ABBISKO-B (02256) announced that its subsidiary, Shanghai Abbisko Biomedical Technology Co., Ltd. (Abbisko Medical), has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its self-developed, highly selective oral small-molecule FGFR4 inhibitor, Irpagratinib (ABSK-011), intended for the treatment of hepatocellular carcinoma (HCC). Irpagratinib is currently undergoing clinical studies in multiple regions globally. The EMA's ODD will provide substantial support for the product's clinical development, regulatory submission, and commercialization process in Europe. Irpagratinib is a highly selective oral small-molecule FGFR4 inhibitor developed independently by Abbisko Medical. In previous clinical studies, Irpagratinib, both as a monotherapy and in combination regimens, demonstrated favorable safety, tolerability, and anti-tumor activity in patients with advanced HCC exhibiting FGF19 overexpression. The drug is currently being evaluated in several global clinical trials for patients with FGF19-overexpressing advanced HCC, including studies combining it with various targeted immunotherapies for first-line treatment of advanced HCC, as well as monotherapy for second-line and later-line treatments. Among these, the first patient dosing for the key monotherapy registration clinical study was completed in June 2025. This clinical study involves over 50 research centers across the country and is currently progressing smoothly. In addition to the recent EMA ODD, Irpagratinib has previously received Orphan Drug Designation and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA), as well as Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA). Leveraging the accelerated review benefits associated with these regulatory designations, Abbisko Medical will continue to advance the global clinical development and regulatory submission processes for Irpagratinib, aiming to bring this innovative therapy to HCC patients worldwide as soon as possible and provide a safe and effective new option for the precision treatment of this refractory disease.