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Jessicachz

Jessicachz

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2021-07-06

这篇文章说得透彻[强]

医药股大跌，究竟发生了什么？

2021-04-01

愚人节？

市场消息：字节跳动的最新估值接近4000亿美元

2021-03-18

希望不要破发呀[开心] [财迷]

2021-02-25

$昭衍新药(06127)$100手中2手

2021-02-25

100手中2手

2021-02-04

又没中签[流泪]

2021-02-03

$心通医疗-B(02160)$暗盘收盘前买入20.25一手，在另外一家券商卖出21.25元一手，算不算无风险套利？😀

2021-02-03

吃土🥲，下次再打

2021-01-22

中了7股😂

去老虎APP查看更多动态

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12:33","market":"hk","language":"zh","title":"医药股大跌，究竟发生了什么？","url":"https://stock-news.laohu8.com/highlight/detail?id=2149612353","media":"华尔街见闻","summary":"究竟应该如何解读这份监管文件，医药行业接下来应该如何看待？","content":"<p>经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。</p>\n<p><img src=\"https://static.tigerbbs.com/66afeb39e93f14a49c57b44e105bffe5\" tg-width=\"840\" tg-height=\"470\"></p>\n<p>一切的原因都是来自7月2日，<b>国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。</b></p>\n<p><img src=\"https://static.tigerbbs.com/4984adcf0afcb985427d07fc5ba4009c\" tg-width=\"1018\" tg-height=\"1444\" referrerpolicy=\"no-referrer\"></p>\n<p>市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式开发的药物未来上市的可能性，从而影响新药公司产品立项数量，减少CXO公司可获得订单数目。</p>\n<p>华尔街见闻·见智研究所在周一早间的<b>文章《市场热议抗肿瘤药物新规，对火爆的CXO行业意味着什么？| 见智研究所》</b>中已经充分解释了该政策对市场的影响。市场对新政存在一些误读和夸大，创新药和CXO行业下一发展阶段因此更应该迎来结构分化，而不是单纯利空。</p>\n<h2><b>市场误读在于将me-too专利约束和临床BSC要求混为一谈</b></h2>\n<p>me-too本身是以原研药为基础，在规避后者化学结构专利后进行研发的一类“新药“，它可能效果更好、也可能效果更差，实际并不绝对。</p>\n<p>既然是“新药“，也就意味着me-too药物的临床，与现有要求一致，<b>需与标准推荐治疗药物作疗效对比</b>。新指导原则本身不会要求必须要跟原研药做“头对头”临床，除非原研药已经上市，并获得标准推荐疗法。</p>\n<p>而此次政策文件实际解决的是临床伦理问题，是提出一个底线思维，要求在临床中给与对照组患者不低于现有标准推荐疗法的治疗手段。<b>此次意见稿中将原先属于伦理范畴的部分制度化</b>，以确保参加临床试验中的对照组患者得到合理治疗。包括美国FDA在内，也正在起草相关以患者为核心的药物研发(patient focused drug development，PFDD)文件。</p>\n<h2><b>对医药行业的实际影响</b></h2>\n<p>这项政策对医药公司在药物开发中的实际影响：要求做me-too类企业更快速推进开发和临床过程。</p>\n<p>需要me-too类药品开发需在竞争对手（原研药和其他me-too类药物）获批上市进入标准疗法前，进入三期临床阶段。否则在三期临床时候的对照组药物就将成为新的标准推荐疗法药物。</p>\n<p>举个例子：现在肝癌一线推荐疗法是PD-L1+仑伐替尼（简化具体适应症应用条件），那么现在肝癌一线药物3期临床对照组就是PD-L1+仑伐替尼，可能就不是此前对照的索拉菲尼。那么目前肝癌适应症已经进入3期临床的公司可能就是利好，没有进入的未来就会面临对照组更换，一方面对临床药物疗效要求更高，另一方面临床采购PD-L1+仑伐替尼的成本也比索拉菲尼高几倍。</p>\n<p><b>因此，这项要求会导致CXO企业和创新药企业的分化，最终用市场化的方式来出清一些占用审批资源的劣质药品。 </b></p>\n<blockquote>\n <b>对CXO企业</b>：政策导向的结果将是行业分化，利好资源能力强的头部公司，利空资源整合能力弱的公司。\n <b>关键变量为，是否有能力加速开发、更快推进临床进度</b>。\n <b>对创新药企</b>：利好开发进度快的公司，利空开发进度慢的公司。\n <b>关键变量是，在进行3期临床时候，适应症的标准推荐疗法是否发生变化</b>。但是我们也要看到一个趋势，\n <b>未来中国新药注册数量的以目前的增速是不可持续的。</b>\n</blockquote>\n<p>自2015年改革以后，中国肿瘤新药注册性临床快速增长，于2018年超越美国和欧洲，成为全球肿瘤临床研究的中心，6年新药注册数量增长6倍，但是药品监管方面的审批资源有限，一些劣质药占用了有限的审批资源将导致审批时间再次延长，这也是不利于中国创新药发展的。因此减量重质将会是下一阶段的重点。</p>\n<p>实际我们可以看到，文件的订立思路是在不断推进创新药市场化，疗效不佳的药物本就会在市场应用中淘汰。而在此过程中，无论是CXO还是创新药企，头部能够创造价值的公司一定还是能继续高增长，一部分浑水摸鱼的公司也会在市场中自然出清。</p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>医药股大跌，究竟发生了什么？</title>\n<style 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}\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n医药股大跌，究竟发生了什么？\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-07-06 12:33 北京时间&nbsp;&nbsp;&nbsp;<a href=https://wallstreetcn.com/articles/3634682><strong>华尔街见闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。\n\n一切的原因都是来自7月2日，国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。\n\n市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式...</p>\n\n<a href=\"https://wallstreetcn.com/articles/3634682\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/85675909dc6c67ee0181339c18bcfdff","relate_stocks":{"159938":"医药","300347":"泰格医药","09939":"开拓药业-B"},"source_url":"https://wallstreetcn.com/articles/3634682","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2149612353","content_text":"经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。\n\n一切的原因都是来自7月2日，国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。\n\n市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式开发的药物未来上市的可能性，从而影响新药公司产品立项数量，减少CXO公司可获得订单数目。\n华尔街见闻·见智研究所在周一早间的文章《市场热议抗肿瘤药物新规，对火爆的CXO行业意味着什么？| 见智研究所》中已经充分解释了该政策对市场的影响。市场对新政存在一些误读和夸大，创新药和CXO行业下一发展阶段因此更应该迎来结构分化，而不是单纯利空。\n市场误读在于将me-too专利约束和临床BSC要求混为一谈\nme-too本身是以原研药为基础，在规避后者化学结构专利后进行研发的一类“新药“，它可能效果更好、也可能效果更差，实际并不绝对。\n既然是“新药“，也就意味着me-too药物的临床，与现有要求一致，需与标准推荐治疗药物作疗效对比。新指导原则本身不会要求必须要跟原研药做“头对头”临床，除非原研药已经上市，并获得标准推荐疗法。\n而此次政策文件实际解决的是临床伦理问题，是提出一个底线思维，要求在临床中给与对照组患者不低于现有标准推荐疗法的治疗手段。此次意见稿中将原先属于伦理范畴的部分制度化，以确保参加临床试验中的对照组患者得到合理治疗。包括美国FDA在内，也正在起草相关以患者为核心的药物研发(patient focused drug development，PFDD)文件。\n对医药行业的实际影响\n这项政策对医药公司在药物开发中的实际影响：要求做me-too类企业更快速推进开发和临床过程。\n需要me-too类药品开发需在竞争对手（原研药和其他me-too类药物）获批上市进入标准疗法前，进入三期临床阶段。否则在三期临床时候的对照组药物就将成为新的标准推荐疗法药物。\n举个例子：现在肝癌一线推荐疗法是PD-L1+仑伐替尼（简化具体适应症应用条件），那么现在肝癌一线药物3期临床对照组就是PD-L1+仑伐替尼，可能就不是此前对照的索拉菲尼。那么目前肝癌适应症已经进入3期临床的公司可能就是利好，没有进入的未来就会面临对照组更换，一方面对临床药物疗效要求更高，另一方面临床采购PD-L1+仑伐替尼的成本也比索拉菲尼高几倍。\n因此，这项要求会导致CXO企业和创新药企业的分化，最终用市场化的方式来出清一些占用审批资源的劣质药品。 \n\n对CXO企业：政策导向的结果将是行业分化，利好资源能力强的头部公司，利空资源整合能力弱的公司。\n 关键变量为，是否有能力加速开发、更快推进临床进度。\n 对创新药企：利好开发进度快的公司，利空开发进度慢的公司。\n 关键变量是，在进行3期临床时候，适应症的标准推荐疗法是否发生变化。但是我们也要看到一个趋势，\n 未来中国新药注册数量的以目前的增速是不可持续的。\n\n自2015年改革以后，中国肿瘤新药注册性临床快速增长，于2018年超越美国和欧洲，成为全球肿瘤临床研究的中心，6年新药注册数量增长6倍，但是药品监管方面的审批资源有限，一些劣质药占用了有限的审批资源将导致审批时间再次延长，这也是不利于中国创新药发展的。因此减量重质将会是下一阶段的重点。\n实际我们可以看到，文件的订立思路是在不断推进创新药市场化，疗效不佳的药物本就会在市场应用中淘汰。而在此过程中，无论是CXO还是创新药企，头部能够创造价值的公司一定还是能继续高增长，一部分浑水摸鱼的公司也会在市场中自然出清。","news_type":1,"symbols_score_info":{"159938":0.9,"300347":0.9,"09939":0.9}},"isVote":1,"tweetType":1,"viewCount":2157,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":357224115,"gmtCreate":1617280476037,"gmtModify":1617280476037,"author":{"id":"3573715185764517","authorId":"3573715185764517","name":"Jessicachz","avatar":"https://static.tigerbbs.com/cff127a053353532402cf8503f659705","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3573715185764517","authorIdStr":"3573715185764517"},"themes":[],"htmlText":"愚人节？","listText":"愚人节？","text":"愚人节？","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/357224115","repostId":"1146146540","repostType":4,"repost":{"id":"1146146540","kind":"news","weMediaInfo":{"introduction":"为用户提供金融资讯、行情、数据，旨在帮助投资者理解世界，做投资决策。","home_visible":1,"media_name":"老虎资讯综合","id":"102","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1617280156,"share":"https://ttm.financial/m/news/1146146540?lang=&edition=full","pubTime":"2021-04-01 20:29","market":"us","language":"zh","title":"市场消息：字节跳动的最新估值接近4000亿美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1146146540","media":"老虎资讯综合","summary":"一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）如果该消息准确，基于分析公司CB ","content":"<p>一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）</p><p>如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。</p><p>一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。</p><p>相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>市场消息：字节跳动的最新估值接近4000亿美元</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; 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margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n市场消息：字节跳动的最新估值接近4000亿美元\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/102\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">老虎资讯综合 </p>\n<p class=\"h-time\">2021-04-01 20:29</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）</p><p>如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。</p><p>一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。</p><p>相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/2958907307044929d330311c413c1a4f","relate_stocks":{},"is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1146146540","content_text":"一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。","news_type":1,"symbols_score_info":{}},"isVote":1,"tweetType":1,"viewCount":2112,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":327691748,"gmtCreate":1616078738284,"gmtModify":1616078738284,"author":{"id":"3573715185764517","authorId":"3573715185764517","name":"Jessicachz","avatar":"https://static.tigerbbs.com/cff127a053353532402cf8503f659705","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3573715185764517","authorIdStr":"3573715185764517"},"themes":[],"htmlText":"希望不要破发呀[开心]&nbsp;[财迷]&nbsp;","listText":"希望不要破发呀[开心]&nbsp;[财迷]&nbsp;","text":"希望不要破发呀[开心] 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12:33","market":"hk","language":"zh","title":"医药股大跌，究竟发生了什么？","url":"https://stock-news.laohu8.com/highlight/detail?id=2149612353","media":"华尔街见闻","summary":"究竟应该如何解读这份监管文件，医药行业接下来应该如何看待？","content":"<p>经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。</p>\n<p><img src=\"https://static.tigerbbs.com/66afeb39e93f14a49c57b44e105bffe5\" tg-width=\"840\" tg-height=\"470\"></p>\n<p>一切的原因都是来自7月2日，<b>国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。</b></p>\n<p><img src=\"https://static.tigerbbs.com/4984adcf0afcb985427d07fc5ba4009c\" tg-width=\"1018\" tg-height=\"1444\" referrerpolicy=\"no-referrer\"></p>\n<p>市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式开发的药物未来上市的可能性，从而影响新药公司产品立项数量，减少CXO公司可获得订单数目。</p>\n<p>华尔街见闻·见智研究所在周一早间的<b>文章《市场热议抗肿瘤药物新规，对火爆的CXO行业意味着什么？| 见智研究所》</b>中已经充分解释了该政策对市场的影响。市场对新政存在一些误读和夸大，创新药和CXO行业下一发展阶段因此更应该迎来结构分化，而不是单纯利空。</p>\n<h2><b>市场误读在于将me-too专利约束和临床BSC要求混为一谈</b></h2>\n<p>me-too本身是以原研药为基础，在规避后者化学结构专利后进行研发的一类“新药“，它可能效果更好、也可能效果更差，实际并不绝对。</p>\n<p>既然是“新药“，也就意味着me-too药物的临床，与现有要求一致，<b>需与标准推荐治疗药物作疗效对比</b>。新指导原则本身不会要求必须要跟原研药做“头对头”临床，除非原研药已经上市，并获得标准推荐疗法。</p>\n<p>而此次政策文件实际解决的是临床伦理问题，是提出一个底线思维，要求在临床中给与对照组患者不低于现有标准推荐疗法的治疗手段。<b>此次意见稿中将原先属于伦理范畴的部分制度化</b>，以确保参加临床试验中的对照组患者得到合理治疗。包括美国FDA在内，也正在起草相关以患者为核心的药物研发(patient focused drug development，PFDD)文件。</p>\n<h2><b>对医药行业的实际影响</b></h2>\n<p>这项政策对医药公司在药物开发中的实际影响：要求做me-too类企业更快速推进开发和临床过程。</p>\n<p>需要me-too类药品开发需在竞争对手（原研药和其他me-too类药物）获批上市进入标准疗法前，进入三期临床阶段。否则在三期临床时候的对照组药物就将成为新的标准推荐疗法药物。</p>\n<p>举个例子：现在肝癌一线推荐疗法是PD-L1+仑伐替尼（简化具体适应症应用条件），那么现在肝癌一线药物3期临床对照组就是PD-L1+仑伐替尼，可能就不是此前对照的索拉菲尼。那么目前肝癌适应症已经进入3期临床的公司可能就是利好，没有进入的未来就会面临对照组更换，一方面对临床药物疗效要求更高，另一方面临床采购PD-L1+仑伐替尼的成本也比索拉菲尼高几倍。</p>\n<p><b>因此，这项要求会导致CXO企业和创新药企业的分化，最终用市场化的方式来出清一些占用审批资源的劣质药品。 </b></p>\n<blockquote>\n <b>对CXO企业</b>：政策导向的结果将是行业分化，利好资源能力强的头部公司，利空资源整合能力弱的公司。\n <b>关键变量为，是否有能力加速开发、更快推进临床进度</b>。\n <b>对创新药企</b>：利好开发进度快的公司，利空开发进度慢的公司。\n <b>关键变量是，在进行3期临床时候，适应症的标准推荐疗法是否发生变化</b>。但是我们也要看到一个趋势，\n <b>未来中国新药注册数量的以目前的增速是不可持续的。</b>\n</blockquote>\n<p>自2015年改革以后，中国肿瘤新药注册性临床快速增长，于2018年超越美国和欧洲，成为全球肿瘤临床研究的中心，6年新药注册数量增长6倍，但是药品监管方面的审批资源有限，一些劣质药占用了有限的审批资源将导致审批时间再次延长，这也是不利于中国创新药发展的。因此减量重质将会是下一阶段的重点。</p>\n<p>实际我们可以看到，文件的订立思路是在不断推进创新药市场化，疗效不佳的药物本就会在市场应用中淘汰。而在此过程中，无论是CXO还是创新药企，头部能够创造价值的公司一定还是能继续高增长，一部分浑水摸鱼的公司也会在市场中自然出清。</p>","source":"wallstreetcn_api","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>医药股大跌，究竟发生了什么？</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n医药股大跌，究竟发生了什么？\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-07-06 12:33 北京时间&nbsp;&nbsp;&nbsp;<a href=https://wallstreetcn.com/articles/3634682><strong>华尔街见闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。\n\n一切的原因都是来自7月2日，国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。\n\n市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式...</p>\n\n<a href=\"https://wallstreetcn.com/articles/3634682\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/85675909dc6c67ee0181339c18bcfdff","relate_stocks":{"159938":"医药","300347":"泰格医药","09939":"开拓药业-B"},"source_url":"https://wallstreetcn.com/articles/3634682","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2149612353","content_text":"经过了一天的发酵，医药板块再次大跌，市场出现恐慌性卖出。\n\n一切的原因都是来自7月2日，国家药品监督管理局药品审评中心（CDE）发布的“关于公开征求《以临床价值为导向的抗肿瘤药物临床研发指导原则》意见的通知”。\n\n市场认为临床对照试验选择的最佳支持药物（BSC）变化将影响未来CXO（医药研究和生产外包服务，包括CRO\\CMO\\CDMO等）行业的景气程度。因为这项变化将直接降低采用me-too方式开发的药物未来上市的可能性，从而影响新药公司产品立项数量，减少CXO公司可获得订单数目。\n华尔街见闻·见智研究所在周一早间的文章《市场热议抗肿瘤药物新规，对火爆的CXO行业意味着什么？| 见智研究所》中已经充分解释了该政策对市场的影响。市场对新政存在一些误读和夸大，创新药和CXO行业下一发展阶段因此更应该迎来结构分化，而不是单纯利空。\n市场误读在于将me-too专利约束和临床BSC要求混为一谈\nme-too本身是以原研药为基础，在规避后者化学结构专利后进行研发的一类“新药“，它可能效果更好、也可能效果更差，实际并不绝对。\n既然是“新药“，也就意味着me-too药物的临床，与现有要求一致，需与标准推荐治疗药物作疗效对比。新指导原则本身不会要求必须要跟原研药做“头对头”临床，除非原研药已经上市，并获得标准推荐疗法。\n而此次政策文件实际解决的是临床伦理问题，是提出一个底线思维，要求在临床中给与对照组患者不低于现有标准推荐疗法的治疗手段。此次意见稿中将原先属于伦理范畴的部分制度化，以确保参加临床试验中的对照组患者得到合理治疗。包括美国FDA在内，也正在起草相关以患者为核心的药物研发(patient focused drug development，PFDD)文件。\n对医药行业的实际影响\n这项政策对医药公司在药物开发中的实际影响：要求做me-too类企业更快速推进开发和临床过程。\n需要me-too类药品开发需在竞争对手（原研药和其他me-too类药物）获批上市进入标准疗法前，进入三期临床阶段。否则在三期临床时候的对照组药物就将成为新的标准推荐疗法药物。\n举个例子：现在肝癌一线推荐疗法是PD-L1+仑伐替尼（简化具体适应症应用条件），那么现在肝癌一线药物3期临床对照组就是PD-L1+仑伐替尼，可能就不是此前对照的索拉菲尼。那么目前肝癌适应症已经进入3期临床的公司可能就是利好，没有进入的未来就会面临对照组更换，一方面对临床药物疗效要求更高，另一方面临床采购PD-L1+仑伐替尼的成本也比索拉菲尼高几倍。\n因此，这项要求会导致CXO企业和创新药企业的分化，最终用市场化的方式来出清一些占用审批资源的劣质药品。 \n\n对CXO企业：政策导向的结果将是行业分化，利好资源能力强的头部公司，利空资源整合能力弱的公司。\n 关键变量为，是否有能力加速开发、更快推进临床进度。\n 对创新药企：利好开发进度快的公司，利空开发进度慢的公司。\n 关键变量是，在进行3期临床时候，适应症的标准推荐疗法是否发生变化。但是我们也要看到一个趋势，\n 未来中国新药注册数量的以目前的增速是不可持续的。\n\n自2015年改革以后，中国肿瘤新药注册性临床快速增长，于2018年超越美国和欧洲，成为全球肿瘤临床研究的中心，6年新药注册数量增长6倍，但是药品监管方面的审批资源有限，一些劣质药占用了有限的审批资源将导致审批时间再次延长，这也是不利于中国创新药发展的。因此减量重质将会是下一阶段的重点。\n实际我们可以看到，文件的订立思路是在不断推进创新药市场化，疗效不佳的药物本就会在市场应用中淘汰。而在此过程中，无论是CXO还是创新药企，头部能够创造价值的公司一定还是能继续高增长，一部分浑水摸鱼的公司也会在市场中自然出清。","news_type":1,"symbols_score_info":{"159938":0.9,"300347":0.9,"09939":0.9}},"isVote":1,"tweetType":1,"viewCount":2157,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":357224115,"gmtCreate":1617280476037,"gmtModify":1617280476037,"author":{"id":"3573715185764517","authorId":"3573715185764517","name":"Jessicachz","avatar":"https://static.tigerbbs.com/cff127a053353532402cf8503f659705","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3573715185764517","authorIdStr":"3573715185764517"},"themes":[],"htmlText":"愚人节？","listText":"愚人节？","text":"愚人节？","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/357224115","repostId":"1146146540","repostType":4,"repost":{"id":"1146146540","kind":"news","weMediaInfo":{"introduction":"为用户提供金融资讯、行情、数据，旨在帮助投资者理解世界，做投资决策。","home_visible":1,"media_name":"老虎资讯综合","id":"102","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1617280156,"share":"https://ttm.financial/m/news/1146146540?lang=&edition=full","pubTime":"2021-04-01 20:29","market":"us","language":"zh","title":"市场消息：字节跳动的最新估值接近4000亿美元","url":"https://stock-news.laohu8.com/highlight/detail?id=1146146540","media":"老虎资讯综合","summary":"一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）如果该消息准确，基于分析公司CB ","content":"<p>一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）</p><p>如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。</p><p>一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。</p><p>相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>市场消息：字节跳动的最新估值接近4000亿美元</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n市场消息：字节跳动的最新估值接近4000亿美元\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/102\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">老虎资讯综合 </p>\n<p class=\"h-time\">2021-04-01 20:29</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）</p><p>如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。</p><p>一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。</p><p>相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://static.tigerbbs.com/2958907307044929d330311c413c1a4f","relate_stocks":{},"is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1146146540","content_text":"一位消息人士称，随着短视频分享应用程序TikTok的中国所有者巩固其在全球科技独角兽中的领先地位，对私募股权投资者而言，字节跳动的最新估值接近4000亿美元。（新浪）如果该消息准确，基于分析公司CB Insights的数据，则4000亿美元的新估值几乎是字节跳动在2020年3月C轮融资后1400亿美元估值的三倍。一年前，字节跳动向员工授予了公司股票，当时为公司估值1000亿美元。两周前，其估值升至2700亿美元。据字节跳动员工称，上周这一数字又跃升至3000亿美元。相比之下，竞争对手快手当前的市值约为1500亿美元。事实上，快手的市值，也为字节跳动的估值提供了基准。","news_type":1,"symbols_score_info":{}},"isVote":1,"tweetType":1,"viewCount":2112,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":327691748,"gmtCreate":1616078738284,"gmtModify":1616078738284,"author":{"id":"3573715185764517","authorId":"3573715185764517","name":"Jessicachz","avatar":"https://static.tigerbbs.com/cff127a053353532402cf8503f659705","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3573715185764517","authorIdStr":"3573715185764517"},"themes":[],"htmlText":"希望不要破发呀[开心]&nbsp;[财迷]&nbsp;","listText":"希望不要破发呀[开心]&nbsp;[财迷]&nbsp;","text":"希望不要破发呀[开心] 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