一、医疗器械注册证的具体情况 | 序号 | 注册人名称 | 产品名称 | 注册证编号 | | | 注册证有效期间 | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | | | 用于体外定量测定人血浆肝 | | 1 | 江西美康 | 肝素结合蛋白检测试剂盒 | 赣 械 | 注 | 准 | 年 月 2025 4 | 11 | 日至 | 素结合蛋白（HBP）的浓度。 | | | | （化学发光免疫分析法） | 20252400234 | | | 2030 年 月 | 11 | 3 日 | 临床上可作为炎症的辅助指 | | | | | | | | | | | 标。 | 二、对公司业绩的影响及风险提示 上述《注册证》的取得，丰富了公司在体外诊断化学发光细分领域产品线的 品种，有利于进一步提升公司的核心竞争力和市场拓展能力，对公司未来的经营 将产生积极影响。上述产品实际销售情况取决于未来市场推广效果，公司目前尚 无法预测其对公司未来业绩的影响，敬请投资者注意投资风险。 美康生物科技股份有限公司 ...

美康生物科技股份有限公司 证券代码：300439 证券简称：美康生物 公告编号：2025-068 美康生物科技股份有限公司 关于召开 2025 年第一次临时股东大会的提示性公告 公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 美康生物科技股份有限公司（以下简称"公司"）于 2025 年 10 月 28 日召 开了第五届董事会第十六次会议，会议审议通过了《关于召开公司 2025 年第一 次临时股东大会的议案》，决定于 2025 年 11 月 14 日（星期五）召开公司 2025 年第一次临时股东大会，相关内容详见公司于 2025 年 10 月 29 日在巨潮资讯网 （www.cninfo.com.cn）上刊登的相关公告（公告编号：2025-065）。 本次股东大会将采取网络投票和现场投票相结合的方式召开，为保护投资者 合法权益，方便各位股东行使股东大会表决权，现将有关事项提示公告如下： 一、本次股东大会召开的基本情况 1、会议届次：2025 年第一次临时股东大会。 2、会议召集人：公司第五届董事会 3、会议召开的合法、合规性：经公司第五届董事会第十六次会议审议通过 ...

Core Viewpoint - Meikang Bio (300439) announced that its subsidiary, Jiangxi Meikang Shengde Biotechnology Co., Ltd., has obtained a medical device registration certificate for an in vitro diagnostic reagent, specifically a heparin-binding protein test kit, which can serve as an auxiliary indicator for inflammation [1] Group 1 - The product is named the heparin-binding protein test kit (chemiluminescent immunoassay) [1] - The test kit is designed for the quantitative measurement of heparin-binding protein (HBP) concentration in human plasma [1] - The clinical application of the product is as an auxiliary indicator for inflammation [1]

Core Viewpoint - Meikang Bio is a leading company in the in vitro diagnostic field in China, with strong market competitiveness and a diverse range of self-developed products [1] Group 1: Business Performance - In Q3 2025, Meikang Bio reported revenue of 1.136 billion yuan, ranking 8th out of 39 in the industry, surpassing the industry average of 708 million yuan and the median of 330 million yuan, but still significantly behind the top two competitors, New Industries at 3.428 billion yuan and Antu Bio at 3.127 billion yuan [2] - The net profit for the same period was 58.8936 million yuan, ranking 15th out of 39, above the industry median of 26.1892 million yuan but below the industry average of 110 million yuan, with a notable gap from the leaders, Ji'an Medical at 1.588 billion yuan and New Industries at 1.205 billion yuan [2] Group 2: Financial Ratios - As of Q3 2025, Meikang Bio's debt-to-asset ratio was 19.34%, slightly higher than the previous year's 19.16% and above the industry average of 18.29% [3] - The gross profit margin for Q3 2025 was 39.64%, down from 45.80% in the previous year and below the industry average of 56.20% [3] Group 3: Executive Compensation - Chairman Zou Bingde's compensation for 2024 was 1.7668 million yuan, an increase of 566,800 yuan from 2023 [4] - General Manager Zou Jihua's compensation for 2024 was 869,900 yuan, an increase of 69,800 yuan from 2023 [4] Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders for Meikang Bio decreased by 6.95% to 23,900, while the average number of circulating A-shares held per shareholder increased by 7.47% to 12,200 [5]

Core Viewpoint - Meikang Bio's stock price has shown slight fluctuations, with a current market capitalization of 3.997 billion yuan, reflecting a mixed performance in recent trading periods [1] Financial Performance - For the period from January to September 2025, Meikang Bio reported a revenue of 1.136 billion yuan, representing a year-on-year decrease of 19.27% [2] - The net profit attributable to shareholders for the same period was 60.5338 million yuan, down 73.02% year-on-year [2] Shareholder Information - As of September 30, 2025, the number of shareholders for Meikang Bio was 23,900, a decrease of 6.95% from the previous period [2] - The average number of circulating shares per shareholder increased by 7.47% to 12,234 shares [2] Dividend Distribution - Since its A-share listing, Meikang Bio has distributed a total of 388 million yuan in dividends, with 143 million yuan distributed over the past three years [3] Institutional Holdings - As of September 30, 2025, the fifth largest circulating shareholder among Meikang Bio's top ten was the Medical Device ETF (159883), which holds 1.4234 million shares as a new shareholder [3]

Core Viewpoint - Meikang Bio (300439.SZ) reported its Q3 2025 results, highlighting a slight increase in institutional ownership and changes in public fund holdings [1] Institutional Investors - As of October 28, 2025, two institutional investors disclosed holdings in Meikang Bio A-shares, totaling 41.41 million shares, which represents 10.78% of the total share capital [1] - The institutional ownership increased by 0.03 percentage points compared to the previous quarter [1] Public Funds - One public fund, the Medical Device ETF, increased its holdings, contributing to a rise of 0.21% in ownership [1] - A total of 33 public funds did not disclose their holdings in this period, including notable funds such as E Fund CSI Wind Bio-Tech Index (LOF) A and others [1]

中天国富证券有限公司 关于美康生物科技股份有限公司 部分募集资金投资项目延期的核查意见 中天国富证券有限公司（以下简称"中天国富证券"或"保荐机构"）作为 美康生物科技股份有限公司（以下简称"美康生物"或"公司"）向特定对象发 行股票持续督导阶段的保荐机构，根据《证券发行上市保荐业务管理办法》《上 市公司募集资金监管规则》《深圳证券交易所创业板股票上市规则》《深圳证券交 易所上市公司自律监管指引第 2 号——创业板上市公司规范运作》《深圳证券交 易所上市公司自律监管指引第 13 号——保荐业务》等有关规定，对美康生物部 分募集资金投资项目延期的事项进行了审慎核查，核查情况及核查意见如下： 一、募集资金基本情况 经中国证券监督管理委员会出具的《关于同意美康生物科技股份有限公司向 特定对象发行股票注册的批复》（证监许可[2021]310 号）同意注册，公司向 11 名 特定对象发行人民币普通股（A 股）39,999,995 股，每股发行价为人民币 15.00 元，募集资金总额为人民币 59,999.99 万元，扣除发行费用 1,339.62 万元（不含 增值税），实际募集资金净额为人民币 58,660.37 万元 ...

Company Summary - Meikang Bio announced a provision for asset impairment of 10.46 million yuan, which will be included in the company's profit and loss for the first three quarters of 2025, reducing operating profit by the same amount [1] - The total amount of assets written off by the company is 546,700 yuan, with credit impairment losses already accounted for, meaning the write-off will not impact the profit and loss for the reporting period [1] - For the year 2024, the company's revenue composition is entirely from medical devices, accounting for 100% [1] - As of the report, Meikang Bio has a market capitalization of 4 billion yuan [1] Industry Summary - The A-share market has surpassed 4,000 points, marking a significant resurgence after a decade of stagnation, with technology leading the market's transformation and a new "slow bull" market pattern emerging [1]

Company Performance - Meikang Bio reported a revenue of approximately 1.136 billion yuan for the first three quarters of 2025, representing a year-on-year decrease of 19.27% [1] - The net profit attributable to shareholders was approximately 60.53 million yuan, down 73.02% year-on-year [1] - Basic earnings per share were 0.1576 yuan, reflecting a decrease of 73.03% compared to the previous year [1] Market Context - As of the report, Meikang Bio's market capitalization stood at 4 billion yuan [2] - The A-share market has recently surpassed 4000 points, indicating a significant market resurgence after a decade of stagnation, with technology leading the market's transformation [2]

美康生物科技股份有限公司 1 内幕信息知情人登记管理制度 司能够产生重大影响的参股公司都应配合做好内幕信息知情人报备工作。 第一章 总 则 第二章 内幕信息及内幕信息知情人的范围 第一条 为进一步完善美康生物科技股份有限公司（以下简称"公司" ）的 治理结构，维护信息披露的公平原则，防范内幕信息知情人员滥用控制权，泄露 内幕信息，进行内幕交易，根据《中华人民共和国公司法》《中华人民共和国证 券法》《上市公司信息披露管理办法》《深圳证券交易所创业板股票上市规则》 《上市公司监管指引第 5 号——上市公司内幕信息知情人登记管理制度》《深圳 证券交易所上市公司自律监管指引第 5 号——信息披露事务管理》等有关法律 法规及《美康生物科技股份有限公司章程》（以下简称"《公司章程》"）的有 关规定，制定本制度。 第二条 公司董事会是内幕信息的管理机构；董事长为内幕信息管理的主要 责任人；董事会秘书作为直接责任人，负责公司内幕信息的保密管理，在相关重 大信息依法公开披露前负责内幕信息知情人的登记入档和报送事宜。证券事务部 门协助董事会秘书做好公司内幕信息的管理、登记、披露及备案的日常工作。 董事长与董事会秘书应当对内幕信息 ...