安科生物(300009.SZ):注射用人生長激素獲《藥品補充申請批准通知書》
格隆匯7月15日丨安科生物(300009.SZ)公佈,近日,公收到國家藥品監督管理局下發的《藥品補充申請批准通知書》(受理號分別為:CYSB2101063、CYSB2101064、CYSB2101065、CYSB2101066、CYSB2101067、CYSB2101068)。
獲批藥品通用名稱為注射用人生長激素。申請增加適應症:用於性腺發育不全(特納綜合徵)所致女孩的生長障礙。
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。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,公司本次獲批的“特納綜合徵”適應症已在美國、歐洲、日本獲批上市。
除上述新增適應症外,公司的注射用人生長激素(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徵。
此次新增適應症是對已獲批適應症的豐富和補充,有利於解決此類患兒的臨牀用藥需求。
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