亚辉龙：取得医疗器械注册证

Core Insights - Company Aihuilong (688575.SH) has received a medical device registration certificate for its soluble CD146 detection kit, marking a significant milestone in its product development [1] Group 1: Product Development - The product, named soluble CD146 detection kit (chemiluminescence method), has been registered with the Guangdong Provincial Drug Administration under registration number 20252401494 [1] - This diagnostic product is the first test kit globally to utilize the innovative biomarker soluble CD146, which was discovered by Academician Yan Xiyun from the Institute of Biophysics, Chinese Academy of Sciences [3] Group 2: Research and Collaboration - Aihuilong is collaborating with top medical institutions, including Peking University First Hospital, Beijing Xuanwu Hospital, and Peking University Third Hospital, to explore the potential applications of soluble CD146 [3] - The approval of this diagnostic reagent is a result of years of research and development in partnership with Academician Yan's team, showcasing the successful transformation of academic research into practical medical solutions [3] Group 3: Market Position and Product Line - With this new registration, Aihuilong has now obtained a total of 173 domestic medical device registration certificates for chemiluminescent reagents, contributing to a total of 250 such registrations [3] - The new product enhances Aihuilong's portfolio in the field of neurological disease diagnostics, expanding its automated chemiluminescence product line [3]