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 ...

Core Viewpoint - Suzhou Jiecheng Medical Technology Co., Ltd.'s "Transcatheter Aortic Valve System" has received approval from the National Medical Products Administration for market launch, marking a significant advancement in innovative medical devices [1][4]. Company Summary - The "Transcatheter Aortic Valve System" is designed for trans-femoral access and features an active positioning clamp for native aortic valve leaflets, along with a bendable delivery system suitable for complex anatomical structures [4]. - This product is intended for patients over 70 years old who have symptomatic severe aortic regurgitation or aortic stenosis and are not suitable for conventional surgical valve replacement [4]. - The system consists of a transcatheter biological valve and a transcatheter delivery system, allowing for valve replacement through minimally invasive techniques without the need for open-heart surgery, significantly reducing surgical risks for elderly patients [4]. Industry Summary - The Jiangsu Provincial Medical Products Administration is implementing the national innovation-driven development strategy, focusing on optimizing the review and approval process for innovative medical devices [4]. - The administration aims to enhance the innovation service environment and improve pre-review mechanisms to address the challenges of long development cycles and high review requirements for Class III innovative medical devices [4]. - Emphasizing breakthroughs in core technologies and addressing critical technical challenges, the administration is committed to accelerating the market launch of innovative products and helping companies build competitive advantages in high-end medical devices [4].

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 ...

Core Insights - The AI Fund Ping An Medical Health Mixed A (003032) reported a profit of 352 million yuan for the first half of 2025, with a weighted average profit per fund share of 1.0034 yuan [2] - The fund's net value growth rate was 57.41% during the reporting period, with a total fund size of 966 million yuan as of the end of June [2] - The fund focuses on long-term investments in pharmaceutical and medical stocks, with a current unit net value of 3.103 yuan as of September 3 [2] Performance Metrics - As of September 3, the fund's one-year cumulative net value growth rate was 111.92%, ranking 5th out of 136 comparable funds [5] - The fund's three-month net value growth rate was 32.83%, ranking 29th out of 138 comparable funds [5] - The fund's three-year Sharpe ratio was 0.4698, ranking 15th out of 105 comparable funds [25] Investment Strategy - The fund manager emphasized the importance of sub-industry prosperity in investment strategy, focusing on companies with valuation advantages in the innovative drug sector [2] - The fund's top ten holdings include companies such as CloudTop New Medicine, Innovent Biologics, and BeiGene, indicating a concentrated investment approach [40] Valuation Metrics - As of June 30, 2025, the fund's weighted average price-to-earnings (P/E) ratio was approximately -202.85, compared to the industry average of 120.96 [9] - The weighted average price-to-book (P/B) ratio was about 7.89, while the industry average was 4.07 [9] - The weighted average price-to-sales (P/S) ratio was approximately 14.98, compared to the industry average of 6.52 [9] Growth Metrics - For the first half of 2025, the fund's weighted average revenue growth rate was 0.17%, while the weighted average net profit growth rate was -0.21% [16] - The fund's weighted annualized return on equity was -0.04% [16] Fund Composition - As of June 30, 2025, the fund had 24,900 holders, with a total of 395 million shares held [34] - Institutional investors held 64.36% of the fund's shares, while individual investors accounted for 35.64% [34] - The fund's turnover rate for the last six months was approximately 143.02%, consistently below the industry average [37]

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]

Core Viewpoint - 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 process for innovative medical devices, marking the sixteenth product of the company to enter this process [1][2] Product Overview - The PDA occluder is designed for interventional treatment of congenital heart PDA and is the first domestic product capable of dual-pathway release, allowing both "venous forward" and "arterial retrograde" approaches [2] - The product features an all-nickel titanium metal structure woven from nickel-titanium alloy wire, utilizing a self-expanding asymmetric double-disc design, which provides flexibility in choosing the implantation path based on patient conditions [2] - Compared to traditional forward pathways, the retrograde approach simplifies the operation, shortens surgery time, and offers better treatment options for patients with venous system contraindications [2] Clinical and Regulatory Progress - 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 and accelerate the product's market launch, benefiting PDA patients and expanding the company's product range in the medical device sector [2]