金吾财讯 | 康方生物(09926)公告，安尼可®（派安普利，PD-1）已获得美国食品药品监督管理局(FDA)批准上市，用于治疗复发或转移性鼻咽癌的一线治疗和以铂类为基础的至少一线化疗治疗失败后治疗的2项适应症。派安普利由公司自主研发并由正大天晴康方负责后续开发和商业化，也是公司第一个获得美国FDA批准上市的自主研发创新生物药。目前，派安普利用于晚期鼻咽癌一线和二线后线治疗的2项适应症也已在中国获得批准。主要基于国际多中心III期临床研究AK105-304(NCT04974398)和关键注册性研究AK105-202(NCT03866967)，FDA批准了派安普利2项适应症的生物制品许可申请(BLA)。其中，AK105-304研究是一项随机、双盲、国际多中心Ⅲ期注册性临床试验。该研究的数据将在2025年美国癌症研究协会(AACR)年会上以口头报告的形式重磅发布。
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