港股异动 | 康宁杰瑞制药-B(09966)涨超4% 此前宣布KN026新药上市申请获国家药监局受理

智通财经
Sep 23

智通财经APP获悉,康宁杰瑞制药-B(09966)涨超4%,截至发稿,涨4.07%,报12.54港元,成交额4316.41万港元。

消息面上,9月12日,康宁杰瑞制药宣布,公司自主研发、与石药集团全资附属公司上海津曼特生物科技有限公司合作开发的安尼妥单抗注射液(研发代号:KN026)的新药上市申请(NDA)已获国家药品监督管理局(NMPA)受理。KN026本次按照治疗用生物制品1类新药申报,适应症为:联合化疗用于至少接受过一种系统性治疗(必须包含曲妥珠单抗联合化疗)失败,HER2阳性局部晚期、复发或转移性的胃/胃-食管结合部腺癌。

目前,HER2阳性胃癌二线治疗尚无获批上市的抗HER2药物,KN026是中国首个在胃癌二线适应症中获得阳性结果的HER2双特异性抗体药物。此外,KN026多项胃癌、乳腺癌适应症的关键III期临床研究正在顺利进行中,有望使更多患者获益。

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