全球已有45款新冠检测产品获美国FDA EUA认证！

admin · 发表于 2020-10-14 12:26:56

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span>来源：CACLP体外诊断资讯</span></p><p><br  /></p><p><span>应对COVID-19疫情，美国食品药品监督管理局（FDA）在2月初发布了“紧急使用授权”，简称FDA EUA认证，这是产品进入美国市场的最快速通道，目前有7大类产品被列入EUA产品目录，包括医疗手套、口罩、新冠检验试剂、额温枪、呼吸机等设备。同样的，世界卫生组织(WHO)开启了《紧急使用清单(EUL)》；中国国家药监局（NMPA）启动了应急审批。</span></p><p><br  /></p><section data-support="96编辑器" data-style-id="26050"><section><section><section><section><section><p><span><strong><span>全球已有45款新冠检测产品获美国FDA EUA认证</span></strong></span></p></section></section></section></section></section></section><section><p><br  /></p><p><span>2020年2月4日，美国食品药品监督管理局（FDA）紧急授权了第一款新冠检测产品。截至4月24日，82天已有45款新冠检测产品获EUA认证（文末附产品总表）。</span></p><p><br  /></p><p><p><img src="image/20201014/95a7fd98514fd844e14791aaa891fc7b_2.png" /></p></p><p><span>截至4月24日，中美新冠病毒检测产品认证数量对比</span></p><p><br  /></p></section><section data-support="96编辑器" data-style-id="26050"><section><section><section><section><section><p><span><strong><span>3家国内上市企业获双证</span></strong></span></p></section></section></section></section></section></section><section><p><br  /></p><p><span>国内上市企业华大基因(300676)、迈克生物(300463)、复星医药(600196)同时获得了中国NMPA应急审批和美国FDA EUA认证。受益新冠检测试剂盒出口及4月22日中央决定国家大规模核酸检测，预计对全年业绩都有正面影响。</span></p><p><br  /></p><p><br  /></p><p><p><img src="image/20201014/903758cfc73dfac6d9820258942d70f1_3.png" /></p></p><p><br  /></p><p><span>迈克生物：2019年营收32.23亿元，同比增长20.02%，超过57.65%上市公司，母归净利润5.19亿元，同比增长18.97，超过71.48%上市公司。</span></p><p><br  /></p><p><span>迈克生物股份有限公司是始创于1994年，公司一直以来专注于体外诊断产品的研究、生产、销售和服务。</span></p><p><br  /></p><p><p><img src="image/20201014/3bd7c7551d59d92eeabc59a5ae2135ee_4.png" /></p></p><p><br  /></p><p><span>复星医药：2019年营收285.85亿（+14.72%），超过90.07%上市公司，母归净利润44.94亿（+27.10%），超过93.04%上市公司。<br  /></span></p><p><span><br  /></span></p><p><br  /></p><p><span>复星医药控股子公司上海复星长征医学科学有限公司成立于1989年10月，是一家集产品研发、生产、销售体外诊断和实验室试剂及诊断仪器设备于一体的市级高新技术企业。</span></p><p><br  /></p><p><p><img src="image/20201014/8eccd72a65426313f046f035e7e5a7b9_5.png" /></p></p><p><br  /></p><p><span>华大基因：2019年营收28.2亿元（+11.22%），母归净利润3.01亿（-21.1%）。2020年第一季度预计盈利13,256.31 万元–14,238.26 万元，较上年同期增长约30%-40%。</span></p><p><br  /></p><p><span>华大基因成立于1999年9月9日，伴随着国际人类基因组计划" 中国部分"的正式启动而诞生。</span></p></section><p><br  /></p><section data-support="96编辑器" data-style-id="26050"><section><section><section><section><section><p><span><strong><span>获批45家企业一览</span></strong></span></p></section></section></section></section></section></section><section><p><br  /></p></section><p><p><img src="image/20201014/60f6ce8008ede5f49779f6cf57393e92_6.png" /></p></p><p><span><br  /></span></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_7.gif" 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