复宏汉霖(02696):帕妥珠单抗生物类似药HLX11 (抗HER2结构域II人源化单克隆抗体注射液)的上市许可申请(MAA)获欧洲药品管理局(EMA)受理

智通财经
28 Mar

智通财经APP讯,复宏汉霖(02696)发布公告,近日,公司自主研发的Perjeta®(帕妥珠单抗)生物类似药候选药HLX11(重组抗HER2结构域II人源化单克隆抗体注射液)的上市许可申请获欧洲药品管理局受理,本次申请涉及的适应症如下:(1)与曲妥珠单抗和化疗联合:用于 HER2阳性、局部晚期、炎性或早期乳腺癌且具有高复发风险成人患者的新辅助治疗;以及用于具有高复发风险的HER2阳性早期乳腺癌成人患者的辅助治疗;(2)与曲妥珠单抗和多西他赛联合:用于治疗既往未接受过针对转移性疾病抗HER2治疗或化疗的HER2阳性、转移性或局部复发不可切除乳腺癌成人患者。

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