安科生物(300009.SZ)：注射用人生長激素新增特發性矮小適應症獲批
格隆匯9月15日丨安科生物(300009.SZ)公佈，2021年9月14日，公司從國家藥監局網站《2021年09月13日藥品批准證明文件待領取信息發佈-1》獲知，公司新增申報的注射用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已經獲得國家藥監局批准，藥品批准證明文件待領取。該次藥品申請共有6個規格，受理號分別為：CXSS2100001國、CXSS2100002國、CXSS2100003國、CXSS2100004國、CXSS2100005國、CXSS2100006國。
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，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%2。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。
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，該次申請增加的ISS適應症，已在美國獲批上市。目前，公司注射用人生長激素是國內首個獲批該適應症上市的產品。
至此，公司的注射用人生長激素(商品名：安蘇萌)已獲批上市8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；7)用於性腺發育不全(特納綜合徵)所致女孩的生長障礙；8)用於治療特發性矮小適應症。該次新增適應症獲批是對已獲批適應症的豐富和補充，將有利於解決此類患兒的臨牀用藥需求。
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