-- Telix Pharmaceuticals(ASX:TLX)周五宣布,其胶质瘤成像候选药物TLX101-Px在欧洲提交的上市许可申请已获验证并被受理,进入为期210天的积极评估阶段。 该公司在一份声明中表示,正在寻求符合当前临床实践指南的广泛临床适应症,预计在第210天取得积极结果后,将很快获得各国的上市许可。 该公司表示,其目标是扩大患者获得先进成像技术的机会,该技术能够区分成人和儿童的进展性或复发性胶质瘤与治疗相关变化,并有可能在未来开发出其他适应症。 声明还指出,TLX101-Px同时也被开发为Telix胶质母细胞瘤治疗候选药物TLX101-Tx的患者选择和疗效评估工具。TLX101-Tx已在欧洲和美国获得孤儿药资格认定。 该公司表示,TLX101-Tx治疗复发性胶质母细胞瘤患者的III期IPAX-BrIGHT试验已在全球范围内启动患者给药,并将在多个欧洲国家开展。 Telix Pharmaceuticals的股价在上周五的交易中上涨了3%。
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