复宏汉霖(02696.HK)治疗乳腺癌注射液临床试验申请获国家药监局批准
复宏汉霖(02696.HK)公布,公司研制的用於转移性乳腺癌、早期乳腺癌治疗的重组抗HER2结构域II人源化单克隆抗体注射液的临床试验申请已於近日获国家药品监督管理局批准。
公司指,HLX11是其自主研发的帕妥珠单抗(Pertuzumab,商品名:Perjeta/帕捷特)的生物类似药,主要适用於转移性乳腺癌,联合曲妥珠单抗和多西他赛,用於治疗既往未接受过抗HER2治疗或化疗的HER2阳性、转移性或不可切除的局部复发性乳腺癌患者,及早期乳腺癌,与曲妥珠单抗和化疗联合,作为早期乳腺癌整体治疗方案的一部分,用於HER2阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗;用於具有高复发风险的HER2阳性早期乳腺癌患者的辅助治疗。去年10月31日,用於转移性乳腺癌、早期乳腺癌治疗的HLX11的临床试验申请获国家药品监督管理局受理。
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