康宁杰瑞制药-B(09966)：恩尼妥® (安尼妥单抗注射液)获国家药品监督管理局批准上市

智通财经

May 29

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，与石药集团有限公司(股份代号：1093)附属公司上海津曼特生物科技有限公司(津曼特生物)合作开发的恩尼妥® (安尼妥单抗注射液，人表皮生长因子受体2(“HER2”)双特异性抗体，研发代号：KN026)已获中国国家药品监督管理局(“NMPA”)批准上市，联合化疗用于治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性(“HER2+”)胃癌╱胃食管结合部腺癌(“GC/GEJ”)成人患者。

本次获批是基于一项关键II/III期临床研究(KC-WISE)，入组对象为至少一线治疗失败的HER2+ GC/GEJ患者。研究结果显示，相比标准化疗，安尼妥单抗联合化疗可显著延长中位无进展生存期(mPFS)(7.1个月vs 2.7个月，风险比(“HR”)为0.25，疾病进展或死亡风险降低75%)和中位总生存期(mOS)(19.6个月vs 11.5 个月，HR为0.29，死亡风险降低71%)，各亚组人群获益趋势一致，客观缓解率 (ORR)和缓解持续时间(DOR)获益趋势一致。不良反应主要为化疗主导的血液学毒性，临床易处理，可管可控;与同类竞品相比，心脏毒性、腹泻以及输注反应发生率低，有显著安全性优势。

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