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] 药监局发布行业标准立项公示，脑机接口或在医 疗场景率先落地 报告要点 [Table_Summary] 1 月 9 日，国家药监局官网发布 2 项推荐性医疗器械行业标准立项的公示，分别为《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》、《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》。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。 1 分析师及联系人 [Table_Author] 宗建树 陈耀文 SAC：S0490520030004 SAC：S0490525070002 SFC：BUX668 软件与服务 cjzqdt11111 请阅读最后评级说明和重要声明 %% %% %% %% research.95579.com [Table_Title 药监局发布行业标准立项公示，脑机接口或在 2] 医疗场景率先落地 [Table_Summary2] 事件描述 1 月 9 日，国家药监局官网发布 2 项推荐性医 ...

格隆汇1月12日｜国家药监局近日发布关于《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项推荐性医疗器械行业标准立项的公示。项目计划内容显示，《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》、《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》 均为推荐性行业标准。国家药监局综合司表示，公示期间，如有异议，请向国家药监局反馈。 ...

——编 者 定标准，规范医疗服务 本报记者 申少铁 国家药品监督管理局发布的《采用脑机接口技术的医疗器械 术语》医疗器械行业标准，于1月1日正式 实施。这是我国首个脑机接口医疗器械标准。为什么要制定这个标准？其主要内容是什么？对脑机接口 技术发展有什么意义？为了回答读者关心的问题，记者采访了国家药监局器械注册司副司长袁鹏。 问：该标准对采用脑机接口技术的医疗器械作出了什么定义？ 图①：中国科学院脑科学与智能技术卓越创新中心微纳电子加工平台，工作人员在加工侵入式脑机接口 柔性电极。 图②：北京天坛医院脑机接口门诊，医生在为患者进行脑电信号检测。 北京天坛医院供图 图③：瘫痪患者通过侵入式脑机接口系统，用意念控制机器狗。 图①③均为中国科学院脑科学与智能 技术卓越创新中心提供 "十五五"规划建议提出，"推动量子科技、生物制造、氢能和核聚变能、脑机接口、具身智能、第六代 移动通信等成为新的经济增长点。" 1月1日，我国首个脑机接口医疗器械标准正式实施。从患者用意念操控电脑到指挥机械臂、机器狗，从 实验室的前沿科技到门诊里的问询评估……当下，脑机接口技术飞速发展，正加快接入现实生活，相关 政策、标准的发布，为"接入" ...

"十五五"规划建议提出，"推动量子科技、生物制造、氢能和核聚变能、脑机接口、具身智能、第六代 移动通信等成为新的经济增长点。" 1月1日，我国首个脑机接口医疗器械标准正式实施。从患者用意念操控电脑到指挥机械臂、机器狗，从 实验室的前沿科技到门诊里的问询评估……当下，脑机接口技术飞速发展，正加快接入现实生活，相关 政策、标准的发布，为"接入"现实描画了更加清晰的路径。本期"瞰前沿"关注脑机接口行业新标准、新 动态，探寻技术与现实的"接口"。 ——编者 定标准，规范医疗服务 该标准有利于为脑机接口这一新兴领域建立统一的"语言体系"。首先，统一术语可打通不同学科间的对 话渠道，为跨领域科研协作、产品研发、临床推广等奠定坚实基础，也为医疗器械监管提供清晰、一致 的技术依据，有助于提升产品研发和注册申报效率；其次，通过为脑机接口医疗器械确立准入门槛与技 术标杆，有效引领市场从概念炒作回归价值竞争，优化创新产业发展生态；第三，它为后续"性能测试 方法""人工智能算法数据质量"等一系列标准的建立奠定了基础，标志着覆盖脑机接口医疗器械全生命 周期的标准体系开始全面构建。 问：采用脑机接口技术的医疗器械有什么潜力？ 国家药品监 ...

1月9日，国家药监局就《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》和《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》2项推荐性医疗器械行业标准制订计划进行公 示。 ...

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].

Market Overview - The A-share pharmaceutical and biotechnology index fell by 0.67%, underperforming the CSI 300 index by 0.23 percentage points and the ChiNext index by 1.97 percentage points, ranking 18th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index dropped by 1.95%, underperforming the Hang Seng Index by 3.1 percentage points [4] Key Insights - The first industry standard for brain-computer interface (BCI) medical devices has been established, suggesting a focus on BCI-related stocks. On September 15, the National Medical Products Administration (NMPA) officially released the YY/T 1987—2025 standard, which constructs a terminology system for BCI medical devices, clarifying core terms and definitions [5] - The implementation of this standard addresses fundamental challenges in the industry, providing a unified technical language and key technical basis for the research, production, and scientific regulation of BCI medical devices, marking a significant step for high-quality development in the sector [5] Global Initiatives - Various global brain initiatives have been launched over the years. The U.S. launched its Brain Initiative in 2013, led by the National Institutes of Health, focusing on brain structure, neural recording, and neuroethics [6] - The European Union initiated the Human Brain Project (HBP) in 2013 with a total investment of €1 billion over ten years [6] - On July 23, 2025, multiple Chinese governmental departments released implementation opinions to promote innovation and development in the BCI industry, providing comprehensive support for industry growth [6]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The first industry standard for brain-computer interface (BCI) medical devices has been established, suggesting a focus on BCI-related stocks [22][24]. - The global BCI market size grew from USD 1.2 billion in 2019 to nearly USD 2 billion in 2023, with a compound annual growth rate (CAGR) exceeding 13% from 2019 to 2023 [22]. - The report emphasizes a dual focus on "technical barriers + clinical implementation," recommending attention to medical scene integrators such as Xiangyu Medical, Weisi Medical, and Chengyitong, which are expected to benefit from the implementation of medical insurance payments and growing rehabilitation demand [24]. Summary by Sections Market Review - Last week, the A-share pharmaceutical and biotechnology index fell by 0.67%, underperforming the CSI 300 index by 0.23 percentage points and the ChiNext index by 1.97 percentage points, ranking 18th among 31 sub-industries [1][16]. - The H-share Hang Seng Medical Health Index dropped by 1.95%, underperforming the Hang Seng Index by 3.1 percentage points [1][16]. Industry Developments - On September 15, the National Medical Products Administration (NMPA) officially released the YY/T 1987-2025 standard for medical devices using BCI technology, which establishes a unified technical language for the industry [22]. - The multi-departmental collaboration in China, involving the Ministry of Industry and Information Technology, National Development and Reform Commission, and others, aims to provide comprehensive support for the BCI industry [24]. Investment Recommendations - Focus on companies with strong technical barriers and clinical application potential, such as Brain Tiger Technology, Ladder Medical, and Borui Kang, which are expected to have strong commercialization certainty for invasive BCI technologies [24]. - The report suggests that the integration of medical scenes will be beneficial for companies like Xiangyu Medical and Weisi Medical due to the anticipated growth in rehabilitation needs and medical insurance payment implementations [24]. Financial Projections - Key companies' earnings per share (EPS) projections for 2024, 2025, and 2026 are provided, with Weisi Medical projected at CNY 1.06, 1.37, and 1.58 respectively, and Xiangyu Medical at CNY 0.64, 0.86, and 1.07 respectively [4].