安科生物(300009.SZ):注射用人生長激素用於治療特納綜合徵適應症的境內生產藥品補充申請獲受理
格隆匯5月31日丨安科生物(300009.SZ)公佈,近日,公司收到國家藥品監督管理局行政許可文書《受理通知書》,公司注射用人生長激素用於治療特納綜合徵(英文簡稱:TS)適應症的境內生產藥品補充申請已獲得受理,受理號分別為:CYSB21****3國、CYSB21****4國、CYSB21****5國、CYSB21****6國、CYSB21****7國、CYSB21****8國。
特納綜合徵又稱先天性卵巢發育不全綜合徵,是由於體細胞中X染色體異常而引起的性染色體相關疾病,是常見的人類染色體異常疾病之一,臨牀主要表現為生長落後和性腺發育不良。特納綜合徵患者生長遲緩始於宮內,部分患者在18月齡左右即出現進一步線性生長速度降低,3歲後更明顯,至青春期時未現正常青春期應有的身高突增,成人身高常低於正常人平均身高20cm左右。
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,本次申請增加的TS適應症,已在美國、歐洲、日本獲批上市。目前已收錄於國內各相關診治指南,如《矮身材兒童診治指南》、《基因重組人生長激素兒科臨牀規範應用的建議》、《Turner綜合徵兒科診療共識》等。
公司的注射用重組人生長激素(商品名:安蘇萌)已獲批上市6個適應症:1)用於因內源性生長激素缺乏所引起的兒童生長緩慢;2)用於因Noonan綜合徵所引起的兒童身材矮小;3)用於因SHOX基因缺陷所引起的兒童身材矮小或生長障礙;4)用於重度燒傷治療;5)用於因軟骨發育不全所引起的兒童身材矮小;6)用於接受營養支持的成人短腸綜合症。此次新增適應症是對已獲批適應症的豐富和補充,如能獲批將有利於解決此類患兒的臨牀用藥需求。
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