翰森制药(03692):B7-H4靶向抗体-药物偶联物HS-20089获国药监局纳入突破性治疗药物

智通财经
01 May

智通财经APP讯,翰森制药(03692)发布公告,于2025年5月1日,集团自研B7-H4靶向抗体-药物偶联物(“ADC”)注射用HS-20089(“该产品”)获中国国家药品监督管理局(NMPA)批准纳入突破性治疗药物,拟定适应症为用于铂耐药复发上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。

据悉,HS-20089是一种B7-H4靶向ADC,其有效载荷为拓扑异构酶抑制剂(TOPOi),正于中国开展用于治疗卵巢癌以及其他妇科肿瘤的多项临床研究,其中最高研究阶段为临床III期。于2023年10月20日,集团与Glaxo Smith KlineIntel lectual Property(No.4) Limited(“GSK”)订立独家许可协议,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、生产及商业化该产品,该产品目前正由GSK开展海外I期临床试验。

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