Core Viewpoint - The company He Yu-B (02256) has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its self-developed selective small molecule FGFR4 inhibitor, Irpagratinib (ABSK-011), aimed at treating hepatocellular carcinoma (HCC) patients who have previously undergone treatment with immune checkpoint inhibitors (ICIs) and multi-target kinase inhibitors (mTKIs) and exhibit FGF19 overexpression [1] Group 1 - The FDA's FTD will expedite the clinical development and regulatory review process of Irpagratinib globally [1] - He Yu-B is committed to advancing the international clinical layout of this project [1] - The company aims to provide more precise and effective innovative treatment solutions for HCC patients worldwide [1]
和誉-B(02256)：FGFR4抑制剂依帕戈替尼获FDA快速通道资格，用于治疗HCC患者