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石药集团(01093.HK):降压新药马来酸左旋氨氯地平片获美FDA批准上市
格隆汇 12-20 12:14

格隆汇12月20日丨石药集团(01093.HK)宣布,美国食品药品监督管理局(FDA)已批准CONJUPRI®(马来酸左旋氨氯地平)片剂用于治疗高血压的新药上市申请(NDA)。据吾等所悉,此为中国医药企业率先向美国FDA递交的新药上市申请并经过FDA正常审批途径,成为首获FDA完全批准的中国本土创新药。

左旋氨氯地平为用于治疗高血压的纯化(S)-氨氯地平,即氨氯地平((R)-及(S)-氨氯地平的消旋混合物)中具有药理活性的对映异构体。氨氯地平是由辉瑞于1992年首先开发并以NORVASC®(苯磺酸氨氯地平)2.5毫克、5.0毫克及10.0毫克片剂进行推广销售的第三代钙通道阻滞剂。获批的CONJUPRI®(马来酸左旋氨氯地平)片剂为1.25毫克、2.5毫克及5.0毫克。

集团自2003年起已于中国推广销售马来酸左旋氨氯地平片(商品名:玄宁)。马来酸左旋氨氯地平片在美国的临床开发是依据中国的安全及疗效数据,以及显示左旋氨氯地平比氨氯地平有较少不良反应的数据。

FDA的批准使集团可于美国推广销售CONJUPRI®,亦有助其于世界其他地区的推广销售。作为FDA批准的首个左旋氨氯地平,CONJUPRI®有资格成为具有相同活性成分药物之参考制剂。

马来酸左旋氨氯地平片在美国获得新药上市申请批准彰显了集团致力于创新并为全球病患者提供最佳药物的决心。

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