智通财经APP获悉，和誉-B(02256)盘中涨超10%，截至发稿，涨8.44%，报13.11港元，成交额3420.99万港元。
消息面上，和誉宣布，其自主研发的高选择性小分子FGFR4抑制剂依帕戈替尼（Irpagratinib/ABSK-011）已获得欧洲药品管理局（EMA）授予的孤儿药资格（ODD），用于治疗肝细胞癌（HCC）。目前，依帕戈替尼正在全球多地开展临床研究，此次获EMA授予ODD，将为该产品在欧洲的临床开发、注册申报与商业化进程提供有力支持。
公开资料显示，依帕戈替尼是和誉医药自主研发的一款高选择性、口服小分子FGFR4抑制剂。除本次获得EMA孤儿药资格外，依帕戈替尼此前还分别获得了美国食品药品监督管理局（FDA）授予的ODD和快速通道资格认定（FTD），以及中国国家药品监督管理局（NMPA）授予的突破性疗法认定（BTD）。
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