科伦博泰生物塔戈利单抗获批上市
财中社12月31日电科伦博泰生物-B（06990）发布公告，宣布其用于治疗既往接受过2线及以上化疗失败的复发或转移性鼻咽癌患者的靶向单抗塔戈利单抗（前称KL-A167，科泰莱®）已获得中国国家药品监督管理局批准上市。此次获批主要基于一项在132例患者中进行的II期临床研究，评估塔戈利单抗的有效性和安全性。
研究结果显示，客观缓解率（ORR）为26.5%，中位持续缓解时间（DoR）为12.4个月，中位总生存期（OS）为16.2个月。此外，塔戈利单抗的安全性可控，3级免疫相关不良事件发生率为3.9%，未观察到3级以上的免疫相关不良事件。尽管如此，公告也提醒投资者，塔戈利单抗最终能否成功商业化仍存在不确定性。
（文章来源：财中社）
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