Hutchmed Says China's Medicines Regulator Accepts NDA With Priority Review for Orpathys, Tagrisso Combination

MT Newswires Live01-02

Hutchmed (China) (HCM) said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys and Tagrisso for the treatment of patients with a specific type of non-small cell lung cancer.

The company said this acceptance also triggers a milestone payment from AstraZeneca (AZN), which is leading the development of Orpathys outside China.

The decision was supported by data from a late-stage trial that evaluated the efficacy and safety of a combination of the two drugs in comparison to chemotherapy and met its primary endpoint of progression-free survival in an interim analysis.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2500427944?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-01-02 19:20","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2500427944","market":"us","top_or_hot":-1,"title":"Hutchmed Says China's Medicines Regulator Accepts NDA With Priority Review for Orpathys, Tagrisso Combination","media":"MT Newswires Live","content":"<html><body><p> Hutchmed (China) (HCM) said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys and Tagrisso for the treatment of patients with a specific type of non-small cell lung cancer.</p><p>The company said this acceptance also triggers a milestone payment from AstraZeneca (AZN), which is leading the development of Orpathys outside China.</p><p>The decision was supported by data from a late-stage trial that evaluated the efficacy and safety of a combination of the two drugs in comparison to chemotherapy and met its primary endpoint of progression-free survival in an interim analysis.</p></body></html>","source":"mtnewswires_news","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>Hutchmed Says China's Medicines Regulator Accepts NDA With Priority Review for Orpathys, Tagrisso Combination</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\">\nHutchmed Says China's Medicines Regulator Accepts NDA With Priority Review for Orpathys, Tagrisso Combination\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-01-02 19:20 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.mtnewswires.com/><strong>MT Newswires Live</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Hutchmed (China) (HCM) said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys ...</p>\n\n<a href=\"https://www.mtnewswires.com/\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2236285917.USD","symbol_name":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2500427944","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2500427944","pubTimestamp":1735816853,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Hutchmed   said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys and Tagrisso for the treatment of patients with a specific type of non-small cell lung cancer.The company said this acceptance also triggers a milestone payment from AstraZeneca , which is leading the development of Orpathys outside China.The decision was supported by data from a late-stage trial that evaluated the efficacy and safety of a combination of the two drugs in comparison to chemotherapy and met its primary endpoint of progression-free survival in an interim analysis.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","AZN":"阿斯利康","00013":"和黄医药","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC","BK4531":"中概回港概念","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU1829250122.USD":"高盛欧洲核心股票组合Acc","BK4585":"ETF&股票定投概念","MDCO":"麦迪逊医药","BK4007":"制药","BK1588":"回港中概股","HCM":"和黄医药","BK4568":"美国抗疫概念","BK4588":"碎股","BK1587":"次新股","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU2417539215.USD":"ALLIANZ GLOBAL INCOME \"AMF\" (USD) INC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK1191":"制药"},"translate_title":"和黄医药表示中国药品监管机构接受Orpathys和Tagrisso组合的NDA并优先审查","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MDCO":1,"00013":1,"HCM":0.9,"AZN":0.9},"content_text":"Hutchmed (China) (HCM) said late Wednesday that the China National Medical Products Administration has accepted and granted priority review to its New Drug Application for the combination of Orpathys and Tagrisso for the treatment of patients with a specific type of non-small cell lung cancer.The company said this acceptance also triggers a milestone payment from AstraZeneca (AZN), which is leading the development of Orpathys outside China.The decision was supported by data from a late-stage trial that evaluated the efficacy and safety of a combination of the two drugs in comparison to chemotherapy and met its primary endpoint of progression-free survival in an interim analysis.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","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":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.4","shortVersion":"4.29.4","platform":"web","vendor":"web","appName":"ttm","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/2500427944"}