康方生物-B(09926.HK):派安普利單抗已在美國啟動提交BLA用於治療三線鼻咽癌
格隆匯5月24日丨康方生物-B(09926.HK)發佈公吿,公司與中國生物製藥有限公司(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)已經向美國食品藥品監督管理局啟動提交生物製品許可申請,尋求上市獲批三線治療轉移性鼻咽癌。
該BLA將在實時腫瘤審評(RTOR)新政下進行審評。RTOR是FDA腫瘤學卓越中心(OCE)頒佈的重大創新性腫瘤新藥審批新政策,比優先審評速度更快,旨在加快藥物審批,儘早及安全有效地用於癌症患者的治療。
派安普利三線治療轉移性鼻咽癌已經獲得FDA授予的突破性療法認定。公司期待根據RTOR計劃提交BLA,可使公司具有差異化的PD-1單抗更快地解決全球鼻咽癌患者的需求。
據悉,派安普利(PD-1單抗,AK105)由公司與中國生物製藥旗下正大天晴藥業集團股份有限公司所設立的合營企業共同開發及商業化。派安普利的結晶(Fc)受體和補體介導效用功能通過Fc區突變而完全去除,同時與國外已上市PD-1抗體相比抗原結合解離速率較慢。這些特點使得派安普利具有更有效地阻斷PD-1通路的活性,並維持更強的T細胞抗腫瘤活性,有可能成為臨牀獲益更好的抗PD-1藥物。
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