全球首款！强生BCMA/CD3双抗获批上市，「王炸CP」能否攻下千亿市场？

 收藏

关键词：上市获批强生

资讯来源：药时代

发布时间： 2022-10-27

博腾股份工艺化学服务部负责人，技术平台负责人史峰博士：诚邀您出席2022第三届中国新药CMC高峰论坛！

</section><p><img arial="" auto="" border-box="" 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" gb="" helvetica="" initial="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;text-align: center;background-color: rgb(255, 255, 255);color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""/><br/></p><p><br/></p><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei="">近日，强生旗下杨森宣布其全球首款BCMA/CD3双特异性抗体teclistamab已经被FDA获批上市，用于治疗复发或难治性多发性骨髓瘤。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" sans="" sans-serif="" style="letter-spacing: 1px;font-family: " text="" transparent="" yahei="">截至目前，全球已经有7款双抗药物上市。</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">teclistamab已经在8月24日被欧盟获批上市，国内teclistamab三期临床研究在去年10月份开始。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">表1 全球上市的双特异性抗体药物</span></section><section style="text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><img class="rich_pages wxw-img js_insertlocalimg" data-backh="248" data-backw="578" data-ratio="0.42834008097165993" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/7515bf9928a5293cc5975a3f82209025.png" data-type="png" data-w="1235" style="width: 100%;height: auto;"/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: right;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="color: rgb(136, 136, 136);box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">来源：网上公开消息整理</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">目前，随着双抗药物获批上市进程持续加快，全球双抗市场规模将快速上升，预计2030年全球双抗市场规模将达807亿美元，2022至2030年平均复合增长率达39.6%！</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" sans="" sans-serif="" style="letter-spacing: 1px;font-family: " text="" transparent="" yahei="">强生BCMA/CD3双抗获批上市，双抗药物再添一员，「王炸CP」能否攻下千亿市场？</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><br/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" rgb="" sans="" sans-serif="" style="letter-spacing: 1px;font-size: 17px;font-family: " text="" transparent="" yahei="">ORR达到63%</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">Teclistamab的商品名TECVAYLI®，是一款完全人源化，同时靶向BCMA与T细胞表面CD3受体的双特异性抗体，</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>可将CD3阳性T细胞募集至表达BCMA的骨髓瘤细胞附近，从而激发T细胞杀伤肿瘤细胞。</strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">Teclistamab最早获得欧洲药品管理局(EMA)授予的PRIME(优先药品)指定，6月1日又被FDA授予突破性疗法认定（BDT），两个月后teclistamab注射液被NMPA纳入突破性治疗品种，用于治疗既往至少接受过3线治疗的复发或难治性多发性骨髓瘤成人患者，同时被中美纳入突破性治疗品种可见其在治疗多发性骨髓瘤的效果非常显著。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">Teclistamab的获批是基于MajesTEC-1研究的积极结果，这是一项开放标签、多中心、I/II期临床试验（登记号：NCT03145181、NCT04557098），</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>旨在评价Teclistamab在复发或难治性多发性骨髓瘤患者中的疗效和安全性。</strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">其试验结果被发表在顶级期刊NEJM上，该研究共纳入165名患者，每周皮下注射Teclistamab（剂量为1.5 mg/kg，递增剂量0.06 mg/kg、0.3 mg/kg）。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">结果显示，</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>总缓解率（ORR）达到63%（104/165）</strong></span><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">，且58.8%的患者获得很好的部分缓解（VGPR）以上的应答，39.4%的患者获得完全缓解（CR）以上的应答。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">中位缓解持续时间为18.4个月，中位无进展生存期为11.3个月，中位总生存期为18.3个月。安全性方面最常见的不良事件是细胞因子释放综合征（CRS）（72%；0.6%3级，无4级）、中性粒细胞减少症（71%；64%3或4级）和贫血（55%；37%3或4级）。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><br/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" rgb="" sans="" sans-serif="" style="letter-spacing: 1px;font-size: 17px;font-family: " text="" transparent="" yahei="">BCMA+CD3，王炸CP？</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">BCMA是肿瘤坏死因子超家族蛋白中的一员，主要表达在恶性和正常浆细胞以及一些成熟的B细胞，在重要组织不表达，是治疗多发性骨髓瘤的有效靶点。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">BCMA双抗药物兼具良好的疗效和安全性，BCMA靶点的CAR-T药物在治疗血液癌症方面疗效显著，</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>多款药物的ORR超过90%</strong></span><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">，但是包括严重的免疫效应细胞相关神经毒性综合征和CRS的毒性问题，ADC药物的虽然毒性较低但是治疗效果和CAR-T和双抗药物存在一定差距，BCMA双抗药物的疗效和安全性介于CAR-T和ADC之间。</span></section><section style="text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" center="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei="">图1 BCMA靶向免疫治疗构建体的示意图</span></section><section style="text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><img class="rich_pages wxw-img js_insertlocalimg" data-backh="375" data-backw="403" data-ratio="0.9310872894333844" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/70bd1732526a6a035321829ef5da4ee1.png" data-type="png" data-w="653" style="width: 100%;height: auto;"/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: right;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">来源：资料3</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">早在上世纪80年代CD3靶点便已经进入双抗开发视野，1985年首次提出T细胞重定向概念，在经过30年研究后，CD3靶点逐渐成熟。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">CD3分子广泛分布于成熟T细胞表面的膜抗原，与T细胞抗原识别受体（TCR）组合成复合受体分子激活T细胞，实现T细胞重定向。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">从已经上市的双抗药物可以看到安进的Blinatumomab、基因泰克的Mosunetuzumab以及最新上市的teclistamab这3款双抗药物都以CD3作为靶点，以及后续进展较快的glofitamab和epcotitama都将CD3作为靶点<strong>，</strong></span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>其目前已经成为全球双抗药物开发主要靶点。</strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">据数据显示，全球共有</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>229款已上市和在研的双抗含有CD3靶点</strong></span><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">，远远高于第二位的PDL-1，BCMA×CD3的靶点组合管线以17个位居第二，仅次于CD3×CD20靶点，仅国内CD3×BCMA组合的双抗就有10款，大多数处于临床早期。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;text-align: center;"><span arial="" center="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei="">图2 全球双抗药靶点分布、组合分布</span></section><section style="text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><img class="rich_pages wxw-img js_insertlocalimg" data-backh="207" data-backw="578" data-ratio="0.3580952380952381" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/4dd31ae054ae573ca1388edfb1ea5c34.png" data-type="png" data-w="1050" style="width: 100%;height: auto;"/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: right;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="font-size: 12px;color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">来源：西南证券</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">辉瑞、再生元、艾伯维、安进等在BCMAxCD3双抗领域均有布局，国内的康诺亚生物、上海岸迈生物进展较快。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">表2 进入临床阶段的BCMA/CD3双抗</span></section><section style="text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><img class="rich_pages wxw-img js_insertlocalimg" data-backh="746" data-backw="578" data-ratio="1.2912844036697249" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/75d3470afa3ef252b2b552a1b4d5cabd.png" data-type="png" data-w="872" style="width: 100%;height: auto;"/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: right;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="color: rgb(136, 136, 136);box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">来源：网上公开资料整理</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">目前，全球共有14款BCMAxCD3双抗进入临床阶段，绝大多数用于治疗多发性骨髓瘤。其中进展最快的是</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>辉瑞Elranatamab(PF-06863135)。</strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">Elranatamab是辉瑞开发的一种靶向BCMA和CD3双特异性抗体，正在开发用于治疗多发性骨髓瘤，Elranatamab对BCMA和CD3的结合亲和力得到了优化，使T细胞介导的抗骨髓瘤活性更强。皮下注射的目的则是允许使用比静脉注射更高的剂量，而不会增加不良事件。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">今年6月份的ASCO年会上辉瑞公布了elranatamab用于复发/难治性多发性骨髓瘤患者的2期MagnetisMM-3注册试验的中期分析数据，截至2022年3月23日，对接受elranatamab的94名患者（患者接受了皮下elranatamab 76 mg每周一次注射）的安全性和有效性进行了分析，中位随访时间为3.71个月，初步疗效结果显示，</span><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><strong>elranatamab的客观缓解率为60.6%，89.5%患者的客观缓解仍在进行中，没有确认疾病进展或死亡。</strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">最常见的治疗紧急不良事件是贫血(43.6%)、中性粒细胞减少(38.3%)、血小板减少(28.7%)、淋巴细胞减少(25.5%)和CRS(60.6%)；此外，2.2%的患者出现免疫效应细胞相关神经毒性综合征，均为2级或以下。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei=""><br/></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;text-align: center;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" rgb="" sans="" sans-serif="" style="letter-spacing: 1px;font-size: 17px;font-family: " text="" transparent="" yahei="">强生如何布局？</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">在多发性骨髓瘤领域，强生还有达雷妥尤单抗这款重磅产品，2021年全球销售额为60.23亿美元。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">今年又获批了Carvykti（西达基奥仑赛，BCMA CAR-T）这款潜力产品，西达基奥仑赛是金斯瑞旗下子公司传奇生物自主研发的CAR-T疗法，2017年传奇生物与杨森达成一项许可协议双方将共同开发和推广西达基奥仑赛，今年2月份西达基奥仑赛获得美国FDA批准治疗复发/难治性多发性骨髓瘤患者，成为首款获得FDA批准的国产CAR-T细胞疗法，其在MM患者中达到惊人的98%的ORR。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="font-size: 15px;font-family: " yahei=""><strong><span arial="" border-box="" gb="" helvetica="" neue="" none="" sans="" sans-serif="" style="letter-spacing: 1px;font-family: " text="" transparent="" yahei="">根据金斯瑞生物发布的公告西达基奥仑赛第三季度销售额约为5500万美元环比增长129%。</span></strong></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">除此之外，强生还有一款first-in-class CD3双抗Talquetamab(GPRC5D x CD3)在多发性骨髓瘤展现出非常好的疗效。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-size: 15px;font-family: " yahei="">截至到目前，今年已经有四款双抗药物获批上市，此外罗氏的glofitamab和艾伯维的epcoritama已提交上市申请，有望近期获批上市。</span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="font-size: 15px;"><strong><span style="color: rgb(16, 101, 230);">推荐阅读：</span></strong></span><span style="color: rgb(16, 101, 230);font-size: 15px;">TCE双抗吹起挑战Car-T的号角！——BCMA战场的硝烟</span><br/></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;margin-bottom: 16px;line-height: 2em;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">参考资料：</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;line-height: 2em;margin-bottom: 0px;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">1.强生BCMA/CD3双抗拟纳入突破性疗法。</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;line-height: 2em;margin-bottom: 0px;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">2.The Agony of Choice—Where to Place the Wave of BCMA-Targeted Therapies in the Multiple Myeloma Treatment Puzzle in 2022 and Beyond.</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;line-height: 2em;margin-bottom: 0px;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">3.辉瑞公布靶向BCMA和CD3双抗Elranatamab的2期MagnetisMM-3注册试验的中期分析积极数据。</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;line-height: 2em;margin-bottom: 0px;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">4.出海半年卖5.7亿，国内竞争的CAR-T未来在哪</span></em></span></section><section style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;margin-top: 0px;line-height: 2em;margin-bottom: 0px;"><span style="color: rgb(136, 136, 136);"><em><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="box-sizing: border-box;user-select: text;-webkit-user-drag: none;-webkit-tap-highlight-color: transparent;font-family: " yahei="">5.西南证券和网上其他公开资料等</span></em></span></section><section powered-by="xiumi.us" style="box-sizing: border-box;"><p><br/></p><section arial="" gb="" helvetica="" neue="" rgba="" right="" sans="" sans-serif="" sc="" style="outline: 0px;font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);"/></section><section arial="" gb="" helvetica="" neue="" rgba="" right="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><em><span style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);">封面图来源：123rf</span></em><br style="outline: 0px;"/></section><p arial="" center="" gb="" helvetica="" neue="" rgba="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><a arial="" data-itemshowtype="0" data-linktype="1" gb="" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248019134&idx=1&sn=1e5539fd43be09bea76f8e77fed4da2e&chksm=ecbb5458dbccdd4ed1bf9da296a734b2217dfa0610449be41ebc91d522a7135dbee26f6c7336&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" neue="" sans="" sans-serif="" sc="" style="outline: 0px;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;font-family: system-ui, -apple-system, " system-ui="" tab="innerlink" target="_blank" textvalue="‍‍" 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" data-backh="215" data-backw="578" data-galleryid="" data-ratio="0.3712962962962963" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/3a964563c1bc53dd507a1cde9db212ee.jpeg" data-type="jpeg" data-w="1080" style="outline: 0px;border-width: 0px;border-style: initial;border-color: initial;display: initial;width: 100%;inset: auto;box-sizing: border-box !important;visibility: visible !important;height: auto;"/></span></a></p><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-top: 8px;margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;caret-color: rgba(0, 0, 0, 0);color: rgb(0, 0, 0);font-size: 15px;visibility: visible;"><span style="outline: 0px;text-decoration: underline;visibility: visible;"><strong mpa-from-tpl="t" msthash="3185793" msttexthash="30069806" style="outline: 0px;visibility: visible;">版权声明/免责声明</strong></span></strong></span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-top: 8px;margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">本文为授权转载文章，版权归拥有者。</span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。</span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">欢迎朋友们批评指正！衷心感谢！</span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络</span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">根据CC0协议使用，版权归拥有者。</span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 12px;color: rgb(136, 136, 136);letter-spacing: 1px;font-family: " visible="" yahei="">任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！</span></section><p arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="margin-bottom: 8px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);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 arial="" gb="" neue="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;caret-color: rgba(0, 0, 0, 0);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><em arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(136, 136, 136);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span arial="" gb="" helvetica="" neue="" normal="" sans="" sans-serif="" style="outline: 0px;letter-spacing: 1px;font-size: 12px;font-family: " yahei=""><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;"><strong arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""/></strong></strong></span></em></section><section arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;text-align: center;font-size: 15px;font-family: " visible="" yahei=""><span style="outline: 0px;caret-color: rgba(0, 0, 0, 0);color: rgb(136, 136, 136);visibility: visible;"><em style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-style: normal;visibility: visible;"><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><em arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" style="outline: 0px;font-family: " visible="" yahei=""><span style="outline: 0px;font-style: normal;visibility: visible;"><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;"><strong arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><img class="__bg_gif rich_pages wxw-img" 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;box-sizing: border-box !important;visibility: visible !important;width: 30px !important;"/></strong></strong></strong></span></em>前FDA检查官、Live Oak Quality Assurance 创始人兼总裁<span style="outline: 0px;letter-spacing: 1px;visibility: visible;">Peter Baker 先生</span></strong></span></em></span></span><em arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;text-align: center;color: rgb(136, 136, 136);caret-color: rgba(0, 0, 0, 0);font-family: " visible="" yahei=""><span style="outline: 0px;font-style: normal;visibility: visible;"><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei="">：诚邀您出席2022第三届中国新药CMC高峰论坛！</strong></span></em></section><section style="white-space: normal;"><iframe allowfullscreen="" class="video_iframe rich_pages" data-cover="http%3A%2F%2Fmmbiz.qpic.cn%2Fmmbiz_jpg%2FLkw2iaE07M9U87Lz4H07BypLmoNXDD51vvHI9Map15AxCI3ibGnYdDeLYyuib1icKMcNS9YkJJ0tEtehb2AuLbSZDg%2F0%3Fwx_fmt%3Djpeg" data-mpvid="wxv_2636686834731073541" data-ratio="1.7777777777777777" data-src="https://mp.weixin.qq.com/mp/readtemplate?t=pages/video_player_tmpl&action=mpvideo&auto=0&vid=wxv_2636686834731073541" data-vidtype="2" data-w="1920" frameborder="0" style="border-radius: 4px;"/></section><section arial="" gb="" neue="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;caret-color: rgba(0, 0, 0, 0);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(136, 136, 136);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><em style="outline: 0px;"><span arial="" gb="" helvetica="" neue="" normal="" sans="" sans-serif="" style="outline: 0px;letter-spacing: 1px;font-size: 12px;font-family: " yahei=""><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;"><strong arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><br style="outline: 0px;"/></strong></strong></strong></span></em></span></section><section arial="" gb="" neue="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;caret-color: rgba(0, 0, 0, 0);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(136, 136, 136);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><em style="outline: 0px;"><span arial="" gb="" helvetica="" neue="" normal="" sans="" sans-serif="" style="outline: 0px;letter-spacing: 1px;font-size: 12px;font-family: " yahei=""><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;"><strong arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""/></strong></strong></span></em></span></section><section arial="" center="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><span arial="" gb="" helvetica="" neue="" sans="" sans-serif="" style="outline: 0px;font-size: 15px;font-family: " visible="" yahei=""><em style="outline: 0px;font-size: 16px;letter-spacing: 0.544px;color: rgb(136, 136, 136);caret-color: rgba(0, 0, 0, 0);visibility: visible;"><span style="outline: 0px;font-style: normal;visibility: visible;"><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei=""><strong style="outline: 0px;letter-spacing: 0.544px;font-size: 15px;visibility: visible;"><strong arial="" gb="" helvetica="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""><img class="__bg_gif rich_pages wxw-img" 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;box-sizing: border-box !important;visibility: visible !important;width: 30px !important;"/></strong></strong></strong></span></em><span style="outline: 0px;caret-color: rgba(0, 0, 0, 0);color: rgb(136, 136, 136);visibility: visible;"><em style="outline: 0px;visibility: visible;"><span style="outline: 0px;font-style: normal;visibility: visible;"><strong arial="" gb="" neue="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, " system-ui="" ui="" visible="" yahei="">华先医药创始人、CEO 叶伟平博士：诚邀您出席2022第三届中国新药CMC高峰论坛！</strong></span></em></span></span><span style="letter-spacing: 0.544px;font-size: 17px;text-align: justify;"/></section><p style="white-space: normal;margin-bottom: 8px;"><iframe allowfullscreen="" class="video_iframe rich_pages" data-cover="http%3A%2F%2Fmmbiz.qpic.cn%2Fmmbiz_jpg%2FLkw2iaE07M9UDuCoTvC3qBsZsVZdPsUBPHvbenJo91mE3RicicNTk0hFtlECWBgxVYmIpjefy0BQK2vtuWLxQYp8Q%2F0%3Fwx_fmt%3Djpeg" data-mpvid="wxv_2635439515964555269" data-ratio="2" data-src="https://mp.weixin.qq.com/mp/readtemplate?t=pages/video_player_tmpl&action=mpvideo&auto=0&vid=wxv_2635439515964555269" data-vidtype="2" data-w="2160" frameborder="0" style="border-radius: 4px;"/></p><section arial="" center="" gb="" helvetica="" neue="" rgba="" sans="" sans-serif="" sc="" style="margin-bottom: 16px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248019134&idx=1&sn=1e5539fd43be09bea76f8e77fed4da2e&chksm=ecbb5458dbccdd4ed1bf9da296a734b2217dfa0610449be41ebc91d522a7135dbee26f6c7336&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="outline: 0px;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;font-size: 15px;" tab="innerlink" target="_blank" textvalue="不惧内卷，我们勇往向前！——2022第三届中国新药CMC高峰论坛最终日程公布"><strong style="outline: 0px;">不惧内卷，我们勇往向前！——2022第三届中国新药CMC高峰论坛最终日程公布</strong></a></section><p arial="" center="" gb="" helvetica="" neue="" rgba="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><a data-itemshowtype="0" data-linktype="2" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248017744&idx=1&sn=f25375af0fb68ca74f7dca24b1bde5a8&chksm=ecbb5fb6dbccd6a0ee49a55ca18a482916510e3f1fa45c993db19992262976ef7d9c7d0c2754&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="outline: 0px;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;font-size: 15px;" tab="innerlink" target="_blank" textvalue="113本新药好书免费送：《新药的故事1-3》《十亿美元分子》《药明康德经典译丛》……中国新药CMC高峰论坛“十三邀”！"><strong style="outline: 0px;">113本新药好书免费送：《新药的故事1-3》《十亿美元分子》《药明康德经典译丛》……中国新药CMC高峰论坛“十三邀”！</strong></a><br style="outline: 0px;"/></p><p arial="" center="" gb="" helvetica="" neue="" rgba="" sans="" sans-serif="" sc="" style="margin-bottom: 8px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><a data-itemshowtype="0" data-linktype="1" hasload="1" href="http://mp.weixin.qq.com/s?__biz=MzI5NzY0NDQyNQ==&mid=2248017744&idx=1&sn=f25375af0fb68ca74f7dca24b1bde5a8&chksm=ecbb5fb6dbccd6a0ee49a55ca18a482916510e3f1fa45c993db19992262976ef7d9c7d0c2754&scene=21#wechat_redirect" imgdata="null" imgurl="" linktype="text" style="outline: 0px;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;" tab="innerlink" target="_blank" textvalue="你已选中了添加链接的内容"><strong arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(255, 41, 65);font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" 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" data-backh="246" data-backw="578" data-cropselx1="0" data-cropselx2="520" data-cropsely1="0" data-cropsely2="105" data-galleryid="" data-ratio="0.4255555555555556" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/5d8007f071270d05d0c250c2701adfd6.png" data-type="png" data-w="1800" 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></strong></a></p><section arial="" center="" gb="" helvetica="" neue="" normal="" rgba="" sans="" sans-serif="" sc="" style="outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><strong style="outline: 0px;"><img class="rich_pages wxw-img" data-backh="1570" data-backw="578" data-cropselx1="0" data-cropselx2="578" data-cropsely1="0" data-cropsely2="1570" data-galleryid="" data-ratio="2.7157407407407406" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/3c5e4056a52fa391e32e13dee2f3c5bb.jpeg" data-type="jpeg" data-w="1080" style="outline: 0px;width: 100%;display: initial;height: auto;box-sizing: border-box !important;visibility: visible !important;"/></strong></section><p arial="" center="" gb="" helvetica="" neue="" rgba="" sans="" sans-serif="" sc="" style="margin-bottom: 0px;white-space: normal;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><img arial="" auto="" border-box="" class="rich_pages wxw-img" data-backh="1235" data-backw="578" data-cropselx1="0" data-cropselx2="578" data-cropsely1="0" data-cropsely2="1235" data-galleryid="" data-ratio="2.136111111111111" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/24df22c912b04508d97f6fdc4121ad0c.jpeg" data-type="jpeg" data-w="1080" gb="" helvetica="" initial="" neue="" sans="" sans-serif="" sc="" style="font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" visible="" yahei=""/><br/></p><p arial="" gb="" helvetica="" left="" neue="" normal="" rgba="" sans="" sans-serif="" sc="" style="margin-top: 8px;outline: 0px;color: rgb(34, 34, 34);font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><strong arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><img class="__bg_gif rich_pages wxw-img" data-fileid="100314835" 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;outline: 0px;vertical-align: middle;letter-spacing: 0.544px;display: initial;box-sizing: border-box !important;visibility: visible !important;width: 30px !important;"/></strong><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><strong style="outline: 0px;">点击这里，报名参会！</strong></span></p><section arial="" gb="" helvetica="" neue="" rgba="" right="" sans="" sans-serif="" sc="" style="outline: 0px;font-size: 16px;letter-spacing: 0.544px;white-space: normal;font-family: -apple-system, BlinkMacSystemFont, " ui="" yahei=""><span arial="" gb="" helvetica="" neue="" rgb="" sans="" sans-serif="" sc="" style="outline: 0px;font-family: system-ui, -apple-system, BlinkMacSystemFont, " ui="" yahei=""><strong style="outline: 0px;"/></span></section></section></section><section style="margin-bottom: 16px;line-height: 2em;"><section style="display: none;margin-bottom: 24px;margin-top: 0px;"><mp-style-type data-value="3"/></section></section></div>