中生製藥(01177.HK)旗下治療非小細胞肺癌藥物獲納入優先審評程序
中生製藥(01177.HK)公佈,集團聯合開發的KRAS G12C抑制劑「Garsorasib(D-1553片)」已被中國國家藥品監督管理局藥品審評中心(CDE)納入優先審評品種名單。
公司指,D-1553是國內首個自主研發並進入臨牀試驗階段的KRAS G12C抑制劑。2022年6月,D-1553被CDE納入突破性治療品種,是首個獲得CDE突破性治療認定的國產KRAS G12C抑制劑。2023年12月,D-1553的新藥上市申請獲CDE正式受理,用於既往經一線系統治療後疾病進展或不可耐受的、並且經檢測確認存在KRAS G12C突變的局部晚期或轉移性非小細胞肺癌(NSCLC)的治療。
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