加科思-B(01167.HK):KRAS G12C抑制劑新藥臨牀實驗申請(IND)在美國獲批
格隆匯 5 月 3日丨加科思-B(01167.HK)發佈公吿,公司JAB-21822項目KRAS G12C抑制劑的新藥臨牀試驗申請(“IND”)已經獲得美國食品藥品監督管理局(“FDA”)批准。
JAB-21822是公司自主研發的創新變構抑制劑,旨在針對KRAS G12C突變。它將用於治療KRAS G12C斜體突變的晚期實體瘤,包括但不限於非小細胞肺癌 (NSCLC),結直腸癌(CRC)等晚期實體瘤。
KRAS為人類癌症中突變頻率最高的致癌基因,迄今為止,全球尚無獲批准及已上市的KRAS G12C抑制劑。在約11.0%的NSCLC患者及較小百分比的其他幾種難治癌症患者中發現了KRAS G12C突變。於2019年,NSCLC、卵巢癌、CRC及胰腺癌患者中KRAS G12C突變的全球發病人數達到約29.5萬人。
在公司的內部頭對頭臨牀前動物研究中,JAB-21822表現出優於同類型藥物的藥代動力學(PK)特性和良好的耐受性,以及具備傑出的劑量特性潛力。科學研究表明,基於KRAS抑制劑和SHP2抑制劑的互補作用機制,其組合可增強抗腫瘤活性。SHP2抑制劑(RAS上游)有望成為KRAS抑制劑克服適應性耐藥的最佳組合搭檔。公司是全球極為少數同時擁有SHP2抑制劑和KRAS G12C抑制劑的少數製藥公司之一,未來公司計劃探索內部的聯合用藥。、
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