证券研究报告 | 公司深度报告 2026 年 01 月 08 日 先瑞达医疗-B（06669.HK） 波科赋能海外可期，新产品带来增长 消费品/生物医药 先瑞达是国内领先的专注于提供泛血管介入综合解决方案的创新医疗器械平台 型企业，率先于国内推出首款膝上及膝下 DCB 产品，在外周介入领域处于领先 地位；2025 年 12 月公司与控股股东波士顿科学签署新的三年期合作协议，在 产品全球商业化、制造服务和研发等领域开展一系列合作。 ❑ 与波科签署新三年期合作协议，海外放量确定性强。2023 年 2 月全球微创介 入医疗器械领先企业波士顿科学成为先瑞达控股股东，持股 65%，并于 2023 年 6 月签署首个合作谅解备忘录；2025 年 12 月，公司与波科签署新的三年 合作协议（2026-2028）：1）全球商业化：共享波科覆盖全球的渠道资源， 预计 2026-2028 年向波科销售产品交易金额上限为 3000/6200/7800 万美元； 2）产品制造：基于先瑞达智造能力提供产品 OEM 服务，预计 2026-2028 年 向波科提供制造服务交易金额上限为 100/100/300 万美元；3）产品研发：互 相 ...

其设计特点主要体现在三个方面，一是其唯一螺旋环绕三角刻痕丝，可实现360°高效压力聚焦扩张；二 是该产品是市场上最高4根刻痕丝的冠脉刻痕球囊，有着更大的刻痕面积；三是其RBP高达20atm，可提 供更高的安全扩张空间 除该产品外，蓝帆医疗在心脑血管领域现已通过多种形式布局冠脉介入、结构性心脏病、神经介入及外 周介入四条赛道。作为行业领先的平台型企业，蓝帆医疗充分发挥公司国际化与科技平台化优势、提高 研发效率和创新能力，灵活调整资源投入，确保人才、技术、资源得到高效利用，并依托公司在心脑血 管领域的资源禀赋，链接医院、科研机构与企业，打造产业集群。 作为中国医疗器械行业的重要一分子，公司表示，未来蓝帆医疗将继续坚持创新，本着为中国和海外患 者带来更多更好医疗器械产品的原则，用更加贴合临床应用和治疗需求的产品和切实的努力践行"做医 疗健康中国创造，为人类生命保驾护航"的使命。 近日，蓝帆医疗（002382）（002382.SZ）心脑血管事业部旗下子公司吉威医疗研发的冠状动脉刻痕球 囊扩张导管——星痕 （国械注准20253032515）顺利通过中国国家药品监督管理局（NMPA）的审查， 正式获得NMPA医疗器械注册 ...

Core Insights - The biopharmaceutical industry in Hangzhou is rapidly advancing, with a focus on innovation in drug development and high-end medical devices, positioning itself as a national leader in the sector [5][11][12] Company Overview - Zhejiang Batai Medical Technology Co., Ltd. operates a modern production facility in the core area of "China Medical Port," producing over 2,000 drug balloons daily, which are crucial for vascular intervention surgeries [6][9] - Batai Medical has developed a breakthrough product, the "Matrix Super PTX™ constrained drug balloon," which is recognized as the second globally and the first in China, enhancing drug delivery precision and reducing vascular damage [8][9] Industry Development - Hangzhou's biopharmaceutical industry has reached a scale of "hundred billion output value and three hundred billion revenue," with 357 industrial enterprises, including 25 listed companies, contributing to high-quality development [5][11] - The city is recognized as a key player in the national biopharmaceutical industry, particularly in new drug research and digital healthcare, while still facing challenges compared to cities like Shanghai and Beijing [11][12] Innovation and Policy Support - Continuous investment in R&D is essential for companies in the biopharmaceutical sector, with Batai Medical emphasizing the importance of innovation and product upgrades to maintain competitiveness [7][10] - The local government has implemented supportive policies, including financial subsidies and measures to accelerate the development of the biopharmaceutical industry, fostering an environment conducive to innovation [8][13][14] Future Outlook - Batai Medical aims to enhance its capabilities by overcoming key technological challenges and expanding its product line, while also seeking to strengthen its market presence both domestically and internationally [10][12] - Hangzhou's biopharmaceutical industry is set to achieve ambitious goals by 2026, including the cultivation of multiple billion-dollar enterprises and a significant increase in listed companies [14]

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 ...

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]

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].

Core Viewpoint - The medical device sector is experiencing a recovery with significant stock price increases, particularly in the medical device index ETF, driven by policy optimization and innovation breakthroughs [1][4]. Group 1: Market Performance - The medical device index ETF (159898) saw a 1.28% increase, with notable gains from stocks such as Innotec (+6.70%), Hotgen Biotech, and Meilan Medical (both over +4%) [1]. - The ETF's trading volume was 8.34 billion, with a turnover rate of 0.78% [2]. Group 2: Industry Trends - The industry is shifting from "valuation compression" to "differentiation recovery," with investment logic transitioning from "beta rebound" to "alpha exploration" [2]. - The National Healthcare Security Administration (NHSA) has introduced principles focusing on clinical stability, quality assurance, and cost-effectiveness, leading to a more moderate price reduction trend [3]. Group 3: Innovation and Globalization - Domestic medical devices are moving from mere replacement to achieving global innovation leadership, with accelerated product approvals and commercialization [3]. - Companies are expanding internationally through local partnerships, acquisitions, and establishing manufacturing facilities, creating a second growth curve [3]. Group 4: Valuation and Restructuring - The medical device index ETF tracks the CSI All-Share Medical Device Index, focusing on leading companies in the ChiNext and STAR Market, which together account for over 80% of the index [4]. - The sector is expected to see a revaluation as domestic production rates increase and long-term policy environments improve, highlighting the value of innovative products [4].

Group 1: Industry Overview - The high-value consumables industry is undergoing significant value reconstruction due to multiple policy influences, including volume-based procurement and healthcare cost control, with a key window for value reconstruction expected in 2025 [1] - The industry is shifting from a "price game" to a "value return," with innovative products that demonstrate real clinical differentiation likely to receive reasonable premiums [1] Group 2: Innovation and Competitiveness - Domestic medical devices are transitioning from domestic substitution to entering the "global innovation" tier, with accelerated approval and commercialization of innovative devices [2] - Companies are leading trends in various medical fields, such as cardiovascular interventions and structural heart disease, with significant advancements in product offerings [2] Group 3: Global Expansion - Companies are accelerating their global presence, moving from "trade export" to "ecosystem export," with overseas revenue becoming a core growth engine [3] - Notable growth in overseas revenue has been reported, with some companies achieving over 40% of their revenue from international markets [3] Group 4: Mergers and Acquisitions - Restructuring and mergers are driving value reassessment, with leading companies optimizing their business structures through asset restructuring and cross-industry expansion [4] - Companies are focusing on continuous innovation and internationalization, with strategic acquisitions enhancing their market positions [4] Group 5: IVD Industry Dynamics - The IVD industry is facing pressures from rising costs and is expected to see increased concentration, with overseas markets becoming essential for growth [5] - Significant growth in overseas revenue has been observed, with some companies reporting over 21% growth in international sales [5] Group 6: Strategic Transformations - Companies like Shengxiang Bio are exemplifying strategic transformations through acquisitions and diversification into new markets [7] - The focus on integrating diagnostics and treatment is becoming a trend among companies aiming for comprehensive healthcare solutions [7] Group 7: Innovation and Efficiency - Continuous high R&D investment is driving product innovation, with companies launching advanced products to capture the high-end hospital market [8] - AI applications are enhancing operational efficiency within the industry, indicating a trend towards technological integration [8]

Core Insights - The 37th TCT conference revealed that drug-coated balloons are non-inferior to the latest drug-eluting stents, showcasing a significant advancement in cardiovascular treatment options [2][3] Group 1: Research Findings - Cordis's Selution SLR drug-coated balloon demonstrated efficacy in treating coronary artery lesions and in-stent restenosis, comparable to traditional stent implantation [2] - The unique drug release technology of Selution SLR, featuring a micro-reservoir and proprietary phospholipid coating, addresses previous limitations in drug delivery [3] Group 2: Market Trends - In 2023, China saw 1.63 million percutaneous coronary interventions, with drug-coated balloons accounting for 18.5% of the procedures, indicating a growing market potential [3] - The domestic market for drug-coated balloons is increasingly competitive, with local companies like Lepu, MicroPort, and Xianruida gaining market share [3][4] Group 3: Competitive Landscape - Bluetide Medical has emerged as a leader in the drug-coated balloon sector, being the first Chinese company to successfully develop a rapamycin-based drug balloon, the Baiteng TMBA9, which has received dual indications [4][5] - The Baiteng TMBA9 balloon has expanded to 50 specifications, catering to various clinical needs [5] Group 4: Sales and Growth - Bluetide Medical reported a 300% year-on-year increase in sales of its drug-coated balloon products in the first half of the year, covering 28 provinces in China [6] - The upcoming national procurement of drug-coated balloons is expected to enhance Bluetide Medical's market position due to its historical usage data [6] Group 5: Business Strategy - Bluetide Medical's cardiovascular division generated over 1 billion yuan in revenue in the first three quarters of 2025, reflecting a 20% growth [7] - The company has a comprehensive product line that includes various interventional devices, enhancing its competitive edge in the market [8] Group 6: Innovation and Development - Bluetide Medical holds nearly 400 patents and has around 30 products in development, indicating a strong focus on innovation [8] - The company is pursuing a dual strategy of self-research and agency partnerships to expand its market presence both domestically and internationally [8]