石藥集團(01093.HK):降壓新藥馬來酸左旋氨氯地平片獲美FDA批准上市
格隆匯12月20日丨石藥集團(01093.HK)宣佈,美國食品藥品監督管理局(FDA)已批准CONJUPRI®(馬來酸左旋氨氯地平)片劑用於治療高血壓的新藥上市申請(NDA)。據吾等所悉,此為中國醫藥企業率先向美國FDA遞交的新藥上市申請並經過FDA正常審批途徑,成為首獲FDA完全批准的中國本土創新藥。
左旋氨氯地平為用於治療高血壓的純化(S)-氨氯地平,即氨氯地平((R)-及(S)-氨氯地平的消旋混合物)中具有藥理活性的對映異構體。氨氯地平是由輝瑞於1992年首先開發並以NORVASC®(苯磺酸氨氯地平)2.5毫克、5.0毫克及10.0毫克片劑進行推廣銷售的第三代鈣通道阻滯劑。獲批的CONJUPRI®(馬來酸左旋氨氯地平)片劑為1.25毫克、2.5毫克及5.0毫克。
集團自2003年起已於中國推廣銷售馬來酸左旋氨氯地平片(商品名:玄寧)。馬來酸左旋氨氯地平片在美國的臨牀開發是依據中國的安全及療效數據,以及顯示左旋氨氯地平比氨氯地平有較少不良反應的數據。
FDA的批准使集團可於美國推廣銷售CONJUPRI®,亦有助其於世界其他地區的推廣銷售。作為FDA批准的首個左旋氨氯地平,CONJUPRI®有資格成為具有相同活性成分藥物之參考製劑。
馬來酸左旋氨氯地平片在美國獲得新藥上市申請批准彰顯了集團致力於創新併為全球病患者提供最佳藥物的決心。
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