3D MEDICINES (01244): New Drug Application for ENVAFOLIMAB as First-Line Treatment for Biliary Tract Cancer Accepted by NMPA

Stock News01-09

3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic name: Envafolimab Injection, original R&D code: KN035) in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical study results from the Phase III clinical trial (KN035-CN-005), which was a randomized, parallel-controlled, multi-center Phase III trial designed for Chinese patients with advanced first-line biliary tract cancer, aiming to evaluate the efficacy and safety of ENVAFOLIMAB® (KN035) combined with the GEMOX regimen compared to the GEMOX regimen alone.

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/1184618286?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-09 22:08","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1184618286","market":"fut","top_or_hot":-1,"title":"3D MEDICINES (01244): New Drug Application for ENVAFOLIMAB as First-Line Treatment for Biliary Tract Cancer Accepted by NMPA","media":"Stock News","content":"<p>3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic name: Envafolimab Injection, original R&D code: KN035) in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical study results from the Phase III clinical trial (KN035-CN-005), which was a randomized, parallel-controlled, multi-center Phase III trial designed for Chinese patients with advanced first-line biliary tract cancer, aiming to evaluate the efficacy and safety of ENVAFOLIMAB® (KN035) combined with the GEMOX regimen compared to the GEMOX regimen alone.</p>","source":null,"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>3D MEDICINES (01244): New Drug Application for ENVAFOLIMAB as First-Line Treatment for Biliary Tract Cancer Accepted by NMPA</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\">\n3D MEDICINES (01244): New Drug Application for ENVAFOLIMAB as First-Line Treatment for Biliary Tract Cancer Accepted by NMPA\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1036600163\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Stock News </p>\n<p class=\"h-time\">2026-01-09 22:08</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic name: Envafolimab Injection, original R&D code: KN035) in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical study results from the Phase III clinical trial (KN035-CN-005), which was a randomized, parallel-controlled, multi-center Phase III trial designed for Chinese patients with advanced first-line biliary tract cancer, aiming to evaluate the efficacy and safety of ENVAFOLIMAB® (KN035) combined with the GEMOX regimen compared to the GEMOX regimen alone.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"01244","symbol_name":"思路迪医药股份","start_time":0,"source_url":"","article_id":"1184618286","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1184618286","pubTimestamp":1767967697,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Stock News","introduction":"Global Stock News First-Time Broadcast","home_visible":1,"id":"1036600163","head_image":"https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a"},"summary":"3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"01244":"思路迪医药股份","BK1161":"生物科技"},"translate_title":"三维药物(01244)：ENVAFOLIMAB一线治疗胆道癌新药申请获NMPA受理","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01244":1},"content_text":"3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic name: Envafolimab Injection, original R&D code: KN035) in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical study results from the Phase III clinical trial (KN035-CN-005), which was a randomized, parallel-controlled, multi-center Phase III trial designed for Chinese patients with advanced first-line biliary tract cancer, aiming to evaluate the efficacy and safety of ENVAFOLIMAB® (KN035) combined with the GEMOX regimen compared to the GEMOX regimen alone.","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":0,"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":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.0","shortVersion":"4.36.0","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/1184618286","isCrawlerRequest":true}