翰森制药自研药HS-20093被国家药监局纳入突破性治疗药物

财中社
25 Feb

  2月25日,翰森制药(03692)发布公告,宣布其自研的B7-H3靶向抗体–药物偶联物HS-20093于2025年2月25日获得中国国家药品监督管理局(NMPA)批准纳入突破性治疗药物,适应症为用于治疗经过至少二线治疗后进展的骨肉瘤患者。这一批准标志着公司在抗癌领域的又一重要进展。

  HS-20093是一种B7-H3靶向ADC,由全人源抗B7-H3单抗与拓扑异构酶抑制剂有效载荷共价连接而成,目前正在中国进行多项临床研究,适应症包括肺癌、肉瘤、头颈癌及其他实体瘤,其中最高研究阶段为临床III期。此外,HS-20093在2024年11月1日也获得NMPA批准,作为突破性治疗药物用于经标准一线治疗后进展的广泛期小细胞肺癌。这些进展将进一步增强公司的市场竞争力。

(文章来源:财中社)

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