石藥集團(1093.HK)收漲2.08% 玄寧獲美國FDA完全批准上市 為中國創新藥首例
格隆匯12月23日丨石藥集團(1093.HK)今日收漲2.08%報18.62港元,成交4.52億港元,最新總市值1161億港元。
12月20日,石藥集團高血壓專利藥玄寧獲美國食品藥品監督管理局,也就是FDA審評通過,成為中國本土企業第一個獲得美國完全批准的創新藥。
馬來酸左旋氨氯地平是治療高血壓的專利藥,於2003年以“玄寧”之名在國內上市,積累了大量的臨牀數據。這次在美國上市是中國醫藥企業率先向美國FDA遞交新藥上市申請,經過正常審批途徑,中國本土企業首獲FDA完全批准的創新藥。作為FDA批准的首個左旋氨氯地平,玄寧有資格成為具有相同活性成分藥物的參考製劑,成為國際標準。
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