医学影像公司Imagion Biosystems向FDA提交Magsense® Her2靶向显影剂二期试验新药临床试验申请

美股速递
Feb 04

医学影像技术企业Imagion Biosystems(ASX: IBX)已正式向美国食品药品监督管理局(FDA)提交新药临床试验申请(IND),计划开展其旗舰产品Magsense® Her2靶向显影剂的二期临床试验。该显影剂采用创新纳米技术,旨在通过高精度磁共振成像实现对HER2阳性肿瘤的早期识别与定位,为乳腺癌等癌症的精准诊疗提供新方案。此次IND获批后将启动多中心临床研究,进一步验证该显影剂的安全性与成像效能,有望填补现有HER2检测技术的可视化诊断空白。

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