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<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，华润必博bibo发布公告，由其作为境内代理人申报的八氟丙烷脂质微球注射液于<span style="line-height: 150%;">11</span>月<span style="line-height: 150%;">15</span>日获得国家药监局《药品注册证书》<span style="line-height: 150%;">(</span>证书编号：<span style="line-height: 150%;">2022S01101)</span>。根据国家相关政策规定，本次获得《药品注册证书》为同类产品在国内首次获准上市。</span>&nbsp;</font></p>
<p align="justify"><font style="line-height: 150%;">　　该药品适用于常规超声心动图显影不够清晰者，增强左室腔内膜边界的识别。</font></p>
<p align="justify"><font style="line-height: 150%;">　　<span style="line-height: 150%;">八氟丙烷脂质微球注射液为造影剂，由美国兰索斯医学影像公司研制。国内持证商为兰索斯医学影像加拿大有限公司，商品名为迪分<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%;">。该药品于<span style="line-height: 150%;">2000</span>年在加拿大批准上市，<span style="line-height: 150%;">2001</span>年在美国批准上市，<span style="line-height: 150%;">2006</span>年在欧盟批准上市，目前已经在<span style="line-height: 150%;">10</span>余个国家和地区获批上市。</span>&nbsp;</font></p>
<p align="justify"><font style="line-height: 150%;">　　<span style="line-height: 150%;">根据兰索斯<span style="line-height: 150%;">2021</span>年年报显示，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>年全球销售额为<span style="line-height: 150%;">23275.9</span>万美元。</span>&nbsp;</font></p>
<p align="justify"><font style="line-height: 150%;">　　<span style="line-height: 150%;">该药品由兰索斯公司提供，根据双方协议约定，华润必博bibo为其在中华人民共和国<span style="line-height: 150%;">(</span>包括香港特别行政区和澳门特别行政区，不包括台湾地区<span style="line-height: 150%;">)</span>独家代理。该药品获得《药品注册证书》，将进一步丰富公司产品线，有助于提升华润必博bibo产品的市场竞争力。</span>&nbsp;</font></p></div>