昆藥集團(600422.SH):嗎替麥考酚酯幹混懸劑藥物上市許可申請獲受理
格隆匯1月14日丨昆藥集團(600422.SH)公佈,全資子公司昆明貝克諾頓製藥有限公司於近日收到國家藥品監督管理局下發的《受理通知書》,全資子公司嗎替麥考酚酯幹混懸劑的藥物上市許可申請獲國家藥監局受理。嗎替麥考酚酯幹混懸劑由Roche公司開發,分別於1996年、1998年在歐盟、美國獲批上市,主要用於腎、心臟、肝臟等移植後的抗排斥反應;2015年在日本上市,當前適應證除用於器官移植後的抗排斥外,還可用於狼瘡性腎炎、幹細胞移植後排斥反應、全身性硬皮病伴間質性肺病等疾病。與嗎替麥考酚酯片或膠囊相比,幹混懸劑更適合吞嚥困難的成人和兒童患者。
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