智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称“公司”)子公司苏州盛迪亚生物医药有限公司收到国家药品监督管理局(以下简称“国家药监局”)下发的《受理通知书》，公司注射用瑞康曲妥珠单抗的药品上市许可申请获受理，且已被纳入优先审评程序。
本次新适应症申报是基于一项随机、开放、阳性药物对照、多中心设计的Ⅲ 期临床试验，该研究旨在评估瑞康曲妥珠单抗(SHR-A1811)对比标准治疗方案在经奥沙利铂、氟尿嘧啶类和伊立替康治疗失败的HER2阳性晚期结直肠癌受试者中的有效性和安全性，并探索该药物的免疫原性及药代动力学特征。本研究由上海高博肿瘤医院李进院长和浙江大学医学院附属第二医院袁瑛教授共同担任主要研究者，全国40家中心共同参与。主要终点为独立影像评审委员会(IRC)依据RECIST v1.1 评估的无进展生存期(PFS)。研究结果显示，与标准治疗方案相比，瑞康曲妥珠单抗能显著延长HER2 阳性晚期结直肠癌患者的PFS，降低疾病进展或死亡风险。总生存期(OS)数据目前观察到获益趋势。
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