迪哲医药ASH大会发布高瑞哲®与Birelentinib淋巴瘤治疗最新积极数据

中金财经

Dec 10, 2025

　　　　中访网数据迪哲(江苏)医药股份有限公司在第67届美国临床血液学会(ASH)年会上，公布了其两款全球首创新药在淋巴瘤治疗领域的最新临床研究进展。其高选择性JAK1抑制剂高瑞哲®(戈利昔替尼)在T细胞淋巴瘤(PTCL)领域展现出广泛潜力。在一线治疗探索中，高瑞哲®联合CHOP化疗方案在初治PTCL患者中显示出高缓解率，客观缓解率(ORR)最高达94.1%，完全缓解率(CRR)最高达64.7%。在复发/难治性PTCL的长期随访中，其单药治疗的ORR为53.8%，中位无进展生存期达37.9个月，疗效持久。此外，该药在T/NK大颗粒淋巴细胞白血病、单形性嗜上皮性肠道T细胞淋巴瘤以及伴噬血细胞综合征的PTCL等罕见亚型中也显示出显著活性。另一方面，其非共价LYN/BTK双靶点抑制剂Birelentinib在B细胞淋巴瘤领域取得新进展。最新数据显示，在推荐剂量下治疗复发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤，ORR达84.2%，且对携带包括BTK激酶“失活”突变在内的多种耐药机制的患者均有效，安全性良好。该药已于2025年8月获美国FDA授予快速通道资格，其全球III期临床研究正在推进中。公司同时披露了Birelentinib联合疗法治疗弥漫性大B细胞淋巴瘤的后续研究计划。这些数据进一步验证了迪哲医药两款核心产品的临床价值，为其在淋巴瘤治疗领域的商业化前景提供了支持。

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