中国生物制药(01177.HK)创新药的新适应症上市申请获受理

阿斯达克财经11-21 12:10

中国生物制药(01177.HK) 公布，集团自主研发的1类创新药盐酸安罗替尼胶囊联合派安普利单抗注射液用作用于晚期肝细胞癌一线治疗的III期临床研究(ALTN-AK105-III-02)已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)以及总生存期(OS)均达到方案预设的优效界值。基于这一积极成果，集团近期已向中国国家药品监督管理局药品审评中心(CDE)递交新适应症上市申请并获得受理。
公司指，一线治疗晚期肝细胞癌是盐酸安罗替尼胶囊申报上市的第10个适应症，有望为晚期肝细胞癌患者提供一种更安全、更便捷的治疗方案。随集团在创新研发中的不断投入，创新产品不断取得新突
破，创新管线已迎来收获期。(vc/a)(港股报价延迟最少十五分钟。沽空资料截至 2024-11-20 16:25。)

AASTOCKS新闻

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/2485482029?lang=zh_CN&edition=full","thumbnail":"https://plib.aastocks.com/aafnnews/image/medialib/20220419121920492_s.jpg","is_english":false,"pubTime":"2024-11-21 12:10","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2485482029","market":"hk","top_or_hot":-1,"title":"中国生物制药(01177.HK)创新药的新适应症上市申请获受理","media":"阿斯达克财经","content":"<html><body><div> <span> <p><a href=\"https://laohu8.com/S/01177\">中国生物制药</a>(01177.HK)<span> </span>公布，集团自主研发的1类创新药盐酸安罗替尼胶囊联合派安普利单抗注射液用作用于晚期肝细胞癌一线治疗的III期临床研究(ALTN-AK105-III-02)已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)以及总生存期(OS)均达到方案预设的优效界值。基于这一积极成果，集团近期已向中国国家药品监督管理局药品审评中心(CDE)递交新适应症上市申请并获得受理。<br/>公司指，一线治疗晚期肝细胞癌是盐酸安罗替尼胶囊申报上市的第10个适应症，有望为晚期肝细胞癌患者提供一种更安全、更便捷的治疗方案。随集团在创新研发中的不断投入，创新产品不断取得新突<br/>破，创新管线已迎来收获期。(vc/a)(港股报价延迟最少十五分钟。沽空资料截至 2024-11-20 16:25。)</p><div></div>AASTOCKS新闻 </span> </div></body></html>","source":"aastocks_highlight","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>中国生物制药(01177.HK)创新药的新适应症上市申请获受理</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中国生物制药(01177.HK)创新药的新适应症上市申请获受理\n</h2>\n\n<h4 class=\"meta\">\n\n<p class=\"head\">\n<strong class=\"h-name small\">阿斯达克财经</strong><span class=\"h-time small\">2024-11-21 12:10</span>\n</p>\n\n</h4>\n\n</header>\n<article>\n<html><body><div> <span> <p><a href=\"https://laohu8.com/S/01177\">中国生物制药</a>(01177.HK)<span> </span>公布，集团自主研发的1类创新药盐酸安罗替尼胶囊联合派安普利单抗注射液用作用于晚期肝细胞癌一线治疗的III期临床研究(ALTN-AK105-III-02)已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)以及总生存期(OS)均达到方案预设的优效界值。基于这一积极成果，集团近期已向中国国家药品监督管理局药品审评中心(CDE)递交新适应症上市申请并获得受理。<br/>公司指，一线治疗晚期肝细胞癌是盐酸安罗替尼胶囊申报上市的第10个适应症，有望为晚期肝细胞癌患者提供一种更安全、更便捷的治疗方案。随集团在创新研发中的不断投入，创新产品不断取得新突<br/>破，创新管线已迎来收获期。(vc/a)(港股报价延迟最少十五分钟。沽空资料截至 2024-11-20 16:25。)</p><div></div>AASTOCKS新闻 </span> </div></body></html>\n\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"http://www.aastocks.com/tc/stocks/analysis/china-hot-topic-content.aspx?id=NOW.1398470&catg=4&source=AAFN\">阿斯达克财经</a> </p>\n\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n</div>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1589","symbol_name":"北水核心资产","start_time":0,"source_url":"http://www.aastocks.com/tc/stocks/analysis/china-hot-topic-content.aspx?id=NOW.1398470&catg=4&source=AAFN","article_id":"2485482029","we_media_id":null,"thumbnails":["https://plib.aastocks.com/aafnnews/image/medialib/20220419121920492_s.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2485482029","pubTimestamp":1732162200,"sourceInfo":{"source_id":"aastocks_highlight","name":"阿思達克財經"},"weMediaInfo":null,"summary":"基于这一积极成果，集团近期已向中国国家药品监督管理局药品审评中心递交新适应症上市申请并获得受理。公司指，一线治疗晚期肝细胞癌是盐酸安罗替尼胶囊申报上市的第10个适应症，有望为晚期肝细胞癌患者提供一种更安全、更便捷的治疗方案。","collect":0,"end_time":0,"defaultTopTitle":"aastocks.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"159992":"创新药","BK1589":"北水核心资产","BK1521":"挪威政府全球养老基金持仓","BK1191":"制药","BK1515":"抗疫概念","06978":"永泰生物-B","BK1161":"生物科技","BK1574":"生物医药B类股","01177":"中国生物制药"},"translate_title":"China Biopharmaceutical (01177. HK) 's new indication marketing application for innovative drugs was accepted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"159992":1,"01177":1,"06978":1},"content_text":"中国生物制药(01177.HK) 公布，集团自主研发的1类创新药盐酸安罗替尼胶囊联合派安普利单抗注射液用作用于晚期肝细胞癌一线治疗的III期临床研究(ALTN-AK105-III-02)已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)以及总生存期(OS)均达到方案预设的优效界值。基于这一积极成果，集团近期已向中国国家药品监督管理局药品审评中心(CDE)递交新适应症上市申请并获得受理。公司指，一线治疗晚期肝细胞癌是盐酸安罗替尼胶囊申报上市的第10个适应症，有望为晚期肝细胞癌患者提供一种更安全、更便捷的治疗方案。随集团在创新研发中的不断投入，创新产品不断取得新突破，创新管线已迎来收获期。(vc/a)(港股报价延迟最少十五分钟。沽空资料截至 2024-11-20 16:25。)AASTOCKS新闻","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"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":"4.29.2","shortVersion":"4.29.2","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/2485482029"}