中國生物製藥(01177.HK):派安普利單抗注射液獲得美國FDA批准上市
格隆匯4月25日丨中國生物製藥(01177.HK)宣佈,集團聯合開發的派安普利單抗注射液已獲得美國食品藥品監督管理局(FDA)批准上市:1)與順鉑或卡鉑和吉西他濱聯合用藥,用於復發或轉移性非角化性鼻咽癌(NPC)成人患者的一線治療;2)作為單藥治療,適用於接受過鉑類化療期間或之後出現疾病進展,且至少接受過一種其他先前治療的轉移性非角化性鼻咽癌成人患者。
派安普利單抗是目前唯一採用IgG1亞型並進行Fc段改造的新型差異化PD-1單抗,能夠更有效增強免疫治療療效,且減少不良反應。目前,派安普利單抗已獲得中國國家藥品監督管理局(NMPA)批准四項適應症,包括:聯合化療一線治療轉移性鼻咽癌、聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌、單藥治療至少經過二線系統化療的復發或難治性經典型霍奇金淋巴瘤、以及單藥治療二線及以上轉移性鼻咽癌。此外,2024年11月,派安普利單抗聯合安羅替尼一線治療晚期肝細胞癌的新藥上市申請已獲NMPA受理。
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