Biogen/卫材阿尔兹海默症药物在华上市申请获受理

 收藏

关键词：药物上市受理药上市申请

资讯来源：药时代

发布时间： 2022-12-23

仅剩一周！报名通 道将于12月29日关闭！

</section></section></section><p arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="padding-right: 10px;padding-left: 10px;white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span style="outline: 0px;letter-spacing: 0.544px;visibility: visible;color: rgb(232, 22, 105);"><strong style="outline: 0px;visibility: visible;"><span style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;">请点击左下方【阅读原文】报名！</span></strong></span></p><p style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">2022年12月22日，CDE官网显示，Biogen/卫材的阿尔兹海默症药物仑卡奈单抗（lecanemab）的上市申请获NMPA受理。</span></p><p style="text-align: center;margin-bottom: 24px;"><img class="rich_pages wxw-img" data-backh="172" data-backw="578" data-galleryid="" data-ratio="0.2970195272353546" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/7f3f2bf217987e2bf992765fbd1f8e7f.png" data-type="png" data-w="973" style="width: 100%;height: auto;"/></p><p style="margin-bottom: 32px;line-height: 2em;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">Lecanemab</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">是一种研究性抗β淀粉样蛋白（Aβ）原纤维抗体，能够选择性结合以中和及清除可溶性毒性Aβ聚集体（原纤维），主要用于治疗阿尔茨海默氏症（AD）引起的轻度认知障碍（MCI）和轻度AD且确认大脑中存在淀粉样病变的患者。</span></p><section arial="" border-box="" break-word="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><img class="rich_pages wxw-img" data-backh="331" data-backw="578" data-galleryid="" data-ratio="0.5733333333333334" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/838386a5d19baa0849d9280bbd05f338.png" data-type="png" data-w="600" style="outline: 0px;display: initial;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 100%;height: auto;"/></section><section style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">11月30日，卫材在阿尔茨海默病临床试验（CTAD）会议上公布了Lecanemab治疗阿尔兹海默症的III期临床（Clarity AD）的完整结果。</span></section><p style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">结果显示，对于</span><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">主要终点CDR-SB评分</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">，18个月时Lecanemab组和对照组评分分别为1.21和1.66，</span><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">Lecanemab组下降27%（p=0.00005）</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">。</span></p><p arial="" border-box="" break-word="" center="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><img class="rich_pages wxw-img" data-backh="286" data-backw="578" data-galleryid="" data-ratio="0.4942857142857143" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/d5456c631d69ba176708beedd8b6ec5d.png" data-type="png" data-w="700" style="outline: 0px;display: initial;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 100%;height: auto;"/></p><section style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">所有次要终点也达到显著性差异（p＜0.01），在18个月时：</span></section><ul class="list-paddingleft-1" style="margin-bottom: 32px;line-height: 2em;"><li style="margin-bottom: 32px;line-height: 2em;"><section style="line-height: 1.6em;margin-bottom: 0px;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">PET：</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">lecanemab组−55.48 centiloids，对照组3.64 centiloids；</span></section><section style="line-height: 1.6em;margin-bottom: 0px;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei=""/></section></li><li style="margin-bottom: 32px;line-height: 2em;"><section style="line-height: 1.6em;margin-bottom: 0px;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">ADAS-cog14：</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">lecanemab组4.14，安慰剂组5.58；</span></section></li><li style="margin-bottom: 32px;line-height: 2em;"><section style="line-height: 1.6em;margin-bottom: 0px;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">ADCOMS：</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">lecanemab组0.164，安慰剂组0.214；</span></section></li><li style="margin-bottom: 32px;line-height: 2em;"><section style="line-height: 1.6em;margin-bottom: 0px;"><strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">ADCS MCI-ADL：</span></strong><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">lecanemab组为-3.5，安慰剂组为-5.5</span></section></li></ul><section arial="" border-box="" break-word="" gb="" helvetica="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;max-width: 100%;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><img class="rich_pages wxw-img" data-backh="451" data-backw="578" data-galleryid="" data-ratio="0.7804347826086957" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/8dc7bea5d5530dec5b5abde4d274bc99.png" data-type="png" data-w="920" style="outline: 0px;text-align: center;display: initial;box-sizing: border-box !important;overflow-wrap: break-word !important;visibility: visible !important;width: 100%;height: auto;"/></section><section style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">安全性方面，lecanemab 组和安慰剂组分别有6名和7名参与者死亡，研究者认为死亡与lecanemab和ARIA现象无关。</span></section><section style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">lecanemab组的898名参与者中有5人（0.6%）发生大出血，安慰剂组的897名参与者中有1人（0.1%）发生大出血。</span></section><section style="margin-bottom: 32px;"><span arial="" border-box="" break-word="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;max-width: 100%;font-size: 15px;letter-spacing: 2px;visibility: visible;font-family: " yahei=""><img class="rich_pages wxw-img" data-backh="1039" data-backw="578" data-ratio="1.7975" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/ad4a42be49519d1c3bb3232d4c083350.png" data-w="800" style="width: 100%;height: auto;"/></span></section><section style="margin-bottom: 32px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;letter-spacing: 2px;font-family: " yahei="">今年7月，FDA已受理了Lecanemab的BLA申请，并授予优先审评资格。PDUFA定于2023年1月6日,且已同意Clarity AD完成后可作为验证lecanemab临床疗效的验证研究。</span></section><p arial="" gb="" helvetica="" neue="" rgb="" right="" sans="" sans-serif="" sc="" style="margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;outline: 0px;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: 0px;"/></p><section arial="" gb="" helvetica="" medium="" neue="" rgb="" rgba="" sans="" sans-serif="" sc="" start="" style="margin-bottom: 16px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><img class="rich_pages wxw-img" data-backh="19" data-backw="578" data-galleryid="" data-ratio="0.03333333333333333" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/d2b47a0ab0c698c48c0b3c55591763ed.png" data-type="png" data-w="1080" style="outline: 0px;color: rgb(63, 63, 63);font-size: 16px;text-align: center;letter-spacing: 0.544px;display: initial;box-sizing: border-box !important;width: 100%;visibility: visible !important;height: auto;"/><br style="outline: 0px;"/></section><p arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><img class="rich_pages wxw-img" data-backh="325" data-backw="578" data-galleryid="" data-ratio="0.5625" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/0e481063b36e070644658f990818b600.png" data-type="png" data-w="1280" style="outline: 0px;font-size: 13px;letter-spacing: 0.544px;caret-color: rgba(0, 0, 0, 0);width: 100%;display: initial;box-sizing: border-box !important;visibility: visible !important;height: auto;"/></p><section arial="" data-mpa-template="t" gb="" helvetica="" mpa-from-tpl="t" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><p arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 8px;outline: 0px;letter-spacing: 0.544px;text-align: center;font-family: -apple-system, system-ui, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;color: rgb(74, 75, 76);visibility: visible;font-size: 15px;font-family: " yahei=""><img class="rich_pages wxw-img __bg_gif" data-galleryid="" data-ratio="1" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/aa868c8da79e721edd14a9f1a5f808c7.gif" data-type="gif" data-w="128" style="outline: 0px;color: rgb(136, 136, 136);letter-spacing: 0.544px;display: initial;box-sizing: border-box !important;visibility: visible !important;width: 57.7969px !important;"/></span></p><section style="margin-bottom: 16px;outline: 0px;line-height: 2em;text-align: center;"><span style="outline: 0px;color: rgb(16, 101, 230);"><strong mpa-from-tpl="t" style="outline: 0px;">推荐阅读</strong></span></section><section data-from="yb-recommend-list" data-mpa-template="t" style="outline: 0px;"><section data-from="yb-recommend-list" data-mpa-template="t"><section data-from="yb-recommend" data-mpa-template="t" data-recommend-article-content-url="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248075332&idx=1&sn=560a5b2f987633b0224901a469643290&chksm=ecbbb0a2dbcc39b40d1e3d217052245bb2af5b914402d2b63b6a44e75d2d8f152d2b1b771c51#rd" data-recommend-article-cover="https://mmbiz.qpic.cn/mmbiz_jpg/Lkw2iaE07M9VZLiaDs0icC2uxia9BicCMIacscf3OWWMIsQiboueBlsJ5qxbCyRDIL1lqUmNYuHE3sdbpzoEAYMxrq1Q/0?wx_fmt=jpeg" data-recommend-article-id="2248075332_1" data-recommend-article-time="1671696751" data-recommend-article-title="卖部门、自愿暂停所有管线、濒临破产，为了通用型CAR-T和实体瘤CAR-T" data-recommend-article-type="normal" data-recomment-template-id="1"><a data-linktype="1" href="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248075332&idx=1&sn=560a5b2f987633b0224901a469643290&chksm=ecbbb0a2dbcc39b40d1e3d217052245bb2af5b914402d2b63b6a44e75d2d8f152d2b1b771c51&scene=21#wechat_redirect"><section data-mid="" data-recommend-tid="1" data-recommend-type="normal" style="width: 578px;display: flex;justify-content: center;align-items: center;"><section data-mid="" style="width: 578px;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;display: flex;justify-content: flex-start;align-items: center;flex-direction: column;"><section data-mid="" style="width: 578px;display: flex;justify-content: center;align-items: center;"><span class="js_jump_icon h5_image_link" data-positionback="static" style="inset: auto;width: 100%;"><img class="rich_pages wxw-img" data-ratio="0.425" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/e1eb6504d29713796fda15187338ffcf.jpeg" data-w="1280" style="width: 578px;max-height: none;object-fit: cover;"/></span></section><section data-mid="" style="margin-top: -35px;padding: 9px 7px 8px;width: 578px;background: rgba(0, 0, 0, 0.65);font-size: 13px;color: rgb(255, 255, 255);line-height: 18px;z-index: 20;"><p data-mid="" data-recommend-title="t">卖部门、自愿暂停所有管线、濒临破产，为了通用型CAR-T和实体瘤CAR-T</p></section></section></section></a></section><br/><section data-from="yb-recommend" data-mpa-template="t" data-recommend-article-content-url="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248074840&idx=1&sn=15263b8570c1231d036c07bb66ed3ce6&chksm=ecbbbebedbcc37a8c8fdd814be85258de3d857ca9ef87d3bc617a8c8fb3325a1b1b42ad311a7#rd" data-recommend-article-cover="https://mmbiz.qpic.cn/mmbiz_jpg/Lkw2iaE07M9VbV1mzauYNcZ6jGf0picQqpv9JvaAphAHVxxtdvc3J89ibkupBrCcatibaJUUPRliaXLjyZeQcBcB69w/0?wx_fmt=jpeg" data-recommend-article-id="2248074840_1" data-recommend-article-time="1671596064" data-recommend-article-title="资本寒冬里，我们一起重温王健博士解读的「新药研发投融资之春夏秋冬四季」！" data-recommend-article-type="normal" data-recomment-template-id="1"><a data-linktype="1" href="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248074840&idx=1&sn=15263b8570c1231d036c07bb66ed3ce6&chksm=ecbbbebedbcc37a8c8fdd814be85258de3d857ca9ef87d3bc617a8c8fb3325a1b1b42ad311a7&scene=21#wechat_redirect"><section data-mid="" data-recommend-tid="1" data-recommend-type="normal" style="width: 578px;display: flex;justify-content: center;align-items: center;"><section data-mid="" style="width: 578px;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;display: flex;justify-content: flex-start;align-items: center;flex-direction: column;"><section data-mid="" style="width: 578px;display: flex;justify-content: center;align-items: center;"><span class="js_jump_icon h5_image_link" data-positionback="static" style="inset: auto;width: 100%;"><img class="rich_pages wxw-img" data-ratio="0.42681564245810055" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/58e0da5fa4e61943f3e7caeff02860e2.jpeg" data-w="895" style="width: 578px;max-height: none;object-fit: cover;"/></span></section><section data-mid="" style="margin-top: -35px;padding: 9px 7px 8px;width: 578px;background: rgba(0, 0, 0, 0.65);font-size: 13px;color: rgb(255, 255, 255);line-height: 18px;z-index: 20;"><p data-mid="" data-recommend-title="t">资本寒冬里，我们一起重温王健博士解读的「新药研发投融资之春夏秋冬四季」！</p></section></section></section></a></section><br/><section data-from="yb-recommend" data-mpa-template="t" data-recommend-article-content-url="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248073423&idx=1&sn=67cbbc9967a55b84fd26ec87e18dad66&chksm=ecbbb829dbcc313f84bd3a9db895dddfd43f3a81c6d62b3cc2cb9ae2a68f4dfb209783b615ae#rd" data-recommend-article-cover="https://mmbiz.qpic.cn/mmbiz_jpg/Lkw2iaE07M9Wia7th5yymoecdLPmoeKn36xP7EXbVCPdXtKydN3FPZppJia1OnJ4xQfQ3VUUgLHECT3rQc4JPhudw/0?wx_fmt=jpeg" data-recommend-article-id="2248073423_1" data-recommend-article-time="1671417861" data-recommend-article-title="我们在冬天里欢聚，一起讲述春天的故事！——第二届中国新药领袖闭门交流会成功举办！" data-recommend-article-type="normal" data-recomment-template-id="1"><a data-linktype="1" href="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248073423&idx=1&sn=67cbbc9967a55b84fd26ec87e18dad66&chksm=ecbbb829dbcc313f84bd3a9db895dddfd43f3a81c6d62b3cc2cb9ae2a68f4dfb209783b615ae&scene=21#wechat_redirect"><section data-mid="" data-recommend-tid="1" data-recommend-type="normal" style="width: 578px;display: flex;justify-content: center;align-items: center;"><section data-mid="" style="width: 578px;background-image: initial;background-position: initial;background-size: initial;background-repeat: initial;background-attachment: initial;background-origin: initial;background-clip: initial;display: flex;justify-content: flex-start;align-items: center;flex-direction: column;"><section data-mid="" style="width: 578px;display: flex;justify-content: center;align-items: center;"><span class="js_jump_icon h5_image_link" data-positionback="static" style="inset: auto;width: 100%;"><img class="rich_pages wxw-img" data-ratio="0.4260958205912334" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/e80ef0a9c523eb0038a9afcf728a1c46.jpeg" data-w="981" style="width: 578px;max-height: none;object-fit: cover;"/></span></section><section data-mid="" style="margin-top: -35px;padding: 9px 7px 8px;width: 578px;background: rgba(0, 0, 0, 0.65);font-size: 13px;color: rgb(255, 255, 255);line-height: 18px;z-index: 20;"><p data-mid="" data-recommend-title="t">我们在冬天里欢聚，一起讲述春天的故事！——第二届中国新药领袖闭门交流会成功举办！</p></section></section></section></a></section><br/></section></section></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;letter-spacing: 0.544px;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(51, 141, 175);font-family: -apple-system, system-ui, " ui="" visible="" yahei=""><section mpa-from-tpl="t" style="padding-right: 1em;padding-left: 1em;outline: 0px;display: inline-block;visibility: visible;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="padding: 0.3em 0.5em;outline: 0px;display: inline-block;box-shadow: rgb(165, 165, 165) 4px 4px 2px;color: rgb(255, 255, 255);background-color: rgb(0, 96, 235);visibility: visible;font-size: 15px;font-family: " yahei=""><p style="outline: 0px;visibility: visible;"><strong style="outline: 0px;visibility: visible;">推荐阅读</strong></p></span></section></section><section arial="" center="" gb="" helvetica="" mpa-from-tpl="t" neue="" rgb="" sans="" sans-serif="" sc="" solid="" style="margin-top: -1em;margin-bottom: 0px;padding: 20px 10px 10px;white-space: normal;outline: 0px;letter-spacing: 0.544px;font-size: 16px;color: rgb(51, 141, 175);font-family: -apple-system, system-ui, " ui="" visible="" yahei=""><section mpa-from-tpl="t" style="outline: 0px;visibility: visible;"><section mpa-from-tpl="t" style="outline: 0px;visibility: visible;"><section mpa-from-tpl="t" style="outline: 0px;text-align: left;visibility: visible;"><section class="channels_iframe_wrp"><mpvideosnap class="js_uneditable custom_select_card channels_iframe videosnap_video_iframe" data-authiconurl="https://dldir1v6.qq.com/weixin/checkresupdate/icons_filled_channels_authentication_enterprise_a2658032368245639e666fb11533a600.png" data-desc="2022年12月10日，由药时代主办、博腾股份战略支持的第二届中国新药领袖闭门交流会在上海召开。来自产业界、投资界、临床研究机构、高校的30多位专家、学者济济一堂，围绕“寒冬与春天”、“合作突围”、“将创新进行到底”、“用新技术降本增效”等焦点议题展开了热烈的讨论。专家们畅所欲言，慷慨分享各自的真知灼见和丰富而宝贵的经验，共同寻找“中国新药行业和企业该如何穿越寒冬，迎接挑战，勇敢迈向春天？”这个问题的答案。#第二届新药领袖闭门交流会 #新药出海 #药时代活动 #药时代投融资学苑 #药时代活动 #生物医药 #创新药 #新药研发 #药时代 #创新药时代 #我和我的药时代 #中国新药觉醒年代 @药时代 @创新药时代（药时代原创视频，上传于2022年12月22日。仅供感兴趣的个人谨慎参考。非商用，非医用，非投资用。任何问题，请联系我们。电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn。衷心感谢！）" data-headimgurl="http://wx.qlogo.cn/finderhead/Q3auHgzwzM4njP4xWmU6ia9smibzXzLWAgbTs5Nx9tqOgsgE7BTfo8eg/0" data-height="1080" data-id="export/UzFfAgtgekIEAQAAAAAA6jEldYl7VQAAAAstQy6ubaLX4KHWvLEZgBPExaJoRWRCJaiBzNPgMIuS_6-slnNVaPj8EH1cK9Vk" data-nickname="药时代" data-nonceid="18277637606242797177" data-pluginname="videosnap" data-type="video" data-url="https://findermp.video.qq.com/251/20304/stodownload?encfilekey=rjD5jyTuFrIpZ2ibE8T7YmwgiahniaXswqzicDfTiadDFd8y4J0xS80RIUPB8k3evDFiabQXOUORu0beQZEu0xRTuOx7sHeKZqnl31Ilu90E7PHuknhVVZkXWfiaA&adaptivelytrans=0&bizid=1023&dotrans=0&hy=SH&idx=1&m=&scene=0&token=AxricY7RBHdUY7iczxgsBwzH2ia0eLKXNB9zgOvo25FjuLnFx59vAQq42nlVyNFwldX3wuH4N4c1zw" data-username="v2_060000231003b20faec8c7e38d1ac2d6c903ed35b0779629073dbff92eb25305ea1c0e2b627a@finder" data-width="1920"/></section><ul class="list-paddingleft-1" style="padding-left: 1.5em;width: 535.458px;outline: 0px;"><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p><a data-itemshowtype="0" data-linktype="2" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248075332&idx=1&sn=560a5b2f987633b0224901a469643290&chksm=ecbbb0a2dbcc39b40d1e3d217052245bb2af5b914402d2b63b6a44e75d2d8f152d2b1b771c51&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="卖部门、自愿暂停所有管线、濒临破产，为了通用型CAR-T和实体瘤CAR-T">卖部门、自愿暂停所有管线、濒临破产，为了通用型CAR-T和实体瘤CAR-T</a><br/></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248074840&idx=1&sn=15263b8570c1231d036c07bb66ed3ce6&chksm=ecbbbebedbcc37a8c8fdd814be85258de3d857ca9ef87d3bc617a8c8fb3325a1b1b42ad311a7&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="资本寒冬里，我们一起重温王健博士解读的「新药研发投融资之春夏秋冬四季」！">资本寒冬里，我们一起重温王健博士解读的「新药研发投融资之春夏秋冬四季」！</a><br/></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248074223&idx=1&sn=129d34d11e52c75540f4248dafe04c36&chksm=ecbbbb09dbcc321f7285a59e75733b40cf9205f600cd63b3726f2f647f281fcfd8ebc3cb8058&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="沙利文发布：中国首个白血病领域CAR-T产品NDA受理，掀起商业化新浪潮">沙利文发布：中国首个白血病领域CAR-T产品NDA受理，掀起商业化新浪潮</a><br style="outline: 0px;"/></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248073423&idx=1&sn=67cbbc9967a55b84fd26ec87e18dad66&chksm=ecbbb829dbcc313f84bd3a9db895dddfd43f3a81c6d62b3cc2cb9ae2a68f4dfb209783b615ae&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="我们在冬天里欢聚，一起讲述春天的故事！——第二届中国新药领袖闭门交流会成功举办！">我们在冬天里欢聚，一起讲述春天的故事！——第二届中国新药领袖闭门交流会成功举办！</a><br style="outline: 0px;"/></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248072822&idx=1&sn=5fd2d7e808c9a8e3593128f3733b19ff&chksm=ecbb8690dbcc0f86a285bfb482807230a29b87934e2c8132f2174ab3780972062ba3cf0a8ce0&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="第四届“健康中国思南峰会”在沪召开：数字化转型推动医疗健康产业变革">第四届“健康中国思南峰会”在沪召开：数字化转型推动医疗健康产业变革</a></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248072062&idx=1&sn=fed31c719f0e8e7e5ecab837cd82bdcb&chksm=ecbb8398dbcc0a8ed31617110ff66a26c8e0443973a717545e162afa0844724a2469c1db0d66&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="【重磅录像】颜宁：“AI在结构生物学中的未达之地”">【重磅录像】颜宁：“AI在结构生物学中的未达之地”</a></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248072062&idx=2&sn=55fc70b75db1f7bbfeb9065b606dfc61&chksm=ecbb8398dbcc0a8e1dad53969600e81b7f6b4a8a6b8a7f58f280867628261f1b58c96274b352&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="首款！FDA批准辉凌制药治疗膀胱癌全新基因疗法">首款！FDA批准辉凌制药治疗膀胱癌全新基因疗法</a></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248072062&idx=2&sn=55fc70b75db1f7bbfeb9065b606dfc61&chksm=ecbb8398dbcc0a8e1dad53969600e81b7f6b4a8a6b8a7f58f280867628261f1b58c96274b352&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="二期临床刚成功，股票就大涨，看了这款mRNA癌症疫苗，我悟了……">二期临床刚成功，股票就大涨，看了这款mRNA癌症疫苗，我悟了……</a></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="11" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248070415&idx=1&sn=00c541668820bf9c84483382bb3c4166&chksm=ecbb8de9dbcc04ff354c4be361b6e5bb4e8ff94f6de71f132c8f341eb23e6c1bc683f401a194&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="动力学+铁死亡：深势科技首次公开RiDymo™平台管线应用进展">动力学+铁死亡：深势科技首次公开RiDymo™平台管线应用进展</a></p></li><li arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><p style="text-align: justify;line-height: 2em;"><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248069752&idx=1&sn=51a5411f641d298d3e36a61b240bc81f&chksm=ecbb8a9edbcc0388e7be81aa127c175da1e44811411a38baa25628268fb311137071dc6289a6&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="color: rgb(16, 101, 230);" tab="innerlink" target="_blank" textvalue="武田60亿美元买的药，其实是AI设计的？">武田60亿美元买的药，其实是AI设计的？</a></p></li></ul></section></section></section></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-top: 16px;margin-bottom: 0px;white-space: normal;outline: 0px;letter-spacing: 0.544px;font-size: 16px;background-color: rgb(255, 255, 255);color: rgb(51, 141, 175);font-family: -apple-system, system-ui, " ui="" visible="" yahei=""><a arial="" data-linktype="1" gb="" helvetica="" href="https://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2247571306&idx=8&sn=0bfa62c9a7c020323acbd3a50bb2e983&chksm=ecb26f8cdbc5e69a7414f285347b4a9d64429364ce2e27e747ce5d4ee207c5a66e984ad46f3c&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" medium="" neue="" sans="" sans-serif="" sc="" start="" style="outline: 0px;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;font-family: system-ui, -apple-system, BlinkMacSystemFont, " tab="innerlink" target="_blank" textvalue="你已选中了添加链接的内容" ui="" yahei=""><span class="js_jump_icon h5_image_link" data-positionback="static" style="outline: 0px;line-height: 0;vertical-align: bottom;user-select: none;inset: auto;"><img class="rich_pages wxw-img __bg_gif" data-backh="325" data-backw="578" data-ratio="0.5625" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/55d214218186b574dc9c77c8d94c72e4.gif" data-w="800" style="outline: 0px;border-width: 0px;border-style: initial;border-color: initial;display: initial;width: 100%;box-sizing: border-box !important;visibility: visible !important;height: auto;"/></span></a></section><section arial="" gb="" helvetica="" medium="" neue="" normal="" rgb="" rgba="" sans="" sans-serif="" sc="" start="" style="margin-top: 8px;margin-bottom: 0px;white-space: normal;outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><strong style="outline: 0px;font-size: 16px;letter-spacing: 0.544px;color: rgb(210, 45, 38);"/><strong style="outline: 0px;font-size: 16px;letter-spacing: 0.544px;color: rgb(210, 45, 38);"/><span style="outline: 0px;color: rgb(160, 160, 160);font-family: 微软雅黑;font-size: 14px;letter-spacing: 1px;"><strong style="outline: 0px;color: rgb(210, 45, 38);letter-spacing: 0.544px;"><img class="__bg_gif rich_pages wxw-img" data-fileid="100321260" data-ratio="1.2105263157894737" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/07ca4375e6f96f87029b82ed898282fc.gif" data-type="gif" data-w="38" style="margin-right: 6px;vertical-align: middle;outline: 0px;letter-spacing: 0.544px;display: initial;border-radius: 0px;box-sizing: border-box !important;width: 19px !important;visibility: visible !important;"/></strong></span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="outline: 0px;letter-spacing: 1px;font-family: " yahei=""><strong style="outline: 0px;">药时代BD高阶研讨会火热报名中！</strong></span></section><p style="display: none;margin-bottom: 24px;"><mp-style-type data-value="3"/></p></div>