证券代码：688114 证券简称：华大智造 公告编号：2025-040 自愿性披露的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 深圳华大智造科技股份有限公司（以下简称"公司"）全资子公司武汉华大 智造科技有限公司的全自动测序文库制备系统于近日取得了中华人民共和国医 疗器械注册证，具体情况如下： 一、注册产品的基本信息 | 注册人名称 | 武汉华大智造科技有限公司 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 注册证编号 | 鄂械注准 20252225617 | | | | | | | | | 产品名称 | 全自动测序文库制备系统 | | | | | | | | | 型号、规格 | GenSIRO-16 | | | | | | | | | 适用范围 | | | | | | | | 与体外诊断试剂配合使用，用于临床诊断方面执行基因测序文库自动化 | | | 构建，产物可用于后续的测序。 | | | | | | | | | ...

Core Points - The company BGI Genomics announced that its wholly-owned subsidiary, Wuhan BGI Genomics Technology Co., Ltd., has received a medical device registration certificate from the Hubei Provincial Drug Administration for its fully automated sequencing library preparation system, GenSIRO-16 [1] - The registration certificate number is 鄂械注准20252225617, and the system is designed for use in conjunction with in vitro diagnostic reagents for clinical diagnostic purposes, specifically for automated construction of gene sequencing libraries [1] - The registration is valid from June 30, 2025, to June 29, 2030 [1]

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index (000683) increased by 0.93% as of July 1, 2025, with notable gains from stocks such as Rongchang Biopharmaceutical (688331) up 7.21% and Shanghai Yizhong (688091) up 3.61% [1] - Starting July 1, 2025, a new policy mandates that all drug sales must include a verification code for medical insurance reimbursement, with full traceability of drug codes required by January 1, 2026, which is expected to enhance drug circulation regulation and impact the entire pharmaceutical industry chain [1] - The current bull market in innovative drugs is driven by the improvement of China's pharmaceutical innovation capabilities, with a trend towards international collaboration in new drug development expected to enhance profitability and market potential for Chinese pharmaceutical companies [2] Group 2 - As of June 30, 2025, the top ten weighted stocks in the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare (688271) and BeiGene (688235) [3] - The Sci-Tech Biopharmaceutical ETF closely tracks the performance of the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which includes 50 large-cap companies in various biopharmaceutical sectors [2]

Core Viewpoint - The AI medical device industry in China is experiencing rapid growth driven by policy support, technological advancements, and market demand, with the market size projected to reach 242.3 billion yuan by 2025, up from 94.61 billion yuan in 2024 and 2.92 billion yuan in 2020 [1][12]. Industry Overview - AI medical devices utilize artificial intelligence to assist in diagnosis, monitoring, and optimizing medical processes, categorized into six main types: medical imaging analysis, diagnostic assistance systems, surgical robots, health monitoring devices, drug development tools, and personalized treatment systems [2][4]. - The industry has formed a multi-dimensional ecosystem involving traditional healthcare providers, internet companies, AI algorithm developers, and medical device manufacturers, creating a closed-loop industry ecology [4]. Industry Environment - The AI chip market, crucial for the smart capabilities of medical devices, is projected to reach 141.2 billion yuan in 2024, growing by 17.1% year-on-year, providing strong technical support for the AI medical device sector [6]. - The machine vision market, which enhances the precision of medical devices, is expected to grow to 207.17 billion yuan in 2024, with an 11.9% increase, indicating significant advancements in this technology [8]. Social Environment - The aging population and uneven distribution of medical resources in China are driving strong demand for AI medical devices, which play a vital role in early disease screening and long-term monitoring [10]. - There is a growing consumer demand for personalized services, prompting AI medical devices to focus on customized offerings through deep learning and big data analysis [10]. Current Industry Status - The AI medical device industry in China is in its early commercialization stage, with a significant increase in product approvals, as evidenced by a 50% year-on-year rise in the number of approved Class III AI medical devices in 2023 [14]. - By mid-2024, 92 Class III AI medical imaging products had been approved, covering various diseases such as cardiovascular, pulmonary, and neurological conditions [14]. Competitive Landscape - Leading companies in the AI medical device sector include United Imaging, Pushang Medical, and Sukun Technology, each leveraging core technology and deep integration with clinical scenarios to establish a differentiated competitive landscape [16]. - United Imaging leads the market with a comprehensive product line and strong partnerships with top-tier hospitals, while Pushang Medical and Sukun Technology focus on specific areas like lung AI imaging and cardiovascular AI [16][17]. Future Trends - The industry is expected to see enhanced technological innovation and accelerated product iterations, driven by advancements in deep learning and computer vision [22]. - Market competition is intensifying, with companies adopting differentiated strategies in niche areas, particularly in medical imaging [23]. - The internationalization of Chinese AI medical device companies is accelerating, facing global competition and regulatory challenges as they expand into overseas markets [25].

证券代码：688114 证券简称：华大智造 公告编号：2025-039 深圳华大智造科技股份有限公司 2025年第二次临时股东大会决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 6 月 24 日 （二） 股东大会召开的地点：深圳市盐田区梅沙街道云华路 9 号华大时空 中心 C 区国际会议中心 419 会议室 （五） 公司董事、监事和董事会秘书的出席情况 1、公司在任董事9人，出席9人； 2、公司在任监事3人，出席3人； 3、公司董事牟峰先生以代行董事会秘书身份出席了本次会议； （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股 东及其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 117 | | --- | --- | | 普通股股东人数 | 117 | | 2、出席会议的股东所持有的表决权数量 | 227,832,004 | | 普通股股东所持有表决权数量 | 227, ...

北京市嘉源律师事务所 关于深圳华大智造科技股份有限公司 2025 年第二次临时股东大会的 法律意见书 西城区复兴门内大街 158 号远洋大厦 4 楼 中国·北京 E SR 在Uit E S Fr A YUAN LAW OFFICES 北京 BEIJING·上海 SHANGHAI·深圳 SHENZHEN·香港 HONG KONG·广州 GUANGZHOU·西安 XI'AN 致:深圳华大智造科技股份有限公司 北京市嘉源律师事务所 关于深圳华大智造科技股份有限公司 2025 年第二次临时股东大会的 法律意见书 嘉源(2025)-04-453 北京市嘉源律师事务所(以下简称"本所")接受深圳华大智造科技股份有 限公司〈以下简称"公司"〉的委托,根据《中华人民共和国公司法》（以下简 称"《公司法》")《上市公司股东会规则》(以下简称"《股东会规则》") 等现行有效的法律、行政法规、部门规章、规范性文件(以下简称"法律法规") 以及《深圳华大智造科技股份有限公司章程》(以下简称"《公司章程》")的 有关规定,指派本所律师对公司2025年第二次临时股东大会(以下简称"本次股 东大会"）进行见证,并依法出具本法律意见书。 为 ...

Core Viewpoint - The article highlights the market capitalization changes of major domestic life science instrument manufacturers in China for 2025, indicating a mixed performance with significant growth for some companies and declines for others due to policy impacts and market dynamics [1][2]. Market Capitalization Summary - The top five companies by market capitalization in 2025 are Mindray Medical, Sunny Optical, BGI Genomics, Antu Bio, and Haier Biomedical [2]. - A total of 10 companies experienced growth in market capitalization compared to 2024, with Zhongke Meiling leading at a growth rate of +130.44% [2]. - Four companies saw a decline in market capitalization, with Antu Bio experiencing the most significant drop at -26.70% [2]. Policy Impact Analysis - The medical anti-corruption and centralized procurement policies have negatively affected the revenue of several companies, leading to a 35% decrease in equipment bidding volume in tertiary hospitals [3]. - Mindray Medical, despite being an industry leader, faced a revenue growth drop from 25% to 9% due to procurement delays and budget constraints from DRG payment reforms [3]. - Antu Bio's revenue decreased by 18% in 2024 due to the impact of centralized procurement on the prices of chemical luminescence reagents [4]. Growth Drivers - Companies are shifting towards technology innovation as traditional high-margin models and bundled sales strategies become less viable under centralized procurement [5]. - Domestic microscope manufacturers have seen significant market capitalization growth, with Sunny Optical (+47.04%), Yongxin Optical (+27.11%), and Motic (+69.22%) benefiting from increased demand and technological advancements [7]. - Zhongke Meiling achieved a market share increase from 3% to 8% by overcoming technical barriers in ultra-low temperature freezing equipment [8]. International Expansion and Market Strategy - Companies are increasingly focusing on international markets to seek new growth opportunities, with Mindray Medical expanding its factory in New Jersey as part of its international strategy [8]. - BGI Genomics and Motic are also pursuing CE/FDA certifications to enter European and American markets, indicating a shift from domestic competition to global opportunities [8].

Summary of Conference Call Records Industry Overview - The long-term care insurance (LTCI) market is expected to reach a scale of 2 trillion RMB, creating significant investment opportunities and driving the development of related companies. Currently, there are 180 million insured individuals, with only 1.3 million receiving benefits, indicating substantial room for penetration growth [1][5][8]. Key Points on Long-Term Care Insurance - The LTCI fund size is projected to grow from over 20 billion RMB to between 170 billion and 2 trillion RMB, representing a potential tenfold to hundredfold growth in this niche market. This growth is supported by overseas experiences showing excellent ROE and ROIC performance from related companies [2][9]. - By 2025, the number of disabled elderly individuals in China is expected to reach approximately 34 million, with annual care expenditures around 740 billion RMB. By 2050, this number may double to 64 million, with total expenditures reaching 1.7 trillion RMB [8][10]. Pharmaceutical and Medical Device Sector Insights - The innovative drug sector has experienced a rapid increase in stock prices, leading to a market correction. This adjustment is seen as normal, with expectations of a rebound in the near future. Key companies to watch include Innovent Biologics and CSPC Pharmaceutical Group [3][4]. - The innovative medical device sector is highlighted, with recommendations for companies such as BGI Genomics, Huatai Medical, and SINO Medical. SINO Medical's self-expanding stent is expected to receive approval by the end of August, while BGI Genomics benefits from AI medical applications [4][6]. Regulatory Support and Market Impact - The National Medical Products Administration (NMPA) has introduced policies to support high-end medical device innovation, particularly in robotics, advanced imaging equipment, AI-related devices, and new biomaterials. These policies are expected to enhance the approval efficiency and market performance of domestic innovative device companies [6][7]. - The surgical robotics sector is also noted for its potential, although it faces challenges from related healthcare policies. If favorable policies are introduced, the innovative device industry could see significant growth [7]. Investment Recommendations - The recommended investment portfolio includes East Sunshine Longjiang Pharmaceutical and Zhenbao Island, with East Sunshine's market capitalization projected to reach 45-50 billion HKD following successful hearings and upcoming data catalysts [6]. Zhenbao Island is expected to release positive information from its recent bidding success and breakthrough therapy plans [6]. Conclusion - The long-term care insurance market presents a significant growth opportunity, while the pharmaceutical and medical device sectors are poised for recovery and innovation, supported by favorable regulatory changes. Investors are encouraged to focus on leading companies in these areas for potential returns.

Core Viewpoint - The article highlights the resilience and innovative vitality of China's scientific instrument industry in the face of global challenges, showcasing significant growth in overseas revenue among domestic listed companies [2][6]. Group 1: Overview of Overseas Revenue - In 2024, the total overseas revenue of 43 domestic listed instrument companies reached 34.707 billion yuan, marking a new high [6][10]. - Over 60% of the companies reported revenue growth, with 21 companies achieving over 100 million yuan in overseas revenue [6][10]. - The top five companies by overseas revenue are Mindray Medical (16.434 billion yuan), Sunny Optical (9.602 billion yuan), Libang Instruments (1.098 billion yuan), BGI Genomics (913 million yuan), and Huashengchang (717 million yuan) [3][6]. Group 2: Performance Analysis - Among the 43 companies, 27 experienced stable or significant growth, with notable examples including Wanyi Technology, which saw a 447.23% increase in overseas revenue [7][12]. - Conversely, 14 companies faced revenue declines, such as Gaode Infrared, which reported a 50.76% drop [7][15]. - Mindray Medical's overseas revenue accounted for 44.75% of its total revenue, reflecting the effectiveness of its globalization strategy [10][17]. Group 3: Market Dynamics - The article indicates a shift in the market, with three companies achieving over 1 billion yuan in overseas revenue, while 18 companies fall within the 100 million to 1 billion yuan range [13]. - Companies with overseas revenue constituting over 10% of total revenue increased to 22, indicating a growing trend in international market engagement [17]. - Wanyi Technology's strategy of "product leadership, quality excellence, competitive pricing, and superior service" has led to substantial growth in overseas markets [13][17]. Group 4: Emerging Companies - New entrants like Titan Technology and Lihua Technology reported 100% growth in overseas revenue, reflecting successful market expansion strategies [14]. - Titan Technology leveraged partnerships with overseas distributors and acquisitions to enhance its competitive brand presence [14]. Group 5: Future Outlook - Despite external uncertainties, the overall trend indicates a robust commitment from Chinese companies to expand in international markets, suggesting a "fast forward" approach to globalization [17].

Core Viewpoint - The article highlights the advancements in portable ultrasound technology, specifically the launch of the EF6 series by BGI Intelligent Manufacturing, which represents a significant leap in imaging capabilities and clinical applicability in the portable ultrasound market [3][11]. Product Mechanism and Design Philosophy - The EF6 series is positioned as a next-generation portable ultrasound flagship model, featuring a systematic redesign in structure and imaging capabilities [4]. - It utilizes a 64-channel/128-element high-precision imaging architecture, doubling the performance compared to mainstream 32-channel portable ultrasound products, significantly enhancing image clarity and detection sensitivity [6]. - The device features a dual-probe integrated design, allowing seamless switching between superficial and deep structures without the need for probe replacement, thus improving operational efficiency [6]. - It supports five common imaging modes (B/M/C/PW/PDI), catering to various clinical applications from routine screening to bedside assessments [6]. - Weighing only 275 grams and roughly the size of a smartphone, the EF6 series is designed for portability, with wireless connectivity and charging capabilities, enhancing operational flexibility [7]. - The device has been tested in extreme conditions, successfully capturing ultrasound images at the summit of Mount Everest, demonstrating its reliability in high-risk environments [7]. Application Scenarios and Clinical Value - The EF6 series is designed for diverse clinical scenarios, including grassroots healthcare, hospital departments, emergency situations, and home care [8]. - In grassroots medical settings, its compact and wireless features make it ideal for initial screenings in community health centers [8]. - Within hospitals, it is particularly suited for ICU, emergency, and postoperative monitoring, enhancing workflow efficiency [8]. - The device is also applicable in emergency and pre-hospital care, suitable for use in ambulances and disaster sites [8]. - In home care and remote consultations, the EF6 can connect with BGI's "Cloud Imaging" platform for real-time image uploads and expert interpretations, facilitating collaborative diagnosis [9]. Industry Trends and Market Significance - The portable ultrasound segment is one of the fastest-growing categories in the global medical device market, driven by increasing demand for mobile healthcare solutions [10]. - The past decade has seen a shift in the domestic market from imitation to innovation, with significant advancements in portable ultrasound technology supported by government policies [10]. - The registration of the EF6 series fills a gap in high-channel dual-probe portable devices in China, providing a competitive edge for domestic brands in the international market [11]. - The device represents a shift from basic diagnostic tools to essential auxiliary equipment in clinical settings, reflecting evolving market demands [10]. BGI Intelligent Manufacturing's Ecosystem Development - The launch of the EF6 series marks a key milestone in BGI Intelligent Manufacturing's ultrasound imaging product line, which focuses on integrating various detection platforms [12]. - BGI has developed a comprehensive ecosystem centered around the "Cloud Imaging" platform, enabling seamless integration with ultrasound devices for remote diagnostics and quality control [13]. - As of June 2025, BGI has obtained over 400 product registration certificates, establishing a global network for its ultrasound, genetic, and pathological devices [13].