集采中标成绩亮眼，国家全方位支持高端医疗器械2022 年以来，公司神经及外周介入产品涉及多轮集 采，品类包括弹簧圈、PTA 球囊、取栓支架、密网支架、静脉支架等。公司中标表现亮眼，渗透率提 升显著：2024 年外周支架国采，公司静脉支架A 组中标，髂总静脉适应证唯一首轮中标；2025 年河北 集采，公司密网支架、颅内球囊和外周球囊均中选。2025 年7 月，国家药监局《优化全生命周期监管支 持高端医疗器械创新发展有关举措》，聚焦优化特殊审批、注册审查、沟通指导、产业跟进、监管科研 及全球协调等；国家医保局明确集采"反内卷"，并陆续召开5 场创新药械系列座谈会，充分说明政策拐 点已至，国内集采规则优化、温和趋势明确，国家支持高端医疗器械创新，提升国际竞争力。 国际化业务蓄势待发，产品矩阵全面放量 机构：华安证券 研究员：谭国超/钱琨 事件： 2025 年8 月19 日，公司发布2025 年中期业绩。报告期内，公司实现营业收入4.82 亿元（+31.7%），毛 利3.43 亿元（+31.5%），毛利率71.2%（-0.1pct）；未经调整盈利1.21 亿元（+76.0%），经调整盈利 1.31 亿元（+68.1% ...

Group 1 - The medical device sector has gained significant attention, with 125 out of 131 companies in the A-share market experiencing stock price increases in the past month, and Sino Medical Science Technology Co., Ltd. achieving a remarkable stock price increase of 207.59% [1] - Institutional investors are actively researching the medical device industry, indicating a reassessment of growth potential in this sector [1] - The Chinese government has introduced supportive policies to accelerate the high-quality development of the medical device industry, aiming to transition from a major pharmaceutical country to a strong one [1] Group 2 - In July, the National Medical Products Administration released measures to support innovation in high-end medical devices, including medical robots and AI medical devices, highlighting the government's focus on high-end innovation [2] - The high-end medical device market in China is projected to grow rapidly, with an estimated market size of 2.8 trillion yuan by 2030, driven by technological advancements and domestic replacements [2] - The push for high-end innovation is expected to break the "low-end lock-in" in the medical device industry, enhancing the overall value and international competitiveness of the sector [2] Group 3 - Companies like Maide Medical Industrial Equipment Co., Ltd. are expanding their overseas channels through exhibitions and customer visits, with overseas orders expected to exceed 60 million yuan by the end of 2024 [3] - Anjies Medical Technology Co., Ltd. is deepening its global layout through localized operations and overseas production bases, successfully selling products to over 60 countries [3] - The global demand for medical devices is increasing, particularly in emerging markets, providing significant opportunities for Chinese medical device companies to expand internationally [3]

Group 1 - The A-share market experienced a significant rise followed by a pullback, indicating a potential exhaustion of the upward momentum [1] - The medical device sector saw a substantial increase due to government support for high-end medical device innovation across ten key areas [4] - The liquor sector, particularly leading brands like Moutai, faced a decline, suggesting a possible end to the recent rebound [6] Group 2 - The securities sector formed a doji candlestick pattern, indicating a balance between bullish and bearish forces at a high level [8] - The overall market environment remains one of risk and reward, emphasizing the importance of caution despite recent gains [8]

Core Insights - Tongxin Medical has successfully completed a strategic financing round exceeding 100 million USD, indicating strong market recognition of its strategic direction and global potential [1] - The funds raised will be primarily used to accelerate international expansion, continue product innovation, and enhance the domestic commercialization system [1] Company Overview - Founded in 2008, Tongxin Medical focuses on original innovation and technological breakthroughs, having developed China's first implantable ventricular assist device (CH-VAD) with complete independent intellectual property rights [1] - The CH-VAD was first implanted in a human by Academician Hu Shengshou from the Chinese Academy of Medical Sciences in June 2017, marking a significant milestone in the clinical application of durable VADs in China [1] - In November 2021, CH-VAD became the first domestically developed ventricular assist device approved for market entry in China, initiating the "artificial heart era" for the treatment of advanced heart failure [1] Investment and Market Position - Beijing Mentougou Zhuxin Fund highlighted Tongxin Medical's representation of international leading standards in the artificial heart field and its pioneering role in high-end medical device research and development in China [2] - Gao Rong Venture Capital noted that Tongxin Medical has successfully commercialized its all-magnetic levitation ventricular assist device in China and has initiated large-scale clinical trials in the U.S. with Medicare coverage, marking a significant recognition of its R&D capabilities [2] - Gao Ke Xinjun emphasized that Tongxin Medical is a leading company in the ventricular assist device sector in China, showcasing global competitiveness through technological breakthroughs and respect for clinical data [2] Future Outlook - The founder of Tongxin Medical, Dr. Chen Chen, stated that the company is advancing its global strategy and achieving key milestones in U.S. clinical trials, demonstrating its competitiveness in the international mainstream market [2] - The company aims to continue expanding the application boundaries of ventricular assist devices and lead technological development in the field on a global scale [2]

Core Viewpoint - The report highlights the performance and management of the Yongying CSI All-Share Medical Device ETF Fund for the second quarter of 2025, emphasizing its investment strategy, financial metrics, and market outlook for the medical device industry. Fund Overview - The fund aims to closely track the performance of the CSI All-Share Medical Device Index, with a total fund share of 470,599,906.92 as of the report date [1]. - The fund operates as an open-ended ETF and was established on November 22, 2021 [1]. Financial Performance - The net asset value (NAV) for the Yongying CSI All-Share Medical Device ETF Initiating Link A was 0.6086 RMB, with a net value growth rate of -0.26% during the reporting period [5]. - For the same period, the performance benchmark yielded a return of -0.89% [5]. - The NAV for the Yongying CSI All-Share Medical Device ETF Initiating Link C was 0.6043 RMB, with a net value growth rate of -0.31% [5]. Investment Strategy - The fund primarily employs an index investment strategy, investing in the target ETF to achieve close tracking of the benchmark index [5]. - The fund's investment strategy includes stock investment, bond investment, and asset-backed securities investment, among others [1]. Market Outlook - The medical device sector is expected to see significant performance improvements in the third quarter, driven by high growth rates in bidding data since November 2024 and supportive government policies for high-end medical devices [4]. - The integration of AI technologies in medical devices is anticipated to enhance innovation and market competitiveness [4]. Management Report - The fund management adheres to strict compliance with investment regulations and maintains a disciplined investment research and decision-making process [3]. - The management emphasizes fair trading practices and has not encountered any significant violations of fair trading during the reporting period [4]. Fund Share Changes - The total shares for Yongying CSI All-Share Medical Device ETF Initiating Link A increased from 131,880,539.89 to 133,505,066.16 during the reporting period [7]. - For Initiating Link C, shares rose from 328,466,280.74 to 337,094,840.76 [7]. Other Important Information - There were no single investors holding more than 20% of the fund shares during the reporting period [7].

Core Viewpoint - The pharmaceutical sector is experiencing a significant recovery after over three years of deep adjustment, with the innovative drug segment leading the way. The overall performance of the sector has outpaced the A-share market due to favorable news and policies supporting innovation in drugs and medical devices [3]. Policy Support for Medical Devices - The Chinese government has significantly increased policy support for the medical device sector in 2023, with a focus on high-end medical devices such as medical robots, advanced imaging equipment, AI medical devices, and new biological materials [4][5]. - The State Drug Administration's announcement in July 2025 outlines ten support measures for high-end medical device innovation, emphasizing a full lifecycle support approach [4]. - Local policies, such as those from Shenzhen, are also promoting the development of medical robots and AI-assisted diagnostic systems, creating a comprehensive support system for innovation, approval, market entry, and international expansion [5][6]. Market Growth and Trends - The Chinese medical device market has grown from 17.9 billion yuan in 2001 to 1.3 trillion yuan in 2022, representing a compound annual growth rate (CAGR) of over 20% [9]. - Projections indicate that the market will reach approximately 1.36 trillion yuan in 2024 and exceed 1.4 trillion yuan in 2025, potentially reaching 1.63 trillion yuan by 2030 [9]. - The domestic market has become the second largest globally, with its share increasing from 8% in 2010 to 25% in 2022 [9]. Domestic Device Replacement Demand - There is a growing demand for domestic medical devices to replace imports, supported by policies that aim for a 70% localization rate in county-level hospitals by 2025 and 95% by 2030 [9]. - Companies like United Imaging Healthcare have achieved over 30% market share in core categories such as CT and MRI, benefiting from policies that restrict EU imports [10][11]. Investment Opportunities in ETFs - There are 11 medical device-related ETFs with assets over 100 million yuan, with the Medical ETF (512170.SH) leading at 26.13 billion yuan [12]. - The performance of Hong Kong medical ETFs has outpaced A-share indices, indicating potential investment opportunities in this area [14]. - Investors are advised to choose ETFs based on their outlook for the industry, with options available for those focusing on innovative drugs or pure medical device investments [24].

Core Insights - The National Medical Products Administration of China emphasizes support for high-end medical device innovation, particularly in advanced medical imaging equipment, to address the growing global demand for cardiovascular disease treatment solutions [1] - Beixin Life, a domestic company focused on high-end medical device innovation, aims to develop high-performance interventional medical devices to tackle the significant public health issue of cardiovascular diseases [1][3] - The company has successfully developed and commercialized proprietary high-performance diagnostic equipment, contributing to the advancement of domestic high-end medical devices [1][3] Industry Overview - Coronary heart disease is recognized as a major health threat globally, with cardiovascular diseases being the leading cause of death in China [2] - China has the highest annual volume of percutaneous coronary intervention (PCI) procedures, with a trend towards precision treatment guided by advanced coronary functional and imaging technologies [2] - The reliance on imported devices and materials has historically dominated the market due to high R&D barriers and long return cycles [2] Company Achievements - Since its establishment in 2015, Beixin Life has developed a series of intelligent cardiovascular interventional solutions, including the first domestically approved IVUS and FFR systems [3][4] - The company has obtained over 20 Class III medical device registrations and successfully launched 11 products [3] - Beixin Life is the only domestic company with the technology to develop and manufacture 60MHz high-frequency micro-ultrasound transducers and MEMS pressure sensor modules [4] Market Potential - The cardiovascular device market is the second largest globally and is expected to grow rapidly over the next decade, with a significant patient population for coronary heart disease [7] - The number of PCI procedures in China is projected to increase from 1.906 million in 2024 to 4.298 million by 2030, with a compound annual growth rate of approximately 14.5% [7] - The precision PCI market in China is expected to grow from 2.04 billion yuan in 2022 to 9.42 billion yuan by 2030, with a compound annual growth rate exceeding 20% [7] Competitive Position - Beixin Life's FFR product captured 30.6% of the domestic market share shortly after its launch, while its IVUS product became the leading domestic option, reducing reliance on imports [8] - The company has successfully expanded its products to international markets, receiving positive feedback and achieving routine clinical use in multiple countries [8] - Beixin Life aims to enhance the synergy of its product system and adapt to international markets, thereby improving the global competitiveness of China's high-performance medical device industry [9]

Group 1 - The core viewpoint of the news highlights the support for innovation in the medical device industry, with significant funding and regulatory approvals driving growth [1][2] - Chengdu High-tech Zone Medical Device Innovation and Transformation Association assisted a startup in obtaining a credit line in the millions from Chengdu Bank, aimed at expanding production lines and technology research [1] - The National Medical Products Administration (NMPA) reported that 45 innovative medical devices were approved in the first half of 2025, representing a year-on-year increase of 87%, indicating ongoing policy benefits for industry innovation [1] Group 2 - Everbright Securities pointed out that the NMPA's announcement supports the innovation of high-end medical devices, including medical robots, advanced imaging equipment, AI medical devices, and new biomaterials [2] - The document emphasizes the expectation of faster commercialization of innovative medical devices under policy support, with a comprehensive standard system gradually being established for product design, production quality control, and post-market supervision [2] - The document also supports the international development of high-end medical device companies, which is expected to promote standardization and internationalization in the industry, benefiting leading companies with strong R&D capabilities and scalable products [2]

Core Viewpoint - The article emphasizes the Chinese government's commitment to enhancing pharmaceutical innovation and development, focusing on the integration of research, industry, and education to improve healthcare outcomes and support the construction of a healthy China [2][3]. Group 1: Pharmaceutical Innovation - Liu Guozhong, a member of the Political Bureau of the CPC Central Committee, highlighted the importance of strengthening basic research and technological innovation in the pharmaceutical sector to support the development of innovative drugs and medical devices [2][3]. - The article notes that China's pharmaceutical innovation has shown positive trends, with significant improvements in research capabilities, market competitiveness, and innovation vitality [3]. - There is a call for deep integration of industry, academia, and research institutions to enhance the level of pharmaceutical technology innovation, particularly in drug, vaccine, and medical device development [3]. Group 2: Regulatory Support - The National Medical Products Administration (NMPA) announced measures to optimize the clinical trial review and approval process for innovative drugs, aiming to complete reviews within 30 working days for eligible applications [4]. - The NMPA is also focusing on high-end medical device innovation, with a new initiative to support the development of advanced medical technologies, including medical robots and AI medical devices [5]. - The article outlines ten specific measures to enhance the regulatory framework for high-end medical devices, including optimizing approval processes and improving post-market surveillance [5]. Group 3: Future Directions - The NMPA plans to release the new measures soon and will coordinate efforts to ensure the successful implementation of these initiatives [6]. - The government aims to expand international cooperation in pharmaceutical technology and enhance the role of commercial health insurance in supporting innovative drug financing and usage [2][3].

Group 1: Market Performance - The Hang Seng Healthcare Index (HSHCI) decreased by 0.18% as of July 10, 2025, with mixed performance among constituent stocks [3] - Major gainers included Giant Bio (02367) up 4.24%, Yaoshi Bang (09885) up 4.13%, and Dongyangguang Changjiang Pharmaceutical (01558) up 3.48% [3] - The Hang Seng Healthcare ETF (513060) fell by 0.17%, with a latest price of 0.58 yuan, but saw a 2.48% increase over the past week [3] Group 2: Regulatory Developments - The National Medical Products Administration (NMPA) announced measures to optimize lifecycle regulation to support high-end medical device innovation, particularly benefiting the in vitro diagnostics (IVD) industry [4] - Policies include accelerated approvals and international registration facilitation, which will enhance the global competitiveness of IVD companies [4] - The document from NMPA is expected to directly benefit the IVD sector, with domestic biochemical diagnostics largely free from foreign constraints [4] Group 3: ETF Performance Metrics - The Hang Seng Healthcare ETF recorded a financing buy-in of 220 million yuan and a financing balance of 267 million yuan [5] - Over the past two years, the ETF's net value increased by 20.23%, with a maximum monthly return of 28.34% and an average monthly return of 6.82% [5] - As of July 4, 2025, the ETF's one-year Sharpe ratio was 2.07, indicating strong risk-adjusted returns [5] Group 4: Valuation and Tracking - The Hang Seng Healthcare ETF has a current price-to-earnings ratio (PE-TTM) of 27.84, which is below the historical average, indicating a low valuation compared to the past three years [6] - The ETF has the highest tracking accuracy among comparable funds, with a tracking error of 0.069% over the past year [5][6] - The ETF's management fee is 0.50%, and the custody fee is 0.15%, contributing to its overall cost structure [5]