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可溶性 CD146 检测试剂盒(化学发光法)
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亚辉龙(688575.SH):取得医疗器械注册证
Ge Long Hui A P P· 2025-11-17 10:54
CD146 最早被发现于黑色素瘤、前列腺癌和乳腺癌细胞上,后研究发现CD146存在膜型和可溶性两种 形式,其中膜形式的 CD146 广泛分布于血管内皮细胞、平滑肌细胞、淋巴细胞等组织细胞上,起到血 管发生发展、细胞黏附迁移、免疫应答及细胞分化等作用。膜型 CD146 的胞外区经过金属蛋白酶切割 等生理过程,从细胞表面脱落进入组织液中,形成可溶性 CD146(soluble CD146,sCD146)。sCD146 与膜型CD146 相比,缺失胞内区域和跨膜区域,其余结构与膜型 CD146 相同。研究表明,在多发性硬 化症、视神经脊髓炎等中枢神经系统免疫性炎性脱髓鞘病人中,血脑屏障内皮细胞中的膜型CD146表达 升高,同时由于金属蛋白酶的表达增加等因素,脑脊液中sCD146 的浓度明显升高。在中枢神经系统免 疫性炎性脱髓鞘病人的脑脊液中,sCD146 的浓度与多种炎症因子(如TNFα、IFNγ、IL-2、IL-17A 等)的浓度呈正相关,且相较于其他与疾病进程相关的分子标志物,如金属蛋白酶(MMP2、 MMP9)、可溶性粘附因子(sICAM、sVCAM)、炎症因子(LI-1β、IL-17A、IL-10、IFN- ...
亚辉龙:取得医疗器械注册证
Ge Long Hui· 2025-11-17 10:50
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]