Group 1 - The company, Meikang Bio (300439.SZ), has recently obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the National Medical Products Administration and the Zhejiang Provincial Drug Administration [1] - The registered products include the hepatitis B virus e antibody detection kit (chemiluminescent microparticle immunoassay) and the Golgi protein 73 detection kit (chemiluminescent microparticle immunoassay) [1]

美康生物科技股份有限公司 关于公司取得医疗器械注册证的公告 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：2026-001 本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"美康生物"或"公司")于近日取得 了由国家药品监督管理局、浙江省药品监督管理局颁发的《中华人民共和国医疗 器械注册证（体外诊断试剂）》（以下简称"《注册证》"），具体情况如下： | 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 | | --- | --- | --- | --- | --- | --- | | | 美康生物 | 乙型肝炎病毒 e 抗体 测定试剂盒（化学发 | 国 械 注 准 | 年 月 日至 2025 12 29 | 本产品用于体外定量检测 人血清或血浆中乙型肝炎 | | 1 | | 光微粒子免疫检测 | 20253402682 | 2030 年 12 月 28 日 | 病毒 e 抗体（Anti-HBe）的 | | | | 法） | | | 含量。 | | 2 | 美 ...

| 股票简称 | 股票代码 | 限售股类型 | 解禁股数 | | --- | --- | --- | --- | | 美康生物 | 300439 | 股权激励限售流通 | 47.5万 | | 安培龙 | 301413 | A股发行法人配售上市 | 94.62万 | 智通财经APP获悉，12月18日共有2家上市公司的限售股解禁，解禁总市值约5942.87万元。 今日具体限售解禁股情况如下： ...

（文章来源：证券日报） 证券日报网讯美康生物11月27日在互动平台回答投资者提问时表示，公司会在定期报告中披露对应时点 的股东信息。截至2025年9月30日，公司的股东人数为23895户。 ...

Core Viewpoint - Meikang Bio's stock price has shown fluctuations, with a recent increase of 2.07% but a year-to-date increase of only 0.53%, indicating potential volatility in the market [1]. Financial Performance - For the period from January to September 2025, Meikang Bio reported a revenue of 1.136 billion yuan, a year-on-year decrease of 19.27% [2]. - The net profit attributable to the parent company was 60.53 million yuan, reflecting a significant year-on-year decline of 73.02% [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]. Market Activity - On November 24, Meikang Bio's stock was trading at 10.37 yuan per share, with a total market capitalization of 3.985 billion yuan [1]. - The stock experienced a net outflow of main funds amounting to 2.9142 million yuan, with large orders accounting for 6.43% of purchases and 16.54% of sales [1]. Business Overview - Meikang Bio, established on July 22, 2003, and listed on April 22, 2015, specializes in the research, production, and sales of in vitro diagnostic products, as well as providing third-party medical diagnostic services [1]. - The revenue composition includes 67.88% from in vitro diagnostic reagents, 20.40% from medical diagnostic services, 10.48% from in vitro diagnostic instruments, and 1.24% from other sources [1]. Dividend Information - 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 was the Medical Device ETF (159883), which holds 1.4234 million shares as a new shareholder [3].

Core Insights - The company is actively embracing policy changes and has implemented measures such as refined management, large-scale production, and supply chain optimization to maintain and enhance its market share in the biochemical immunology products sector [1][3] - The company has launched innovative products, including an "11-minute myocardial marker test" and VAP precision lipid testing technology, addressing critical clinical needs and filling gaps in the domestic market [2] - The company is accelerating its international market expansion by enhancing its international sales team and pursuing product registrations and certifications in strategic markets such as the Middle East, Southeast Asia, and South America [3] Summary by Sections Company Strategy - The company is focusing on refined management, large-scale production, and supply chain optimization to counteract the revenue and profit pressures from domestic policy changes in the in vitro diagnostic industry [1] - The company aims to maintain and enhance its market share and brand influence in the biochemical immunology products sector through these strategic measures [1] Product Innovation - The company introduced a groundbreaking "11-minute myocardial marker test" at its channel conference in October 2025, representing a significant technological advancement [2] - The VAP precision lipid testing technology targets high morbidity and mortality rates associated with atherosclerosis in China, providing critical diagnostic indicators [2] - The company has made significant progress in building its mass spectrometry testing platform, obtaining multiple registrations for various testing reagents by 2025 [2] International Expansion - The company is deepening its international strategy by enhancing the quality and capabilities of its international sales team and accelerating product registrations and certifications [3] - The strategic focus on international markets aims to mitigate risks associated with domestic policies and broaden the reach of its innovative products [3] - The company has identified several strategic markets for expansion and is committed to a "technology output + localized operation" model to facilitate overseas business growth [3]

Core Viewpoint - The company is accelerating the registration and certification of its products in international markets while actively expanding its presence in overseas markets [1] Group 1: International Market Strategy - The company is focused on speeding up the registration and certification of its products for international markets [1] - The company is making efforts to establish a strong foothold in overseas markets [1] Group 2: Domestic Operations - The company has established medical testing laboratories in provinces such as Zhejiang, Jiangxi, Henan, Guangdong, and Shandong [1] - These laboratories provide testing services to medical institutions and engage in collaborative construction of medical testing laboratories [1]

（文章来源：证券日报） 证券日报网讯 11月14日晚间，美康生物发布公告称，选举黄盖鹏先生担任公司第五届董事会职工代表 董事。 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 证券代码： 300439证券简称：美康生物公告编号： 2025-071美康生物科技股份有限公司关于非独立董事辞职暨选举职工代表董事及补选董事会审计委员会 委员的公告 四、备查文件 、公司第五届董事会第十七次会议决议； 二、关于选举职工代表董事的情况为保障公司董事会的正常运作，根据《中华人民共和国公司法》（以 下简称"《公司法》"）、《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》等法律法规、规范性文件及《美康生物科技股份有限公司章 本公司及董事会全体成员保证本公告内容真实、准确和完整，并对公告中的任何虚假记载、误导性陈述 或重大遗漏承担责任。 程》（以下简称"《公司章程》"）的有关规定，公司于2025年11月14日召开职工代表大会，经与会职工 代表审议，选举黄盖鹏先生担任公司第五届董事会职工代表董事（简历详见附件），任期自本次职工代 表大会审议通过之日起至第五届董事会届满之日止。黄盖鹏先生符合相关法律法规、规范性文件及《公 司章程》有关董事任职的资格和条件。 鉴于黄盖鹏先生原已担任公司非独立董事，故公司第五届董事 ...

南财智讯11月14日电，美康生物公告，公司董事会近日收到非独立董事黄盖鹏先生的书面辞职报告，因 公司组织架构调整申请辞去公司第五届董事会非独立董事及董事会审计委员会委员职务，辞职后将继续 在公司担任其他职务。黄盖鹏先生的辞职报告自送达公司董事会之日起生效。截至公告披露日，黄盖鹏 先生持有公司股份50,000股，占公司总股本的0.013%。公司将选举黄盖鹏先生为公司第五届董事会职工 代表董事，并补选其为董事会审计委员会委员。 ...