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科興製藥(688136.SH):人干擾素α1b吸入溶液獲得美國FDA新藥臨牀試驗許可
格隆匯 02-05 16:56

格隆匯2月5日丨科興製藥(688136.SH)公佈,公司全資子公司深圳科興藥業有限公司(以下簡稱“深圳科興”)收到美國食品藥品監督管理局(以下簡稱“FDA”)的通知,深圳科興自主研發的人干擾素α1b吸入溶液藥品臨牀試驗申請已獲得FDA批准,可在美國開展臨牀試驗,適應症為小兒呼吸道合胞病毒性下呼吸道感染(肺炎、毛細支氣管炎)。

公司人干擾素α1b吸入溶液適應症為小兒呼吸道合胞病毒性下呼吸道感染(肺炎、毛細支氣管炎)。呼吸道合胞病毒(RSV)是引起嬰幼兒急性呼吸道感染最常見的病毒病原,5歲以下兒童為易感人羣,特別是嬰幼兒或有基礎疾病的患兒,感染後容易發展為重症肺炎,WHO關於兒童急性呼吸道感染的病因學研究表明,RSV感染佔兒童呼吸道疾病的60%以上。

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