安科生物(300009.SZ):人生長激素注射液新增適應症申請獲受理
格隆匯11月25日丨安科生物(300009.SZ)公佈,近日,安徽安科生物工程(集團)股份有限公司收到國家藥品監督管理局行政許可文書《受理通知書》,公司人生長激素注射液新增小於胎齡兒(small for gestational age,SGA)適應症的補充申請事項獲得受理,受理號為:CYSB2400303。
人生長激素治療SGA的目標是加速兒童早期的線性生長過程完成追趕性生長,在兒童生長髮育後期維持正常生長速度,最終使成年期身高達到正常水平。人生長激素在國內外上市多年,已廣泛用於SGA矮小兒童的治療。
公司人生長激素注射液具有不含防腐劑、使用便捷的特點,本次新增適應症是對公司人生長激素已獲批8個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,提升公司的市場競爭力。
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