重磅BD资讯！4个月4款申报上市！“Follow”的DPP-4抑制剂迎爆发！4.77亿美元！韩国大熊制药双靶点抑制剂海外授权

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关键词：抑制剂制剂制药靶点药上市

资讯来源：药时代

发布时间： 2023-05-01

</section><section style="margin-bottom: 0px;outline: 0px;letter-spacing: 0.578px;white-space: normal;color: rgb(62, 62, 62);font-size: 19px;text-align: center;line-height: 1.5em;visibility: visible;"><img class="rich_pages wxw-img" data-backh="19" data-backw="578" data-galleryid="" data-ratio="0.03333333333333333" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/Lkw2iaE07M9VdpWTCkMvY4ibwPdadaqz8TiaC6QUHo2ay416OJfe0eCs0bgZ74JoSIoCm8qJDHeicdictolYDRhandw/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="1080" style="outline: 0px;color: rgb(51, 51, 51);letter-spacing: 0.578px;width: 100%;visibility: visible !important;height: auto;"/></section><section style="margin-bottom: 0px;outline: 0px;letter-spacing: 0.578px;white-space: normal;color: rgb(62, 62, 62);font-size: 19px;text-align: center;line-height: 1.5em;visibility: visible;"><br arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="letter-spacing: 0.578px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""/></section><h1 arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span style="font-size: 20px;"><strong>4个月4款申报上市！“Follow”的DPP-4抑制剂将迎爆发</strong></span></h1><section style="text-align: center;margin-top: 0px;"><span style="font-size: 20px;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" start="" style="color: rgb(141, 141, 141);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei="">2023-04-27</span></strong></span></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><section style="padding-right: 21px;padding-bottom: 21px;padding-left: 21px;outline: 0px;display: inline-block;width: 677px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);visibility: visible;"><p style="outline: 0px;text-align: center;visibility: visible;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5805825242718446" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp88Fmwum3hH4Y7JuR3q92SMtt9ZJZANbTa50jMROqzIZL8C9muibLCDjOtmicaGRdjJpY0QdbjL8gvWw/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="515" style="outline: 0px;width: 332px !important;visibility: visible !important;"/></p><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;visibility: visible;"><p style="outline: 0px;visibility: visible;"><br style="outline: 0px;visibility: visible;"/></p><p style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">2023</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">年</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">4</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">月</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">26</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">日，石药集团开发的</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">1</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">类新药普卢格列汀片（</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">DBPR108</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">片）递交的上市申请获得国家药品监督管理局正式受理，用于治疗</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">2</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">型糖尿病。</span></p></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;visibility: visible;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;visibility: visible;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;visibility: visible;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);visibility: visible;"><p style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 16px;visibility: visible;"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;visibility: visible;">关于普卢格列汀片</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;"/><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">普卢格列汀片是一种新型口服二肽基肽酶</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">-IV(DPP-4)</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">抑制剂，对</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">DPP-4</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">具有高选择性和强抑制性。通过抑制</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">DPP-4</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">，使内源性活性胰高血糖素样肽</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">-1(GLP-1)</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">水平升高从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌并增强葡萄糖对胰高血糖素分泌的抑制作用，进而降低血糖水平且不诱发低血糖和增加体重。</span></p></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="outline: 0px;font-size: 16px;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">关键性</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">3</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">期临床研究</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">此次申报是基于在中国开展的两项关键3期研究，即普卢格列汀片单药3期试验（CTR20191987）、普卢格列汀片联合二甲双胍3期试验（CTR20192506），这两项研究共纳入约1000例2型糖尿病受试者。2022年8月，石药集团公布了该研究的主要结果，这两项3期试验结果均达到预设终点。结果显示：</span><span style="outline: 0px;font-size: 15px;"/></p><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;"><br style="outline: 0px;"/></span></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;text-decoration: underline;">单药试验</span><span style="outline: 0px;font-size: 15px;">结果</span><span style="outline: 0px;font-size: 15px;">显示，治疗24周后，普卢格列汀片治疗组HbA1c水平变化显著优于安慰剂组，同时非劣于阳性药磷酸西格列汀片组。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;text-decoration: underline;">与二甲双胍的联合试验</span><span style="outline: 0px;font-size: 15px;">结果显示，治疗第24周后，普卢格列汀片治疗组HbA1c水平变化显著优于安慰剂组。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">此外，普卢格列汀片组的安全性数据显示安全性与西格列汀组和安慰剂组相似。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><p style="outline: 0px;text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.07283236994219654" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp88Fmwum3hH4Y7JuR3q92SMtbsibkeCXAiaRaGZIH9qUtnDGpiaYUEIl5TlJPTrCDibQzWemo8HTQxJKOg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="865" style="outline: 0px;width: 677px !important;visibility: visible !important;"/></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;color: rgb(136, 136, 136);font-size: 14px;">来源：CDE官网</span><span style="outline: 0px;font-size: 15px;"/></section></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="outline: 0px;font-size: 16px;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">中国糖尿病市场持续扩容</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.544px;">2型糖尿病是一种慢性代谢疾病，近些年糖尿病患病率持续上升，已经成为全球重大公共卫生问题之一。根据国际糖尿病联盟（IDF）统计，2021年中国成人糖尿病患者有1.41亿人，患病率高达11.6%，其中90%以上为2型糖尿病。</span><span style="outline: 0px;font-size: 15px;"/></p><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.544px;"><br style="outline: 0px;"/></span></p><section style="outline: 0px;line-height: 1.6em;"><p style="outline: 0px;"/></section><section style="outline: 0px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">根据公开数据，2021年中国糖尿病药物市场规模为454亿元人民币，同比增长12.8%，2016年至2021年复合增长率为8.6%，预计2021年至2026年复合增长率为11%。</span><p style="outline: 0px;"/></section><section style="outline: 0px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">2021年中国医院终端糖尿病销售额为343亿元人民币，占比75.5%，同比增长8.2%，2016年至2021年复合增长率为8.3%。</span><p style="outline: 0px;"/></section><section style="outline: 0px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><p style="outline: 0px;text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6942003514938488" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp88Fmwum3hH4Y7JuR3q92SMtyc2UyibtaslqTBZpmicSkQgXLw8jEUtO5nsibMf115dFlbvWiam3yJ4s9w/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="569" style="outline: 0px;width: 397px !important;visibility: visible !important;"/></p><section style="outline: 0px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;color: rgb(136, 136, 136);font-size: 14px;">中国糖尿病药物市场规模（2016年至2021年）</span></section></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="outline: 0px;font-size: 16px;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">国内DPP-4</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">抑制剂研究情况</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">DPP-4抑制剂是治疗糖尿病主要药物之一，它通过抑制体内胰高血糖素样肽-1(GLP-1)分解代谢而发挥作用。</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">DPP-4抑制剂能提高内源性GLP-1和GIP的水平，促进胰岛β细胞释放胰岛素，抑制胰岛α细胞分泌胰高血糖素，从而提高胰岛素水平，降低血糖，且不易诱发低血糖和增加体重。</span><span style="outline: 0px;font-size: 15px;"/></p><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;"><br style="outline: 0px;"/></span></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">DPP-4抑制剂是一种新型的糖尿病口服药物，具有很多优点，如：一天服用一次，餐前餐后均可服用；不增加低血糖风险，胃肠道副作用少；不增加心血管事件的发生率，安全性及耐受性高等诸多优势。因此，DPP-4抑制剂是各大药企眼中的香饽饽，国内市场火热。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">根据公开数据，国内DPP-4抑制剂市场规模持续增长，中国DPP-4靶点药物的年销售额呈持续增长趋势，同比增长率在2018年为最高。2021年，DPP-4抑制剂销售额近30亿。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">迄今为止，全球范围内上市了多款DPP-4抑制剂，进入国内市场的有DPP-4抑制剂有利格列汀、曲格列汀、提格列汀、沙格列汀、维格列汀、西格列汀等。除了曲格列汀，其余DPP-4抑制剂均被纳入国家医保目录。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;font-size: 14px;"><strong style="outline: 0px;">国内获批DPP-4抑制剂</strong></span><span style="outline: 0px;font-size: 15px;"/><p style="outline: 0px;"/></section><p style="outline: 0px;text-align: center;"><img class="rich_pages wxw-img js_insertlocalimg" data-ratio="0.2925682031984948" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp88Fmwum3hH4Y7JuR3q92SMt6kRvapYSZKf8kGXqUh81FUibjRpHbose9pmvaoncG1gWGjfu4McvtKA/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="1063" style="outline: 0px;width: 677px !important;visibility: visible !important;"/></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;color: rgb(136, 136, 136);font-size: 14px;">凯莱英药闻整理，截止2023年4月</span><span style="outline: 0px;font-size: 15px;"/><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">全球范围内临床在研的DPP-4抑制剂约有28款，第一梯队临床3期的有4款，临床2期的有15款，临床1期的有9款。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">目前国内约有12款临床在研的DPP-4药物，涉及的企业有海思科、轩竹生物、苑东生物等。申报上市的产品多达5款，虽然还没有上市的国产DPP-4抑制剂创新药，但该类药物研发竞争格局已十分激烈。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">2023年2月，<strong style="outline: 0px;">信立泰</strong>的1类新药苯<strong style="outline: 0px;">甲酸复格列汀片（信复清）</strong>申报上市申请获得国家药监局受理。苯甲酸复格列汀片为DPP-4抑制剂，具有口服吸收迅速，半衰期长，作用持久等特点，目标适应症为2型糖尿病。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">恒瑞医药</span></strong><span style="outline: 0px;font-size: 15px;">布局了<strong style="outline: 0px;">瑞格列汀二甲双胍片</strong>，已于今年1月13日提交上市申请。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">2023年1月，<strong style="outline: 0px;">海思科</strong>的DPP-4</span><span style="outline: 0px;font-size: 15px;text-decoration: underline;">超长效抑制剂</span><span style="outline: 0px;font-size: 15px;"><strong style="outline: 0px;">HSK7653片</strong>的上市申请获得CDE受理，用于治疗2型糖尿病。该药最大的特色是双周降糖药，</span><span style="outline: 0px;font-size: 15px;text-decoration: underline;">有望成为全球首个DPP-4双周制剂</span><span style="outline: 0px;font-size: 15px;">。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">苑东生物</span></strong><span style="outline: 0px;font-size: 15px;">自主研发的1类小分子<strong style="outline: 0px;">优格列汀</strong>正在开展3期研究，是一款周制剂。目前国内尚无DPP-4周制剂口服降糖药上市。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">由<strong style="outline: 0px;">华东理工大学</strong>研究团队研发的<strong style="outline: 0px;">马来酸博格列汀</strong>同样为DPP-4周制剂，该研发项目已与山东百极地长制药达成合作协议，目前处于临床1/2期阶段。</span><p style="outline: 0px;"/></section><p style="outline: 0px;text-align: center;"><br style="outline: 0px;"/></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">正大天晴</span></strong><span style="outline: 0px;font-size: 15px;">布局了2款DPP-4抑制剂1类新药，分别为<strong style="outline: 0px;">TQ-F3083胶囊</strong>、<strong style="outline: 0px;">TQ05510胶囊</strong>，足见公司对该类药物的重视。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><br style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;font-size: 14px;"><strong style="outline: 0px;">国内在研DPP-4抑制剂</strong></span><span style="outline: 0px;font-size: 15px;"/><p style="outline: 0px;"/></section><p style="outline: 0px;text-align: center;"><img class="rich_pages wxw-img js_insertlocalimg" data-cropselx1="0" data-cropselx2="527" data-cropsely1="0" data-cropsely2="287" data-ratio="0.5396825396825397" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp88Fmwum3hH4Y7JuR3q92SMtibXbI8omp9WKMu92GFS4oa9DQnqOmwxuz52FG7sfO6V6SCHiaoTC9kRA/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="945" style="outline: 0px;width: 532px !important;visibility: visible !important;"/></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;text-align: center;"><span style="outline: 0px;color: rgb(136, 136, 136);font-size: 14px;">凯莱英药闻整理，截止2023年4月</span></section></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="outline: 0px;font-size: 16px;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">GLP-1</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">受体激动剂与</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">DPP-4</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">抑制剂的对比</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" normal="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">GLP-1受体激动剂作为近几年非常火热的降糖药，占据了很大的市场空间。那么，DPP-4抑制剂与之相比，有哪些优势呢？</span><span style="outline: 0px;font-size: 15px;"/></p><p style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;"><br style="outline: 0px;"/></span></p><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">梳理二者的相关信息，我们发现，GLP-1受体激动剂与DPP-4抑制剂有相同的<strong style="outline: 0px;">作用机制</strong>，即增强胰岛素分泌，一直胰高血糖素分泌；<strong style="outline: 0px;">不良反应</strong>的表现上也相似，均是胃肠道反应；<strong style="outline: 0px;">低血糖风险</strong>上也基本一致。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;">不同点具体表现在以下几个方面。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><br style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">给药途径</span></strong><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">：</span><span style="outline: 0px;font-size: 15px;letter-spacing: 0.578px;">GLP-1受体激动剂目前主要是皮下注射，DPP-4抑制剂是口服给药。</span><br style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">作用方式</span></strong><span style="outline: 0px;font-size: 15px;">：GLP-1受体激动剂可以抵抗DPP-4降解，半衰期更长；而DPP-4抑制剂有效GLP-1的失活，使内源性GLP-1在体内蓄积，在生理范围内增加有活性的GLP-1水平。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">心血管作用</span></strong><span style="outline: 0px;font-size: 15px;">：GLP-1受体激动剂具有心血管获益；DPP-4抑制剂不增加心血管病变风险。</span><p style="outline: 0px;"/></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><span style="outline: 0px;font-size: 15px;"><br style="outline: 0px;"/></span></section><section style="outline: 0px;letter-spacing: 0.578px;line-height: 1.6em;"><strong style="outline: 0px;"><span style="outline: 0px;font-size: 15px;">对体重的影响</span></strong><span style="outline: 0px;font-size: 15px;">：GLP-1受体激动剂能延缓胃排空，降低食欲，显著降低体重；DPP-4抑制剂在胃排空、抑制食欲等方面的作用较弱。</span></section></section></section></section></section></section><section style="margin-bottom: 0px;outline: 0px;letter-spacing: 0.578px;white-space: normal;color: rgb(62, 62, 62);font-size: 19px;text-align: center;line-height: 1.5em;visibility: visible;"><br/></section><section style="margin-bottom: 0px;outline: 0px;letter-spacing: 0.578px;white-space: normal;color: rgb(62, 62, 62);font-size: 19px;text-align: center;line-height: 1.5em;visibility: visible;"><img class="rich_pages wxw-img" data-backh="19" data-backw="578" data-galleryid="" data-ratio="0.03333333333333333" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/Lkw2iaE07M9VdpWTCkMvY4ibwPdadaqz8TiaC6QUHo2ay416OJfe0eCs0bgZ74JoSIoCm8qJDHeicdictolYDRhandw/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1" data-type="png" data-w="1080" style="outline: 0px;color: rgb(51, 51, 51);letter-spacing: 0.578px;width: 100%;visibility: visible !important;height: auto;"/></section><section style="line-height: normal;margin-bottom: 0px;"><br/></section><section arial="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span style="outline: 0px;letter-spacing: 0.034em;text-align: left;"/></section><p arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span style="font-size: 18px;"><strong>4.77亿美元！韩国大熊制药早期BTK&ITK双靶点抑制剂海外授权</strong></span></p><p style="text-align: center;"><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" start="" style="color: rgb(141, 141, 141);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei="">2023-04-28</span></p><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-right: 21px;padding-bottom: 21px;padding-left: 21px;outline: 0px;display: inline-block;width: 677px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);"><section powered-by="xiumi.us" style="outline: 0px;"><section style="outline: 0px;display: inline-block;vertical-align: top;overflow: hidden;height: 18px;width: 18px;background-color: rgb(215, 227, 245);"><section arial="" center="" gb="" helvetica="" neue="" normal="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><p arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><br style="outline: 0px;"/></p></section></section></section><p style="text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.11485451761102604" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp8icZ3XKfqS3gqRNJREwIoQO1fQpx1p71MeGV39oh49dEIJPg25NeejiaiaJ4ntnaYHPV5sYB4yG9mEMA/640?wx_fmt=png" data-type="png" data-w="653" style="width: 444px;height: 51px;"/></p><section arial="" center="" gb="" helvetica="" neue="" normal="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><p arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><br style="outline: 0px;"/></p></section><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><section style="outline: 0px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;letter-spacing: 0.578px;">2023年4月27日，Daewoong Pharmaceutical（大熊制药）宣布已与美国生物技术公司Vitali Bio签署了其自身免疫性疾病候选药物DWP213388的全球许可协议。根据该协议，Aditum Bio的投资组合公司Vitalli Bio获得Daewoong的候选药物DWP213388在全球范围内的开发和商业化独家权利，Daewoong保留该产品在包括韩国在内的一些亚洲地区的权利。Daewoong将获得超过1000万美元的预付款，这笔交易高达4.77亿美元。此外，Vitali Bio将获得Daewoong开发的早期双靶点抑制剂的许可权。</span></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="font-size: 16px;"><strong style="outline: 0px;">关于<span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei="">DWP213388</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;"/><span style="font-size: 15px;letter-spacing: 0.578px;">DWP213388是大熊制药开发的一款自身免疫性疾病口服药物，目前在临床1期研究阶段，拟用于治疗系统性红斑狼疮、类风湿性关节炎、慢性自发性荨麻疹等适应症。</span></p><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;"><br/></span></p><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">该产品可选择性抑制布鲁顿酪氨酸激酶（BTK）和白细胞介素-2可诱导T细胞激酶（ITK），这两种酶参与B细胞和T细胞等免疫细胞的激活。与现有的仅抑制B细胞或T细胞的治疗方法不同，DWP213388是一种first-in-class新药，可以同时抑制BTK和ITK，因此比传统的单一疗法更具疗效潜力。去年8月，DWP213388的IND申请获得美国FDA批准，启动1期临床试验。在各种自身免疫性疾病动物模型中，如类风湿性关节炎（RA），该候选药物已经证实了优异的疗效。</span></p></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="font-size: 16px;"><strong style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">自身免疫性疾病市场规模</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">自身免疫性疾病（AID）是指机体对自身抗体发生免疫反应而导致自身组织损害所引起的疾病，具有患病人口多、致残致死率高的特点。</span><span style="font-size: 15px;letter-spacing: 0.578px;">常见的自身免疫性疾病包括类风湿关节炎、系统性红斑狼疮、自身免疫性肝病、自身免疫性糖尿病等。</span><span style="font-size: 15px;"/></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">根据公开数据，全球自身免疫性疾病治疗市场保持稳定增长，2020年全球自身免疫性疾病药物市场规模约为1206亿美元，同比上升1.43%，预计2021年达到1270亿美元。在整体市场增长同时，治疗手段也出现了产品迭代。目前，BTK抑制剂、JAK抑制剂等新一代小分子靶向药因为较传统治疗手段更优的临床疗效将逐步替代传统药物的市场地位。</span></section><p style="outline: 0px;"><span style="font-size: 15px;"/></p><p style="text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6362297496318114" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp8icZ3XKfqS3gqRNJREwIoQO1cja0HxFaDHbVE5kXA1EMNT5cbJnFrjH2R8Dr9MpkoRjoEh7ibCYHLeA/640?wx_fmt=png" data-type="png" data-w="679" style=""/></p></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="font-size: 16px;"><strong style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">BTK/ITK抑制剂研究情况</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">自身免疫性疾病的机制复杂，对这类疾病相关信号通路的研究非常有挑战。</span><span style="font-size: 15px;letter-spacing: 0.578px;">激酶是一类能够磷酸化人类蛋白组中三分之一蛋白的酶，且在免疫细胞的多个信号通路中都有分布，因此小分子激酶抑制剂针对自身免疫面疾病具有很好的治疗潜力。</span><span style="font-size: 15px;"/></p><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;"><br/></span></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">TEC激酶家族主要在造血细胞中表达，TEC家族所介导的信号转导主要在免疫细胞的分化、发育、增殖和凋亡等多种过程中起着重要的作用。TEC家族成员有BTK、ITK/TSK/EMT、TEC、TXK和BMX，其结构具有高度同源性。其中，BTK和ITK两个激酶分别在B细胞和T细胞的激活中发挥作用，BTK和ITK是具有吸引力的药物靶点。</span><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">ITK属于非受体型酪氨酸激酶TEC家族成员之一，其在T细胞系中特异性表达，从而诱导IL-2、IL-4和IL-13的产生。ITK是在T细胞信号通路中起着重要作用，能够正向调节TCR信号通路，诱导IL-2、IL-4和IL-13的生成。ITK可调节人体的免疫功能。</span><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">BTK是TEC家族的成员之一，除T细胞和终末分化的浆细胞外，在所有造血细胞中均有表达。BTK能够调节肥大细胞中的Fcε受体(FcεR)信号传导，参与到IgE介导的疾病。在啮齿类动物模型中，BTK抑制剂可通过减少自身抗体的产生和炎症细胞因子的产生来防止关节炎或系统性红斑狼疮的发展。</span><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><p style="text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6992248062015504" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp8icZ3XKfqS3gqRNJREwIoQO1hnwaQ7SpEW7xZAkgfrHtHpXqf3XxicpfCY6mw2ZJrHlYw33PcGoicrGA/640?wx_fmt=png" data-type="png" data-w="645" style="width: 401px;height: 280px;"/></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;text-align: center;"><span style="letter-spacing: 0.578px;color: rgb(136, 136, 136);font-size: 14px;">ITK和BTK信号通路</span><span style="font-size: 15px;letter-spacing: 0.578px;"/></section><section arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><br/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">目前，全球有5款BTK/ITK抑制剂，其中上市1款，为伊布替尼。</span><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;text-align: center;"><span style="font-size: 14px;"><strong><span style="color: rgb(0, 0, 0);">全球BTK/ITK抑制剂研究情况</span></strong></span><span style="font-size: 15px;"/><p/></section><p style="text-align: center;"><img class="rich_pages wxw-img js_insertlocalimg" data-ratio="0.31574074074074077" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp8icZ3XKfqS3gqRNJREwIoQO13G4g0QNJ8oxGKnficyfbQmiavhOyBn1DMxRqOQS1qDtepxd2AbNiaKlAg/640?wx_fmt=png" data-type="png" data-w="1080" style=""/></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;text-align: center;"><span style="color: rgb(136, 136, 136);font-size: 14px;">凯莱英药闻团队整理，截止2023年4月</span><span style="font-size: 15px;"/><p/></section><section arial="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 14px;outline: 0px;font-size: 22px;line-height: 1.4;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><br/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">伊布替尼是由艾伯维和强生共同研发的第一代BTK抑制剂，伊布替尼之所以疗效卓越，在于其独特的的BTK/ITK多靶点作用机制。除了强效抑制BTK靶点外，伊布替尼对ITK靶点的抑制作用同样强效。伊布替尼通过抑制ITK靶点，可恢复或增加T细胞的数量，促进T细胞向有利方向分化，抑制其向不利方向分化，改善T细胞功能，调控肿瘤微环境。</span><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">作为第一代BTK抑制剂，伊布替尼攻克了许多适应症，从上市后便保持连年增长的势头，2021年拿下97亿美元的亮眼业绩。2022年销售业绩为83亿美元，业绩的下滑与新一代BTK抑制剂上市抢夺市场有关系。</span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><p style="text-align: center;"><img class="rich_pages wxw-img js_insertlocalimg" data-ratio="0.5815028901734104" data-s="300,640" data-src="https://mmbiz.qpic.cn/mmbiz_png/V5wksYicgp8icZ3XKfqS3gqRNJREwIoQO10bS3YFOdLOcaqNrwAuVxwbIKm0xHHWVLicUNbGfgnrkfYTUrx2fibOtA/640?wx_fmt=png" data-type="png" data-w="865" style=""/></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;text-align: center;"><span arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei="">2017-2022伊布替尼的销售情况（来源：佰傲谷）</span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;"><br/></span></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">除了DWP213388，大熊制药还布局了一款BTK/ITK双靶点抑制剂，即DWP218，同样用于自身免疫性疾病的治疗，目前正在临床前开发阶段。</span></section></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="font-size: 16px;"><strong style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">关于</span><strong><span style="color: rgb(63, 114, 183);font-size: 15px;letter-spacing: 0.578px;text-decoration: none solid rgb(63, 114, 183);">Daewoong Pharmaceutical</span></strong><span style="font-size: 15px;letter-spacing: 0.578px;"/></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">大熊制药成立于1945年，是韩国一家领先的制药公司。</span><span style="font-size: 15px;letter-spacing: 0.578px;">凭借强大且创新的内部研发和先进的制造设施，大熊制药为全球客户提供全面的医疗保健解决方案。</span><span style="font-size: 15px;letter-spacing: 0.578px;">为了继续建设其成为一家强大的全球医疗保健公司，大熊制药在亚洲和美国建立分支机构和研究中心，扩大了国际业务。</span><span style="font-size: 15px;letter-spacing: 0.578px;">大熊制药还在全球100多个国家扩大了战略伙伴关系。</span><span style="font-size: 15px;"/></p><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;"><br/></span></p><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><p/></section><section style="letter-spacing: 0.578px;white-space: normal;line-height: 1.6em;"><span style="font-size: 15px;">2022年，大熊制药签订了一笔价值为9.23亿美元的许可协议，扩大了其在全球市场的影响力，该协议许可 Fexuclue（用于治疗胃食管反流）在上市的第一年内在菲律宾和厄瓜多尔使用。此外，大熊制药成功推出了Envlo，这是韩国首个用于治疗糖尿病的SGLT2抑制剂，并与巴西和墨西哥签署了价值8436万美元的出口合同。</span></section></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;font-size: 18px;color: rgb(63, 114, 183);"><p style="outline: 0px;"><span style="font-size: 16px;"><strong style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">关于Adi</span><span style="font-size: 15px;letter-spacing: 0.578px;">tum Bio</span></strong></span></p></section></section></section></section></section><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;letter-spacing: 0.578px;">Aditum Bio是由诺华前首席执行官Joe Jimenez和诺华生物医学研究院（NIBR）前院长Mark Fishman博士于2019年共同创立的一家生物技术投资公司。</span><span style="font-size: 15px;letter-spacing: 0.578px;">Mark Fishman博士目前也是哈佛医学院的教授。</span><span style="font-size: 15px;letter-spacing: 0.578px;">在Mark Fishman博士任期内，NIBR发现并成功进行了120多个适应症的90种新药的临床试验。</span><span style="font-size: 15px;letter-spacing: 0.578px;">Vitalli Bio是Aditum Bio组建的第九家公司，与传统制药公司相比，Vitalli Bio具有独特的投资和运营模式，利用数据、软件和技术积极推动候选新药进入临床。</span><span style="font-size: 15px;letter-spacing: 0.578px;">Aditum Bio公司团队在全球制药行业和临床开发方面拥有丰富的经验，将积极参与DWP213388的开发。</span></p></section></section></section></section></section><section arial="" column="" flex="" gb="" helvetica="" neue="" nowrap="" powered-by="xiumi.us" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><section powered-by="xiumi.us" style="outline: 0px;z-index: 1;"><section style="margin-top: 10px;margin-bottom: 10px;outline: 0px;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;"><section style="padding-left: 13px;outline: 0px;display: inline-block;width: auto;vertical-align: top;align-self: flex-start;flex: 0 0 auto;border-left: 6px solid rgb(180, 203, 237);min-width: 5%;height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;color: rgb(63, 114, 183);"><p style="outline: 0px;"><strong style="outline: 0px;"><span style="font-size: 15px;">生物技术已成为韩国新的经济引擎</span><span style="font-size: 15px;letter-spacing: 0.578px;"/></strong></p></section></section></section></section></section><section style="line-height: 1.6em;margin-bottom: 24px;"><section arial="" flex="" flex-start="" gb="" helvetica="" left="" neue="" nowrap="" powered-by="xiumi.us" rgb="" row="" sans="" sans-serif="" sc="" style="margin-top: 10px;margin-bottom: 10px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " translate3d="" ui="" yahei=""><section style="outline: 0px;display: inline-block;width: 670.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(244, 248, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="margin-top: -5px;margin-bottom: 5px;outline: 0px;text-align: center;justify-content: center;display: flex;flex-flow: row nowrap;transform: translate3d(-4px, 0px, 0px);"><section style="padding: 24px;outline: 0px;display: inline-block;width: 668.229px;vertical-align: top;align-self: flex-start;flex: 0 0 auto;background-color: rgb(255, 255, 255);border-style: solid;border-width: 1px;border-color: rgb(215, 227, 245);height: auto;"><section powered-by="xiumi.us" style="outline: 0px;text-align: justify;"><p style="outline: 0px;"><span style="font-size: 15px;">生物技术和医学相关产业已成为韩国新的经济增长引擎。根据韩国食品医药品安全处的数据统计显示，2021年韩国医药品市场规模突破25万亿韩元（约合人民币1285亿元），同比增长9.6%。同时，根据韩国产业通商资源部发布的《2021年全年进出口动向》显示，2021年韩国医药品出口额为84.9亿美元，同比增长20.5%。制药、生物产业正在成为引领韩国经济的未来主力产业。2022年度，韩国新增上市药品1782件，目前，韩国的生物药产业年产值己进入世界Top15榜单，并成为全球第十大临床试验基地，首尔在全球临床试验城市排名中位列第一，在美国FDA批准的新药数量排名中，韩国位列第十位。</span></p></section></section></section></section></section></section><section arial="" gb="" helvetica="" neue="" rgb="" right="" sans="" sans-serif="" sc="" style="margin-top: 16px;margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span 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