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我国首部脑机接口医疗器械标准明年1月1日正式实施,脑机接口产业明确路线图
Ge Long Hui· 2025-10-04 22:37
格隆汇10月5日|据经济日报,国家药监局日前批准发布《采用脑机接口技术的医疗器械 术语》行业标 准,明年1月1日正式实施,这是我国第一部脑机接口医疗器械标准。此前,工信部等7部门印发《关于 推动脑机接口产业创新发展的实施意见》(以下简称《意见》),提出到2030年,脑机接口产业创新能 力显著提升,形成安全可靠的产业体系,培育2至3家有全球影响力的领军企业和一批专精特新中小企 业,构建具有国际竞争力的产业生态,综合实力迈入世界前列。伴随各项政策的出台,脑机接口产业发 展日趋标准化、体系化。 脑机接口通过在脑与机器之间建立信息通道,实现生物智能与机器智能的协 同交互,是一项生命科学和信息科学融合发展的前沿技术。 近年来,随着创新成果持续涌现,脑机接 口产业加速壮大。公开数据显示,2024年中国脑机接口市场规模为32.0亿元,预计到2028年将达61.4亿 元。 中国信息通信研究院总工程师敖立认为,《意见》的出台是中国在脑机接口领域从"跟跑"到"并 跑"乃至"领跑"的关键一步,为应对人口老龄化、提升国家安全能力、培育新质生产力提供战略支撑。 《意见》明确了加强基础软硬件攻关、打造高性能产品、推动技术成果应用、壮大创 ...
影响市场重大事件:工信部等八部门印发《有色金属行业稳增长工作方案(2025—2026年)》,要求科学合理布局氧化铝、铜冶炼、碳酸锂等项目,避免重复低水平建设
Mei Ri Jing Ji Xin Wen· 2025-09-28 22:35
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].
脑机接口术语标准发布:行业规范化里程碑,开启产业化加速期
Shanxi Securities· 2025-09-24 03:39
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].
【医药】首项脑机接口医疗器械行业标准落地,建议关注脑机接口相关标的——医药行业跨市场周报(20250921)(王明瑞/黎一江)
光大证券研究· 2025-09-22 23:07
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]
首项脑机接口医疗器械行业标准落地,建议关注脑机接口相关标的:医药生物行业跨市场周报(20250921)-20250922
EBSCN· 2025-09-22 08:25
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].
机构:我国脑机接口产业有望迎来黄金发展期
Group 1 - The National Medical Products Administration of China has approved the first medical device standard for brain-computer interface technology, which will be implemented on January 1, 2026, laying the foundation for high-quality development in the industry [1] - Brain-computer interface technology is seen as a frontier technology that integrates life sciences and information sciences, enabling collaborative interaction between biological intelligence and machine intelligence [1] - The industry is experiencing rapid growth with continuous innovation, and there is potential for disruptive breakthroughs as policies become clearer and various medical institutions and companies accelerate research and development [1] Group 2 - The brain-computer interface technology has become a strategic high ground in global technological competition, with the U.S. government investing over $4 billion in the "Brain Initiative" from 2014 to 2023 [2] - China is strengthening its top-level planning in the brain-computer interface field, with the first prospective clinical trial of an invasive brain-computer interface expected to be conducted by 2025 [2] - Applications in neural rehabilitation and motor function reconstruction are anticipated to be among the first to achieve commercialization in the invasive brain-computer interface sector, indicating a golden development period for the industry in China [2]
早新闻|商务部等九部门重磅发声!
Zheng Quan Shi Bao· 2025-09-16 23:47
Macro Trends - The Ministry of Commerce and nine other departments issued policies to expand service consumption, including actions to enhance service quality and promote consumer activities [1] - The Ministry of Ecology and Environment is seeking public opinion on the draft technical guidelines for environmental impact assessments of magnetic confinement fusion devices, aiming to support the high-quality development of the domestic fusion industry [1] - The National Internet Information Office is soliciting opinions on a draft method for identifying online platform service providers that significantly impact minors, in line with the requirements of the Minor Online Protection Regulations [1] Industry News - The National Medical Products Administration approved the release of the first industry standard for medical devices using brain-computer interface technology, which will take effect on January 1, 2026, laying a foundation for the high-quality development of this industry [2] - The construction of the Tibet-Guangdong DC transmission project, a key cross-provincial power transmission project, has begun, with a total length of 2,681 kilometers and a transmission capacity of 10 million kilowatts, expected to deliver over 43 billion kilowatt-hours of clean energy annually to the Guangdong-Hong Kong-Macao Greater Bay Area by 2029 [3] - Suzhou announced the "Artificial Intelligence+" city action plan, aiming to establish a leading AI industry cluster with over 3,000 AI companies by the end of 2026 and an annual growth rate of over 20% in the core scale of the intelligent economy [4][5] Company News - Changgao Electric New plans to invest 79.6177 million yuan in a rooftop photovoltaic project [6] - Guang'an Aizhong intends to acquire 90% of Qitai Hengtai's shares for 0 yuan [7] - Suzhou plans to acquire 80% of the shares of the Kunshan Development Zone Architectural Design Institute [8] - China Shenhua reported a 3.1% year-on-year decline in coal sales volume for August [9] - Newhua Co., Ltd. announced that board member Fang Junwei plans to reduce his holdings by no more than 75,200 shares [9] - Madi Technology's shareholder Weng Kang intends to reduce his holdings by no more than 1.7% of the company's shares [9] - Artes plans to reduce its holdings by no more than 2.04% of the company's shares [9] - Zhongyou Technology's shareholder plans to reduce holdings by no more than 3% of the company's shares [9] - Sanbian Technology will supply 58 box transformers to Taizhou Beibu Bay and the total procurement amount is 14.1148 million yuan [10] - Tiancheng Technology's shareholder Ruixing Phase II plans to reduce holdings by no more than 1.68% of the company's shares [11] - Fuchuang Precision's shareholder Guotou Chuangye Fund plans to reduce holdings by no more than 3% of the company's shares [11] - Suzhou Bank's 12 directors and supervisors completed their shareholding increase plan, with a total increase amount of nearly 5 million yuan [11] - Digital Vision plans to sell no more than 5% of its shares in Bohui Technology [11] - Haon Automotive Electric received a product designation letter, with an estimated total revenue of approximately 2.477 billion yuan over its lifecycle [11] - Runjian Co., Ltd. plans to win a 1.11 billion yuan project from China Unicom [11] - Jingzhida's subsidiary signed a procurement agreement for semiconductor testing equipment worth 323 million yuan [11] - Vanke A received a loan of no more than 2.064 billion yuan from Shenzhen Metro Group [11]
我国《采用脑机接口技术的医疗器械 术语》行业标准发布
Yang Shi Wang· 2025-09-16 09:36
Core Points - The National Medical Products Administration (NMPA) has approved the release of a new industry standard for medical devices utilizing brain-computer interface technology [1] - The standard, titled YY/T 1987—2025, will officially take effect on January 1, 2026 [1] Industry Summary - The introduction of the YY/T 1987—2025 standard signifies a regulatory advancement in the medical device sector, particularly for innovations involving brain-computer interfaces [1] - This standard aims to establish clear terminology and guidelines for the development and application of medical devices that leverage brain-computer interface technology [1]