智通财经APP讯，翰森制药(03692)发布公告，于2024年11月1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”)。
HS-20093是一种新型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，正于中国开展用于小细胞肺癌的III期临床研究，以及肉瘤、头颈癌、其他实体瘤的多项I期及II期研究。
于2023年12月20日，集团与GlaxoSmithKline Intellectual Property (No. 4) Limited(“GSK”)订立许可协议，授予GSK全球独占许可(不含中国内地、中国香港、中国澳门及中国台湾)，以开发、生产及商业化HS-20093(亦称GSK5764227)，该药物目前正由GSK开展全球I期临床试验。于2024年八月二十日，GSK宣布美国食品药品监督管理局(FDA)授予GSK5764227突破性疗法认定，用于含铂化疗期间或之后进展的(复发或难治性)ES-SCLC患者治疗。
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