证券代码：603658 证券简称：安图生物 公告编号：2025-066 郑州安图生物工程股份有限公司 关于全资子公司完成医疗器械经营许可证及 药品经营许可证变更登记的公告 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。 郑州安图生物工程股份有限公司（以下简称"公司"或"安图生物"）全资 子公司郑州安图科技发展有限公司（以下简称"安图科技"）于近日取得郑州经 济技术开发区市场监督管理局换发的《医疗器械经营许可证》以及河南省药品监 督管理局换发的《药品经营许可证》，变更后具体情况如下： 法定代表人：刘军 企业负责人：刘军 住 所：河南自贸试验区郑州片区（经开）经北一路87号院生产研发中心 生产楼 经营场所：河南自贸试验区郑州片区（经开）经北一路87号院生产研发中心 生产楼二楼 库房地址：郑州经济技术开发区经开第十五大街199号12号楼1层B区；武汉 市东西湖区田园大道99号（委托九州通医药集团物流有限公司贮存、配送，仅 限自营产品）；广州市白云区钟落潭镇梅田村康安一街46号仓库楼一层、六层、 八层；中山市火炬开发区沿江东二路11号 ...

Core Viewpoint - The announcement highlights that Zhengzhou Antu Biological Engineering Co., Ltd. and its wholly-owned subsidiary, Antu Instrument (Zhengzhou) Co., Ltd., have received medical device registration certificates from the National Medical Products Administration, which enhances the company's product offerings and competitiveness in the market [1][2]. Group 1: Medical Device Registration - The company and its subsidiary have recently obtained medical device registration certificates, which are crucial for expanding their product portfolio [1]. - The registration certificates were issued by the National Medical Products Administration and the Henan Provincial Drug Administration [1]. Group 2: Market Impact - The acquisition of the medical device registration certificates will enrich the company's product menu and meet market demands, serving as an effective supplement to existing detection products [2]. - The short-term impact on the company's operating performance is expected to be minimal [2]. Group 3: Industry Context - Similar products have been registered by various domestic and international manufacturers, indicating a competitive landscape in the medical device sector [1].

Core Viewpoint - Antu Biology (603658.SH) has received medical device registration certificates from the National Medical Products Administration and the Henan Provincial Drug Administration, enhancing its product offerings and competitiveness in the market [1] Group 1 - The acquisition of the medical device registration certificates enriches the company's product menu [1] - The new certifications serve as an effective supplement to the company's existing testing products [1] - The short-term impact on the company's operating performance is expected to be minimal [1]

Core Viewpoint - Antu Biology (603658.SH) has received medical device registration certificates from the National Medical Products Administration and the Henan Provincial Drug Administration, enhancing its product offerings and competitiveness in the market [1] Group 1 - The company and its wholly-owned subsidiary, Antu Instrument (Zhengzhou) Co., Ltd., have recently obtained medical device registration certificates [1] - The acquisition of these certificates enriches the company's product menu and meets market demand [1] - This development serves as an effective supplement to the company's existing testing products, gradually improving overall competitiveness [1] Group 2 - The short-term impact on the company's operating performance is expected to be minimal [1]

二、同类产品相关情况 证券代码：603658 证券简称：安图生物 公告编号：2025-065 郑州安图生物工程股份有限公司 关于公司及全资子公司获得医疗器械注册证的公告 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。 郑州安图生物工程股份有限公司（以下简称"公司"或"安图生物"）及全 资子公司安图实验仪器（郑州）有限公司（以下简称"安图仪器"）于近日收到 国家药品监督管理局、河南省药品监督管理局颁发的医疗器械注册证，具体如下： | 编号 | 产品名称 | 注册证编号 | 注册证 | 预期用途 | 所属 | | --- | --- | --- | --- | --- | --- | | | | | 有效期 | | 公司 | | 1 | 曲霉菌半乳甘露聚糖 抗原检测试剂盒（磁 微粒化学发光法） | 国械注准 20253401899 | 年 5 | 本产品用于体外定性检测人血清中的 曲霉菌半乳甘露聚糖抗原（GM）。 | | | 2 | 曲霉菌 抗体检测 IgG 试剂盒（磁微粒化学 发光法） | 国械注准 20253402004 | ...

基本情况 | 投资金额 | 万元 17,000 | | --- | --- | | 投资种类 | 大额存单 | | 资金来源 | 募集资金 | 郑州安图生物工程股份有限公司 关于使用闲置募集资金进行现金管理 赎回及进展的公告 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。 重要内容提示： 证券代码：603658 证券简称：安图生物 公告编号：2025-064 已履行的审议程序 郑州安图生物工程股份有限公司（以下简称"公司"）于 2024 年 12 月 11 日召开第五届董事会第二次会议、第五届监事会第二次会议，审议 通过《关于使用部分闲置募集资金进行现金管理的议案》，同意公司在 确保不影响募集资金投资项目建设和募集资金使用的情况下，公司拟分 别使用不超过 1.7 亿元公开发行可转换公司债券闲置募集资金和不超过 17 亿元非公开发行股票闲置募集资金进行现金管理，分别用于购买单次 持有期限不超过 12 个月的结构性存款、大额存单、国债逆回购、券商收 益凭证、券商理财产品等安全性高、流动性好的保本型产品。在上述额 度范围内，资金可在 ...

Core Viewpoint - Antu Biology's stock performance shows a slight decline, with a trading volume of 1.01 billion yuan and a net financing purchase indicating low investor confidence [1][2]. Financing Summary - On September 22, Antu Biology had a financing purchase of 10.57 million yuan and a net financing purchase of 3.90 million yuan, with a total financing balance of 622 million yuan, representing 2.72% of its market capitalization [1]. - The financing balance is below the 50th percentile level over the past year, indicating a low position [1]. - The short selling data shows a repayment of 100 shares with no shares sold, and a short selling balance of 1.81 million yuan, also below the 10th percentile level over the past year [1]. Financial Performance - For the first half of 2025, Antu Biology reported a revenue of 2.06 billion yuan, a year-on-year decrease of 6.65%, and a net profit of 571 million yuan, down 7.83% year-on-year [2]. - Cumulatively, the company has distributed 4.046 billion yuan in dividends since its A-share listing, with 1.794 billion yuan distributed in the last three years [2]. Shareholder Structure - As of June 30, 2025, the number of shareholders increased to 34,200, with an average of 16,719 circulating shares per person, a slight decrease of 0.04% [2]. - The top ten circulating shareholders include notable institutional investors, with changes in holdings indicating varying levels of confidence among investors [3].

Core Insights - Antu Biotech held a performance briefing for the first half of 2025, highlighting significant growth in overseas markets [1] Overseas Business Performance - The company has successfully sold products to over 100 countries and regions globally, with a focus on Asia, Europe, the Middle East, Africa, and Latin America [1] - Key products for international promotion include chemiluminescence, mass spectrometry, and immunoassay systems, with rapid growth observed in Asia (India, Southeast Asia), Latin America, and Europe [1] - The Asia-Pacific region primarily drives sales through chemiluminescence products, while Europe focuses on mass spectrometry products [1] Market Contribution - Overseas sales from the Asian market contribute over 40% to the company's revenue and continue to grow rapidly [1] - The contribution from emerging markets in Latin America is increasing year by year [1] - In Europe, the high-end market is gradually increasing its market share using mass spectrometry as an entry point [1]

Investment Rating - The report maintains a "Recommended" rating for the company with a target price of 51 yuan [2][8]. Core Views - The company's revenue for the first half of 2025 was 2.06 billion yuan, a decrease of 6.65% year-on-year, while the net profit attributable to the parent company was 571 million yuan, down 7.83% [2]. - In Q2 2025, the company achieved revenue of 1.064 billion yuan, a decline of 4.79%, but the net profit attributable to the parent company increased by 1.97% to 301 million yuan, indicating a quarter-on-quarter improvement [2]. - The domestic luminous business is under pressure, but there was a sequential improvement in Q2 [2][8]. - The company continues to focus on R&D, with an investment of 350 million yuan in the first half of 2025, accounting for 16.99% of revenue [8]. Financial Summary - For 2025, the company is projected to achieve total revenue of 4.658 billion yuan, with a year-on-year growth rate of 4.2% [4]. - The net profit attributable to the parent company is expected to be 1.264 billion yuan in 2025, reflecting a growth rate of 5.8% [4]. - The earnings per share (EPS) for 2025 is estimated at 2.21 yuan, with a price-to-earnings (P/E) ratio of 19 times [4]. - The company’s total assets are projected to reach 12.306 billion yuan by 2025, with a debt-to-equity ratio of 9.9% [9]. Business Performance - Domestic revenue in the first half of 2025 was 1.904 billion yuan, down 8.32%, while overseas revenue increased by 19.78% to 157 million yuan [8]. - The company has accelerated its global expansion, entering over 100 countries and regions, and has established subsidiaries in Hong Kong, Hungary, and Indonesia to enhance local operations [8]. - The company has launched several innovative products, including a series of gene sequencers and an AI-assisted clinical decision-making system [8].

Core Viewpoint - The article discusses the evolving landscape of the medical device industry in China, highlighting the importance of business development (BD) strategies that go beyond mere numbers to encompass strategic partnerships, market expansion, and technological integration [1][24]. Group 1: Key Trends in Medical Device BD - The primary keywords for the period from July to September include cross-border introduction and global distribution, strategic cooperation, and capital and cross-industry integration [2]. - Companies are accelerating market expansion and ecosystem building through transactions across various fields, including cardiovascular, neuro-intervention, ophthalmology, IVD, and critical care [3]. Group 2: Representative Events - A total of 20 significant events were summarized, showcasing a "multi-line advancement" scenario in the industry [4]. - Notable collaborations include: - Nanjing Jianxin Medical and Heqi Family Office focusing on medical device R&D and wealth management [6]. - Olympus and Xingchenhai Medical signing a global distribution agreement for disposable urology products [6]. - He’s Eye Group and Zeiss China Medical forming a strategic partnership to enhance ophthalmic surgical technology [6]. Group 3: Cross-Border and Global Distribution - Cross-border transactions remain a hot topic, with domestic companies leveraging global markets for growth while foreign giants introduce Chinese innovations [9]. - The partnership between Ruichao Dinkai Group and Beijing Amite focuses on vascular intervention products, marking a new phase in safety standards [7]. Group 4: Strategic Cooperation and Channel Expansion - Strategic cooperation is increasingly focused on building ecosystems rather than single product breakthroughs, with companies forming partnerships in fields like ophthalmology, IVD, and diagnostics [19]. - The collaboration between Wanfu Biological and Beiden Medical aims to match products with non-public medical channels effectively [15]. Group 5: Capital Support and Cross-Industry Integration - Capital is becoming an invisible driver of medical device BD, with partnerships exploring new models for medical device distribution [20]. - The collaboration between Beijing Huamai Supply Chain Management and Hongyi Consulting aims to create a one-stop service for medical device distribution [20]. Group 6: Smart Hospitals and Full-Chain Coordination - The focus on smart hospitals and full-chain coordination is becoming a priority for large enterprises, integrating supply chains, academic promotion, and clinical needs [23]. - Collaborations like that of Ruibo Zehou Technology and China National Pharmaceutical Group aim to develop automated systems for smart hospitals [21]. Conclusion - The medical device industry in China is transitioning from a "single product-driven" phase to a more diversified approach supported by capital, channels, and ecosystems, indicating a long-term growth trajectory [24].