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]

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]

Core Viewpoint - Valiant Bio-B (09887) has seen a significant stock increase, rising over 6% and currently trading at 62.2 HKD, with a transaction volume of 24.4 million HKD, following the announcement of its core product, Valiantxin (LBL-024), receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1 - Valiantxin has reached an important milestone in its global development process, now in Phase II or registration clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC, demonstrating first-in-class (FIC) or best-in-class (BIC) potential [1] - On January 14, Valiantxin was granted Fast Track designation by the FDA for the treatment of extra-pulmonary neuroendocrine carcinoma, marking it as the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage globally [1]