云顶新耀(01952.HK)在中国完成依拉环素之3期桥接临床试验
云顶新耀(01952.HK)公布,在中国完成了依拉环素(在美国和欧盟以Xerava品牌推广)用於治疗复杂性腹腔内感染(cIAI)的3期桥接临床试验,试验共纳入144名患者。加上来自全球关键性3期IGNITE 1和IGNITE 4临床试验获得的结果,公司相信依拉环素对中国cIAI患者所展现的有效性和安全性,将支持在中国提交新药申请(NDA)。
IGNITE 1和IGNITE 4研究是全球关键性3期临床试验,由Tetraphase制药公司开展,试验共纳入1,037名患者,Tetraphase制药公司现为La Jolla制药公司的一部分。
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