科興製藥(688136.SH):創新藥GB18注射液獲得美國FDA新藥臨牀試驗許可
格隆匯5月21日丨科興製藥(688136.SH)公佈,公司全資子公司深圳科興藥業有限公司(簡稱“深圳科興”)收到美國食品藥品監督管理局(簡稱“FDA”)的通知,深圳科興自主研發的創新藥GB18注射液藥品臨牀試驗申請已獲得FDA批準,可在美國開展臨牀試驗,適應症爲治療腫瘤惡病質。
GB18注射液是一種針對GDF15(生長分化因子15)靶點的創新型藥物,用於治療腫瘤惡病質。該分子採用了獨特的Fc融合納米抗體結構設計,不僅提高了藥物的穩定性和生物利用度,還顯著增強了其在抑制信號通路傳遞中的表現。
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