Core Viewpoint - The company has developed Irpagratinib, a highly selective oral small molecule FGFR4 inhibitor, which has shown promising safety, tolerability, and anti-tumor activity in clinical studies for advanced HCC patients with FGF19 overexpression [1][2] Group 1: Clinical Development - Irpagratinib is currently undergoing multiple clinical trials globally for advanced HCC patients with FGF19 overexpression, including combinations with various targeted immunotherapies for first-line treatment and as a monotherapy for second-line and later treatments [1] - The first patient dosing in the key registration clinical study for Irpagratinib was completed in June 2025, with the study covering over 50 research centers nationwide and progressing smoothly [1] Group 2: Regulatory Approvals - Irpagratinib has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of HCC, which will support its clinical development, registration, and commercialization in Europe [2] - The drug has also previously obtained ODD and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China [1]
和誉-B：FGFR4抑制剂依帕戈替尼获EMA授予孤儿药资格，用于治疗肝细胞癌