美康生物9月17日公告，公司的控股子公司江西美康盛德生物科技有限公司（简称"江西美康"）取得了由江西省药品监督管理局 颁发的《中华人民共和国医疗器械注册证（体外诊断试剂）》，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 | | --- | --- | --- | --- | --- | --- | | 1 | 江西美康 | 组织型纤溶酶原激活剂- 抑制剂 1 复合物检测试剂 | 赣 械 注 准 20252400203 | 2025年9月15日至 2030年9月14日 | 用于体外定量测定人血浆中 | | | | | | | 组织型纤溶酶原激活剂-抑制 | | | | | | | 剂 1 复合物(t-PAIC)的浓度。 | | | | | | | 临床上用于心血管疾病和弥 | | | | 盒(化学发光免疫分析法) | | | 散性血管内凝血血栓的辅助 | | | | | | | 诊断。 | | 2 | 江西美康 | 凝血酶-抗凝血酶复合物 检测试剂盒(化学发光免 | 赣 械 注 准 | 2025年9月15日至 | 用于体外定量测定人血浆中 凝血酶-抗凝 ...

Core Viewpoint - Meikang Biotech (300439.SZ) has obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the Jiangxi Provincial Drug Administration, enhancing its product line in the field of chemiluminescence diagnostics and positively impacting its core competitiveness and market expansion capabilities [1]. Group 1: Product Registration Details - The registered product is a complex of tissue-type plasminogen activator-inhibitor 1 detection reagent, valid from September 15, 2025, to September 14, 2030, used for quantitative measurement of t-PAIC concentration in human plasma, aiding in the diagnosis of cardiovascular diseases and disseminated intravascular coagulation [2]. - Another registered product is the thrombin-antithrombin complex detection reagent, also valid from September 15, 2025, to September 14, 2030, used for assessing coagulation activation status and assisting in the diagnosis of thrombotic diseases [2]. - The company has also registered a thrombomodulin detection reagent, valid for the same period, which is used for quantitative measurement of TM concentration in human plasma, assisting in the diagnosis of endothelial cell injury [2]. - Additionally, a detection reagent for plasmin-α2-plasmin inhibitor complex has been registered, with the same validity period, aimed at assisting in the diagnosis of thrombotic diseases [2].

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 证券代码：300439 证券简称：美康生物 公告编号：2025-055 美康生物科技股份有限公司 近日，美康生物科技股份有限公司（以下简称"公司"）的控股子公司江西 美康盛德生物科技有限公司（以下简称"江西美康"）取得了由江西省药品监督 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： 关于控股子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 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。 三、备查文件 《中华人民共和国医疗器械注册证（体外诊断试剂）》。 | 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 | | --- | --- | --- | --- | -- ...

Core Viewpoint - Meikang Bio (300439.SZ) has obtained a medical device registration certificate for chromatography columns, enhancing its product line in the in vitro diagnostic mass spectrometry sector, which is expected to positively impact the company's future operations [1] Group 1 - Meikang Bio's wholly-owned subsidiary, Ningbo Meikang Shengde Biotechnology Co., Ltd., received the medical device registration certificate from the Zhejiang Provincial Drug Administration [1] - The acquisition of the registration certificate enriches the company's product offerings in the in vitro diagnostic mass spectrometry niche [1] - This development is anticipated to strengthen the company's core competitiveness and market expansion capabilities [1]

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：2025-054 美康生物科技股份有限公司 关于全资子公司取得医疗器械注册证的公告 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"公司")的全资子公司宁波美康盛德 生物科技有限公司(以下简称"盛德生物")于近日取得了由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》（以下简称"《注册证》"），具 体情况如下： 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 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 盛德生物 | 色谱柱 | 浙械注准 | 20252221668 | 2025 2030 | 年 9 月 年 月 9 | 4 日至 日 3 | 与液相色谱系统或液相色谱串联 质谱系统配套使用，用于对人体样 本中被测物进行分离。 | 二、对公司业绩的影响及风险提示 上述《注册 ...

（编辑 袁冠琳） 证券日报网讯 美康生物9月5日在互动平台回答投资者提问时表示，公司持续深化国际化战略，积极布 局海外市场，将继续提升国际销售团队素质及业务能力，加快推进产品国际市场注册及认证，提升企业 在国际市场的综合实力。 ...

Core Viewpoint - Meikang Bio announced on September 5 that as of June 30, 2025, the number of its shareholders will be 25,679 [2] Company Summary - The company is actively engaging with investors through interactive platforms [2] - The projected number of shareholders indicates a growing interest in the company [2]

Group 1: Company Announcements - Heng Rui Medicine has received the clinical trial approval notice for HRS-4729 injection, a self-developed peptide drug targeting GLP-1R, GIPR, and GCGR receptors, with no similar products approved in the market [1] - Hubei Yihua has successfully launched its 200,000 tons/year caustic soda project, aimed at upgrading its chlor-alkali chemical industry and enhancing market competitiveness [2] - Ji Min Health announced that its shareholder, Shuangge Group, plans to reduce its stake by up to 3%, equating to a maximum of 15.75 million shares [3] - China Shipbuilding intends to absorb and merge with China Shipbuilding Industry Corporation through a share exchange, with the latter's A-shares set to be delisted on September 5, 2025 [4] - Changfei Fiber reported that its shareholder, Changjiang Communication, plans to reduce its stake by up to 0.15%, totaling no more than 1.1 million shares [5] Group 2: Strategic Collaborations and Developments - Beijing Lier has signed a strategic cooperation agreement with SenseTime and Xiwang Technology to explore AI computing power collaboration and related applications [6] - Junsheng Electronics is collaborating with leading clients like Zhiyuan Robotics, having achieved bulk supply of customized main control boards and various sensors [7][8] - Guoxin Technology has successfully tested a new generation of high-performance chips for automotive electronic BLDC motor control, aimed at addressing the MCU chip shortage in the automotive sector [9] Group 3: Other Corporate Actions - Guoguang Chain's actual controller plans to reduce their stake by up to 2.99%, totaling a maximum of 12.506 million shares [10] - Zhonghuan Hailu has terminated its control change plan, with its stock set to resume trading on September 5, 2025 [11] - Various companies have reported significant project wins, including Ningbo Construction winning contracts worth 1.117 billion yuan [12]

Group 1 - The core point of the article is that Meikang Bio has announced that its subsidiary, Jiangxi Meikang Shengde Biotechnology Co., Ltd., has obtained a medical device registration certificate for in vitro diagnostic reagents from the Jiangxi Provincial Drug Administration [2] Group 2 - The registration certificate is a significant regulatory approval that may enhance the company's product offerings in the medical device sector [2] - This development indicates the company's ongoing efforts to expand its presence in the biotechnology industry [2] - The approval could potentially lead to increased revenue opportunities for the company through the commercialization of its diagnostic products [2]

Group 1 - Meikang Bio's subsidiary, Jiangxi Meikang Shengde Biotechnology Co., Ltd., has obtained the Medical Device Registration Certificate from the Jiangxi Provincial Drug Administration for products including the "Trace Element Testing Kit" [1] - For the fiscal year 2024, Meikang Bio's revenue composition will be 100% from medical devices [1] - As of the report date, Meikang Bio has a market capitalization of 4.1 billion yuan [1]