Core Insights - The integration of high-tech medical devices such as AI medical devices, medical robots, and implantable medical devices is crucial for shaping new productive forces in the medical device industry [1] - In the first half of this year, China approved 43 innovative drugs and 45 innovative medical devices, marking year-on-year growth of 59% and 87% respectively, indicating that reform policy dividends are transforming into industrial development momentum [1] - The approval of innovative medical devices has reached a new high, with the National Medical Products Administration (NMPA) introducing 10 measures to optimize lifecycle supervision and support the innovation of high-end medical devices [1] Medical Device Innovation - Domestic innovative medical device companies are increasingly emerging, with Shenzhen Beixin Life Technology's peripheral IVUS (intravascular ultrasound) catheter breaking the monopoly of imported products, marking a breakthrough in China's peripheral vascular precision intervention [3] - The introduction of IVUS technology allows for clearer visualization of vascular conditions, addressing limitations of traditional DSA (digital subtraction angiography) methods [3] - The application of IVUS in peripheral vascular intervention is still limited due to product usability issues and insufficient training [3] Market Competition in High-End Medical Devices - The competition in the high-end innovative medical device sector is intensifying, particularly in the field of cardiac pulsed field ablation (PFA), which has seen multiple domestic PFA products approved recently [5] - PFA technology is primarily used for atrial fibrillation treatment and is expected to benefit patients with difficult-to-treat conditions [5] - Major global players like Johnson & Johnson, Medtronic, Boston Scientific, and Abbott dominate over 85% of the electrophysiology market in China, while domestic companies are beginning to gain traction [5] Market Growth Projections - The Chinese cardiac electrophysiology surgery volume is expected to approach 500,000 cases by 2024, with the PFA market projected to reach 1.3 billion yuan by 2025 and grow to 16.3 billion yuan by 2032, reflecting a compound annual growth rate of 43.73% [6] Breakthroughs in Heart Valve Technology - The approval of Shanghai Huihe Medical's transcatheter tricuspid valve ring shaping system K-Clip marks the first domestic tricuspid valve medical device, filling a long-standing gap in the market [7] - There are over 1 million patients with severe tricuspid regurgitation in China, with nearly half potentially benefiting from new tricuspid valve devices [7] - The global market for tricuspid valve devices is expected to expand as more products receive regulatory approval [8] AI and Robotics in Healthcare - The integration of AI technology and robotics in healthcare is anticipated to create innovative opportunities, with the NMPA initiating a second batch of tasks for AI medical devices and biomedical materials [8] - AI models are empowering various aspects of the healthcare industry, from diagnostic assistance to personalized treatment plans and medical image analysis [9]

证券研究报告：医药生物|行业周报 发布时间：2025-06-23 行业投资评级 强于大市 |维持 | 行业基本情况 | | --- | | 收盘点位 | | 7552.12 | | --- | --- | --- | | 52 | 周最高 | 8490.25 | | 52 周最低 | | 6070.89 | 行业相对指数表现 2024-06 2024-09 2024-11 2025-01 2025-04 2025-06 -10% -6% -2% 2% 6% 10% 14% 18% 22% 26% 医药生物 沪深300 资料来源：聚源，中邮证券研究所 研究所 分析师:龙永茂 SAC 登记编号:S1340523110002 Email:longyongmao@cnpsec.com 研究助理:陈峻 SAC 登记编号:S1340123110013 Email:chenjun@cnpsec.com 近期研究报告 《创新药主题热度仍在升温，关注中药 创新药研发企业的投资机会》 - 2025.06.17 医药生物行业报告 （2025.06.16-2025.06.20） 强生公布 PFA 研究进展，2025 年国产 PFA ...

丨证券研究报告丨 公司研究丨点评报告丨怡合达（301029.SZ） [Table_Title] 怡合达：25Q1 盈利能力显著改善，行业结构更 趋均衡 报告要点 [Table_Summary] 公司发布 2024 年报及 2025 一季报，2024 年公司实现收入 25.04 亿元，同比-13.08%；归母 净利润 4.04 亿元，同比-25.87%；扣非归母净利润 3.98 亿元，同比-26.25%。25Q1 公司收入 6.20 亿元，同比+14.75%；归母净利润 1.22 亿元，同比+26.48%；扣非归母净利润 1.22 亿元， 同比+27.80%。25Q1 公司盈利能力显著改善，行业结构更趋均衡，基于公司传统业务优势持 续巩固，不断优化产品品类、推进业务全球化等新增长曲线，市占率有望持续提升。 分析师及联系人 [Table_Author] 赵智勇 曹小敏 SAC：S0490517110001 SAC：S0490521050001 SFC：BRP550 怡合达（301029.SZ） cjzqdt11111 1 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com ...

2025 年海外收入有望维持高速增长，27 省联盟集采续约有望于2H25启动。海外1Q25 手术量1,000+台 （同比双位数增长），其中约一半手术使用压力导管。海外业务中拉美市场增速最高。从收入角度，公 司预计全年海外增速仍将维持较高增速，但增速相较2024 年将有所放缓（2024 年海外收入同比 +52%）。国内1Q25 手术量5,000+台（同比个位数增长），其中约30%使用压力导管，目前公司进入了 约50 家在国内手术量排名前200 的手术中心，入院数量仍有进一步提升空间。 福建牵头的27 省联盟电生理集采续约有望于2H25 启动，预计中标价仍将有温和的下降压力。 关税战背景下，公司加快原材料国产化比例。公司2024 年原材料中进口比例约40%（vs 2022 年：约 60%），由美国进口原材料比例约10%（vs 2022 年：约30%），美国进口原材料比例并不高。公司目前 正在加快对美国进口原材料的替代，该部分原材料此前多有美国、中国两个供方，目前正逐步加大中国 供方比例。 研发管线顺利推进：1）PFA：参股的商阳医疗PFA 产品已于今年4 月获批，目前在挂网过程中；此 外，公司自研导管预计也将于2 ...

证券研究报告：医药生物|行业周报 发布时间：2025-04-28 行业投资评级 强于大市 |维持 | 行业基本情况 | | --- | | 收盘点位 | | 7199.79 | | --- | --- | --- | | 52 | 周最高 | 8490.25 | | 52 | 周最低 | 6070.89 | 行业相对指数表现 2024-04 2024-07 2024-09 2024-12 2025-02 2025-04 -20% -16% -12% -8% -4% 0% 4% 8% 12% 16% 医药生物 沪深300 资料来源：聚源，中邮证券研究所 研究所 分析师:蔡明子 SAC 登记编号:S1340523110001 Email:caimingzi@cnpsec.com 研究助理:陈峻 SAC 登记编号:S1340123110013 Email:chenjun@cnpsec.com 近期研究报告 《12 部门联合发布《促进健康消费专 项行动方案》，药店板块有望受益》 - 2025.04.21 医药生物行业报告 （2025.04.21-2025.04.27） 强生公布 PFA 研究进展，2025 年国产 P ...