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康方生物-B(09926.HK):AK112單藥或聯合化療新輔助╱輔助治療可切除非小細胞肺癌II期臨牀研究獲批開展
格隆匯 11-02 06:16

格隆匯11月2日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的新型腫瘤免疫治療藥物PD-1/VEGF雙特異性抗體(研發代號:AK112)獲得中國國家藥品監督管理局藥品審評中心(CDE)批准,開展單藥或聯合化療新輔助╱輔助治療可切除非小細胞肺癌(“NSCLC”)的II期臨牀研究。

這是一項開放性、多中心的II期隨機臨牀研究,旨在評估對於可切除的NSCLC患者,手術前AK112單藥或聯合化療新輔助╱輔助治療是否可以改善手術病理緩解率。AK112在針對包括NSCLC、小細胞肺癌(“SCLC”)在內的各類型肺癌的早期臨牀研究中,表現出了良好的安全性和耐受性,也已經顯示出優異的抗腫瘤效果。

AK112是全球領先進入III期臨牀研究階段的同類藥物,是繼全球首創的凱得寧(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)進入審評階段後,公司又一個率先進入後期臨牀階段的全球首創雙特異性抗體藥物。此外,AK112治療表皮細胞生長因子受體-酪氨酸激酶抑制劑(EGFR-TKI)治療失敗的NSCLC的註冊性III期臨牀研究已經啟動;AK112一線治療驅動基因陰性的PD-L1陽性NSCLCIII期臨牀研究,以及AK112一線治療廣泛期SCLC的III期臨牀研究即將啟動。

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