智通财经APP讯，和誉-B(02256)发布公告，美国食品药品监督管理局(FDA)已授予和誉医药自主研发的高选择性小分子FGFR4抑制剂依帕戈替尼(Irpagratinib/ ABSK-011)快速通道资格认定(FTD)，用于治疗既往接受过免疫检查点抑制剂(ICIs)和多靶点激酶抑制剂(mTKIs)治疗，且存在FGF19过表达的肝细胞癌(HCC)患者。
本次获得FDA的FTD，将有助于加快依帕戈替尼在全球范围内的临床开发与监管审评进程。和誉医药将持续推进该项目的国际化临床布局，致力于为全球HCC患者提供更加精准有效的创新治疗方案。
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