Group 1 - The core point of the article is that He Yu-B (02256) announced that its subsidiary, Shanghai He Yu Biopharmaceutical Technology Co., Ltd., has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its orally administered FGFR4 inhibitor, Irpagratinib, for the treatment of hepatocellular carcinoma (HCC) [1] - Irpagratinib has shown good safety, tolerability, and anti-tumor activity in previous clinical studies involving advanced HCC patients with FGF19 overexpression [1] - The key registration clinical study for Irpagratinib has completed its first patient dosing in June 2025 and is currently progressing smoothly across over 50 research centers nationwide [1] Group 2 - In addition to the EMA orphan drug designation, Irpagratinib has also received orphan drug designation (ODD) and fast track designation (FTD) from the U.S. FDA, as well as breakthrough therapy designation (BTD) from the NMPA in China [2] - The company aims to leverage the accelerated review advantages provided by these regulatory designations to advance the global clinical development and registration process of Irpagratinib, striving to offer this innovative therapy to HCC patients worldwide as soon as possible [2]
和誉-B(02256)：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