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加科思-B(01167.HK):KRAS G12C抑制劑JAB-21822與西妥昔單抗聯用臨試在中國獲批
格隆匯 12-06 08:08

格隆匯12月6日丨加科思-B(01167.HK)發佈公吿,公司自主研發的KRAS G12C抑制劑JAB-21822與西妥昔單抗注射液的聯用試驗於2021年12月3日獲得中國國家藥品監督管理局評審中心批准。

此項臨牀試驗獲批後,加科思將在中國開啟一項I/II期、開放標籤、多中心、劑量遞增和擴展的臨牀研究,旨在探索JAB-21822聯合西妥昔單抗在KRAS G12C突變的晚期結直腸癌患者中的安全性、耐受性和初步療效。

加科思的臨牀前研究顯示,JAB-21822與西妥昔單抗聯用可增強JAB-21822抑制劑在結直腸癌腫瘤模型中抗腫瘤活性,使腫瘤發生消退,且延緩停藥後的腫瘤再生長。JAB-21822目前已在中美兩國獲批五項臨牀試驗,包括單藥試驗以及分別與PD-1單抗或西妥昔單抗的聯合用藥試驗,適應症包括非小細胞肺癌、結直腸癌等KRAS G12C突變的晚期實體瘤。

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