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加科思-B(01167.HK)治療肺癌藥物獲藥監局授予突破性治療藥物認定
阿思達克 12-16 09:01
加科思-B(01167.HK)公布,其自主研發的KRAS G12C抑制劑JAB-21822被藥監局(NMPA)藥品審評中心(CDE)授予用於KRAS G12C突變的晚期或轉移性非小細胞肺癌(NSCLC)患者二線及以上治療的突破性治療藥物認定。此次認定是基於JAB-21822前期良好的療效和安全性資料獲得,突破性治療的認定將有助於藥物上市的加速審評、註冊及加快患者提早獲得藥物。 JAB-21822的II期關鍵性臨床試驗已於2022年9月5日在中國獲批。這項多中心、單臂、開放研究旨在評估JAB-21822單藥用於KRAS G12C突變的非小細胞肺癌患者的療效及安全性。
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