信立泰(002294.SZ):YOLT-101獲得臨牀試驗默示許可
格隆匯7月14日丨信立泰(002294.SZ)公佈,近日,深圳信立泰藥業股份有限公司收到通知,公司引進的創新基因編輯藥物YOLT-101注射液(下稱“YOLT-101”)已獲得國家藥品監督管理局的臨牀試驗默示許可。
YOLT-101是公司從堯唐(上海)生物科技有限公司(下稱“堯唐生物”)引進的靶向PCSK9鹼基編輯藥物,擬開發適應症包括家族性高膽固醇血癥等,公司擁有YOLT-101於中國大陸區域的獨家許可權益。
相比較現有PCSK9抗體、siRNA藥物等治療方法,YOLT-101作爲PCSK9鹼基編輯藥物,可在DNA水平編輯PCSK9基因的單個鹼基,降低靶蛋白表達。如能研發成功並獲批上市,將有望顯著提高家族性高膽固醇血癥患者服藥依從性,爲患者提供更便捷的全新治療選擇。
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