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康方生物(09926.HK)自主研發雙特異性抗體PD-1/VEGF(AK112)獲NMPA臨牀試驗批件
格隆匯 08-11 06:10

格隆匯8月11日丨康方生物-B(09926.HK)發佈公告,公司自主研發的雙特異性抗體PD-1/VEGF(AK112)獲得中國國家藥品監督管理局(NMPA)頒發的藥物臨牀試驗批件,將在中國進一步開展針對晚期實體瘤的1b期臨牀試驗。AK112是公司繼雙抗PD-1/CTLA-4(AK104)之後第二款全球首創並進入臨牀開發階段的雙特異性抗體藥物,已經於2019年10月在澳洲開展一期臨牀研究。

近來PD-1/PD-L1抗體與VEGF阻斷劑的聯合療法頻繁在包括肺癌、腎癌和肝癌等多種腫瘤適應症中顯示出強大的療效,甚至獲得美國食品藥品監督管理局(FDA)批准。這也預示着針對PD-1/PD-L1和VEGF雙靶點的雙特異性抗體將有可能有較高的成功概率。

AK112是公司自主研發,全球行業內首個進入臨牀研究的PD-1/VEGF雙特異性抗體。AK112是基於公司獨特的TETRABODY技術設計,可阻斷PD-1與PD-L1和PD-L2的結合,並同時阻斷VEGF與VEGF受體的結合。PD-1抗體與VEGF阻斷劑的聯合療法已在多種瘤種(如腎細胞癌、非小細胞肺癌和肝細胞癌)中顯示出強大的療效。鑑於VEGF和PD-1在腫瘤微環境中的共表達,與聯合療法相比,AK112作為單一藥物同時阻斷這兩個靶點,可能會更有效地阻斷這兩個通路從而增強抗腫瘤活性。

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