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長春高新(000661.SZ):子公司聚乙二醇重組人生長激素注射液新規格新適應症上市申請獲得批准
格隆匯 08-19 18:49

格隆匯8月19日丨長春高新(000661.SZ)公佈,近日,長春高新技術產業(集團)股份有限公司子公司——長春金賽藥業有限責任公司(以下簡稱“金賽藥業”)聚乙二醇重組人生長激素注射液(以下簡稱“長效生長激素”)新規格新適應症上市申請獲得國家藥品監督管理局批准。

公司長效生長激素在國內特納綜合徵患兒中開展的臨牀試驗結果證實,採用長效生長激素治療顯著改善患兒身高標準差積分和生長速率,且安全性和耐受性良好。公司長效生長激素成為全球首個獲批特納綜合徵的長效生長激素,有效填補了目前特納綜合徵矮小治療領域未被滿足的臨牀需求,助力兒童身心健康成長。

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