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]

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has successfully completed the first patient dosing in a global multicenter Phase I clinical study of its self-developed selective small molecule FGFR4 inhibitor, Irpagratinib (ABSK-011), targeting FGF19 overexpressing advanced hepatocellular carcinoma (HCC) [1] Group 1 - The Phase I clinical study (ABSK-011-101) is focused on advanced hepatocellular carcinoma (HCC) [1] - Irpagratinib has received Fast Track Designation from the U.S. Food and Drug Administration (FDA), which is expected to accelerate its global clinical development process [1]

Core Viewpoint - The company, He Yu-B (02256.HK), has successfully completed the first patient dosing in a global multicenter Phase I clinical study of its self-developed high-selectivity small molecule FGFR4 inhibitor, Irpagratinib (ABSK-011), targeting FGF19 overexpressing advanced hepatocellular carcinoma (HCC) [1] Group 1 - Irpagratinib has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA), which is expected to accelerate its global clinical development process [1]

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]