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天下足球网天下足球网匹伐他汀钙片通过仿制药质量和疗效一致性评价
信息来源: 发布时间:2020-11-04 【字体:大 中 小】
天下足球网天下足球网匹伐他汀钙片通过仿制药质量和疗效一致性评价
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<div><font style="line-height: 150%;"><span lang="EN-US" style="line-height: 150%;"> 11</span><span style="line-height: 150%;">月<span lang="EN-US" style="line-height: 150%;">3</span>日,天下足球网天下足球网发布公告,</span>公司产品匹伐他汀钙片(<span lang="EN-US" style="line-height: 150%;">2mg</span>)于<span lang="EN-US" style="line-height: 150%;">2020</span>年<span lang="EN-US" style="line-height: 150%;">10</span>月<span lang="EN-US" style="line-height: 150%;">26</span>日通过国家药品监督管理局仿制药质量和疗效一致性评价审批,<span style="line-height: 150%;">取得</span>《药品补充申请批准通知书》<span lang="EN-US" style="line-height: 150%;">(</span>通知书编号:<span lang="EN-US" style="line-height: 150%;">2020B04885)</span><span style="line-height: 150%;">。</span></font>
<p align="justify"><font style="line-height: 150%;"> 匹伐他汀钙片用于治疗高胆固醇血症、家族性高胆固醇血症,原研公司为日本兴和株式会社,商品名为<span lang="EN-US" style="line-height: 150%;">“</span>力清之<span lang="EN-US" style="line-height: 150%;">”</span><span lang="EN-US" style="line-height: 150%;">(Livalo Kowa)</span>, 于<span lang="EN-US" style="line-height: 150%;">2003</span>年在日本上市,<span lang="EN-US" style="line-height: 150%;">2008</span>年在中国批准上市,<span lang="EN-US" style="line-height: 150%;">2010</span>年在美国上市,<span lang="EN-US" style="line-height: 150%;">2011</span>年在西班牙和德国获批准上市。根据米内网数据显示,<span lang="EN-US" style="line-height: 150%;">2019</span>年匹伐他汀钙片中国市场销售总额(终端价)为<span lang="EN-US" style="line-height: 150%;">15.52</span>亿元人民币,其中天下足球网天下足球网市场份额为<span lang="EN-US" style="line-height: 150%;">43.56%</span>,企业份额排名第一。<span lang="EN-US" style="line-height: 150%;">2019</span>年度,天下足球网天下足球网该药品销售收入为<span lang="EN-US" style="line-height: 150%;">5.49</span>亿元人民币(经审计)。</font></p>
<p align="justify"><font style="line-height: 150%;"> 本次通过一致性评价将有利于该药品未来的市场销售,并为后续其他产品开展仿制药一致性评价积累宝贵经验。</font></p>
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