华东医药：索米妥昔单抗注射液上市许可申请获得批准

智通财经网11-27

智通财经APP讯，华东医药(000963.SZ)发布公告，2024年11月27日，公司全资子公司杭州中美华东制药有限公司(“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》，中美华东申报的索米妥昔单抗注射液(爱拉赫®/ELAHERE®)用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌(PROC)适应症的上市许可申请获得批准。据悉，索米妥昔单抗注射液为中美华东...

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/2486841601?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2024-11-27 18:17","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2486841601","market":"us","top_or_hot":-1,"title":"华东医药：索米妥昔单抗注射液上市许可申请获得批准","media":"智通财经网","content":"<div>\n<p>智通财经APP讯，华东医药(000963.SZ)发布公告，2024年11月27日，公司全资子公司杭州中美华东制药有限公司(“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》，中美华东申报的索米妥昔单抗注射液(爱拉赫®/ELAHERE®)用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌(PROC)适应症的上市许可申请获得批准。据悉，索米妥昔单抗注射液为中美华东...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241127182229a2597819&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>华东医药：索米妥昔单抗注射液上市许可申请获得批准</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华东医药：索米妥昔单抗注射液上市许可申请获得批准\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-27 18:17 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241127182229a2597819&s=b><strong>智通财经网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，华东医药(000963.SZ)发布公告，2024年11月27日，公司全资子公司杭州中美华东制药有限公司(“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》，中美华东申报的索米妥昔单抗注射液(爱拉赫®/ELAHERE®)用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌(PROC)适应症的上市许可申请获得批准。据悉，索米妥昔单抗注射液为中美华东...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241127182229a2597819&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":"LU1934455194.USD","symbol_name":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241127182229a2597819&s=b","article_id":"2486841601","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20241127182229a2597819&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=2486841601","pubTimestamp":1732702657,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"智通财经APP讯，华东医药 发布公告，2024年11月27日，公司全资子公司杭州中美华东制药有限公司收到国家药品监督管理局核准签发的《药品注册证书》，中美华东申报的索米妥昔单抗注射液用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌适应症的上市许可申请获得批准。2022年11月，ImmunoGen宣布该产品获得美国FDA加速批准上市。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU1934455194.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC","LU0661504455.SGD":"Blackrock Global Equity Income A5 SGD-H","LU0965509010.AUD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (AUDHDG) INC","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","LU1267930573.SGD":"TEMPLETON GLOBAL \"AA\" (SGD) ACC A","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","LU0965508806.USD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (USD) INC","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","LU0861579265.USD":"联博低波幅策略股票基金A","LU0965509283.SGD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (SGDHDG) INC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU1267930490.SGD":"TEMPLETON GLOBAL EQUITY INCOME \"AS\" (SGD) INC A","LU0211327993.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (USD) ACC","LU1718418525.SGD":"JPMorgan Investment Funds - Global Select Equity A (acc) SGD","PROC":"Procaps","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","LU0738911758.USD":"Blackrock Global Equity Income A6 USD","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","IE00B42XCP33.USD":"GUINNESS GLOBAL EQUITY INCOME \"C\" (USD) INC","ABBV":"艾伯维公司","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","LU0211328371.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (MDIS) (USD)   INC","LU0029864427.USD":"TEMPLETON GLOBAL \"A\" (USD) INC","LU1732799900.SGD":"JPMorgan Investment Funds - Global Income A (irc) SGD-H","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","LU2089984988.USD":"MANULIFE GF HEALTHCARE \"AA\" (USD) ACC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU2112291526.USD":"BGF WORLD HEALTHSCIENCE \"A4\" (USD) INC","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","LU0256863902.USD":"ALLIANZ US EQUITY \"AT\" (USD) ACC","LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU1732800096.USD":"摩根大通环球收益基金A (irc)","LU2237443549.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA SGD-H","BK4007":"制药","LU1037948897.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (HKD) INC","LU0310800379.SGD":"FTIF - Templeton Global A Acc SGD","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU2237443465.HKD":"abrdn SICAV I -  GLOBAL DYNAMIC DIVIDEND \"A\" (HKD) INC","LU2237443622.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc USD","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU1037948541.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (HKD) ACC","EC":"哥伦比亚国家石油"},"translate_title":"Huadong Medicine: Somituximab Injection Marketing Authorization Application Approved","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PROC":1,"EC":1,"ABBV":0.9},"content_text":"智通财经APP讯，华东医药(000963.SZ)发布公告，2024年11月27日，公司全资子公司杭州中美华东制药有限公司(“中美华东”)收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》，中美华东申报的索米妥昔单抗注射液(爱拉赫®/ELAHERE®)用于既往接受过1-3线系统性治疗的叶酸受体α阳性的铂类耐药卵巢癌(PROC)适应症的上市许可申请获得批准。据悉，索米妥昔单抗注射液为中美华东与ImmunoGen,Inc.(目前已被AbbVie收购)合作开发的针对叶酸受体α(FRα，一种在卵巢癌中高表达的细胞表面蛋白)靶点的ADC创新药，由FRα结合抗体、可裂解的连接子和美登木素生物碱DM4组成，在中国、美国和欧盟均为首个也是目前唯一一个批准用于治疗PROC的靶向FRα的ADC药物。中美华东拥有该产品在大中华区(含中国大陆、香港、澳门和台湾地区)的独家临床开发及商业化权益。2022年5月，ImmunoGen宣布美国FDA已受理该产品的生物制品许可申请(BLA)，并授予优先审评资格。2022年11月，ImmunoGen宣布该产品获得美国FDA加速批准上市。2024年3月，AbbVie宣布该产品获得美国FDA完全批准，用于治疗既往接受过1-3线系统性治疗的叶酸受体α(FRα)阳性的铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。2024年11月15日(美国时间)，AbbVie宣布该产品获得欧盟委员会(EC)批准上市，用于治疗既往接受过1-3线系统性治疗的叶酸受体α(FRα)阳性、铂类耐药的高级别浆液性上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","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":"4.29.3","shortVersion":"4.29.3","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/2486841601"}