康方生物-B(09926.HK):派安普利单抗已在美国启动提交BLA用于治疗三线鼻咽癌
格隆汇5月24日丨康方生物-B(09926.HK)发布公告,公司与中国生物制药有限公司(股份代号:1177.HK)共同开发的PD-1单抗药物派安普利单抗(研发代号:AK105)已经向美国食品药品监督管理局启动提交生物制品许可申请,寻求上市获批三线治疗转移性鼻咽癌。
该BLA将在实时肿瘤审评(RTOR)新政下进行审评。RTOR是FDA肿瘤学卓越中心(OCE)颁布的重大创新性肿瘤新药审批新政策,比优先审评速度更快,旨在加快药物审批,尽早及安全有效地用于癌症患者的治疗。
派安普利三线治疗转移性鼻咽癌已经获得FDA授予的突破性疗法认定。公司期待根据RTOR计划提交BLA,可使公司具有差异化的PD-1单抗更快地解决全球鼻咽癌患者的需求。
据悉,派安普利(PD-1单抗,AK105)由公司与中国生物制药旗下正大天晴药业集团股份有限公司所设立的合营企业共同开发及商业化。派安普利的结晶(Fc)受体和补体介导效用功能通过Fc区突变而完全去除,同时与国外已上市PD-1抗体相比抗原结合解离速率较慢。这些特点使得派安普利具有更有效地阻断PD-1通路的活性,并维持更强的T细胞抗肿瘤活性,有可能成为临床获益更好的抗PD-1药物。
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