<style type="text/css">.TRS_Editor P{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor DIV{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor TD{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor TH{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor SPAN{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor FONT{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor UL{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor LI{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor A{line-height:1;font-family:宋體;font-size:15pt;}</style><div class=TRS_Editor><style type="text/css">
.TRS_Editor P{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor DIV{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor TD{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor TH{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor SPAN{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor FONT{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor UL{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor LI{line-height:1;font-family:宋體;font-size:15pt;}.TRS_Editor A{line-height:1;font-family:宋體;font-size:15pt;}</style>
<p align="justify"><font style="line-height: 150%;"> <span style="line-height: 150%;">11</span><span style="line-height: 150%;">月<span style="line-height: 150%;">25</span>日，華潤雙鶴發(fā)布公告，由其作為境內代理人申報的八氟丙烷脂質微球注射液于<span style="line-height: 150%;">11</span>月<span style="line-height: 150%;">15</span>日獲得國家藥監(jiān)局《藥品注冊證書》<span style="line-height: 150%;">(</span>證書編號：<span style="line-height: 150%;">2022S01101)</span>。根據(jù)國家相關政策規(guī)定，本次獲得《藥品注冊證書》為同類產品在國內首次獲準上市。</span> </font></p>
<p align="justify"><font style="line-height: 150%;"> 該藥品適用于常規(guī)超聲心動圖顯影不夠清晰者，增強左室腔內膜邊界的識別。</font></p>
<p align="justify"><font style="line-height: 150%;"> <span style="line-height: 150%;">八氟丙烷脂質微球注射液為造影劑，由美國蘭索斯醫(yī)學影像公司研制。國內持證商為蘭索斯醫(yī)學影像加拿大有限公司，商品名為迪分<span style="line-height: 150%;">？(DEFINITY</span></span><span style="line-height: 150%;">？</span><span style="line-height: 150%;">)</span><span style="line-height: 150%;">。該藥品于<span style="line-height: 150%;">2000</span>年在加拿大批準上市，<span style="line-height: 150%;">2001</span>年在美國批準上市，<span style="line-height: 150%;">2006</span>年在歐盟批準上市，目前已經(jīng)在<span style="line-height: 150%;">10</span>余個國家和地區(qū)獲批上市。</span> </font></p>
<p align="justify"><font style="line-height: 150%;"> <span style="line-height: 150%;">根據(jù)蘭索斯<span style="line-height: 150%;">2021</span>年年報顯示，其“<span style="line-height: 150%;">DEFINITY</span></span><span style="line-height: 150%;">？</span><span style="line-height: 150%;">”<span style="line-height: 150%;">2021</span>年全球銷售額為<span style="line-height: 150%;">23275.9</span>萬美元。</span> </font></p>
<p align="justify"><font style="line-height: 150%;"> <span style="line-height: 150%;">該藥品由蘭索斯公司提供，根據(jù)雙方協(xié)議約定，華潤雙鶴為其在中華人民共和國<span style="line-height: 150%;">(</span>包括香港特別行政區(qū)和澳門特別行政區(qū)，不包括臺灣地區(qū)<span style="line-height: 150%;">)</span>獨家代理。該藥品獲得《藥品注冊證書》，將進一步豐富公司產品線，有助于提升華潤雙鶴產品的市場競爭力。</span> </font></p></div>
