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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，华润双鹤发布公告，</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，其中华润双鹤市场份额为<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，华润双鹤该药品销售收入为<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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