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异界西游记,助你轻松选择最适合的鞋码!
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  中国生物制药(01177)发布公告,集团联合开发的派安普利单抗注射液已获得美国食品药品监督管理局(FDA)批准上市:1)与顺铂或卡铂和吉西他滨联合用药,用于复发或转移性非角化性鼻咽癌(NPC)成人患者的一线治疗;2)作为单药治疗,适用于接受过铂类化疗期间或之后出现疾病进展,且至少接受过一种其他先前治疗的转移性非角化性鼻咽癌成人患者。

  派安普利单抗是目前唯一采用IgG1亚型并进行Fc段改造的新型差异化PD-1单抗,能够更有效增强免疫治疗疗效,且减少不良反应。目前,派安普利单抗已获得中国国家药品监督管理局(NMPA)批准四项适应症,包括:联合化疗一线治疗转移性鼻咽癌、联合化疗一线治疗局部晚期或转移性鳞状非小细胞肺癌、单药治疗至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤、以及单药治疗二线及以上转移性鼻咽癌。此外,2024年11月,派安普利单抗联合安罗替尼一线治疗晚期肝细胞癌的新药上市申请已获NMPA受理。

  集团将积极推进派安普利单抗的适应症开发,加速开拓国际市场,满足全球患者的迫切临床需求。

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