智通财经APP讯,翰森制药(03692)发布公告,于2025年2月25日,集团自研B7-H3靶向抗体–药物偶联物(ADC)注射用HS-20093获中国国家药品监督管理局(NMPA)批准纳入突破性治疗药物,拟定适应症为用于治疗经至少二线治疗后进展的骨肉瘤患者。
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(TOPOi)有效载荷共价连接而成,正于中国开展用于治疗肺癌、肉瘤、头颈癌以及其他实体瘤的多项临床研究,其中最高研究阶段为临床III期。于2024年11月1日,HS-20093用于经标准一线治疗(含铂双药化疗联合免疫)后进展的广泛期小细胞肺癌(ES-SCLC)适应症已被NMPA纳入突破性治疗药物。
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