以下文章来源于Medtec医疗器械设计与制造 ，作者立即预登记 Medtec医疗器械设计与制造 . 2025年国际医疗器械设计与制造技术展览会专注于医疗级别原材料、高精密配件和加工技术与制造设备的展览会。将于2025年9月24-26日在上海世博展 览馆1&2号馆举办。网址：medtecchina.com 行业媒体、自媒体账号， 不限粉丝数量 ，均可使用。 报名方式 扫描下方二维码，填写登记信息（请写明媒体名称，9月23日前报名免费） 大会当天，到 上海世博展览馆 南北大厅观众注册台 4 号媒体通道 ，即可换取专属胸卡，自由进入会场。 展会概况｜ 2 0 2 5 M e d t e c C h i n a 医疗器械产品部件、医械创新材料、电子元件/组件、医疗管件及挤压加工产品、制造设备， 470+ 年度 首发新品 即将亮相在Medtec！ 2023年我国医疗器械工业市场规模达1.18万亿元，流通市场规模1.36万亿元，同比增长6.25%。2024年预计生产企业营收达1.35万亿 元，稳居全球第二大单体国家市场。 2018-2024年累计批准创新医疗器械608项，其中国产占比91.45%（556项），2024年同 ...

中国的创新医疗器械要获得全球市场的认可，挑战仍然很大。 今年中国创新生物药对外授权引发全球关注。相关数据显示，上半年创新药对外授权金额近660亿美 元，让全世界见证了中国生物医药的DeepSeek一刻。 为何创新器械授权难 微光医疗创始人CEO朱锐对第一财经记者表示："中国创新医疗器械目前还没有到爆发点，创新器械爆 发的路径与创新药有较大的差异。创新药把靶点改一下，就成了一个新的专利，但医疗器械的小创新仍 会涉及知识产权问题。" 不过在医疗器械领域，中国创新产品的DeepSeek一刻尚未来临。创新药的出海路径是否能在创新器械 领域重演，是业内热议的话题。 从模仿到创新 9月13日，在中国心血管医生创新俱乐部（CCI）成立十周年大会上，中国心血管创新医疗器械领头 人、中国科学院院士、复旦大学附属中山医院心内科主任葛均波教授表示，中国创新药对外授权如今已 经占据了全球的半壁江山，大量源自于中国的创新药获得了全球的认可，这也为中国创新医疗器械的发 展增添了信心，期待未来有更多的创新医疗器械能走向世界。 回顾过去十年CCI的发展，葛均波称，中国心血管介入医疗器械在很长一段时间内高度依赖进口，价格 高昂，我们最初是希望 ...

近期，苏州杰成医疗科技有限公司的"经导管主动脉瓣膜系统"第三类创新医疗（002173）器械通过国家 药监局审查，获批上市。 该产品为经股动脉入路，具有活动式定位件夹持原生主动脉瓣叶，可调弯输送系统适配横位心等复杂解 剖结构。适用于经心脏团队结合评分系统评估后认为患有有症状的、重度主动脉瓣膜关闭不全(重度主 动脉瓣反流)，或同时合并主动脉瓣狭窄，不适合进行常规外科手术置换瓣膜、年龄大于等于70岁的患 者。产品由经导管生物瓣膜和经导管输送系统组成，通过微创介入技术，无需开胸手术即可完成瓣膜置 换，显著降低了手术风险，为高龄、无法耐受传统外科手术的患者提供了全新的治疗选择。 苏州杰成医疗科技有限公司"经导管主动脉瓣膜系统" 江苏省药监局深入贯彻落实国家创新驱动发展战略，持续深化审评审批制度改革，紧密围绕国家药监局 关于审评重心前移的工作部署，针对第三类创新医疗器械研发周期长、审评要求高等现实难题，不断优 化创新服务环境，完善审评前置机制。聚焦核心技术突破和"卡脖子"技术攻关，省药监局坚持以临床价 值为导向，强化医疗器械源头创新，围绕"前端帮扶、全程提速"的工作思路，通过深化审批改革、加强 技术支撑、优化产业生态等措 ...

Core Viewpoint - The Chinese medical device industry faced a challenging yet opportunity-filled first half of 2025, with a decline in overall performance due to complex global macroeconomic conditions, despite signs of recovery in medical equipment procurement [1][2]. Industry Performance - In the first half of 2025, 131 A-share medical device companies reported a total revenue of 1188.17 billion yuan, a decrease of 4.29% from 1241.43 billion yuan in the previous year. Net profit fell by 17.17% to 188.12 billion yuan from 227.11 billion yuan [1]. - The in vitro diagnostics sector experienced significant downturns, with over 80% of companies reporting declining performance, including major players like Mindray Medical, which saw its first negative mid-year report since listing [1]. Growth Areas - Despite the overall decline, certain sectors such as orthopedics and cardiovascular devices showed rapid growth, with companies like Sanyou Medical and Dabo Medical achieving revenue growth rates exceeding 40% [1]. - The electrophysiology sector also performed well, with companies like Huitai Medical and Microelectrophysiology reporting net profit increases of 24.11% and 92.02%, respectively [4]. International Market Expansion - The overseas market has become a crucial growth path for leading companies, with significant revenue increases reported by companies like Ruimait and Yuyue Medical, which saw growth rates of 61.33% and 49.96% in international sales [2][9]. - A total of 89 companies reported overseas revenue of 332.47 billion yuan, marking an 8.2% increase compared to the same period in 2024 [9]. Future Outlook - There is a general expectation that the medical device industry will see a turning point in the second half of 2025, driven by improved demand and a recovery in procurement activities [13][14]. - The National Medical Products Administration reported a significant increase in the approval of innovative medical devices, with 45 new devices approved in the first half of 2025, reflecting a 87% year-on-year growth [14].

AI基金中海医疗保健主题股票A（399011）披露2025年半年报，上半年基金利润2829.74万元，加权平均基金份额本期利润0.0575元。报告期内，基金净值增 长率为5.62%，截至上半年末，基金规模为4.93亿元。 该基金属于标准股票型基金，长期投资于医药医疗股票。截至9月3日，单位净值为1.225元。基金经理是梁静静，目前管理的2只基金近一年均为正收益。其 中，截至9月3日，中海医药混合A近一年复权单位净值增长率最高，达41.83%；中海医疗保健主题股票A最低，为27.08%。 基金管理人在中期报告中表示，展望下半年，我们将重点关注创新医疗器械（耗材、设备）的终端需求变化。整体来看，医药行业基本面已见底。2018 年 到 2025 年，医药行业经历了集采、DRGS 推行、反腐、医院飞检等，价格体系持续下行，疫情期间还出现了产能过度扩张。企业在这一过程中，通过创新 产品升级、出海拓展新的增量市场，逐渐走出通缩，医药行业基本面下半年有望迎来彻底的拐点。 截至9月3日，中海医疗保健主题股票A近三个月复权单位净值增长率为7.55%，位于同类可比基金50/54；近半年复权单位净值增长率为18.13%，位于同类可 ...

AI基金平安医疗健康混合A（003032）披露2025年半年报，上半年基金利润3.52亿元，加权平均基金份额本期利润1.0034元。报告期内，基金净值增长率为 57.41%，截至上半年末，基金规模为9.66亿元。 该基金属于偏股混合型基金，长期投资于医药医疗股票。截至9月3日，单位净值为3.103元。基金经理是周思聪，目前管理4只基金。其中，截至9月3日，平 安核心优势混合A近一年复权单位净值增长率最高，达124.1%；平安医疗健康混合A最低，为111.92%。 基金管理人在中期报告中表示，本报告期内，以子行业的景气度为投资的重要策略，在商业模式、竞争力和业绩的多维度比较中寻找具有估值性价比的优秀 公司，重点布局了创新药方向。未来仍然看好以创新药、创新医疗器械为代表的成长型的医药子行业。 截至9月3日，平安医疗健康混合A近三个月复权单位净值增长率为32.83%，位于同类可比基金29/138；近半年复权单位净值增长率为67.74%，位于同类可比 基金15/138；近一年复权单位净值增长率为111.92%，位于同类可比基金5/136；近三年复权单位净值增长率为72.37%，位于同类可比基金7/108。 通过所选区 ...

Core Insights - The Chinese medical device industry faced challenges and opportunities in the first half of 2025, with a recovery in bidding for medical equipment not yet translating into improved company performance [1][3] - Overall performance of the industry remained under pressure due to complex global macroeconomic conditions, with a decline in revenue and net profit for A-share medical device companies [1][3] Financial Performance - In the first half of 2025, 131 A-share medical device companies reported total revenue of 1188.17 billion yuan, a decrease of 4.29% from 1241.43 billion yuan in the previous year [1] - Net profit for these companies fell to 188.12 billion yuan, down 17.17% from 227.11 billion yuan year-on-year [1] - Over 80% of companies in the in vitro diagnostics sector experienced a decline in performance due to factors like centralized procurement and medical insurance cost control [1] Sector Highlights - Despite overall declines, certain sectors like orthopedics and cardiovascular devices showed significant growth, with companies such as Sanyou Medical and Dabo Medical reporting revenue growth exceeding 40% [1][4] - Sanyou Medical achieved a remarkable net profit growth of 2083.64%, driven by acquisitions and recovery in domestic business [4] International Market Expansion - Overseas markets have become crucial for leading companies to overcome growth bottlenecks, with companies like Ruimai Te and Yuyue Medical reporting revenue growth of 61.33% and 49.96% respectively from international sales [2][7] - The international revenue for 89 companies reached 332.47 billion yuan, marking an 8.2% increase year-on-year [6] Future Outlook - The industry anticipates a turning point in the second half of 2025, with signs of demand recovery and improved bidding activity for medical devices [3][10] - The approval of innovative medical devices and drugs is on the rise, with 45 innovative medical devices approved in the first half of 2025, a year-on-year increase of 87% [12][13]

Investment Rating - The investment rating for the company is "Buy" (maintained) due to the recovery of domestic business and continuous breakthroughs in innovative products [5]. Core Views - The company reported a revenue of 6.016 billion yuan for the first half of 2025, representing a year-on-year increase of 12.79%, and a net profit attributable to shareholders of 999.8 million yuan, up 5.03% year-on-year [7]. - The domestic revenue reached 4.873 billion yuan, with a year-on-year growth of 10.74%, while overseas revenue was 1.142 billion yuan, growing by 22.48% year-on-year [7]. - The overall gross margin for the first half of 2025 was 47.93%, a decrease of 2.44 percentage points year-on-year, with service business gross margin remaining above 60% [7]. - The company is expected to achieve revenues of 12.604 billion yuan, 15.157 billion yuan, and 18.224 billion yuan for 2025, 2026, and 2027 respectively, with corresponding year-on-year growth rates of 22.37%, 20.25%, and 20.24% [6][7]. Financial Performance Summary - For 2025, the company is projected to have a net profit attributable to shareholders of 1.871 billion yuan, with a year-on-year growth of 48.26% [6]. - The earnings per share (EPS) for 2025 is estimated at 2.27 yuan, with a projected price-to-earnings (P/E) ratio of 65.57 [6][9]. - The company’s total market capitalization is approximately 122.67 billion yuan, with a closing price of 148.84 yuan [3].

Core Viewpoint - The article highlights the approval of two innovative medical devices in China, indicating a growing trend in the development and registration of advanced medical technologies in the country [2][5]. Group 1: Product Overview - The "TaminoVIA® Intracranial Aneurysm Assisting Embolization Stent" developed by Jiangsu Changyida Medical Technology Co., Ltd. is designed to assist in the treatment of intracranial aneurysms using spring coils [4]. - The "TwiFlow™ Pulmonary Artery Thrombectomy System" by Morning Star (Nantong) Medical Devices Co., Ltd. is aimed at treating pulmonary embolism, a critical cardiovascular condition with high morbidity and mortality rates [13][16]. Group 2: Clinical Value - The TaminoVIA® stent offers clinical advantages such as reduced vascular wall damage, improved neck closure effectiveness, and enhanced distal operability, potentially improving patient treatment experiences and outcomes [11]. - The TwiFlow™ system provides a direct, rapid, and low-complication risk solution for pulmonary embolism, which may enhance early survival rates and long-term quality of life for patients [21]. Group 3: Company Profiles - Jiangsu Changyida Medical Technology Co., Ltd. is a high-tech innovative enterprise integrating research, production, and marketing, focusing on neurointervention and neuroregulation treatments [12]. - Morning Star (Nantong) Medical Devices Co., Ltd. specializes in the research, production, and sales of cardiopulmonary interventional devices, having developed key products such as artificial heart valves and thrombectomy devices since its establishment in April 2021 [21].

Core Insights - The company has received formal notification from the National Medical Products Administration confirming that its nickel-titanium alloy patent ductus arteriosus (PDA) occluder has entered the special review procedure for innovative medical devices [1][2] - This product is the company's sixteenth to enter this special review process, indicating a strong pipeline of innovative medical devices [1][2] Product Details - The PDA occluder is designed for the interventional treatment of congenital heart PDA and features a full nickel-titanium metal structure that allows for both "venous forward" and "arterial retrograde" release paths [2] - The device is made from woven nickel-titanium alloy wire and employs a self-expanding asymmetric double-disc design, providing flexibility in implantation based on patient conditions [2] - Compared to traditional approaches, the retrograde access method simplifies the procedure, reduces operation time, and offers better treatment options for patients with venous system contraindications [2] Clinical and Market Implications - The company holds independent intellectual property rights for the product, and clinical trials for registration in China are progressing steadily [2] - The board believes that entering the special review process will shorten the registration timeline, accelerating the product's market launch [2] - The anticipated launch of the product is expected to benefit PDA patients and expand the company's product offerings, thereby promoting growth in the medical device sector [2]