智通财经APP讯，百利天恒(688506.SH)发布公告，近日，公司收到国家药品监督管理局的《药品注册证书》，批准公司自主研发的全球首创(First-in-class)、新概念(Newconcept)、全球首个且唯一获批上市的EGFR×HER3双抗ADC伦康依隆妥单抗/宜泽康(BL-B01D1/iza-bren)食管癌晚期二线适应症的上市申请获得批准。
伦康依隆妥单抗已在中国和美国开展了40余项针对多种肿瘤类型的临床试验，其中，III期临床研究(含II/III期)20项。截至目前，伦康依隆妥单抗已有7项适应症被国家药品监督管理局药品审评中心(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(FDA)纳入突破性治疗品种名单。
除本次获得药品注册批准外，伦康依隆妥单抗用于治疗复发或转移性鼻咽癌已获得国家药品监督管理局(NMPA)的上市批准，治疗局部晚期或转移性三阴乳腺癌的药品上市申请(NDA)也已获得CDE受理。
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