南方财经1月20日电，百利天恒(688506.SH)公告称，公司收到国家药品监督管理局药品审评中心核准签发的《受理通知书》，公司自主研发的全球首创（First-in-class）、新概念（New concept）且唯一进入III期临床阶段的EGFR×HER3双抗ADC（iza-bren）的药品上市申请（NDA）已获得正式受理。iza-bren用于治疗复发性或转移性食管鳞癌也已被CDE纳入优先审评品种名单。该药品是全球首个药品上市申请获得受理的EGFR×HER3双抗ADC。iza-bren正在中国和美国进行40余项针对多种肿瘤类型的临床试验。截至目前，iza-bren已有7项适应症被CDE纳入突破性治疗品种名单，2项适应症被CDE纳入优先审评品种名单，以及1项适应症被美国食品药品监督管理局纳入突破性治疗品种名单。
（文章来源：南方财经网）
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