智通财经APP获悉，翰森制药(03692)涨近3%，截至发稿，涨2.97%，报20.8港元，成交额9838.2万港元。
消息面上，10月24日，国家药监局药品审评中心(CDE)官网最新公示，翰森制药注射用HS-20093拟纳入突破性治疗品种，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)。公开资料显示，HS-20093是翰森制药研发的一款B7-H3靶向抗体偶联药物(ADC)。
据悉，2023年12月，翰森制药与葛兰素史克(GSK)订立一项超17亿美元的独家许可协议，后者获得开发、生产及商业化HS-20093的全球独占许可(不含大中华区)。今年8月，GSK宣布就HS-20093获FDA突破性疗法认定，用于治疗含铂化疗期间或之后进展的复发或难治性ES-SCLC患者。本次FDA突破性疗法的认定得到了1期ARTEMIS-001首次人体临床试验的数据支持。
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