康方生物-B(09926)：派安普利单抗(PD-1)治疗三线鼻咽癌注册性临床试验达到主要终点

智通财经网

Oct 12, 2020

智通财经APP讯，康方生物-B(09926)发布公告，该公司与中国生物制药有限公司(01177)共同开发的抗PD-1单抗药物派安普利单抗(安尼可)(研发代号：AK105)用于三线治疗转移性鼻咽癌(NPC)注册性临床试验，于9月份完成入组，达到了由独立影像评估的客观缓解率(ORR)主要终点。派安普利单抗在既往经过多线治疗后的NPC患者中，展示了良好的临床疗效和安全性。本公司拟于近期向中国国家药品监督管理局(NMPA)进行新药上市申请前沟通。

于2020年5月，派安普利用于治疗至少经过二线系统化疗复发或难治性(r/r)经典型霍奇金淋巴瘤(r/rcHL)的新药上市申请已经获得NMPA受理。目前派安普利的主要适应症包括肝癌、胃癌、肺癌等疾病。

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