40%原研药通过开发新配方阻击仿制药

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关键词：制药仿制药药

资讯来源：药时代

发布时间： 2022-12-21

点击欣赏推介会全程——优秀BD是怎样炼成的？

</section></section><section arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0em;padding-right: 10px;padding-left: 10px;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><strong style="outline: 0px;visibility: visible;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei="">请点击左下方【阅读原文】报名！</span></strong></span></section><section arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0em;padding-right: 10px;padding-left: 10px;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><strong style="outline: 0px;visibility: visible;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><br/></span></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">原研</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">专利</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;"><span style="line-height: 27.2px;">药物公司为了延长其产品生命周期和阻击仿制药的竞争，可以通过诸如新配方（如新剂型、新复方）等途径对已批准上市现有药物</span><span style="line-height: 27.2px;">“</span><span style="line-height: 27.2px;">修改</span><span style="line-height: 27.2px;">”</span><span style="line-height: 27.2px;">。新配方通常可以通过增加用药便利性、减少给药频率或提高耐受性，进而改善的患者依从性，并为疾病治疗提供额外的益处。</span></span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">然而，在某些情况下，新配方，特别是片剂和胶囊，在临床上可能不优于原始新药，其潜在的便利性益处可能会被其成本所抵消。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">精心策划的</span></strong><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">产品跳转策略</span></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">令人担忧的问题是，新配方构成了原研药物公司产品生命周期管理的精心策略之一。原研药物公司使用这些策略来延长市场排他性保护期，从而在面临仿制药竞争时延长与药物相关的收入。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">有研究发现，在第一个仿制药获批进入市场时，原研药物公司通常会提前开发出新配方对仿制药竞争进行阻击。原研药物公司一般会根据仿制药对原研新药的影响程度决定何时采用新配方策略。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">战略性地推迟新配方的应用，直到仿制药进入市场时，使仿制药欲达到广泛使用和降低处方药支出的能力复杂化。例如，在一种被称为产品跳转</span>(product hopping)<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">的策略中，原研药物公司可能会大力推广新配方产品而不是首次获批的新药，进而阻止仿制药替代新配方。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">由于新配方的延迟供应，以及边际价值不确定的延长释放配方和固定剂量复方药物的进入市场，产品跳跃策略导致了大量的过度医疗支出。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">原研药公司如何“策划</span></strong><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">”</span></strong><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">新配方</span></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">研究者通过对自原研新药获批以来第一个新配方获批时间以及第一个仿制药获批时间的研究，可以看到原研药物公司如何通过产品跳跃策略开发新配方。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">通过</span>Drugs@FDA<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">数据库，收集</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1995</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">年</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">月</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">日至</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2010</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">年</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">12</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">月</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">31</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">日期间美国食品药品管理局（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">FDA</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）批准的</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">206</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种片剂和胶囊剂型的新分子实体（新药）。<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-weight: bold;">截至</span></span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-weight: bold;"><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2021</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">年</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">12</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">月</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">31</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">日，在</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">206</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药中，</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">81</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">39.3%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）至少有一种新配方再次获得</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">FDA</span></span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;"><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-weight: bold;">批准</span>，至少有一种仿制药获得</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">FDA</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">批准新药有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">167</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">81.1%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）；</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">65</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">31.6%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）至少一种新配方和一种仿制药同时获得</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">FDA</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">批准。</span></span></section><p grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><br/></p><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><br/></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;"><span style="line-height: 27.2px;">提前近</span>6<span style="line-height: 27.2px;">年布局</span></span></em></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">在有新配方获得</span>FDA<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">批准的</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">81</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药中，有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">个新配方获批的新药是</span>45<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">21.8%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">），</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">23</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">11.2%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）新药有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">个新配方获批，</span>13<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">6.3%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）新药有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">3</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">个及以上新配方获批。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">其中，近一半的首批新配方是新剂型（如延长释放剂型），为</span>34<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">41.9%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">），首批新配方是复方药物</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">29</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">35.8%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）超过三分之一，首批新适应症是</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">13</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">16.0%)</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">在至少有一种新配方获得批准的药物中，从原始新药上市到第一种新配方获批的中位（</span>IQR<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）时间为</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">4.6</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2.3-8.6</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）年。在至少有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种仿制药的药物中，从原始新药到仿制药首次获得批准的中位时间为</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">11.4</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">8.1-14.5</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）年。对于既有新配方又有仿制药的品种，第一个新配方批准在第一个仿制药获批前的中位时间为</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">5.9</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1.5-10.9</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）年。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">重磅和加速批准</span></em></strong><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">药应用率高</span></em></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">在多变量分析中，新配方在重磅药物（</span>58.2%<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）和获得加速批准的新药（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">50.0%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）应用可能性明显更高，在孤儿药产品中的比例较小（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">11.8%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）。世卫组织基本药物清单、首创性新药或优于已有类似药物、根据法国药品行业监管机构</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">Prescrire International</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">的评级进行评分与新配方的可能性增加几乎无关。不同治疗区域的新配方的可能性在统计学上也没有显著差异。</span></span></section><p style="text-align: center;margin-bottom: 24px;"><img class="rich_pages wxw-img" data-backh="632" data-backw="578" data-galleryid="" data-ratio="1.0931871574001566" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/57b20a921f26d2cb0e3ff6e140e40332.png" data-type="png" data-w="1277" style="height: auto;width: 100%;"/></p><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><br/></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">和</span></em></strong><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">仿制药</span></em></strong><strong><em><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">争速度</span></em></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">在同时至少有一种新配方和一种仿制药的</span>65<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新药中，</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">55</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">84.6%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）新配方在首次仿制药批准前获得批准，</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">10</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种（</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">15.4%</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">）在仿制药批准后获得批准。由此可见，首次新配方如果不能赶在首次仿制药产品获批准之前上市，其获批的可能性较小。</span></span></section><section style="margin-bottom: 24px;text-align: center;"><section style="display: inline-block;"><img class="rich_pages wxw-img" data-backh="295" data-backw="578" data-ratio="0.5106382978723404" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/4542d04e7ff664e8324bb861d5dfb6f6.png" data-type="jpg" data-w="752" style="height: auto;width: 100%;"/></section></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><br/></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">启示</span></strong></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">在</span>1995<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">年至</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2010</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">年</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">FDA</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">批准的</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">206</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种片剂或胶囊剂型的新药中，超过三分之一的新药在</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">2021</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">前至少有</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">1</span><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">种新配方获得批准，其中重磅炸弹级和加速批准的药物药物开发新配方获批上市比例明显增高，而其他的治疗价值的衡量标准（包括创新性和临床价值）与新配方的批准比例无关。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">由于获得加速批准的药物最常用于治疗癌症，因此，这些药物更有可能再次通过开发新配方以提高患者的便利性或耐受性。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">此外，在第一个仿制药获得批准后，新配方的批准急剧减少。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">这些结果表明，市场收入是原研药品公司是否以及何时推出获得</span>FDA<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">批准现有药物第一个新配方的主要驱动因素，这说明原研药品公司使用延长产品生命周期管理策略主要目的是维持收入并避免仿制药竞争。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">对新配方批准时间的分析表明，原研药物开发者在战略上对其进行时间安排，特别是相对于首次仿制药批准。一旦原研专利药物市场面临仿制药竞争并且难以挽回，原研药物开发者对开发新配方的兴趣可能会减弱。另一项基于新适应症检查新配方的研究发现，</span>32%<span style="letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;line-height: 27.2px;">的药物在仿制药上市前获得了新适应症的批准，但之后此类批准有所下降。</span></span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei="">新配方对患者获取、临床护理和医疗保健资金具有重要影响。有的新配方可能对患者的依从性益处不明确，但会给患者和医疗系统带来经济压力。</span></section><section grande="" justify="" lucida="" normal="" rgb="" style="line-height: 12.6pt;color: rgb(0, 0, 0);font-family: " verdana="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="line-height: 27.2px;letter-spacing: 0pt;font-size: 12pt;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;font-family: " yahei=""><br/></span></section><p arial="" gb="" helvetica="" neue="" normal="" rgb="" right="" sans="" sans-serif="" sc="" style="margin-right: 8px;margin-bottom: 0px;margin-left: 8px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span style="outline: 0px;font-size: 14px;color: rgb(136, 136, 136);">封面图来源：123rf</span><br style="outline: 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