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加科思-B(01167.HK):KRAS G12C抑制劑艾瑞凱®獲批上市

格隆匯5月22日丨加科思-B(01167.HK)發佈公告,根據國家藥品監督管理局官方網站信息,公司自主研發的KRAS G12C抑制劑艾瑞®(通用名:戈來雷塞)正式獲批上市。適應症爲至少經歷過一種系統性治療的KRASG12C突變的非小細胞肺癌。此次獲批觸發里程碑付款條件,加科思將收到來自合作夥伴艾力斯(688578.SH)5,000萬元里程碑付款。

艾瑞凱®獲得批準上市,是基於一項在中國開展的二期註冊性臨牀試驗,該試驗的完整數據已刊登在《Nature Medicine》(影響因子58.7)。基於戈來雷塞關鍵性II期單臂研究的積極結果,在單藥二線及以上非小細胞肺癌患者中,戈來雷塞客觀緩解率(ORR)爲49.6%,疾病控制率(DCR)達86.3%,中位無進展生存期(PFS)達8.2個月,中位總生存期(OS)達17.5個月。從安全性數據顯示,戈來雷塞有良好的安全性特徵,和其他KRAS G12C抑制劑相比,具有良好的消化道安全性特徵。加科思已將艾瑞凱®的中國(包括中國大陸、中國香港、中國澳門和中國臺灣)權益授權授予艾力斯。

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