静脉腔内射频消融系统
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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].
先瑞达医疗-B(06669):静脉腔内射频消融系统取得美国食品药品监督管理局510(K)市场准入许可
智通财经网· 2025-10-09 09:22
Core Viewpoint - The company, Xianruida Medical-B (06669), has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and the intravascular radiofrequency generator, which are used in conjunction for treatment [1] - The system targets lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member of the BSC Group for the sales of this product in the United States [1] - The BSC Group will begin to advance the commercialization of the product in the U.S. at an appropriate time [1]
先瑞达医疗-B:静脉腔内射频消融系统取得美国食品药品监督管理局510(K)市场准入许可
Zhi Tong Cai Jing· 2025-10-09 09:18
Core Viewpoint - The company has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and the intravascular radiofrequency generator, which are used in combination for treatment [1] - The system targets lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member company of the BSC Group for the sales of this product in the United States [1] - The BSC Group will initiate the commercialization of the product in the U.S. at an appropriate time [1]
先瑞达医疗-B(06669.HK):静脉腔内射频消融系统取得美国食品药品监督管理局510(K)市场准入许可
Ge Long Hui· 2025-10-09 09:16
Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received FDA 510(k) market clearance for its intravascular radiofrequency ablation system, which is designed to treat lower limb varicose veins caused by superficial venous reflux [1] Group 1: Product Details - The intravascular radiofrequency ablation system includes the CedarTM intravascular radiofrequency catheter and an intravascular radiofrequency generator, which are used in conjunction for treatment [1] - The system is specifically aimed at addressing lower limb varicose veins resulting from superficial venous reflux [1] Group 2: Commercialization Plans - The company has signed a distribution agreement with a member of the BSC Group for the sales of this product in the United States [1] - The BSC Group is expected to initiate the commercialization of the product in the U.S. at an appropriate time [1]