智通财经APP讯，和黄医药(00013)发布公告，凡瑞格拉替尼 (fanregratinib ，HMPL-453)用于既往接受过系统性治疗，且具有成纤维细胞生长因子受体(“FGFR”)2融合或重排的晚期、转移性或不可手术切除的肝内胆管癌(ICC)成人患者的新药上市申请已获中国国家药品监督管理局(“国家药监局”)受理 ，并获纳入优先审评。
凡瑞格拉替尼是一种新型、选择性的FGFR1 、2和3口服抑制剂。肝内胆管癌是一种起源于肝内胆管上皮的具有高度侵袭性的恶性肿瘤，占原发性肝癌的约8.2%至15.0% ，是继肝细胞癌之后第二常见的肝癌类型。近年来，肝内胆管癌发病率呈持续上升趋势，5年总生存率约9%。全球肝内胆管癌患者中约有10-15%伴有FGFR2融合或重排。
一项在中国开展的单臂、多中心、开放标签的II期注册研究的数据支持了提交此项中国新药上市申请。该研究已达到客观缓解率(ORR)这一主要终点 。包括无进展生存期(PFS)、疾病控制率(DCR)、缓解持续时间(DoR)和总生存期(OS)在内的次要终点结果亦支持了主要终点的发现。完整的研究数据将于近期提交学术会议上发表。
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