证券代码：603658 证券简称：安图生物 公告编号：2026-008 郑州安图生物工程股份有限公司 关于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。 | | 同型半胱氨酸检测试 | 豫械注准 | | 本产品用于体外定量检测人血清样本中同型半 | | --- | --- | --- | --- | --- | | 5 | 剂盒（液相色谱-串联 | 20262400103 | 5 年 | 胱氨酸的含量。 | | | 质谱法） | | | | 二、同类产品相关情况 根据国家药品监督管理局官网数据查询信息，截至公告日，国内外同行业部 分厂家已取得上述部分类似产品的医疗器械注册证。详情请登录国家药品监督管 理局（https://www.nmpa.gov.cn）查阅。 三、对公司的影响 上述医疗器械注册证的取得进一步丰富了公司产品菜单，不断满足市场需 求，是对公司现有检测产品的有效补充，可以逐步提高公司产品的整体竞争力， 短期内对公司的经营业绩影响较小。 四、风险提示 上述产品上市后实际销售情况取决于未来市场 ...

重要内容提示： 一、本次使用闲置募集资金进行现金管理赎回的情况 2025 年 9 月 26 日，公司通过上海浦东发展银行郑州未来路支行使用非公开发行 股票闲置募集资金购买大额存单 2,000 万元。上述大额存单已于 2026 年 3 月 2 日到 期，公司收到到期本金人民币 2,000 万元，获得利息收益人民币 26.87 万元。上述大 额存单本金和收益于 2026 年 3 月 2 日归还至募集资金账户。 证券代码：603658 证券简称：安图生物 公告编号：2026-007 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。 | 募集资金总投资额度（万元） | 168,000.00 | | --- | --- | | 目前已使用的投资额度（万元） | 155,000.00 | | 尚未使用的投资额度（万元） | 13,000.00 | 注：上述最近12个月截至目前公司募集资金现金管理情况包括：2019年公开发行可转换公司 债券闲置募集资金和2020年非公开 ...

Core Viewpoint - The diagnostic reagent industry in China is experiencing fluctuations in market size due to the impact of COVID-19, with a projected recovery and growth expected by 2025, reaching a market size of 140 billion yuan, an 8% increase year-on-year [6][7]. Industry Overview - Diagnostic reagents are essential tools in medicine and biology for detecting diseases, infections, and other medical conditions through interactions with biological samples [4][6]. - The market is primarily dominated by in vitro diagnostic reagents, while in vivo diagnostics remain relatively small [6]. Market Size and Trends - The market for in vitro diagnostic reagents in China has shown an upward trend since 2015, with rapid growth from 2020 to 2022 due to the pandemic, but a 14% decline in 2023 due to reduced demand for COVID-19 diagnostic reagents [6][7]. - The market is expected to recover in 2024, with projections indicating a market size of 140 billion yuan by 2025, reflecting an 8% year-on-year growth [6][7]. Competitive Landscape - The diagnostic reagent market includes both domestic companies like Mindray Medical, Antu Bio, and Wanfu Bio, and international firms such as Roche Diagnostics and Abbott, all competing for market share [8]. - Domestic companies are noted for their strong R&D capabilities and significant market presence [8]. Industry Development Stages - The diagnostic reagent industry in China has progressed through four stages: nascent, initial, extensive development, and rapid growth, with significant advancements in technology and regulatory improvements since the 21st century [5]. Industry Chain - The industry chain consists of upstream raw materials (diagnostic enzymes, antigens, antibodies, etc.), the midstream diagnostic reagent production, and downstream applications in medical institutions and third-party diagnostic organizations [6]. Market Segmentation - The in vitro diagnostic reagent market is segmented, with immunodiagnostic reagents holding a 32% market share, followed by molecular diagnostic reagents at 19%, and biochemical diagnostic reagents at 18% [7]. Future Trends - The industry is expected to focus on high-end product upgrades, with companies increasing R&D investments to enhance product value amidst price pressures from centralized procurement [9]. - There is a trend towards market penetration in lower-tier cities and global expansion, with domestic products entering emerging markets in Southeast Asia and Africa [10]. - The industry is evolving towards a model centered on clinical value and personalized medicine, integrating diagnostic solutions with treatment recommendations [11].

证券代码：603658 证券简称：安图生物 公告编号：2026-006 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： 郑州安图生物工程股份有限公司（以下简称"公司"）于 2025 年 12 月 9 日召开第五届董事会第九次会议，审议通过了《关于使用闲置募集 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 1.4 亿元公开发行可转 换公司债券闲置募集资金和不超过15.4 亿元非公开发行股票闲置募集资 金进行现金管理，分别用于购买产品期限或剩余期限不超过 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 12 个月 内滚动使用。具体内容详见公司于 2025 年 12 月 10 日在上海证券交易所 网站（www.sse.com.cn）披露的《安图生物关于使用闲置募集资金进行 现金管理的公 ...

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 河南省药品监督管理局颁发的医疗器械注册证，具体如下： 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：2026-005 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 郑州安图生物工程股份有限公司董事会 2026 年 2 月 12 日 根据国家药品监督管理局官网数据查询信息，截至公告日，国内外同行业部 分厂家已取得上述部分类似产品的医疗器械注册证。详情请登录国家药品监督管 理局（https://www.nmpa.gov.cn）查阅。 三、对公司的影响 上述医疗器械注册证的取得进一步丰富了公司产品菜单，不断满足市场需 编号 产品名称 注册证编号 注册证 有效期 预期用途 所属 公司 1 霉酚酸检测试剂盒（液 相色谱-串联质谱法） 豫械注准 20262400056 5 年 本产品用于体外定量 ...

Core Insights - The digital PCR (dPCR) technology is emerging as a significant advancement in nucleic acid detection, providing more precise and sensitive methods for quantitative analysis, addressing limitations of traditional PCR methods [1][10] - The Chinese digital PCR market is projected to grow from 1.584 billion yuan in 2019 to 8.815 billion yuan by 2025, with a compound annual growth rate (CAGR) of 33.1% [1][10] - The growth is driven by technological advantages and supportive national policies, with increasing recognition of its value among researchers and clinicians [1][10] Industry Overview - Digital PCR is categorized into droplet digital PCR (ddPCR) and chip digital PCR (cdPCR), allowing for absolute quantification without relying on standard curves, suitable for single-cell analysis and early cancer diagnosis [3][4] - The technology offers significant advantages over traditional PCR, including higher sensitivity, accuracy, and better tolerance to complex samples [4][5] Market Dynamics - The digital PCR industry is supported by a robust supply chain, with upstream components including essential biological materials and core parts like optical and fluid control components [6] - The midstream involves the research, production, and sales of digital PCR devices, with notable domestic companies like New Yi Biological and Zhenzhun Biological emerging as competitors [6][7] Application Areas - Digital PCR is utilized in various fields, including clinical diagnostics for pathogen detection, research for gene expression analysis, food safety testing, and agricultural applications [7][8] - In clinical settings, it plays a crucial role in early disease diagnosis and monitoring, particularly in oncology and infectious diseases [8] Competitive Landscape - The digital PCR market in China has seen the emergence of several domestic companies, with 16 manufacturers winning bids in 2024, of which 11 are local brands [12][12] - New Yi Biological and Linghang Gene lead in market share, with respective bid shares of 20% and 17.14% [12] Future Trends - Continuous technological innovation is expected to enhance detection efficiency and reduce costs, with advancements in multi-color fluorescence detection and microfluidic chip technology [16][17] - Collaboration among upstream suppliers, midstream manufacturers, and downstream application sectors will foster a synergistic development environment [17] - There is a growing focus on expanding into international markets, with domestic companies aiming to enhance their global presence and competitiveness [18][19]

Core Viewpoint - The company acknowledges that its stock price in the secondary market is influenced by multiple factors including industry policies, macroeconomic conditions, capital market supply and demand, and investor risk appetite [1] Group 1: Company Strategy - The company emphasizes the importance of stock price performance and shareholder concerns, indicating a commitment to addressing these issues [1] - The company plans to continue focusing on its core business, increasing research and development investment, and expanding its product line to enhance operational quality and core competitiveness [1] - The company aims to comprehensively layout in precision medicine and smart healthcare, while also strengthening market communication through compliant channels to protect the long-term interests of all shareholders [1]

Group 1 - The core viewpoint of the article is that Antu Bio has successfully installed its AI-assisted clinical decision-making system in over 30 hospitals, integrating smoothly with existing laboratory equipment and LIS systems, with minimal impact on the company's gross margin [1] Group 2 - The AI inspection system is currently operational in more than 30 hospitals [1] - The integration of the AI system with existing hospital equipment and LIS systems has been successful [1] - The impact of the AI system on the company's gross margin is reported to be small [1]

Group 1: Economic Growth and Industrial Performance - The industrial added value of Zhengzhou is projected to grow by 9% year-on-year by 2025, with over 70% of industries experiencing growth [1][2] - Among the 38 major industrial categories, 27 are expected to maintain growth, increasing the growth rate by 8.9 percentage points compared to 2024 [2] - Key industries such as electronics and automotive manufacturing are expected to see added value growth of 16.2% and 11.9% respectively, contributing 6.4 percentage points to the overall industrial growth [2] Group 2: Leading Enterprises and Their Contributions - Leading companies like Yutong Bus, Antu Bio, and Super Fusion are driving industrial transformation in Zhengzhou [3] - Yutong Group is expected to sell 63,798 commercial vehicles in 2025, achieving a revenue of 49.38 billion yuan, a year-on-year increase of 11.4% [3] - Yutong's sales of new energy buses are projected to grow by 22.94%, with exports reaching 17,149 units, a 22.49% increase [3][4] Group 3: Research and Development Investments - Antu Bio's R&D investment reached 545 million yuan in the first three quarters of 2025, accounting for 17.42% of its revenue, with over 1,000 medical device registrations [4] - Super Fusion, established in Zhengzhou in 2021, aims for a revenue target of 50 billion yuan in 2025, with rapid growth in its server business [4] Group 4: Systemic Competitiveness and Future Outlook - Zhengzhou's economic total is expected to exceed 1.5 trillion yuan by 2025, reflecting both quantitative and qualitative transformations [5] - The city has become a pilot for comprehensive market-oriented reform, enhancing its development potential [6] - Zhengzhou's talent pool has surpassed 3.2 million, supported by initiatives like the "Zheng Gathering Talent Plan" [6]

Group 1: Nipah Virus Detection Products - Wanfu Biology announced the launch of "Nipah Virus Nucleic Acid Detection Kit (Fluorescent PCR Method)" to meet the demand for rapid and accurate testing [2] - Kehua Bio stated that its subsidiary has developed a Nipah virus detection kit to support key prevention and control points such as customs and disease control centers [3] - Zhijiang Biology emphasized the importance of early virus isolation and nucleic acid testing due to the non-specific symptoms in early-stage patients, offering a high-sensitivity detection kit [4] - Capbio has developed a Nipah virus detection kit, providing core technical support for global quarantine and disease control monitoring [4] - Shengxiang Biology offers a dual-platform solution for rapid and accurate detection of Nipah virus, with its detection kit already receiving EU CE certification [4] - Antu Biology provides rapid detection support through its fully automated nucleic acid purification and real-time fluorescent PCR analysis system [4] Group 2: Market Reactions and Clarifications - Some A-share companies clarified their positions, stating they do not have any business related to Nipah virus. Hualan Biological announced it has no vaccine products for Nipah virus [5] - Sely Medical confirmed it currently has no Nipah virus testing reagents or treatment drugs in reserve [6] - Other companies like Weixin Kang and CanSino also stated they do not have related products [7]