【复旦张江:注射用FZ-P001钠获得药物临床试验申请受理】复旦张江公告,公司自主研发的注射用FZ-P001钠用于癌症术中恶性病变可视化获得国家药品监督管理局核准签发的《受理通知书》,其I期临床试验申请获得受理。注射用FZ-P001钠为化学药品1类新化合物,活性成分为叶酸受体靶向小分子与花菁类光敏剂偶联而成的分子,计划用于开发术中荧光指引技术,指示肿瘤恶性病变组织残留与切缘状态,旨在提高实体瘤手术切除效果,为肿瘤外科提供创新解决方案。此次注册申请事项为首次人体I期临床试验,旨在评价该药物在人体的安全性、耐受性及药代动力学特征。

金融界
16 Jun
复旦张江公告,公司自主研发的注射用FZ-P001钠用于癌症术中恶性病变可视化获得国家药品监督管理局核准签发的《受理通知书》,其I期临床试验申请获得受理。注射用FZ-P001钠为化学药品1类新化合物,活性成分为叶酸受体靶向小分子与花菁类光敏剂偶联而成的分子,计划用于开发术中荧光指引技术,指示肿瘤恶性病变组织残留与切缘状态,旨在提高实体瘤手术切除效果,为肿瘤外科提供创新解决方案。此次注册申请事项为首次人体I期临床试验,旨在评价该药物在人体的安全性、耐受性及药代动力学特征。

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