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康方生物-B(09926.HK):派安普利單抗(PD-1單抗)一線治療鱗狀非小細胞肺癌新藥上市申請獲NMPA受理
格隆匯 07-02 08:10

格隆匯7月2日丨康方生物-B(09926.HK)發佈公吿,公司與中國生物製藥(01177.HK)共同開發的PD-1單抗藥物派安普利單抗(研發代號:AK105)聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌,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。這是公司繼2020年5月派安普利治療至少經過二線系統化療復發或難治性經典型霍奇金淋巴瘤NDA成功被NMPA受理後,派安普利在中國成功提交的第二個適應症NDA。

派安普利採用免疫球蛋白G1(IgG1)亞型且經結晶段改造的新型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。

派安普利聯合化療一線治療鱗狀非小細胞肺癌研究的中期分析結果顯示,派安普利聯合化療對比單純化療組的中位無進展生存期(PFS)顯著延長,疾病進展或死亡風險顯著降低,為患者帶來更優的臨牀獲益。

來自所有接受過派安普利治療患者的安全性數據分析顯示,派安普利治療發生三級及以上免疫相關不良反應較低,免疫相關性肺炎、肝炎發生率低(目前尚未觀察到心肌炎、胰腺炎等案例)。派安普利如此獨特的藥物特性,本公司很期待後續療效、安全性具體數據的分析,期待順利獲批為肺鱗癌標準一線治療,為患者提供更佳的治療方案選擇。

日前,派安普利三線治療轉移性鼻咽癌已經通過即時腫瘤審評(RTOR)項目,向美國食品藥品監督管理局(“FDA”)提交生物製品許可申請(BLA)。此前,派安普利三線治療轉移性鼻咽癌已經獲得了FDA授予的突破性療法認定、孤兒藥資格認定以及快速審批通道資格。

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