动脉覆膜支架系统(G-iliacPro) 获中国国家药品监督管理局正式注册批准。公告称,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。 智通财经APP获悉,先健科技(01302)现涨超4%,截至发稿,涨4.43%,报1.65港元,成交额4352.11万港 元。 ...
港股公告掘金 | 协鑫新能源拟发行1.865亿股认购股份 牵手 Pharos加速Web3与新能源产业的融合
Zhi Tong Cai Jing· 2026-01-08 15:28
Major Events - GCL-Poly Energy (00451) plans to issue 186.5 million subscription shares to partner with Pharos to accelerate the integration of Web3 and the renewable energy industry [1] - Hansoh Pharmaceutical (03692) receives drug registration certificate from the National Medical Products Administration for the fifth indication of Amelot (Ametinib Mesylate Tablets) [1] - Green Leaf Pharmaceutical (02186) has its application for the new indication of the innovative drug Ruoxinlin for the treatment of generalized anxiety disorder accepted in China [1] - Xianjian Technology (01302) receives formal registration approval from the National Medical Products Administration for the G-iliacTM Pro iliac artery covered stent system [1] - Meirui Health International (02327) plans to acquire 100% equity of Jiangsu Yide for 125 million yuan [1] - Century International (00959) joint venture signs a memorandum of understanding with WPT to jointly develop, operate, and commercialize mobile applications [1] Operating Performance - Fast Retailing (06288) reports first-quarter earnings with a net profit attributable to shareholders of 147.445 billion yen, an increase of 11.7% year-on-year [1] - Agile Group (01813) reports December pre-sale amount of 420 million yuan, a decrease of 56.7% year-on-year [1] - Baolong Real Estate (01238) projects total contract sales of approximately 7.272 billion yuan for 2025, a decrease of 43.13% year-on-year [1] - China General Nuclear Power (01816) expects total on-grid electricity of approximately 2,326.48 billion kilowatt-hours for 2025, an increase of 2.36% year-on-year [1] - Lingbao Gold (03330) issues a profit warning, expecting net profit for the 2025 fiscal year to be approximately 1.503 to 1.573 billion yuan, an increase of about 115% to 125% year-on-year [1]