礼来重磅新药！GCRP受体拮抗剂国内申报上市

市场资讯2022-07-29

近日，Wind万得医药库统计显示，礼来偏头痛药物 Galcanezumab注射液在国内的上市申请已被CDE受理。（CDE受理情况）据悉，Galcanezumab是由礼来开发的一款靶向降钙素基因相关肽(CGRP)的全人源单抗，曾获FDA突破性疗法认定，2018年首次在美国上市，用于预防性治疗偏头痛，商品名Emgality。CGRP是一种有效的血管舒张神经肽，其释放水平在偏头痛发作时明显增高，抑制...

网页链接

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

我们需要你的真知灼见来填补这片空白

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/2255561025?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2022-07-29 11:26","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2255561025","market":"hk","top_or_hot":-1,"title":"礼来重磅新药！GCRP受体拮抗剂国内申报上市","media":"市场资讯","content":"<div>\n<p>近日，Wind万得医药库统计显示，礼来偏头痛药物 Galcanezumab注射液在国内的上市申请已被CDE受理。（CDE受理情况）据悉，Galcanezumab是由礼来开发的一款靶向降钙素基因相关肽(CGRP)的全人源单抗，曾获FDA突破性疗法认定，2018年首次在美国上市，用于预防性治疗偏头痛，商品名Emgality。CGRP是一种有效的血管舒张神经肽，其释放水平在偏头痛发作时明显增高，抑制...</p>\n\n<a href=\"https://cj.sina.cn/article/normal_detail?url=https://finance.sina.com.cn/money/fund/jjzl/2022-07-29/doc-imizmscv3996224.shtml\">网页链接</a>\n\n</div>\n","source":"sina_symbol","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>礼来重磅新药！GCRP受体拮抗剂国内申报上市</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礼来重磅新药！GCRP受体拮抗剂国内申报上市\n</h2>\n\n<h4 class=\"meta\">\n\n\n2022-07-29 11:26 北京时间&nbsp;&nbsp;&nbsp;<a href=https://cj.sina.cn/article/normal_detail?url=https://finance.sina.com.cn/money/fund/jjzl/2022-07-29/doc-imizmscv3996224.shtml><strong>市场资讯</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>近日，Wind万得医药库统计显示，礼来偏头痛药物 Galcanezumab注射液在国内的上市申请已被CDE受理。（CDE受理情况）据悉，Galcanezumab是由礼来开发的一款靶向降钙素基因相关肽(CGRP)的全人源单抗，曾获FDA突破性疗法认定，2018年首次在美国上市，用于预防性治疗偏头痛，商品名Emgality。CGRP是一种有效的血管舒张神经肽，其释放水平在偏头痛发作时明显增高，抑制...</p>\n\n<a href=\"https://cj.sina.cn/article/normal_detail?url=https://finance.sina.com.cn/money/fund/jjzl/2022-07-29/doc-imizmscv3996224.shtml\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4534","symbol_name":"瑞士信贷持仓","start_time":0,"source_url":"https://cj.sina.cn/article/normal_detail?url=https://finance.sina.com.cn/money/fund/jjzl/2022-07-29/doc-imizmscv3996224.shtml","article_id":"2255561025","we_media_id":null,"thumbnails":[],"rights":{"source":"sina_symbol","url":"https://cj.sina.cn/article/normal_detail?url=https://finance.sina.com.cn/money/fund/jjzl/2022-07-29/doc-imizmscv3996224.shtml","rn_cache_url":null,"customStyle":"body{padding-top:10px;}.title{#titleStyle#}a{#lv2TextColor#}.extra-info, .source{#sourceStyle#;}","selectors":".module-article, article","filters":"header, .voice2, .tags, #norm_qrcode_link_auto, .unfold-box, .action","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2255561025","pubTimestamp":1659065162,"sourceInfo":{"source_id":"sina_symbol","name":"新浪媒体新闻"},"weMediaInfo":null,"summary":"近日，Wind万得医药库统计显示，礼来偏头痛药物 Galcanezumab注射液在国内的上市申请已被CDE受理。近年来发展起来的GCRP受体拮抗剂有望成为终止偏头痛急性发作安全有效的特异性药物。该申请如果获批，atogepant将成为欧洲首个用于预防偏头痛的每日口服CGRP受体抑制剂。目前全球已有七款CGRP药物和一款5-HT1F受体激动剂上市，CGRP正在逐步取代曲坦类药物，成为偏头痛的新标准。","collect":0,"end_time":0,"defaultTopTitle":"sina.cn","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK4534":"瑞士信贷持仓","BK4581":"高盛持仓","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4007":"制药","LLY":"礼来"},"translate_title":"Lilly is a heavy new drug! GCRP receptor antagonist declared for marketing in China","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LLY":1},"content_text":"近日，Wind万得医药库统计显示，礼来偏头痛药物 Galcanezumab注射液在国内的上市申请已被CDE受理。（CDE受理情况）据悉，Galcanezumab是由礼来开发的一款靶向降钙素基因相关肽(CGRP)的全人源单抗，曾获FDA突破性疗法认定，2018年首次在美国上市，用于预防性治疗偏头痛，商品名Emgality。CGRP是一种有效的血管舒张神经肽，其释放水平在偏头痛发作时明显增高，抑制CGRP及其受体(CGRPR)的活性可以缓解头痛和预防偏头痛发作。（Galcanezumab在美上市情况）// 临床试验详情 //该上市申请主要基于一项Galcanezumab针对中国患者的III期研究(CGAX研究)结果。2021年9月6日，礼来宣布Galcanezumab用于预防性治疗成人发作性偏头痛的全球多中心III期CGAX研究取得积极主要研究结果，在主要研究终点和全部4个关键次要终点与既往完成的所有Galcanezumab全球研究结果高度一致。（临床试验信息）（研发概览）//  偏头痛  //偏头痛是临床常见的原发性头痛，是一种常见的慢性血管性疾病，患病率为5%~10%，多起病于儿童和青春期，中青年期达发病高峰。治疗药物包括非特异性止痛药如非甾体抗炎药和阿片类药物，特异性药物如麦角类制剂和曲普坦类药物。近年来发展起来的GCRP受体拮抗剂有望成为终止偏头痛急性发作安全有效的特异性药物。// 销售市场 //Wind万得医药库统计显示，2021年抗偏头痛药样本医院市场份额最高的药物是天麻素注射液，销售额超过1亿元，占比83.77%。企业份额最高的是昆药集团，销售额957万，占比56.96%。（药品销售份额）（企业销售份额）// 相关药品情况 //今年4月，诺华与安进合作开发的偏头痛新药Erenumab提交上市申请并获CDE受理，这是国内首款申报上市的抗CGRPR单抗。Erenumab最早由安进开发，是一种全人源IgG2单抗，通过结合并拮抗CGRP受体功能来治疗偏头痛。近日，艾伯维(AbbVie)宣布已向EMA提交了其口服降钙素基因相关肽(CGRP)受体抑制剂atogepant(商品名：Qulipta)的营销授权申请，用于预防每月至少有四天偏头痛发作成人患者的偏头痛预防。该申请如果获批，atogepant将成为欧洲首个用于预防偏头痛的每日口服CGRP受体抑制剂。目前全球已有七款CGRP药物和一款5-HT1F受体激动剂上市，CGRP正在逐步取代曲坦类药物，成为偏头痛的新标准。","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2255561025"}