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先瑞达医疗(06669) - 自愿性公告 微导管V-otter的註册申请获中国国家药品监督管理局批准
2025-12-03 08:42
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所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Acotec Scientific Holdings Limited 先瑞達醫療科技控股有限公司 (於開曼群島註冊成立的有限公司) (股份代號:6669) 本公告由先瑞達醫療科技控股有限公司(「本公司」,連同其附屬公司統稱「本集 團」)自願刊發,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 開發進展的最新資訊。 本公司董事會(「董事會」)欣然宣佈,於2025年12月1日,本集團收到中國國家藥 品監督管理局對微導管V-otter的註冊批准。V-otter適用於外周和冠脈血管經皮介 入手術中,到達預期血管部位後輸注診斷性、栓塞性或治療性的材料。V-otter是 一款應用在肝動脈化療栓塞術(TACE)中的微導管,其採用大內腔設計,可有效避 免術中導管堵塞;產品提供直型、45°單彎及多彎曲三種頭端塑形選擇,可根據臨 床實際需求從容適配不同角度的分支血管,從而實現精準、穩定地抵達靶血管, 為後續操作做 ...
先瑞达医疗(06669) - 截至二零二五年十一月三十日止月份之股份发行人的证券变动月报表
2025-12-01 08:42
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11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: 先瑞達醫療科技控股有限公司 呈交日期: 2025年12月1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) | 06669 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | | 0.00001 | USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | | USD | | 0 | | 本月底結存 | | | 10,000,000,000 | USD | | 0.00001 | USD | | 100,000 | ...
先瑞达医疗-B(06669.HK):全球领先的创新型医疗器械
Ge Long Hui· 2025-11-28 05:18
Core Viewpoint - The company focuses on "intervention without implantation" treatment philosophy, utilizing drug-coated balloons (DCB) and other devices to treat narrowed blood vessels without leaving permanent implants, thus avoiding related complications and preserving future treatment options [1] Group 1: Technology and Competitive Advantage - The company emphasizes a multi-technology platform including drug coating technology, radiofrequency ablation technology, suction platform technology, and material technology, which not only fosters product innovation but also reduces production costs, creating a core competitive advantage [1] Group 2: Domestic Market Dynamics - The upcoming centralized procurement policy is expected to ease pressure on the company, with its core product, peripheral drug balloons, included in the procurement scope. The new procurement rules may be more lenient compared to previous ones [1] - Recent approvals for new products such as vertebral artery DCB and coronary DCB are anticipated to mitigate growth pressures from centralized procurement [1] - The company's peripheral venous product line, including the intravascular radiofrequency ablation system and peripheral thrombectomy system, is experiencing stable growth, providing additional growth momentum [1] Group 3: International Expansion - The company has formed a deep partnership with Boston Scientific, with complementary product lines and significant long-term collaboration potential. Currently, the intravascular radiofrequency ablation system has been approved in the U.S., and the below-knee drug balloon is undergoing clinical trials in the U.S., indicating an accelerated international expansion process [1] Group 4: Investment Outlook - The company has been assigned a "Buy-A" investment rating with a 6-month target price of 15 HKD. Projected revenue growth rates for 2025 to 2027 are 19.99%, 21.99%, and 29.05%, respectively, while net profit growth rates are expected to be 130.43%, 66.62%, and 73.46%, indicating strong growth potential [1]
国投证券:首予先瑞达医疗-B“买入”评级 全球领先的创新型医疗器械
Zhi Tong Cai Jing· 2025-11-26 05:24
国投证券发布研报称,首次覆盖给予先瑞达医疗-B(06669)"买入"评级,目标价15港元,先瑞达以"介入 无植入"为核心理念,凭借药物涂层球囊(DCB)等创新产品及多元技术平台构建核心竞争力。面对国内 集采政策可能出现的缓和,公司通过椎动脉、冠脉DCB等新品上市及静脉产品线增长应对挑战。同 时,公司与波士顿科学深度绑定,产品在美国获批并推进临床试验,海外出海进程有望加速,成长性突 出。 2025年10月10日,发布《国家组织药物涂层球囊类、泌尿介入类医用耗材集中带量采购方案(征求意见 稿)》的文件,公司核心产品外周药球纳入集采范围,集采规则相较于之前或有缓和,同时公司椎动脉 DCB、冠脉DCB等新品也于近期获批上市,有望对冲集采带来的增长压力。此外,在外周静脉产品 线,公司的静脉腔内射频消融系统、外周血栓抽吸系统等也处于稳定增长阶段,提供增长动力。 海外携手波士顿科学,出海进程有望加速 公司深度绑定波士顿科学,产品线与波士顿科学有效互补,长期来看,潜在合作空间大。着眼现在,公 司的静脉腔内射频消融系统已在美国获批,膝下药球正在美国开展临床试验,出海进程有望加速。 风险提示 国内集采政策风险、产品海外商业化不及 ...
国投证券:首予先瑞达医疗-B(06669)“买入”评级 全球领先的创新型医疗器械
智通财经网· 2025-11-26 03:26
Core Viewpoint - Guotou Securities initiates coverage on Xianruida Medical-B (06669) with a "Buy" rating and a target price of 15 HKD, highlighting the company's core concept of "intervention without implantation" and its innovative products like drug-coated balloons (DCB) as key competitive advantages [1] Group 1: Core Competitiveness - The company focuses on the "intervention without implantation" treatment philosophy, utilizing drug-coated balloons (DCB) to expand narrowed blood vessels and release therapeutic drugs without leaving permanent implants, thus avoiding related complications and preserving future treatment options [2] - By concentrating on drug coating technology, radiofrequency ablation technology, suction platform technology, and material technology, the company achieves product innovation while reducing production costs, thereby establishing a core competitive edge [2] Group 2: Domestic Market Dynamics - The domestic centralized procurement policy is expected to ease, with the company's core product, peripheral drug balloons, included in the procurement scope, and the new products like vertebral artery DCB and coronary DCB recently approved for market entry, which may offset growth pressures from procurement [3] - The company's peripheral venous product line, including the venous intraluminal radiofrequency ablation system and peripheral thrombectomy system, is also experiencing stable growth, providing additional growth momentum [3] Group 3: International Expansion - The company has a deep partnership with Boston Scientific, with complementary product lines and significant potential for long-term collaboration [4] - Currently, the company's venous intraluminal radiofrequency ablation system has been approved in the U.S., and the below-the-knee drug balloon is undergoing clinical trials in the U.S., indicating an accelerated international expansion process [4]
先瑞达医疗-B(06669):深耕介入无植入,技术平台打造核心竞争力
Guotou Securities· 2025-11-26 03:20
Investment Rating - The report assigns a "Buy-A" investment rating with a target price of 15 HKD over the next six months, reflecting a dynamic P/E ratio of 21 times for 2026 [4][6]. Core Insights - The company focuses on "interventional non-implant" treatment, utilizing drug-coated balloons (DCB) to expand narrowed blood vessels without leaving permanent implants, thus avoiding related complications and preserving future treatment options [1][19]. - Recent domestic procurement policies are expected to ease, and new products are entering a growth phase, with the company's core products included in the procurement scope [2][39]. - The partnership with Boston Scientific is anticipated to accelerate the company's international expansion, with several products already approved in the U.S. [3][38]. Summary by Sections Company Overview - The company, established in 2011, specializes in "interventional non-implant" treatment solutions for various vascular diseases and has developed several leading medical devices [15]. - The company has a strong management team with extensive experience in the medical device industry [16][17]. Product and Technology - The company has developed a comprehensive range of DCB products for multiple indications, including above-knee, below-knee, coronary, and arteriovenous fistula stenosis [22][26]. - The technology platforms include drug coating technology, aspiration platform technology, radiofrequency ablation technology, and materials technology, which enhance product functionality and reduce production costs [28][29]. Market Dynamics - The domestic procurement policy is set to ease, with the sixth batch of high-value consumables procurement rules expected to optimize the bidding process [2][39]. - The DCB market in China is projected to grow significantly, from over 1 billion CNY in 2019 to 14.2 billion CNY by 2030 [22]. Financial Projections - Revenue growth is expected to be 19.99%, 21.99%, and 29.05% from 2025 to 2027, with net profit growth of 130.43%, 66.62%, and 73.46% during the same period [4][9].
智通港股沽空统计|11月19日
智通财经网· 2025-11-19 00:25
Core Insights - The article highlights the top short-selling stocks in the market, with AIA Group (81299), Li Ning (82331), and JD Group (89618) having the highest short-selling ratios at 100.00%, 100.00%, and 91.68% respectively [1][2] - Alibaba (09988), Xiaomi (01810), and Tencent (00700) lead in short-selling amounts, with figures of 3.531 billion, 1.787 billion, and 1.421 billion respectively [1][3] - China Mobile (80941), Shanghai Industrial Holdings (00807), and AIA Group (81299) have the highest deviation values, indicating significant differences from their historical short-selling averages [1][3] Short-Selling Ratios - AIA Group (81299) and Li Ning (82331) both have a short-selling ratio of 100.00%, while JD Group (89618) has a ratio of 91.68% [2] - Other notable companies with high short-selling ratios include Kuaishou (81024) at 90.75% and China Mobile (80941) at 90.20% [2] Short-Selling Amounts - Alibaba (09988) has the highest short-selling amount at 3.531 billion, followed by Xiaomi (01810) at 1.787 billion and Tencent (00700) at 1.421 billion [3] - Other companies with significant short-selling amounts include XPeng Motors (09868) at 1.012 billion and BYD (01211) at 1.001 billion [3] Deviation Values - China Mobile (80941) leads with a deviation value of 43.82%, indicating a significant increase in its short-selling ratio compared to its historical average [3] - Other companies with high deviation values include Shanghai Industrial Holdings (00807) at 40.85% and AIA Group (81299) at 36.63% [3]
先瑞达医疗-B:冠脉整体交换型球囊扩张导管井翼 的注册申请获中国国家药品监督管理局批准
Zhi Tong Cai Jing· 2025-11-18 10:06
Core Viewpoint - The company received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, enhancing its product portfolio in the cardiovascular medical device market [1] Product Approval - The approval is for the "井翼" balloon dilation catheter, which is designed for treating coronary artery stenosis and bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, suitable for post-stent dilation [1] Product Features - The "井翼" is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - It effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving procedural efficiency and safety [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B(06669):冠脉整体交换型球囊扩张导管井翼®的注册申请获中国国家药品监督管理局批准
智通财经网· 2025-11-18 10:02
Core Viewpoint - The company, Xianruida Medical-B (06669), has received registration approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, Jingyi®, which is designed to improve myocardial perfusion in patients with coronary artery stenosis [1] Group 1: Product Details - Jingyi® is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis, with balloon diameters ranging from 2.0 to 5.0 mm also applicable for post-stent dilation [1] - The product features a semi-compliant balloon dilation catheter with a smaller head diameter and optimized delivery system, enhancing its passability and pushability [1] - Jingyi® effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving surgical efficiency and safety through its overall exchange design [1] Group 2: Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B(06669.HK):冠脉整体交换型球囊扩张导管井翼®的注册申请获中国国家药品监督管理局批准
Ge Long Hui· 2025-11-18 10:01
Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, Jingyi®, which is designed to improve myocardial perfusion in patients with coronary artery stenosis [1] Group 1: Product Approval - The approval was granted on November 13, 2025, for the Jingyi® balloon dilation catheter [1] - The product is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, which is also applicable for post-stent dilation [1] Group 2: Product Features - Jingyi® is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - The design effectively addresses complex lesions such as chronic total occlusions and severe calcifications [1] - The overall exchange design enhances surgical efficiency and safety [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]