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东曜药业(01875.HK):TAB014 III期临床试验申请获美国许可
阿思达克 02-02 08:38
东曜药业(01875.HK)公布,获得美国食品和药物管理局(FDA)通知,有关单克隆抗体药物TAB014(重组人源化抗血管内皮细胞生长因子(VEGF)单克隆抗体)玻璃体注射剂,用於治疗湿性(新生血管性)年龄相关性黄斑变性(wAMD)的III期临床试验之新药临床(IND)申请,近期获得FDA许可。

是次IND申请是通过TAB014在中国进行的I期临床试验数据及相关临床文献资料为依据,直接申请III期临床试验许可(免於II期临床试验),亦是集团首个於海外提交IND申请并获许可的项目。

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