新諾威(300765.SZ):巨石生物SYS6043抗體偶聯藥物獲得美國藥物臨牀試驗批准
格隆匯1月16日丨新諾威(300765.SZ)公佈,公司的控股子公司石藥集團巨石生物製藥有限公司(簡稱“巨石生物”)於近日收到美國食品藥品監督管理局(簡稱“FDA”)通知,由巨石生物申報的注射用SYS6043藥品臨牀試驗申請已獲得美國FDA批准,可以在美國開展臨牀試驗。
SYS6043是一款單克隆抗體偶聯藥物,可與腫瘤表面的特異性受體結合,通過內吞作用進入細胞並釋放毒素,達到殺傷腫瘤細胞的作用。本次獲批的適應症為晚期/轉移性實體瘤,預計適用於治療小細胞肺癌、食管鱗癌、頭頸鱗癌、前列腺癌、肝細胞癌等。臨牀前研究顯示,SYS6043對多種癌症顯示出了較好的抗腫瘤作用,具備較高的臨牀開發價值。該產品已在國內外提交多項專利申請。
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