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]

Financial Performance - The company achieved revenue of approximately RMB 1,303.7 million for the year ended December 31, 2024, representing an increase of 2.9% compared to RMB 1,267.2 million in 2023[10] - Gross profit for the same period was approximately RMB 981.4 million, a decrease of 1.4% from RMB 995.6 million in 2023[10] - The company's net profit attributable to shareholders was approximately RMB 222.4 million, down 15.5% from RMB 263.2 million in 2023[10] - The company reported a significant decrease in operating profit of 51.4%, from RMB 383.3 million in 2023 to RMB 186.3 million in 2024[7] - The company's net profit for the fiscal year was approximately RMB 168.5 million, up approximately 56.7% from RMB 107.5 million in the previous year, primarily due to a decrease in fair value losses related to financial liabilities[19] - The company's profit attributable to owners was approximately RMB 222.4 million, a decrease of about 15.5% from RMB 263.2 million in the previous year, mainly due to a reduction in other income and an increase in share-based payment expenses[20] - Other income, expenses, gains, and losses decreased significantly from approximately RMB 99.3 million to about RMB 15.1 million, primarily due to increased impairment losses on certain suspended development projects[33] - Operating profit decreased by approximately 51.4% to about RMB 186.3 million from RMB 383.3 million in the previous year[41] - The total employee cost for the year is approximately RMB 467.9 million, an increase from RMB 379.8 million in 2023[70] Assets and Liabilities - Total assets increased to RMB 4,900.4 million in 2024, up from RMB 4,696.4 million in 2023[8] - The company's total liabilities rose to RMB 1,424.9 million in 2024, compared to RMB 1,372.4 million in 2023[8] - The company's equity attributable to owners was approximately RMB 222.4 million for the year ended December 31, 2024, down approximately 15.5% from RMB 263.2 million in 2023[47] - Total current assets as of December 31, 2024, were approximately RMB 2,334.2 million, compared to RMB 2,231.1 million in 2023, reflecting an increase of about 4.6%[50] - Cash and cash equivalents decreased by approximately 32.0% to RMB 665.8 million as of December 31, 2024, from RMB 979.3 million in 2023[51] - The company had no bank borrowings as of December 31, 2024, resulting in a debt-to-equity ratio of zero[52] - The total equity attributable to owners was approximately RMB 3,494.5 million as of December 31, 2024, compared to RMB 3,370.2 million in 2023[53] Research and Development - The company has submitted 321 patent applications and registered 161 patents as of December 31, 2024, with a cumulative total of 2,426 patent applications submitted and 1,089 registered patents[25] - Research and development expenses increased by approximately 1.7% to about RMB 302.9 million, while capitalized development expenditures were approximately RMB 144.9 million[39] - The company plans to increase R&D investment, focusing on new materials and technologies to drive product innovation and expand production lines[74] - The company continues to strengthen its innovation capabilities and accelerate product development to maintain its leading position in the industry[23] Market Expansion and Sales - The company has accelerated its international market expansion while consolidating its leading position in the domestic market[11] - Domestic sales decreased by approximately 3.5%, while overseas sales increased by approximately 26.0%, driven by the company's active expansion of overseas business and effective marketing strategies[19] - Revenue from the structural heart disease business was approximately RMB 527.6 million, representing a growth of about 6.4% from RMB 495.7 million in the previous year[28] - Revenue from the peripheral vascular business was approximately RMB 751.1 million, an increase of about 6.2% from RMB 707.1 million year-on-year[29] - Revenue from Europe accounts for approximately 10.1% of total revenue, up from 8.8% in 2023[62] Corporate Governance - The company is committed to maintaining high standards of corporate governance and transparency in its operations[89] - The company has adopted corporate governance principles and confirmed compliance with the corporate governance code throughout the year ending December 31, 2024, with a deviation noted in section C.2.1 regarding the dual role of the Chairman and CEO[90] - The board consists of three executive directors, one non-executive director, and three independent non-executive directors, with changes noted as of December 31, 2024[92] - The company has established internal guidelines requiring board approval for significant matters, ensuring clear directives for management's authority[95] - The independent non-executive directors have confirmed their independence in accordance with the listing rules, with re-election pending for those serving over nine years at the upcoming annual general meeting[96] - The company has implemented a strict code of conduct for directors regarding securities trading, with no violations reported for the year ending December 31, 2024[91] - The board is committed to reviewing and enhancing corporate governance practices to meet the rising expectations of shareholders and investors[90] Shareholder Engagement - The annual general meeting provides shareholders the opportunity to engage directly with the board regarding the company's performance and operations[145] - The company maintains a high level of transparency and regularly communicates with institutional investors and analysts[142] - Shareholders can submit inquiries and proposals to the company, ensuring their voices are heard[140] - The board has reviewed the effectiveness of the shareholder communication policy for the year ending December 31, 2024[143] Compliance and Risk Management - The company has established a comprehensive internal audit function and risk management system to ensure compliance with legal and regulatory requirements[110] - The audit committee is responsible for reviewing the independence and effectiveness of external auditors and monitoring the integrity of financial statements[110] - The company has implemented formal policies and procedures regarding the authorization and use of group assets, ensuring accountability among qualified employees[130] - A comprehensive whistleblowing policy has been established, encouraging reports of illegal or unethical behavior, with a clear process for handling such reports[131] Employee and Director Compensation - The company has a compensation policy that considers operational performance, individual performance, and market practices for its directors and senior management[175] - The remuneration committee approved the grant of 174,750,000 share options under the company's share option plan as a reward for eligible participants, aimed at incentivizing continued contributions to the group's business growth[117] - The executive director's salary ranges from RMB 8,500,001 to RMB 9,000,000 for one individual and from RMB 10,500,001 to RMB 11,000,000 for another[176] - The independent non-executive directors have confirmed their independence according to the listing rules[178] Stock Options and Incentives - The stock option plan was adopted on October 22, 2011, and was amended on May 5, 2015, with a new plan effective from September 17, 2021, for a duration of ten years[185][186] - The total number of options that may be issued under the share option plan is capped at 462,929,240 shares, which is 10% of the company's issued share capital as of September 17, 2021[188] - The stock options granted to employees include 155,920,000 options, with 60,847,600 options remaining unexercised as of December 31, 2024[195] - The performance vesting schedule for the options includes percentages of 15%, 15%, 20%, 25%, and 25% over the years 2024 to 2028[199] Future Strategies - The company is actively seeking investment and collaboration opportunities with companies that have strong market potential to broaden its business scope in the global medical device industry[75] - The company aims to diversify its business strategy to expand revenue sources and reduce business risks while maintaining operational stability[74] - Future strategies include leveraging the expertise of the board to navigate market trends and enhance competitive positioning[82][84][85][86]

Core Points - The China Securities Hong Kong Stock Connect Medical Comprehensive Index (932271) opened at 1310.24 points, showing a decline of 15.51% over the past month, an increase of 7.01% over the past three months, and a year-to-date increase of 1.58% [1] - The index is compiled based on the classification standards of the China Securities Index, reflecting the overall performance of different industry securities within the Hong Kong Stock Connect [1] - The top ten holdings of the index include Alibaba Health (14.23%), JD Health (14.01%), Sinopharm (12.15%), Weigao Group (7.98%), MicroPort Medical (5.06%), Ping An Good Doctor (4.48%), Shanghai Pharmaceuticals (4.05%), Jinxin Fertility (3.72%), Xianjian Technology (3.29%), and MicroPort Robotics-B (3.28%) [1] Industry Composition - The index's holdings are entirely from the Hong Kong Stock Exchange, with the pharmaceutical commercial sector accounting for 46.78%, medical services for 24.51%, medical consumables for 24.08%, medical devices for 3.70%, and in vitro diagnostics for 0.92% [2] - The index samples are adjusted biannually, with adjustments occurring on the next trading day after the second Friday of June and December each year [2] - Weight factors are generally fixed until the next scheduled adjustment, with provisions for temporary adjustments in case of special events affecting the index sample [2]