石药集团(1093.HK)收涨2.08% 玄宁获美国FDA完全批准上市 为中国创新药首例
格隆汇12月23日丨石药集团(1093.HK)今日收涨2.08%报18.62港元,成交4.52亿港元,最新总市值1161亿港元。
12月20日,石药集团高血压专利药玄宁获美国食品药品监督管理局,也就是FDA审评通过,成为中国本土企业第一个获得美国完全批准的创新药。
马来酸左旋氨氯地平是治疗高血压的专利药,于2003年以“玄宁”之名在国内上市,积累了大量的临床数据。这次在美国上市是中国医药企业率先向美国FDA递交新药上市申请,经过正常审批途径,中国本土企业首获FDA完全批准的创新药。作为FDA批准的首个左旋氨氯地平,玄宁有资格成为具有相同活性成分药物的参考制剂,成为国际标准。
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