证券代码：688575 证券简称：亚辉龙 公告编号：2025-066 深圳市亚辉龙生物科技股份有限公司 关于自愿披露取得医疗器械注册证的公告 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 到了由广东省药品监督管理局签发的医疗器械注册证，具体信息如下： 深圳市亚辉龙生物科技股份有限公司董事会 2025 年 11 月 28 日 | 序 | 产品名称 | 注册编号 | 注册证有效期 | 注册 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 号 | | | | 分类 | | | 1 | 抗 抗体检测 gp210 IgG 试剂盒（化学发光法） | 粤械注准 20252401549 | 至 2030/11/25 | 二类 | 用于体外定性检测人血清和（或）血 浆中的抗 抗体。临床上用 gp210 IgG 于原发性胆汁性胆管炎的辅助诊断。 | | | | | | | 用于体外定量测定人血清和（或）血 | | | ...

Core Viewpoint - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash - HIV Combo test kit, marking a significant achievement in its product certification journey [1] Group 1 - The HIV test kit has successfully passed the IVDR CE certification, which is crucial for market entry in the European Union [1] - This certification covers the full range of eight preoperative chemiluminescent test reagents, bringing the total number of certified products to 229 [1] - The certification is expected to positively impact business promotion, although the exact effect on performance remains unpredictable [1]

Core Viewpoint - The company, Aihuilong, has received medical device registration certificates for two products from the Guangdong Provincial Drug Administration, enhancing its product line in the field of liver and kidney disease diagnostics [1] Group 1: Product Registration - The two registered products are the anti-gp210 IgG antibody test kit and the anti-phospholipase A2 receptor IgG antibody assay kit, both utilizing chemiluminescence technology [1] - The registration certificates are valid until November 25, 2030, and both products are classified as Class II medical devices [1] Group 2: Diagnostic Applications - The products are intended for auxiliary diagnosis of primary biliary cholangitis and idiopathic membranous nephropathy [1] Group 3: Market Impact - The company has obtained a total of 176 domestic medical device registration certificates for chemiluminescence reagents [1] - The new certifications will help enrich the fully automated chemiluminescence product line, but the sales performance of these products is subject to market conditions, making the impact on financial performance difficult to predict [1]

Core Viewpoint - The company, 亚辉龙 (688575.SH), currently does not have any certified products for influenza A testing, but it continues to focus on respiratory infection immunity, particularly in the areas of Mycoplasma pneumoniae and Epstein-Barr virus [1] Group 1: Company Overview - 亚辉龙 is the first domestic biotechnology company to apply chemiluminescence technology to serological testing for Mycoplasma pneumoniae [1] - The company is one of the few domestic IVD suppliers that can provide simultaneous testing for Mycoplasma pneumoniae, Chlamydia IgG, and IgM typing [1]

Core Viewpoint - Shenzhen YHLO Biotech Co., Ltd. is set to hold a Q3 2025 earnings presentation on December 3, 2025, to discuss its operational results and financial indicators, inviting investors to submit questions in advance [2][3][4]. Group 1: Earnings Presentation Details - The earnings presentation will take place on December 3, 2025, from 15:00 to 16:00 at the Shanghai Stock Exchange Roadshow Center [2][6]. - Investors can participate online through the Shanghai Stock Exchange Roadshow Center and are encouraged to submit questions from November 26 to December 2, 2025 [5][6]. - Key company personnel, including the Chairman and CFO, will be present to address investor inquiries [4]. Group 2: Medical Device Registration - The company has recently received a medical device registration certificate from the Guangdong Provincial Drug Administration for the ST2 protein test, which is significant for cardiovascular disease detection [7][8]. - The ST2 protein is linked to heart function and can predict outcomes in acute myocardial infarction (AMI) patients, enhancing the company's product offerings in the cardiovascular diagnostics sector [8][9]. - The newly registered iMegaFlow analyzer is a semi-automated device designed for quantitative or semi-quantitative analysis of human samples, featuring a compact design and ease of use [9].

Core Viewpoint - The company, Aihuilong (688575.SH), has recently received a medical device registration certificate from the Guangdong Provincial Drug Administration for its product, the Soluble Growth Stimulating Expression Gene 2 Protein Detection Kit (Chemiluminescence Method) and Chemiluminescence Immunoassay Analyzer [1] Group 1 - The product is aimed at enhancing diagnostic capabilities in the medical field [1] - The registration certificate signifies regulatory approval, which is crucial for market entry and commercialization [1] - This development may open new revenue streams for the company in the healthcare sector [1]

关于自愿披露取得医疗器械注册证的公告 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 到了由广东省药品监督管理局签发的医疗器械注册证，具体信息如下： 二、对公司的影响 生长刺激表达基因 2 蛋白（ST2）是白细胞介素-1 受体/Toll 样受体超家族的成员， 编码基因位于人染色体 2q12 位点，有膜结合型 ST2（ST2L）和 sST2 两种类型，与心 血管疾病密切相关。sST2 和 ST2L 作为白细胞介素-33（IL-33）的功能配体，当 sST2 浓度低时，ST2 的配体 IL-33 可与 ST2L 结合对心脏有保护作用，这种相互作用可减少 心肌纤维化，防止心肌细胞肥大，并改善心肌功能。当可溶性 ST2 水平高时，sST2 充 当诱饵受体可竞争性的与 IL-33 结合，使 IL-33 与 ST2L 结合减少，从而抑制 IL-33 的 作用使其无法进入心脏保护的信号转导途径。导致心脏持续承受压力，造成细胞死亡和 证券代码：688575 证券简称 ...

证券代码：688575 证券简称：亚辉龙 公告编号：2025-064 深圳市亚辉龙生物科技股份有限公司 重要内容提示： 会议召开时间：2025 年 12 月 3 日（星期三）15:00-16:00 会议召开地点：上海证券交易所上证路演中心（网址：https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 为提高交流效率，深圳市亚辉龙生物科技股份有限公司（以下简称"公司"）现 提前向投资者征集相关问题，欢迎广大投资者于 2025 年 11 月 26 日（星期三） 至 12 月 2 日（星期二）16:00 前登录上证路演中心网站首页点击"提问预征集" 栏目或通过公司投资者关系邮箱 ir@szyhlo.com 进行提问。公司将在说明会上对 投资者普遍关注的问题进行回答。 公司已于 2025 年 10 月 30 日发布公司 2025 年第三季度报告，为便于广大投 资者更全面深入地了解公司 2025 年第三季度经营成果、财务状况，公司计划于 2025 年 12 月 3 日（星期三）15:00-16:00 举行 2025 年第三季度业绩说明会，就 投资者关心的问题进行交流。 一、说明 ...

机构持仓方面，截止2025年9月30日，亚辉龙十大流通股东中，华宝中证医疗ETF（512170）位居第七 大流通股东，持股965.16万股，相比上期减少176.69万股。 责任编辑：小浪快报 截至9月30日，亚辉龙股东户数1.28万，较上期增加7.40%；人均流通股44595股，较上期减少6.89%。 2025年1月-9月，亚辉龙实现营业收入12.87亿元，同比减少7.69%；归母净利润6042.09万元，同比减少 72.36%。 分红方面，亚辉龙A股上市后累计派现6.93亿元。近三年，累计派现5.31亿元。 11月21日，亚辉龙跌3.68%，成交额9994.92万元。两融数据显示，当日亚辉龙获融资买入额1253.69万 元，融资偿还1579.12万元，融资净买入-325.43万元。截至11月21日，亚辉龙融资融券余额合计4.45亿 元。 融资方面，亚辉龙当日融资买入1253.69万元。当前融资余额4.43亿元，占流通市值的5.21%，融资余额 超过近一年70%分位水平，处于较高位。 融券方面，亚辉龙11月21日融券偿还0.00股，融券卖出400.00股，按当日收盘价计算，卖出金额5964.00 元；融券余量 ...

Core Insights - The article presents the results of quality management system inspections for medical device registrations in October 2025, highlighting the compliance status of various companies and their products [2][3] Group 1: Company Compliance Results - Shenzhen Huian Biological Technology Co., Ltd. successfully passed the inspection for the Influenza Virus Antigen Detection Kit after rectification on October 8, 2025 [2] - Shenzhen Yihuilong Biotechnology Co., Ltd. passed the inspection for the EB Virus Antigen IgG Antibody Detection Kit on October 8, 2025 [2] - Shenzhen Gamma Knife Technology Co., Ltd. passed the inspection for the Head Gamma Ray Stereotactic Radiotherapy System after rectification on October 10, 2025 [2] - Shenzhen Jingfeng Medical Technology Co., Ltd. passed the inspection for the Single-Port Laparoscopic Surgery System after rectification on October 15, 2025 [2] - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. passed multiple inspections for various medical testing kits and products between October 17 and October 22, 2025 [2][3] Group 2: Product Categories - The inspected products include diagnostic kits for various viruses, surgical systems, and medical imaging devices, indicating a diverse range of medical technologies being evaluated [2][3] - The successful inspections reflect the companies' adherence to quality management standards set by the Guangdong Provincial Drug Administration [3] Group 3: Regulatory Context - The inspections are part of a regulatory framework established by the Guangdong Provincial Drug Administration, which began notifying applicants of inspection results via SMS or web queries since May 2022 [3]