风险提示 投资建议 我们预计公司2025-2027 年营业收入有望分别实现14.03/15.28/17.36亿元，同比增长8%/9%/14%；归母净 利润分别实现3.16/3.88/5.26 亿元，同比增长42%/23%/35%；对应EPS 为0.07/0.08/0.11 元；对应PE 倍数 为31/25/19x。看好公司长期深耕血管介入领域的行业地位和极强产品力，看好国内部分产品困境反转 及国际化业务快速增长的潜力。 首次覆盖，给予"买入"评级。 机构：华安证券 研究员：谭国超/钱琨 结构心+外周介入领军企业，有望合作多个外延 BD项目公司是结构心+外周介入高值耗材领域的领军企 业，公司目前主营业务呈现"3+N"业务布局，分3 大产品线和N 个战略合作业务：三大产品线分别是结 构性心脏病业务，外周血管介入和起搏电生理业务，战略合作业务是指公司未来2-3 年有望战略合作及 增资多个BD 项目，以此拓展公司产品版图。根据2024 年年报，公司营业收入实现13.04 亿元，同比增 长2.88%，是国内为数不多的高值耗材收入体量达到10 亿元的头部企业之一。截至2024 年12 月31 日， 公司已实现高质量专利布 ...

[Table_StockNameRptType] 先健科技（01302） 港股公司覆盖 执业证书号：S0010521120002 邮箱：tangc@hazq.com [分析师： Table_Author] 钱琨 执业证书号：S0010524110002 邮箱：qiankun@hazq.com [Table_CompanyReport] 相关报告 主要观点： 结构心+外周介入领军企业，国际化业务加速 [Table_Rank] 投资评级：买入 首次覆盖 报告日期： 2025-07-31 [收盘价（港元） Table_BaseData] 2.12 近 12 个月最高/最低（港元） 2.15/1.24 总股本（百万股） 4,632 流通股本（百万股） 4,632 流通股比例（%） 100.00 总市值（亿港元） 98 [公司价格与恒生指数走势比较 Table_Chart] -18% 1% 21% 40% 59% 7/24 10/24 1/25 4/25 先健科技 恒生指数 [Table_Author] 分析师：谭国超 ⚫[Table_Summary] 结构心+外周介入领军企业，有望合作多个外延 BD 项目 公司是结构 ...

继2024年8月， 乐普心泰医疗旗下上海形状记忆合金材料有限公司 自主研发的 MemoSorb ® 生物可降解房间隔缺损封堵器 获国家药监局（NMPA）注册批 准，成为 全球首款我国自主研发的生物可降解封堵器 ，标志着我国在结构性心脏病介入治疗可降解领域取得重大突破之后，锦葵医疗于本次申报的可降解房 间隔缺损封堵器正式进入创新通道，则有望为我国该领域自主可控、高端创新格局再添新力。 # 研发背景 2025年7月2日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第6号），有 14款产品 进入创新通道。 其中包括 上海锦葵医疗器械股份有限公司 （简称" 锦葵医疗 "）申请的 可降解房间隔缺损封堵器 。 房间隔缺损（ASD） 常被描述为 "心脏上的一个洞" ，是指左心房和右心房之间的心脏隔膜上的一个开口。 ASD 是临床上常见的先天性心脏缺陷， 约占所有先天性心脏病的10% ，发病率在小儿先天性心脏病中排第二位，占成人先天性心脏病的20%-30%， 是成 年人中最常见的先天性心脏病 。 当需要关闭 ASD 时，目前的治疗标准是 植入房间隔封堵器 。 房间隔缺损封堵器是一种专门设计用来治疗房间隔缺损 ...

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, highlighting innovative drugs and left-side sector recovery as the main investment opportunities [4][44]. Core Insights - The innovative drug sector remains in a high prosperity state, with significant collaborations continuing to emerge. The upcoming 85th American Diabetes Association (ADA) Scientific Sessions in June 2025 is expected to provide important clinical and research updates from endocrine and metabolic drug companies, suggesting investment opportunities in this area [11][44]. - The report emphasizes the increasing approval and quality of new drugs in China, indicating a recovery in the innovative drug sector that has been undervalued for several years. The global recognition of China's technological capabilities is also drawing renewed attention from capital markets towards domestic pharmaceutical companies [27][44]. - The report suggests focusing on leading companies with international expansion and innovation progress, such as Heng Rui Medicine, BeiGene, Innovent Biologics, and others, as well as ADC leaders like Keren Pharmaceutical and Bai Li Tianheng [27][44]. Summary by Sections Pharmaceutical Sector - UroGen Pharma's FDA approval of Zusduri, the first and only drug for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, marks a significant breakthrough in drug delivery systems [20][21]. - The report highlights the progress in chronic disease metabolism, with Eli Lilly's oral Lp(a) lowering drug being considered for breakthrough therapy designation, indicating a growing pipeline of innovative treatments [23][27]. - Merck's oral PCSK9 inhibitor Enlicitide has shown positive results in Phase III trials, representing a significant advancement in cholesterol management therapies [28][29]. Medical Devices - The launch of the MAGLUMI X10, a high-speed automated chemiluminescence immunoassay analyzer, reflects the increasing demand for innovative medical devices in China [33][35]. - The investment by Xianjian Technology in Jianhu Medical to develop electrophysiology products indicates a strategic move to enhance capabilities in high-end medical devices [36][38]. Medical Services - The successful initiation of China's first invasive brain-computer interface clinical trial signifies a major advancement in medical technology, with potential applications for improving the quality of life for patients with spinal cord injuries and amputations [39][40]. - The report anticipates rapid growth in related industries, including high-end imaging equipment and surgical robots, driven by technological advancements and policy support [40]. Traditional Chinese Medicine - The approval of Fangsheng Pharmaceutical's innovative traditional Chinese medicine product marks a significant step in the development of new drugs in this sector, with an expected increase in new drug applications in the coming years [41][43].

Q&A 先健科技为何选择剑虎医疗科技作为合作对象，并且剑虎医疗科技的电生理 3D 标测系统和脉冲电场消融技术有哪些优势？ 先健科技选择剑虎医疗科技作为合作对象，主要基于两方面的考虑。首先，剑 虎医疗科技在电生理领域拥有独特的技术优势。它是全球唯一一家同时拥有电 极方式进行 3D 标测系统和纳秒级脉冲消融系统（PFA）的企业。这种技术组 合使其在市场上具备显著竞争力。其次，市场前景广阔。根据沙利文及其他专 业机构预测，到 2032 年，中国电生理市场规模将接近 420 亿人民币，复合年 增长率为 18.5%。特别是 PFA 市场，到 2025 年预计达到 13 亿人民币，到 2032 年将增长至 163 亿人民币，复合年增长率为 43.7%。 剑虎医疗科技的 3D 标测系统与主流的电磁标测系统相比，其优势主要体现在精确度和安全性上。 这种技术能够更精准地定位心脏异常区域，提高手术成功率。同时，其纳秒级 脉冲消融技术（PFA）利用高压脉冲电场选择性消融心肌细胞，不仅安全性更 高，而且手术时间更短，这些都使得其产品在临床应用中表现优异。此外，剑 虎医疗已被纳入创新医疗器械特别审查程序，这进一步证明了其技术领先性和 ...

Industry Overview - Innovative medical devices refer to new medical equipment with core technology patents, internationally leading technology levels, and significant clinical application value, such as AI-assisted diagnostic devices, 3D-printed implants, and gene testing instruments [2][5] - The development process for innovative medical devices in China typically takes about 5-8 years, including R&D, clinical trials, and regulatory approval [2] - The number of approved innovative medical devices in China has been increasing, with 65 approved in 2024 and 34 in the first four months of 2025 [1][5] Market Status - The medical device industry is a crucial pillar of the modern healthcare system, with significant strategic importance and growth potential [5] - The Chinese government has implemented various policies to encourage innovation and the domestic production of high-end medical devices, leading to rapid industry development [5][7] Enterprise Landscape - The competitive landscape of the innovative medical device industry in China is still in the R&D investment phase, resulting in a low market concentration with over 200 approved production enterprises [11] - Leading companies in the innovative medical device sector include Beijing Pinchi Medical Equipment Co., Ltd., Shenzhen Xianjian Technology Co., Ltd., and Shanghai United Imaging Healthcare Co., Ltd., among others [12][11] Future Trends - The integration of artificial intelligence and the Internet of Things is accelerating in the medical device field, enhancing diagnostic efficiency and accuracy [16] - Domestic companies are rapidly advancing in high-end medical equipment and consumables, with increasing market share for products like vascular stents and artificial joints [17] - Chinese innovative medical device companies are actively expanding into overseas markets through technology licensing and cross-border cooperation [18]

图：Ankura Plus主体支架和CSkirt裙边分支支架 中国医工原创 定义原位开窗技术新标准 2025年5月14日，由国家心血管病中心、中国医学科学院阜外医院舒畅教授领衔，与先健科技 (01302.HK)联合研发的主动脉原位开窗分支重建创新产品矩阵，成功获得国家药品监督管理局(NMPA) 批准，重磅上市。为全球首创重建弓部分支的原位开窗(ISF)创新产品解决方案，填补了行业空白，定 义原位开窗技术新标准，推动主动脉腔内重建全面迈入精准化、规范化新时代! 该主动脉原位开窗分支重建创新产品矩阵由Ankura Plus 原位开窗分支重建主体支架和原位开窗自适应 防漏CSkirt裙边分支支架组成，结合复旦大学附属中山医院符伟国教授与先健联合研发的Futhrough 破 膜系统和Fustar 可调弯鞘，构建成了先健全球首创"三位一体"原位开窗分支重建一站式解决方案。不仅 为临床医生提供了前所未有的ISF技术专用解决方案，也为累及分支的主动脉病变患者带来了更优更丰 富的治疗新选择。 主动脉夹层和动脉瘤是危害极大的心血管疾病，因破裂风险高，常致严重出血甚至猝死。约2/3胸主动 脉夹层累及升主动脉与弓部，常需处理弓上分 ...

Core Viewpoint - The high-end medical device industry in Shenzhen is a significant indicator of national manufacturing capability and technological development, with a projected revenue of 200 billion yuan by 2025, highlighting its importance in the global medical device market [1]. Group 1: Industry Overview - Shenzhen's medical device output reached 99 billion yuan in 2023, accounting for approximately 10% of the national total, with exports also around 10% [1]. - The city is home to leading companies like Mindray Medical and BGI, which are recognized among the top 100 global medical device firms [1]. Group 2: Technological Advancements - The brain-computer interface technology developed by Shenzhen Ruihan Medical has shown significant promise in rehabilitation, with patients experiencing better recovery outcomes compared to traditional methods [2][3]. - Ruihan Medical's brain-computer interface rehabilitation robot system is the first commercialized product of its kind globally, with over 100 patents and a focus on practical application [3]. Group 3: Collaborative Innovation - The National High-Performance Medical Device Innovation Center in Shenzhen is addressing core technological challenges in the medical device sector through collaborative projects with key enterprises [6][7]. - The center has successfully developed a 5.0T whole-body MRI system, marking a significant breakthrough in high-field MRI technology [6]. Group 4: Market Dynamics - The medical device industry in Shenzhen is characterized by a "chain development" model, where breakthroughs in technology stimulate growth across the entire supply chain [8]. - Companies like Mindray Medical and Libang Instruments have successfully disrupted international monopolies in their respective fields, leading to increased domestic production capabilities [9][10]. Group 5: Spatial and Policy Support - Shenzhen's medical device industry faces challenges such as limited industrial space, prompting local governments to create favorable conditions for business growth [11][12]. - The city has introduced comprehensive support measures for the medical and pharmaceutical sectors, aiming to solidify its position as a leading hub for medical device innovation [13].

Core Viewpoint - The announcement highlights the approval of the aortic arch stent system by the National Medical Products Administration of China, marking a significant advancement in the treatment of Stanford type B aortic dissection patients through innovative technology [1][2] Group 1: Product Approval and Features - The aortic arch stent system is the first of its kind approved for the specific use of windowing technology in aortic arch branch reconstruction, aimed at treating Stanford type B aortic dissection [1] - The system consists of the AnkuraTM Plus aortic arch main stent system and the CSkirtTM aortic arch branch stent system, which entered the "Special Review Procedure for Innovative Medical Devices" in 2022 [1] - Clinical research involving 120 participants demonstrated a technical success rate of 97.5% during surgery, a branch vessel patency rate of 99.1% after one year, and a low type III endoleak occurrence rate of only 1.8% [1] Group 2: Technological and Market Implications - Windowing technology is recognized as a mainstream technique for reconstructing aortic arch branches in thoracic endovascular aortic repair (TEVAR), with international guidelines recommending its use for patients with insufficient anchoring zones or affected left subclavian arteries [2] - The company holds independent intellectual property rights for the product, which is expected to provide a complete, safe, and effective endovascular treatment solution for aortic dissection involving the aortic arch [2] - The product's market approval enhances the company's product portfolio in the peripheral vascular intervention field, aiming to offer a more flexible, comprehensive, and user-friendly solution for aortic arch endovascular reconstruction [2]

Group 1 - The defense and military industry sector in the A-share market experienced a significant surge, with the sector rising over 6% at one point during the trading session [2][4][5] - Notable stocks in the sector included Huaru Technology, which hit the daily limit up, and other companies like Aerospace South Lake and AVIC Chengfei, which saw substantial gains [6][8] - The overall A-share market showed strong performance, with major indices such as the Shanghai Composite Index and Shenzhen Component Index increasing by 0.37% and 1.06% respectively [4][5] Group 2 - In the Hong Kong stock market, the Hang Seng Index rose and surpassed the 23,000-point mark, with Dragon Power Technology experiencing a dramatic increase of over 50% during trading [11][12] - Dragon Power Technology announced a significant contract with Chuangneng New Energy, which is expected to generate over 5 billion RMB in sales from the supply of lithium iron phosphate materials from 2025 to 2029 [13]