和黄医药(00013)：他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤的中国新药上市申请获受理并获纳入优先审评

智通财经07-04

智通财经APP讯，和黄医药(00013)发布公告，他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤成人患者的新药上市申请已获中国国家药品监督管理局(“国家药监局”)受理并予以优先审评。他泽司他是由益普生(Ipsen)旗下公司Epizyme,Inc.(“Epizyme”)开发的全球同类首创的EZH2甲基转移酶抑制剂，已获美国食品药品监督管理局(“FDA”)加速批准用于治疗特定的...

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/2448452468?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2024-07-04 08:06","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2448452468","market":"sh","top_or_hot":-1,"title":"和黄医药(00013)：他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤的中国新药上市申请获受理并获纳入优先审评","media":"智通财经","content":"<div>\n<p>智通财经APP讯，和黄医药(00013)发布公告，他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤成人患者的新药上市申请已获中国国家药品监督管理局(“国家药监局”)受理并予以优先审评。他泽司他是由益普生(Ipsen)旗下公司Epizyme,Inc.(“Epizyme”)开发的全球同类首创的EZH2甲基转移酶抑制剂，已获美国食品药品监督管理局(“FDA”)加速批准用于治疗特定的...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1145375.html\">网页链接</a>\n\n</div>\n","source":"stock_zhitongcaijing","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>和黄医药(00013)：他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤的中国新药上市申请获受理并获纳入优先审评</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和黄医药(00013)：他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤的中国新药上市申请获受理并获纳入优先审评\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-07-04 08:06 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1145375.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，和黄医药(00013)发布公告，他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤成人患者的新药上市申请已获中国国家药品监督管理局(“国家药监局”)受理并予以优先审评。他泽司他是由益普生(Ipsen)旗下公司Epizyme,Inc.(“Epizyme”)开发的全球同类首创的EZH2甲基转移酶抑制剂，已获美国食品药品监督管理局(“FDA”)加速批准用于治疗特定的...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1145375.html\">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":"BK1588","symbol_name":"回港中概股","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1145375.html","article_id":"2448452468","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2448452468","pubTimestamp":1720051592,"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，和黄医药 发布公告，他泽司他用于治疗复发或难治性滤泡性淋巴瘤成人患者的新药上市申请已获中国国家药品监督管理局受理并予以优先审评。一项在中国开展的多中心、开放标签的II期桥接研究，以及Epizyme在中国以外地区开展的临床研究支持了此项中国新药上市申请。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK1588":"回港中概股","BK4007":"制药","BK4531":"中概回港概念","00013":"和黄医药","HCM":"和黄医药","BK1191":"制药","BK4585":"ETF&股票定投概念","BK4588":"碎股","BK1587":"次新股"},"translate_title":"Chi-Med (00013): China's new drug marketing application for tazemetostat for the treatment of relapsed or refractory follicular lymphoma was accepted and included in priority review","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00013":1,"HCM":1},"content_text":"智通财经APP讯，和黄医药(00013)发布公告，他泽司他(tazemetostat)用于治疗复发或难治性滤泡性淋巴瘤成人患者的新药上市申请已获中国国家药品监督管理局(“国家药监局”)受理并予以优先审评。他泽司他是由益普生(Ipsen)旗下公司Epizyme,Inc.(“Epizyme”)开发的全球同类首创的EZH2甲基转移酶抑制剂，已获美国食品药品监督管理局(“FDA”)加速批准用于治疗特定的复发/难治性滤泡性淋巴瘤患者以及特定的晚期上皮样肉瘤患者。日本厚生劳动省亦已批准其用于治疗特定的复发/难治性滤泡性淋巴瘤患者。和黄医药达成一项战略合作，负责在中国内地、中国香港、中国澳门和中国台湾进行他泽司他的研究、开发、生产以及商业化。一项在中国开展的多中心、开放标签的II期桥接研究，以及Epizyme在中国以外地区开展的临床研究支持了此项中国新药上市申请。他泽司他的临床急需进口药品申请已于2022年5月获批于海南博鳌乐城国际医疗旅游先行区(简称“海南先行区”)使用，用于治疗特定的上皮样肉瘤和滤泡性淋巴瘤患者，与FDA已批准的标签一致。他泽司他已于2023年3月在中国澳门特别行政区获批使用，并于2024年5月在中国香港特别行政区获批使用。","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"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":"4.25.1","shortVersion":"4.25.1","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/2448452468"}