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科伦博泰生物-B(06990.HK):核心产品芦康沙妥珠单抗(SAC-TMT)的新药申请获国家药品监督管理局受理
格隆汇 08-19 20:55

格隆汇8月19日丨科伦博泰生物-B(06990.HK)公吿,基于芦康沙妥珠单抗(sac-TMT,前称SKB264/MK-2870)OptiTROP-Lung03关键研究积极结果的新药申请(NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理。

OptiTROP-Lung03是一项多中心、随机、关键临床研究,评估了芦康沙妥珠单抗(sac-TMT)单一疗法每两周(Q2W)5mg/kg静脉注射对比多西他赛治疗接受表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)疗法和含铂化疗治疗失败后的局部晚期或转移性EGFR突变非小细胞肺癌(NSCLC)患者的结果。在预设的分析中,与多西他赛相比,芦康沙妥珠单抗(sac-TMT)单一疗法在客观缓释率(ORR)和无进展生存期(PFS)方面具有显著统计学意义和临床意义的改善。

公司已就芦康沙妥珠单抗(sac-TMT)治疗接受EGFR-TKI和含铂化疗治疗失败后的局部晚期或转移性EGFR突变NSCLC成人患者提交该申请。

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