瑞科生物-B(02179.HK)：新佐剂重组带状疱疹疫苗REC610中国临床试验申请获得受理

格隆汇资讯2023-07-26

格隆汇7月26日丨瑞科生物-B(02179.HK)公告，集团已于近日收到国家药品监督管理局签发的受理通知书(受理号：CXSL2300518)，同意受理其自主研发的新佐剂重组带状疱疹疫苗REC610临床试验申请。自受理日起60日内，未收到国家药监局药品审评中心否定或质疑意见的，公司可以按照提交的方案开展临床试验。公司计划采用随机、双盲、Shingrix®平行对照设计，在中国境内招募180例40岁及...

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/2354585706?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2023-07-26 21:03","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2354585706","market":"hk","top_or_hot":-1,"title":"瑞科生物-B(02179.HK)：新佐剂重组带状疱疹疫苗REC610中国临床试验申请获得受理","media":"格隆汇资讯","content":"<div>\n<p>格隆汇7月26日丨瑞科生物-B(02179.HK)公告，集团已于近日收到国家药品监督管理局签发的受理通知书(受理号：CXSL2300518)，同意受理其自主研发的新佐剂重组带状疱疹疫苗REC610临床试验申请。自受理日起60日内，未收到国家药监局药品审评中心否定或质疑意见的，公司可以按照提交的方案开展临床试验。公司计划采用随机、双盲、Shingrix®平行对照设计，在中国境内招募180例40岁及...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20230726210502825312a8&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>瑞科生物-B(02179.HK)：新佐剂重组带状疱疹疫苗REC610中国临床试验申请获得受理</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瑞科生物-B(02179.HK)：新佐剂重组带状疱疹疫苗REC610中国临床试验申请获得受理\n</h2>\n\n<h4 class=\"meta\">\n\n\n2023-07-26 21:03 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20230726210502825312a8&s=b><strong>格隆汇资讯</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>格隆汇7月26日丨瑞科生物-B(02179.HK)公告，集团已于近日收到国家药品监督管理局签发的受理通知书(受理号：CXSL2300518)，同意受理其自主研发的新佐剂重组带状疱疹疫苗REC610临床试验申请。自受理日起60日内，未收到国家药监局药品审评中心否定或质疑意见的，公司可以按照提交的方案开展临床试验。公司计划采用随机、双盲、Shingrix®平行对照设计，在中国境内招募180例40岁及...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20230726210502825312a8&s=b\">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":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20230726210502825312a8&s=b","article_id":"2354585706","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20230726210502825312a8&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2354585706","pubTimestamp":1690376607,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"格隆汇7月26日丨瑞科生物-B公告，集团已于近日收到国家药品监督管理局签发的受理通知书，同意受理其自主研发的新佐剂重组带状疱疹疫苗REC610临床试验申请。此前，公司已于2023年2月在菲律宾开展以葛兰素史克Shingrix为阳性对照的REC610首次人体试验。目前该研究进展顺利，所有受试者已完成两剂疫苗接种后30天随访，且安全性与耐受性良好。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK1161":"生物科技","BK1141":"生命科学工具和服务","02179":"瑞科生物-B","BK1583":"高瓴概念","03347":"泰格医药","BK1576":"医药外包概念"},"translate_title":"Ruike Bio-B (02179. HK): The application for clinical trial of new adjuvant recombinant herpes zoster vaccine REC610 in China was accepted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02179":1,"03347":1},"content_text":"格隆汇7月26日丨瑞科生物-B(02179.HK)公告，集团已于近日收到国家药品监督管理局签发的受理通知书(受理号：CXSL2300518)，同意受理其自主研发的新佐剂重组带状疱疹疫苗REC610临床试验申请。自受理日起60日内，未收到国家药监局药品审评中心否定或质疑意见的，公司可以按照提交的方案开展临床试验。公司计划采用随机、双盲、Shingrix®平行对照设计，在中国境内招募180例40岁及以上健康受试者开展I期临床，以评价REC610的安全性、耐受性，并初步评价免疫原性。带状疱疹是一种常见的病毒感染性疾病，严重影响患者特别是老年患者的生活质量。据估计，我国50岁及以上人群每年新发带状疱疹病例在150万例以上，且近年来随着生活节奏加快，其发病率有逐步年轻化的趋势。REC610搭载由本公司自主研发的新型佐剂BFA01，可促进产生高水平的VZV糖蛋白E(gE)特异性CD4+T细胞和抗体，拟用于在40岁及以上成人中预防带状疱疹。临床前研究显示，REC610具有较好的免疫原性，可诱导产生高水平的gE抗原特异性CD4+T细胞反应和IgG抗体，其免疫反应非劣于对照疫苗Shingrix®。此前，公司已于2023年2月在菲律宾开展以葛兰素史克Shingrix®为阳性对照的REC610首次人体试验。目前该研究进展顺利，所有受试者已完成两剂疫苗接种后30天随访，且安全性与耐受性良好。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"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":"4.35.13","shortVersion":"4.35.13","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/2354585706","isCrawlerRequest":true}