港股异动 | 和誉-B(02256)涨近4% 获CDE批准开展依帕戈替尼治疗肝细胞癌的注册性临床研究

智通财经
Dec 18, 2024

智通财经APP获悉,和誉-B(02256)涨近4%,截至发稿,涨3.78%,报4.67港元,成交额537.73万港元。

消息面上,和誉医药近日宣布,其自主研发的高选择性小分子FGFR4抑制剂依帕戈替尼 (Irpagratinib/ABSK011) 已获中国国家药品监督管理局药品审评中心(CDE)批准,开展治疗肝细胞癌(HCC)的注册性临床研究。这项研究将作为支持依帕戈替尼上市的关键依据,也标志着依帕戈替尼在晚期或不可切除肝细胞癌(HCC)治疗领域迈出了重要的一步。

另外,12月8日,公司公告在第66届美国血液学会(ASH)年会上口头报告了匹米替尼(Pimicotinib,ABSK021)治疗2L+慢性移植物抗宿主病(cGvHD)的初步II期研究结果。尽管大多数入组患者尚未完成cGvHD缓解评估所需要的6个月治疗周期,但匹米替尼20mg QD治疗患者的初步ORR已经达到64%。

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