康方生物-B(09926.HK):派安普利單抗(PD-1單抗)三線治療轉移性鼻咽癌新藥上市申請獲NMPA受理
格隆匯8月5日丨康方生物-B(09926.HK)發佈公吿,公司與中國生物製藥(股份代號:1177.HK)共同開發的PD-1單抗藥物派安普利單抗(研發代號:AK105)三線治療轉移性鼻咽癌,已經向中國國家藥品監督管理局(“NMPA”)提交新藥上市申請(“NDA”),並獲得受理。這是派安普利在中國和美國成功提交的第四個適應症新藥上市申請。此前,派安普利已經在中國提交了兩項NDA,在美國提交了一項生物製品許可申請(“BLA”)。派安普利採用免疫球蛋白G1(“IgG1”)亞型且經結晶(“Fc”)段改造的新型PD-1單抗,其抗原結合解離速率更慢,晶體結構分析顯示具有獨特的結合表位,持久阻斷PD-1/PD-L1結合,與其他已上市PD-1產品的差異化,可能使得派安普利能夠更有效增強免疫治療療效,且減少免疫相關不良反應。
根據披露,鼻咽癌是一種局部區域高發的惡性腫瘤。復發或轉移性鼻咽癌患者的預後較差,中位總生存期少於20個月,二線治療失敗後更無有效的治療方案。派安普利在過往多線治療失敗的轉移性鼻咽癌患者中顯示出了相當高的腫瘤持續緩解率和更長的生存獲益,對難治的鼻咽癌肝轉移患者療效突出。派安普利的安全性和耐受性良好,整體免疫相關不良反應發生率低。公司期待派安普利的獲批上市,為患者提供更佳的治療方案選擇。
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