信達生物(01801.HK):國家藥監局理IBI-351(KRAS G12C抑制劑)的新藥上市申請並納入優先審評
格隆匯11月24日丨信達生物(01801.HK)發佈公吿,中國國家藥品監督管理局(“NMPA”)已經正式受理IBI-351(KRAS G12C抑制劑)的新藥上市許可申請(“NDA”)並納入優先審評程序,用於治療至少接受過一種系統性治療的KRAS G12C突變型的晚期非小細胞肺癌(“NSCLC”)患者。IBI-351是中國首個遞交NDA的KRAS G12C抑制劑,並納入優先審評,有望儘早惠及KRAS G12C突變的肺癌患者。
此次NDA獲受理並納入優先審評是基於一項在中國開展的臨牀II期單臂註冊研究 (NCT05005234)結果。研究旨在評估IBI-351單藥在標準治療失敗或不耐受且攜帶 KRAS G12C突變的晚期NSCLC受試者中的安全性、耐受性和療效。註冊研究結果預計在2023年歐洲腫瘤內科學會亞洲年會(ESMO ASIA 2023)上公佈。
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