证券代码：688575 证券简称：亚辉龙 公告编号：2025-050 深圳市亚辉龙生物科技股份有限公司 上述发明专利技术涉及体外诊断技术领域，特别地涉及一种抗 Nephrin 自身抗体测 定试剂盒及其检测方法和制备方法。肾病综合征作为一种常见肾脏疾病，发病机制复杂， 精准诊疗一直面临挑战。Nephrin 作为足细胞裂孔膜上的关键蛋白，是维持肾小球滤过 屏障完整性的核心分子，其自身抗体与微小病变肾病（MCD）、原发性局灶节段性肾 小球硬化症（FSGS）、儿童特发性肾病综合征（INS）等免疫介导性足细胞病变密切相 关。近年来，国内外多个研究团队在探索肾病综合征发病机制时，已明确 Nephrin 自身 抗体与该病发生发展的紧密关联，相关成果刊登在包括《新英格兰医学杂志》在内的多 个国际顶级学术期刊，这也凸显出检测该抗体对肾病综合征诊断、病情监测及预后评估 的重要意义。 作为亚辉龙深耕自身免疫性肾病检测领域的核心产品，此次抗 Nephrin 自身抗体测 定试剂盒相关发明专利权的获批，不会对公司目前的经营状况产生重大的影响，但有利 于公司持续保持肾病相关检测产品的技术领先优势，丰富公司产品体系，提升公司的核 心竞争力。 ...

证券代码：688575 证券简称：亚辉龙 公告编号：2025-049 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得IVDR CE认证的公告 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、准确性和完整性依法承担法律责任。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收到了由BSI Group The Netherlands B.V.签发的IVDR CE最高风险等级Class D认证证书，具体信息如下： 董事会 2025年9月6日 ■ 新的欧盟体外诊断医疗器械法规（IVDR, EU 2017/746）已替代原欧盟体外诊断医疗器械指令（IVDD, 98/79/EC）对欧盟市场的体外诊断医疗器械进行管理。 截至目前，公司累计已有226个产品获得IVDR CE认证。根据欧盟体外诊断医疗器械法规的规定，本次 获得认证的产品已经具备进入欧盟市场的必要条件，对公司在欧盟地区及认可CE认证地区的业务推广 将产生积极影响，但产品具体销售情况受到市场等因素影响，公司尚无法预测上述产品对公司未来业绩 的影响，敬请广大投资者理性投资，注意投资风险。 ...

证券日报网讯 9月5日晚间，亚辉龙发布公告称，公司于近日收到了由BSI Group The Netherlands B.V.签 发的IVDR CE最高风险等级Class D认证证书。 （文章来源：证券日报） ...

Core Viewpoint - The company, Aihuilong (688575), has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash-HBsAg and iFlash-Anti-HBs test kits, enabling entry into the EU market [1] Company Summary - The certified products include the iFlash-HBsAg hepatitis B virus surface antigen test kit and the iFlash-Anti-HBs hepatitis B virus surface antibody test kit, both utilizing chemiluminescence [1] - The certification meets the necessary conditions for the products to enter the EU market, which is expected to positively impact the company's business promotion in the EU and CE-recognized regions [1]

证券代码：688575 证券简称：亚辉龙 公告编号：2025-049 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得IVDR CE认证的公告 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、准确性和完整性依法承担法律责任。 深圳市亚辉龙生物科技股份有限公司（以下简称"公司"或"亚辉龙"）于近日收 到了由BSI Group The Netherlands B.V.签发的IVDR CE最高风险等级Class D认证证书， 具体信息如下： 截至目前，公司累计已有 226 个产品获得 IVDR CE 认证。根据欧盟体外诊断医疗 器械法规的规定，本次获得认证的产品已经具备进入欧盟市场的必要条件，对公司在欧 盟地区及认可 CE 认证地区的业务推广将产生积极影响，但产品具体销售情况受到市场 等因素影响，公司尚无法预测上述产品对公司未来业绩的影响，敬请广大投资者理性投 资，注意投资风险。 特此公告。 深圳市亚辉龙生物科技股份有限公司 董事会 2025 年 9 月 6 日 | 序号 | 产品名称 | | 证书编号 | 有效期 | 临床用途 | | --- | --- | ...

亚辉龙(688575.SH)发布公告，公司于近日收到了由BSI Group The Netherlands B.V.签发的IVDR CE最高 风险等级Class D认证证书。产品名称分别为：iFlash-HBsAg乙型肝炎病毒表面抗原测定试剂盒(化学发 光法)、iFlash-Anti-HBs乙型肝炎病毒表面抗体测定试剂盒(化学发光法)。 ...

Core Points - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its products under the IVDR CE marking [1] - A total of 226 products have now obtained IVDR CE certification, allowing them to enter the EU market [1] - The certification will positively impact the company's business promotion in the EU and CE-recognized regions, although the specific sales performance remains uncertain due to market factors [1]

| 序号 | 产品名称 | 证书编号 | 有效期 | 临床用途 | | --- | --- | --- | --- | --- | | | iFlash-HBsAg 乙型肝炎柄毒衣 | IVDR 781230 | 全 2030/09/01 | 用于定量检测人血清或血浆中 的乙型肝炎表面抗原,辅助诊断 | | | 面抗原测定试剂 盒(化学发光法) | IVDR 742445 | 4 | 乙型肝炎病毒感染和用于献血 筛查。 | | | | | 2026/10/18 | | | 2 | iFlash-Anti-HBs 乙型肝炎病毒衣 | IVDR 781231 | 至 | 用于定量检测人血清或血浆中 的乙型肝炎表面抗体,辅助监测 | | | | | 2030/09/01 | | | | 面抗体测定试剂 | | | 乙肝疫苗接种效果或感染者康复进程 | | | 盒(化学发光法) | IVDR 742445 | 中 | | | | | | 2026/10/18 | | | | | | | 51 6 5 | 格隆汇9月5日丨亚辉龙(688575.SH)公布，近日收到了由BSIGroupTheNetherlandsB.V. ...

Core Insights - The company reported a significant decline in revenue and net profit for the first half of 2025, with total revenue of 808 million yuan, down 15.79% year-on-year, and a net profit of 26 million yuan, down 84.82% year-on-year [1] Group 1: Domestic and Overseas Performance - Domestic performance is under pressure due to factors such as medical insurance cost control, price reductions from centralized procurement, and intensified market competition, leading to a total revenue of 671 million yuan from domestic operations, a decrease of 14.98% [2] - Overseas self-operated revenue showed strong growth, reaching 129 million yuan, an increase of 26% [2] - The demand for terminal testing of domestic luminescent reagents is beginning to recover, which, along with continued overseas growth, is expected to drive performance recovery in the second half of the year [2] Group 2: Equipment Installation and Market Expansion - The company accelerated the installation of self-produced luminescent instruments, with 1,090 new installations in the first half of 2025, including 546 in the domestic market and 544 overseas [3] - The company has also installed 57 new production lines, representing a year-on-year growth of 54.05% [3] - The integration of AI technology with the production line is expected to enhance detection efficiency and accuracy, strengthening the company's competitive edge and aiding market expansion, particularly in top-tier hospitals [3] Group 3: Profit Forecast - The company forecasts total revenue for 2025-2027 to be 1.996 billion yuan, 2.290 billion yuan, and 2.632 billion yuan, with year-on-year growth rates of -0.75%, 14.70%, and 14.94% respectively [4] - The projected net profit for the same period is 126 million yuan, 297 million yuan, and 403 million yuan, with year-on-year growth rates of -58.20%, 135.64%, and 35.60% respectively [4]

Group 1 - Dan Yi Investment recently conducted research on two listed companies: YHLO and Sinocare [1] - YHLO has completed the prototype of its second-generation sequencing system, achieving full self-research and production of core reagents, auxiliary reagents, and auxiliary enzyme reagents [1] - YHLO is integrating its product matrix, technology research and development, customer service, and data with AI platforms like DeepSeek, enhancing its laboratory automation solutions [1] - Sinocare's medical AI platform, SinoGPT, has integrated with DeepSeek to scale intelligent services, focusing on diabetes management [1] - Sinocare plans to leverage DeepSeek's reasoning capabilities to develop a specialized model for the diabetes vertical [1] Group 2 - Shanghai Dan Yi Investment Management Partnership is a domestic private investment management institution established in April 2015 with a paid-in capital of 10 million [2] - The core executives of Dan Yi Investment have over ten years of experience in investment research, having worked at prominent institutions like Huabao Xingye Fund and Guotou Ruijin Fund [2] - During their careers, the executives managed funds totaling several billion, ranking among the top in the industry [2]