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安科生物(300009.SZ):注射用重組人生長激素新增適應症上市申請納入優先審評程序
格隆匯 02-08 22:15

格隆匯 2 月 8日丨安科生物(300009.SZ)公佈,公司新增申報的注射用重組人生長激素用於治療特發性矮小(英文簡稱:ISS)適應症的上市許可申請,於2021年2月1日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,現公示期滿,正式進入優先審評程序。

矮身材是指在相似生活環境下,個體身高低於同種族、同年齡、同性別正常人羣第3百分位數或低於正常人羣平均身高2個標準差(-2SD)者。據統計,我國兒童矮身材發生率為3%左右,而特發性矮小是兒童身材矮小中最常見的類型,是指無全身性、內分泌、營養性疾病或染色體異常的身材矮小,ISS患兒的出生體重和生長激素水平均正常,ISS可由多種目前尚不明確的病因引起,約佔所有身材矮小兒童的60%-80%1。兒童矮身材不僅給患兒身心健康、人際交往、社會就業等帶來嚴重危害,也給社會帶來沉重的負擔。

重組人生長激素已在國內外獲批用於治療多種兒童矮身材相關適應症,此次申請增加的ISS適應症,已在美國獲批上市。目前,國內尚未批准上市,但生長激素用於治療特發性矮小已納入中華醫學會兒科學雜誌《矮身材兒童診治指南》及《特發性身材矮小兒童診斷和治療的共識聲明》等行業診療指南。

公司的注射用重組人生長激素(商品名:安蘇萌)用於治療特發性矮小適應症的上市申請已於日前獲得國家藥品監督管理局受理,此次被納入優先審評程序,將有力推動特發性矮小適應症早日獲批,進一步強化公司“安蘇萌”產品的差異化競爭優勢,為此類患兒提供一種有效的治療途徑。

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