和誉-B(02256.HK):FGFR4抑制剂依帕戈替尼获FDA快速通道资格,用于治疗HCC患者
Group 1 - The core point of the article is that HeYu-B (02256.HK) announced that its subsidiary, Shanghai HeYu Biomedical Technology Co., Ltd. ("HeYu Pharma"), 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) [1] Group 2 - The FTD is specifically for the treatment of hepatocellular carcinoma (HCC) patients who have previously received immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs) and exhibit overexpression of FGF19 [1]