Core Viewpoint - Meikang Bio (300439.SZ) has recently obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the Zhejiang Provincial Drug Administration, which is expected to enhance the company's product line in the field of blood coagulation diagnostics and positively impact its future operations [1] Group 1 - The product name is Anti-Xa Test Kit (Colorimetric Substrate Method) [1] - The acquisition of the registration certificate enriches the company's product offerings in the in vitro diagnostic blood coagulation niche [1] - This development is anticipated to improve the company's core competitiveness and market expansion capabilities [1]

美康生物科技股份有限公司 三、备查文件 证券代码：300439 证券简称：美康生物 公告编号：2025-056 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 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： 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 | 美康生物 | 抗 Xa | 检测试剂盒（发 | 浙 械 注 准 | 2025年9月16 | 日至 | 用于体外定量测定人血浆 中普通肝素（UFH）和低分 | | | | 色底物法） | | 20252401717 | 年 月 2030 9 15 | 日 | 子量肝素（LMWH）的活性。 | 二、对公司业绩的影响及风 ...

美康生物（300439）(300439.SZ)公告，公司近日取得了由浙江省药品监督管理局颁发的《医疗器械注 册证(体外诊断试剂)》，产品名称为抗Xa检测试剂盒(发色底物法)。 ...

智通财经APP讯，美康生物(300439.SZ)公告，公司近日取得了由浙江省药品监督管理局颁发的《医疗器 械注册证(体外诊断试剂)》，产品名称为抗Xa检测试剂盒(发色底物法)。 ...

Group 1 - The core point of the article is that Meikang Bio has recently obtained a medical device registration certificate for its "Anti-Xa Test Kit" from the Zhejiang Provincial Drug Administration [1] - Meikang Bio's revenue composition for the year 2024 is projected to be 100.0% from medical devices [1] - As of the report, Meikang Bio has a market capitalization of 3.9 billion yuan [1]

Market Strategy - The market experienced a pullback after a brief rise, with total trading volume exceeding 30 trillion yuan [5][7] - The Shanghai Composite Index fell by 1.15% to close at 3831.66 points, while the ChiNext Index dropped by 1.64% to 3095.85 points [7][9] - The technology sector remained active, particularly in semiconductor and computing hardware, while other sectors like non-bank financials and materials lagged [8][9] Important Economic News - The People's Bank of China conducted a 487 billion yuan reverse repurchase operation with a 1.40% interest rate, resulting in a net injection of 195 billion yuan [14][15] - The Federal Reserve lowered interest rates by 25 basis points to a range of 4.00%-4.25%, marking the first rate cut in nine months [16][17] - In August, the postal industry in China saw a revenue increase of 4.4% year-on-year, with total revenue reaching 142.99 billion yuan [18][19] - By the end of August, the number of electric vehicle charging infrastructure units in China grew by 53.5% year-on-year, totaling 17.348 million units [20][21] Industry and Company Dynamics - JD Group and Giant Dragon Technology have formed a strategic partnership, successfully delivering their first batch of electric two-wheelers [25][26] - In August 2025, China's securities transaction stamp duty saw a significant increase of 226% year-on-year, with total revenue reaching 25.1 billion yuan [27][28] - Tesla signed a letter of intent with PharmAGRI to supply up to 10,000 Optimus 3+ robots for agricultural operations [29][30] - Meta launched AI smart glasses with a built-in display, starting at a price of $799, featuring new interaction methods [31][32][34] - In August, the average operating rate of engineering machinery in China was 43.42%, with Zhejiang province leading in performance [35][36] - TCL Technology announced plans to invest in an 8.6-generation printed OLED production line, with a total investment of approximately 29.5 billion yuan [37][39] - Meikang Bio obtained four medical device registration certificates for in vitro diagnostic reagents, enhancing its product portfolio [40][41]

Policy Developments - The head of the National Medical Products Administration emphasized the importance of improving the efficiency of drug review and approval processes to ensure product quality and accelerate the market entry of new drugs [2] - Measures include prioritizing the review of urgently needed clinical products, reducing the review time for innovative drug clinical trials from 60 to 30 working days, and optimizing supplementary application review procedures [2] Industry Insights - The optimization of the review and approval process addresses the issues of "difficult and expensive medication" for patients, while also reducing time and institutional transaction costs for pharmaceutical companies, alleviating core pressures in R&D, production, and operations [3] Market Developments - Health 160 successfully listed on the Hong Kong Stock Exchange, closing at HKD 28.22 per share, with a market capitalization of HKD 9.495 billion [10] - Meikang Bio's subsidiary obtained a medical device registration certificate for four products, enhancing the company's product line and market competitiveness [7] Innovation and Drug Approvals - In the first seven months of the year, 50 innovative drugs were approved, surpassing the total of 48 for the entire previous year, indicating a strong momentum in drug innovation [13] - The approval of innovative drugs is driven by policy support, technological advancements, and increased capital investment, with a shift from me-too drugs to first-in-class innovations [13] Strategic Partnerships - Maiwei Bio signed an exclusive licensing agreement with Kalexo Bio, potentially receiving up to USD 1 billion in upfront and milestone payments, which is expected to positively impact the company's future performance [14]

美康生物（300439）(300439.SZ)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《医疗器械注册证(体外诊断试剂)》，产品包括：组织型纤 溶酶原激活剂-抑制剂1复合物检测试剂盒(化学发光免疫分析法)、凝血酶-抗凝血酶复合物检测试剂盒 (化学发光免疫分析法)、血栓调节蛋白检测试剂盒(化学发光免疫分析法)、纤溶酶-α2纤溶酶抑制剂复合 物检测试剂盒(化学发光免疫分析法)。 ...

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 ...

格隆汇9月17日丨美康生物(300439.SZ)公布，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）》，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。 | 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 | | --- | --- | --- | --- | --- | --- | | | 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 | 2025年9月15日至 | 用于体外定量测定人血浆中 剂 1 复合物(t-PAIC)的浓度。 临床上用于心血管疾病和弥 | | | | | | | 组织型纤溶酶原激活剂-抑制 | | | | | 20252400203 | 2030年9月14日 | | | | | 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 ...