丨证券研究报告丨 行业研究丨点评报告丨软件与服务 [Table_Title] 2 项医疗器械行业标准制修订项目立项，脑机接 口再迎政策利好 报告要点 [Table_Summary] 1 月 28 日，据国家药监局官网消息，为满足监管急需，助推采用脑机接口技术的医疗器械高质 量发展，经研究，国家药监局批准《采用脑机接口技术的医疗器械范式设计与应用规范运动功 能重建》《采用脑机接口技术的医疗器械侵入式设备可靠性验证方法》等 2 项医疗器械行业标 准制修订项目立项。政策层面的持续完善有望为脑机接口的发展提供了关键推力，加速脑机接 口产业商业化落地。建议关注三条主线：1、侵入式脑机接口海外先进产业链的国内映射标的； 2、非侵入式脑机接口在消费场景的产品落地相关标的；3、脑机接口下游应用端相关标的。 分析师及联系人 [Table_Author] 宗建树 陈耀文 SAC：S0490520030004 SAC：S0490525070002 SFC：BUX668 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com 1 软件与服务 cjzqdt11111 [Table_Title 2 项 ...

近日，国家药监局批准《采用脑机接口技术的医疗器械 范式设计与应用规范 运动功能重建》《采用脑 机接口技术的医疗器械 侵入式设备 可靠性验证方法》等2项医疗器械行业标准制修订项目立项，为采用 脑机接口技术的医疗器械高质量发展提供标准支撑。 脑机接口标准化建设传来新消息。 脑机接口是一种在脑与外部设备之间建立直接的通信渠道。常用于辅助、增强、修复人体的感觉—运动 功能或提升人机交互能力，目前在医学领域应用较为广泛。根据植入条件，脑机接口可分为侵入式、非 侵入式和半侵入式三种。 近年来，随着神经信号处理、生物兼容材料、高性能芯片等一系列核心技术接连突破，脑机接口得以快 速发展。与此同时，相关支持政策不断落地，标准化建设成为规范行业发展、保障产品安全有效的关键 抓手。 健康通副总裁、首席发展官张畅向21世纪经济报道记者表示，此次2项标准的立项是对工信部等七部门 此前发布的《关于推动脑机接口产业创新发展的实施意见》（简称《实施意见》）中标准体系建设相关 内容的具体落实，同时也结合行业反馈的共性难题实现了空白填补。由此，也为医疗领域开展相关研 究、临床试验等后续"专业步骤"，迈出了有章可循的关键第一步。 强化标准建设 脑 ...

每经AI快讯，1月28日，据国家药监局官网消息，为满足监管急需，助推采用脑机接口技术的医疗器械 高质量发展，经研究，国家药监局批准《采用脑机接口技术的医疗器械范式设计与应用规范运动功能重 建》《采用脑机接口技术的医疗器械侵入式设备可靠性验证方法》等2项医疗器械行业标准制修订项目 立项。 ...

Investment Rating - The industry investment rating is "Positive" and maintained [7] Core Insights - On January 9, the National Medical Products Administration (NMPA) announced two recommended industry standards for medical devices utilizing brain-computer interface (BCI) technology, focusing on reliability verification methods for invasive devices and design/application specifications for motor function reconstruction [2][4] - The BCI industry is transitioning from "technical exploration" to "standard implementation," with the establishment of systematic terminology and definitions for BCI medical devices, which is expected to promote standardization and large-scale application [4] - Recent developments in pricing standards for BCI services across various provinces indicate a clearer path for reimbursement, which is anticipated to enhance clinical application of this new technology [4] - The report suggests that BCI technology may achieve commercial application in medical settings first, driven by supportive policies that address both supply and demand aspects [4] Summary by Sections Industry Standards - The NMPA has published two new standards for BCI medical devices, which include methods for verifying the reliability of key components and definitions for the motor function reconstruction paradigm [4] Market Dynamics - Multiple regions have established pricing for BCI medical services, with guidelines set to take effect from April 30, 2025, which is expected to facilitate the clinical use of BCI technology [4] Policy Support - The report emphasizes that government policies are actively promoting the adoption of BCI technology in medical applications, addressing critical issues such as affordability and institutional hesitance [4]

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the initiation of two recommended industry standards for medical devices utilizing brain-computer interface technology, focusing on reliability verification methods and design/application specifications for invasive devices [1] Group 1: Industry Standards - The two proposed standards are titled "Reliability Verification Methods for Invasive Medical Devices Using Brain-Computer Interface Technology" and "Design and Application Specifications for Movement Function Reconstruction Using Brain-Computer Interface Technology" [1] - These standards are categorized as recommended industry standards, indicating a push towards formalizing guidelines in this emerging field [1] Group 2: Public Feedback - The NMPA has opened a public feedback period for any objections regarding the proposed standards, encouraging stakeholders to communicate their concerns [1]

Core Insights - The first medical device standard for brain-computer interface (BCI) technology in China was implemented on January 1, marking a significant step in the integration of BCI technology into clinical practice and patient care [3][4][5]. Group 1: Standardization and Definition - The newly established standard defines "medical devices using brain-computer interface technology" as devices that decode neural signals from the central nervous system in real-time, facilitating bidirectional information exchange between patients and external devices [3][4]. - The standard aims to unify terminology across various disciplines involved in BCI technology, addressing inconsistencies that hinder industry development and providing a clear technical basis for regulatory oversight [5]. Group 2: Clinical Applications and Innovations - BCI medical devices are seen as a revolutionary advancement in healthcare, with potential applications including aiding patients with paralysis to regain motor functions and improving communication capabilities [6]. - Clinical trials at Beijing Tiantan Hospital have demonstrated the effectiveness of BCI technology in rehabilitation, with patients showing significant improvements in motor skills after receiving BCI implants [7][8]. Group 3: Future Prospects and Technological Development - The BCI sector is expected to grow significantly, with the potential to treat various neurological conditions such as epilepsy and Alzheimer's disease [6]. - Ongoing research and development efforts are focused on enhancing the performance of BCI systems, including reducing latency in signal processing to improve user experience and control accuracy [11].

Core Viewpoint - The implementation of China's first medical device standard for brain-computer interface (BCI) technology marks a significant step towards integrating advanced technologies into healthcare, aiming to enhance patient rehabilitation and treatment options [1][2]. Group 1: Standard Definition and Significance - The newly established standard defines "medical devices using brain-computer interface technology" as devices that decode neural signals from the central nervous system to facilitate real-time interaction between patients and external devices, improving or replacing certain physiological functions [3]. - The standard aims to unify terminology across various disciplines involved in BCI technology, addressing inconsistencies that hinder industry development and providing a clear technical basis for regulatory oversight [4]. - Establishing this standard is expected to create a unified language system for the emerging BCI field, enhancing collaboration across disciplines, improving product development efficiency, and setting benchmarks for market competition [4]. Group 2: Potential and Future Directions - BCI medical devices represent a revolutionary advancement in healthcare, with the potential to restore bodily functions for patients with conditions like spinal cord injuries, enabling them to control robotic arms or communicate through thought [5]. - The National Medical Products Administration plans to promote innovation in BCI medical devices through regulatory measures and scientific research, facilitating the transition from concept to clinical application [5]. - Clinical trials at institutions like Beijing Tiantan Hospital demonstrate the practical applications of BCI technology, with patients undergoing rehabilitation training showing significant improvements in motor functions [7][8]. Group 3: Technological Advancements and Applications - Recent clinical trials have showcased the ability of high-level paraplegic patients to control electric wheelchairs and robotic dogs using implanted BCI devices, expanding the scope of traditional medical applications [9]. - The development of advanced neural data compression techniques and low-latency control systems is crucial for ensuring effective interaction between patients and external devices, enhancing the user experience [10][11]. - The integration of BCI technology with smart devices like robotic arms and electric wheelchairs is essential for improving the quality of life for patients, highlighting the importance of external device development in realizing the full potential of BCI systems [11].

Core Viewpoint - The approval of the first industry standard for brain-computer interface (BCI) medical devices by the National Medical Products Administration marks a significant step in the development of the BCI industry in China, aiming for substantial growth and international competitiveness by 2030 [1] Industry Development - The new standard will be implemented on January 1, 2024, and is part of broader efforts to standardize and systematize the BCI industry in China [1] - The Ministry of Industry and Information Technology and six other departments have issued an implementation opinion that aims to enhance innovation capabilities and establish a reliable industrial system by 2030 [1] Market Potential - The BCI market in China is projected to reach 3.2 billion yuan in 2024 and is expected to grow to 6.14 billion yuan by 2028 [1] Strategic Support - The implementation opinion is seen as a critical step for China to transition from "catching up" to "keeping pace" and eventually "leading" in the BCI field, providing strategic support for addressing aging population issues and enhancing national security [1] Key Tasks and Measures - The opinion outlines six key tasks, including strengthening basic software and hardware development, creating high-performance products, promoting the application of technological achievements, and enhancing industrial support capabilities [1] - A total of 17 specific measures have been detailed to form a complete and systematic framework for advancing industry development [1] Ecosystem Enhancement - Experts believe that these initiatives will improve the BCI industry ecosystem, enhance international competitiveness, and promote applications across multiple fields, ultimately benefiting public welfare [1]

Core Insights - The Ministry of Industry and Information Technology and eight other departments have issued a plan for the non-ferrous metals industry aimed at stabilizing growth from 2025 to 2026, targeting an average annual growth of around 5% in added value and a 1.5% increase in the production of ten non-ferrous metals [1][2][3][4][5]. Group 1: Industry Growth and Development - The plan anticipates an average annual growth of approximately 5% in the added value of the non-ferrous metals industry from 2025 to 2026 [1]. - Production of ten non-ferrous metals is expected to grow by about 1.5% annually, with significant progress in domestic resource development for copper, aluminum, and lithium [1][2]. - The production of recycled metals is projected to exceed 20 million tons, enhancing the supply capacity of high-end products [1][2]. Group 2: Financial and Policy Support - The plan includes utilizing long-term special government bonds and other funding channels to support resource development, high-end material research, energy conservation, and digital transformation [2]. - It emphasizes the importance of expanding important non-ferrous metal futures trading varieties and financial derivatives [2]. Group 3: Project Management and Infrastructure - The plan advocates for a scientific and reasonable layout of projects related to alumina, copper smelting, and lithium carbonate to avoid redundant low-level construction [3]. - It aims to accelerate the approval processes for mineral resource development projects through the establishment of green channels [3]. Group 4: Innovation and High-End Product Development - The initiative promotes innovation in high-end products, focusing on the needs of key industries such as new-generation information technology and new energy vehicles [4]. - It encourages breakthroughs in high-quality raw materials and advanced rare earth materials, enhancing the performance of aluminum and magnesium alloys [4][5]. Group 5: Application of Rare Metals - The plan aims to elevate the application levels of rare metals in emerging industries such as integrated circuits, industrial mother machines, and artificial intelligence [5]. - It promotes the validation of high-end products like high-purity gallium and tungsten hard alloys, as well as the innovative application of frontier materials [5].

Investment Rating - The report maintains an investment rating of "Leading the Market-A" for the biopharmaceutical industry, indicating an expected price increase exceeding the benchmark index by more than 10% [10]. Core Insights - The biopharmaceutical industry has shown significant market performance over the past year, with innovations in drug development, particularly in the area of cancer therapies such as PD-1 and ADCs [2]. - The release of the YY/T 1987-2025 standard for brain-computer interface (BCI) medical devices marks a critical step in the industrialization of BCI technology in China, addressing long-standing issues of concept ambiguity and standardization [3][4]. - The establishment of a unified terminology system is expected to enhance communication between research, clinical applications, and regulatory bodies, thereby improving the efficiency of technology transfer [3]. - The report highlights the ongoing policy evolution in the BCI sector, characterized by national strategic guidance, industry collaboration, and localized implementation efforts [4][6]. Summary by Sections Industry Performance - The biopharmaceutical sector has experienced notable advancements, particularly in innovative drug therapies for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [2]. Policy Developments - The introduction of the BCI terminology standard is part of a broader policy framework aimed at fostering the development of the BCI industry, which has been recognized as a strategic priority since the launch of the China Brain Project in 2016 [3][4]. Technological Innovations - Recent breakthroughs in BCI technology, such as the "NeuroWorm" developed by the Shenzhen Institute of Advanced Technology, demonstrate China's leading position in implantable BCI solutions, with applications in treating neurological disorders [6]. Investment Recommendations - The report suggests focusing on companies involved in BCI technology, including Chengyitong, Xiangyu Medical, Aipeng Medical, Weisi Medical, Mcland, and Xinwei Medical, as potential investment opportunities [7].