进入下半年，除了创新药，市场也在挖掘其他潜在的复苏方向。风云君认为，医疗器械板块的上涨新 动能正在涌现。 政策指出明路。 | 作者 | | 紫枫 | | --- | --- | --- | | 编辑 | | 小白 | 在连续深度调整3年以上后，医药板块在今年迎来明显的复苏。 创新药板块率先"发力"，今年上半年利好消息层出不穷，创新药出海交易放量叠加国内一系列政策鼓 励创新药发展等因素叠加下，板块整体迎来"业绩+估值"的戴维斯双击，阶段性表现领先A股市场。 医疗器械 行业 政策端迎来拐点 首先是最受市场关注的政策端。今年以来，国家在医疗器械领域的政策支持力度显著增强。 2025年7月，国家药监局发布《关于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的公 告》，明确将医用机器人、高端医学影像设备、人工智能医疗器械和新型生物材料医疗器械列为重点 发展领域，提出十大支持举措。 据了解，医用机器人、高端医学影像设备、人工智能医疗器械和新型生物材料医疗器械等技术集成度 高，是高端医疗器械的典型产品，也是塑造医疗器械新质生产力的关键。 政策核心聚焦于为高端医疗器械创新提供全生命周期支持。例如，对创新医疗器械实施特别审 ...

Core Viewpoint - The National Medical Products Administration (NMPA) has introduced 10 measures to support the innovation and development of high-end medical devices in China, focusing on key areas such as medical robots, advanced medical imaging equipment, new biomaterials, and artificial intelligence medical devices [1][3][4]. Group 1: Key Areas of Focus - The measures target representative products in high-end medical devices, which are crucial for shaping new productive forces in the industry [3]. - Specific products highlighted include brain-machine interface technology devices, laparoscopic surgical systems, and multi-disease AI medical devices [4]. Group 2: Market Potential and Growth - The market size for high-end medical devices in China has surpassed 800 billion yuan, with a compound annual growth rate (CAGR) of over 10% for the past decade and 18% for the last five years [4]. - The NMPA anticipates that the market could exceed 1 trillion yuan, aiming for breakthroughs in smart diagnosis and precision medicine [6]. Group 3: Policy Innovations - The new policies cover the entire lifecycle of medical devices, including pre-market and post-market phases, with several being domestic firsts and internationally leading [6][10]. - The NMPA will shift the focus of reviews to the R&D stage, simplifying registration requirements for AI products and enhancing pre-application services [8]. Group 4: Quality Management and Standards - Companies will be guided to establish robust quality management systems during the R&D phase, with inspections conducted in stages to align with their progress [12]. - The NMPA has introduced classification guidance and naming standards for medical robots, aiming to create industry standards for surgical and exoskeleton robots [16]. Group 5: International Collaboration and Standards - The NMPA plans to promote global regulatory coordination and support companies in expanding internationally, participating in international standard-setting and regulatory forums [18]. - A proposal to establish a standardization organization for medical robots and AI medical devices has been made to lead innovation in these areas [19].

Core Insights - The National Medical Products Administration (NMPA) has introduced ten measures to support the innovation and development of high-end medical devices in China, focusing on key areas such as medical robots, advanced medical imaging equipment, new biological materials, and artificial intelligence medical devices [2][4]. Group 1: Market Potential - The high-end medical device market in China has surpassed 800 billion yuan in 2023, with a compound annual growth rate (CAGR) of over 10% in the past decade and 18% in the last five years [2]. - The market is expected to exceed 1 trillion yuan, with aspirations for breakthroughs in smart diagnosis and precision medicine, enhancing international competitiveness [3]. Group 2: Policy Innovations - The new policies cover the entire lifecycle of medical devices, including pre-market and post-market phases, with several measures being domestic firsts or internationally leading [4]. - Key innovations include shifting the focus of reviews to the R&D stage, simplifying registration requirements for AI products, and providing enhanced pre-application services for cutting-edge technologies [4][5]. Group 3: Industry Standards and Global Expansion - The policies establish classification guidelines and naming standards for medical robots, aiming to create industry standards for surgical robots and exoskeleton robots, which will support domestic products in international competition [7]. - The NMPA plans to actively participate in international standard-setting and regulatory coordination, promoting Chinese regulatory models and facilitating the global expansion of Chinese enterprises [6][7].

Core Viewpoint - The article emphasizes the Chinese government's commitment to enhancing pharmaceutical innovation and development, particularly in the areas of innovative drugs and medical devices, to support public health and the construction of a healthy China [1][2]. Group 1: Government Initiatives - Liu Guozhong, a member of the Political Bureau of the CPC Central Committee, highlighted the importance of strengthening collaborative efforts and policy implementation in the pharmaceutical sector to boost innovation and development [2]. - The government aims to enhance the integration of industry, academia, and research institutions to improve the level of pharmaceutical technology innovation and achieve breakthroughs in drug, vaccine, and medical device development [2][4]. - The State Drug Administration (NMPA) is working on optimizing the clinical trial review and approval process for innovative drugs, aiming to complete reviews within 30 working days for eligible applications [3]. Group 2: Regulatory Framework - The NMPA has proposed measures to support high-end medical device innovation, including optimizing special approval procedures and improving classification and naming principles [4]. - The upcoming measures will focus on enhancing the regulatory framework for high-end medical devices, which include medical robots, advanced imaging equipment, and AI medical devices [4][5]. - The government is committed to creating a favorable development environment by strengthening policy guarantees and promoting international cooperation in pharmaceutical technology [2][4]. Group 3: Industry Development - The article notes that China's pharmaceutical innovation has shown positive trends, with significant improvements in research and development capabilities, market competitiveness, and innovation vitality [2]. - The integration of new technologies such as artificial intelligence and big data is expected to accelerate the construction of health databases and improve the efficiency of pharmaceutical research and medical services [2][4]. - The measures introduced by the NMPA are seen as crucial for supporting major innovations in high-end medical devices and meeting the health needs of the population [4][5].

Core Viewpoint - The Chinese government emphasizes the importance of strengthening pharmaceutical innovation and development to support public health and enhance the country's healthcare system [1][2]. Group 1: Pharmaceutical Innovation - The Vice Premier Liu Guozhong highlighted the need for collaboration in tackling key challenges in the pharmaceutical sector, aiming to boost innovation and high-quality development [2]. - Recent years have seen significant improvements in China's pharmaceutical research capabilities, market competitiveness, and innovation vitality [2]. - The government encourages deep integration of industry, academia, and research institutions to enhance pharmaceutical technology innovation, particularly in drug, vaccine, and medical device development [2]. Group 2: Regulatory Support - The National Medical Products Administration (NMPA) is working on optimizing the clinical trial review and approval process for innovative drugs, aiming to complete reviews within 30 working days for eligible applications [3]. - The NMPA has also approved measures to support the innovation of high-end medical devices, emphasizing the importance of a comprehensive regulatory reform in the medical device sector [4]. - Specific measures include optimizing special approval processes, improving classification and naming principles, and enhancing post-market surveillance and quality monitoring [4]. Group 3: Future Initiatives - The NMPA plans to release detailed guidelines soon, focusing on coordination and clarifying requirements to ensure the successful implementation of new initiatives [5].

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].

Core Viewpoint - The recent announcement of measures to support the high-quality development of innovative drugs has also positively impacted the high-end medical device sector, with the National Medical Products Administration (NMPA) introducing specific policies to enhance innovation in this field [1][3]. Group 1: Policy Measures - The NMPA's announcement includes ten specific measures aimed at optimizing special approval processes and improving classification and naming principles for high-end medical devices [1]. - The measures emphasize a full lifecycle regulatory approach to support significant innovations in high-end medical devices, facilitating the transformation of new technologies, materials, and methods into marketable products [1][3]. - The measures are expected to enhance the efficiency of material submissions, approvals, and research and development for companies in the medical device industry [1][4]. Group 2: Market Impact - Following the announcement, several medical device companies saw significant stock price increases, with companies like Hotgen Biotech rising by 20% and others like Zhongyuan Union and Jianfan Bio increasing by nearly 10% [2]. - The measures are anticipated to accelerate the market entry of high-end medical devices, particularly those related to artificial intelligence and new biological materials [3]. Group 3: Regulatory Improvements - The measures propose to streamline the approval process for high-end medical devices, reducing the average approval cycle from 12 months to potentially 9 or 10 months [3][4]. - The NMPA aims to enhance the standardization of medical devices, including the development of standards for medical robots and artificial intelligence devices [4][6]. - The focus will also be on improving post-market surveillance and quality safety monitoring for innovative products [6]. Group 4: Internationalization and Challenges - The measures support high-end medical device companies in participating in international standard-setting and expanding their global market presence [7]. - Despite advancements, challenges remain for Chinese companies in terms of technology implementation and market competition with established Western firms, which may require significant time and investment [8].

Core Viewpoint - The National Medical Products Administration (NMPA) of China is implementing special reviews for high-end medical devices that are domestically innovative, internationally leading, and have significant clinical application value to support their development and international expansion [1][2][3] Regulatory Measures - The NMPA has announced ten key measures focusing on the entire lifecycle regulation of high-end medical devices, including optimizing review and approval processes, strengthening post-market supervision, and enhancing standard system construction [1][2] - The approval time for clinical trials of medical devices has been reduced from 60 working days to 30 working days, with a focus on advancing the review process to the product development stage [2][3] Innovation and Approval Process - Since 2014, the number of approved innovative medical devices has significantly increased from 33 to 323 by April 2023, indicating a rapid acceleration in technology breakthroughs and product launches in high-end medical devices [3] - The NMPA will continue to implement special reviews for high-end innovative medical devices, ensuring priority processing under the principles of early intervention, dedicated responsibility, and scientific review [3][4] Standardization and Guidance - The NMPA aims to enhance standardization research to help domestic high-end medical devices compete internationally, emphasizing the need for improved registration and classification guidance [4][5] - Key areas of focus for standardization include artificial intelligence, brain-computer interfaces, and new biological materials, with plans to establish technical organizations for standardization in these fields [5][6] Post-Market Supervision - The NMPA will strengthen post-market supervision requirements for innovative medical devices, encouraging manufacturers to conduct post-market evaluations and real-world studies to enhance product safety and reliability [5][6] - The regulatory framework will also be improved to support companies in expanding their international market presence, including policies related to export sales certification [6]

Group 1 - The medical device sector is experiencing strong performance, with the medical device ETF (159797) rising by 1.08% and attracting net inflows for the second consecutive day [1][3] - The majority of the constituent stocks of the medical device ETF saw gains, with notable increases such as Hotgen Biotech rising over 11%, and Xiangyu Medical and Xinmai Medical both increasing over 8% [3] - The National Healthcare Security Administration and the National Health Commission issued measures to support the high-quality development of innovative drugs, which includes enhancing the use of medical insurance data for drug research and improving the dynamic adjustment mechanism for the basic medical insurance drug list [3] Group 2 - The release of the RuiPath pathology model by Ruijin Hospital marks a significant advancement in domestic medical AI, transitioning from technical breakthroughs to ecosystem sharing [4] - The measures approved by the National Medical Products Administration aim to optimize the lifecycle regulation to support the innovation of high-end medical devices, including improving special approval processes and enhancing communication mechanisms [5] - The external skeleton robot industry is viewed positively due to recent technological breakthroughs and product innovations, with applications in both medical and industrial sectors expected to grow rapidly [6][7] Group 3 - The medical device ETF (159797) encompasses a wide range of medical equipment and diagnostics, with the top ten weighted stocks accounting for nearly 47% of the fund [7][8] - The top holdings in the medical device ETF include Mindray Medical (14.65%), United Imaging Healthcare (9.44%), and Aimeike (3.95%) among others [8]

Group 1 - The core viewpoint is that by 2025, domestic PFA brands are expected to enter a rapid commercialization phase, gradually replacing traditional radiofrequency and cryoablation technologies due to their non-thermal ablation characteristics, shorter operation times, lower complication risks, and better long-term efficacy [1] - Six domestic brands have already been approved, indicating a growing market presence [1] - The National Medical Products Administration has approved measures to optimize the lifecycle regulation to support the innovation and development of high-end medical devices, which includes ten initiatives aimed at promoting the development of medical robots, high-end medical imaging equipment, AI medical devices, and new biological materials [1] Group 2 - The medical device sector is currently valued at historical lows, with policy benefits expected to materialize starting from Q2 2025, particularly in the AI + imaging/surgery direction [1] - The innovative drug sector is experiencing short-term fluctuations but is viewed positively in the long term, driven by accelerated overseas expansion and changes in payment systems [1] - The traditional Chinese medicine sector is seeing reduced impacts from centralized procurement, with improved gross margins for OTC products; the blood products industry is experiencing increased concentration and favorable demand for immunoglobulin [1] Group 3 - The retail pharmacy industry is undergoing accelerated clearing, with AI empowerment enhancing operational efficiency and outpatient coordination creating incremental opportunities [1] - The CXO sector is gradually stabilizing in performance, with a recovery in overseas investment and financing driving industry growth [1] Group 4 - The ChiNext Medical ETF tracks the ChiNext Medical Index, which is compiled by China Securities Index Co., Ltd., selecting listed companies in the medical and health industry from the ChiNext market to reflect the overall performance of the medical and biological sector [2] - This index focuses on high-growth and innovative sub-sectors such as biomedicine, medical devices, and medical services, effectively showcasing the investment value and development potential of the ChiNext medical industry [2]