Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (02196.HK, 600196.SH) Receives NMPA Approval for Phase II Clinical Trial of Luvometinib in KRAS-Mutant NSCLC

Bulletin Express02-25

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the National Medical Products Administration to conduct a Phase II clinical trial of 复迈宁® (Luvometinib Tablets) in combination with Anlotinib for patients with KRAS-mutant advanced non-small cell lung cancer.

Luvometinib, an innovative MEK1/2 selective inhibitor developed by the Company, is already approved in China for two indications: adult patients with Langerhans cell histiocytosis and histiocytic neoplasms, and pediatric patients aged two years or above with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection. Two further indications have been accepted by the regulator and included in the Priority Review list, and additional trials are ongoing in children’s low-grade glioma and extracranial arteriovenous malformations.

As of January 2026, research and development investment in Luvometinib had reached approximately 668.00 million renminbi. According to IQVIA MIDAS™, sales of MEK1/2 selective inhibitors globally amounted to around US$2,068 million in 2024.

The Company highlighted that further clinical confirmation and regulatory approvals are required before the new indication can be brought to market.

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/1147082994?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-02-25 18:04","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1147082994","market":"hk","top_or_hot":-1,"title":"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (02196.HK, 600196.SH) Receives NMPA Approval for Phase II Clinical Trial of Luvometinib in KRAS-Mutant NSCLC","media":"Bulletin Express","content":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the National Medical Products Administration to conduct a Phase II clinical trial of 复迈宁® (Luvometinib Tablets) in combination with Anlotinib for patients with KRAS-mutant advanced non-small cell lung cancer.</p>\n<p>Luvometinib, an innovative MEK1/2 selective inhibitor developed by the Company, is already approved in China for two indications: adult patients with Langerhans cell histiocytosis and histiocytic neoplasms, and pediatric patients aged two years or above with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection. Two further indications have been accepted by the regulator and included in the Priority Review list, and additional trials are ongoing in children’s low-grade glioma and extracranial arteriovenous malformations.</p>\n<p>As of January 2026, research and development investment in Luvometinib had reached approximately 668.00 million renminbi. According to IQVIA MIDAS™, sales of MEK1/2 selective inhibitors globally amounted to around US$2,068 million in 2024.</p>\n<p>The Company highlighted that further clinical confirmation and regulatory approvals are required before the new indication can be brought to market.</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>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (02196.HK, 600196.SH) Receives NMPA Approval for Phase II Clinical Trial of Luvometinib in KRAS-Mutant NSCLC</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\">\nShanghai Fosun Pharmaceutical (Group) Co., Ltd. (02196.HK, 600196.SH) Receives NMPA Approval for Phase II Clinical Trial of Luvometinib in KRAS-Mutant NSCLC\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1053168898\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/ed558ed0402cbe7d1ef4d150458f2b2e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Bulletin Express </p>\n<p class=\"h-time\">2026-02-25 18:04</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the National Medical Products Administration to conduct a Phase II clinical trial of 复迈宁® (Luvometinib Tablets) in combination with Anlotinib for patients with KRAS-mutant advanced non-small cell lung cancer.</p>\n<p>Luvometinib, an innovative MEK1/2 selective inhibitor developed by the Company, is already approved in China for two indications: adult patients with Langerhans cell histiocytosis and histiocytic neoplasms, and pediatric patients aged two years or above with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection. Two further indications have been accepted by the regulator and included in the Priority Review list, and additional trials are ongoing in children’s low-grade glioma and extracranial arteriovenous malformations.</p>\n<p>As of January 2026, research and development investment in Luvometinib had reached approximately 668.00 million renminbi. According to IQVIA MIDAS™, sales of MEK1/2 selective inhibitors globally amounted to around US$2,068 million in 2024.</p>\n<p>The Company highlighted that further clinical confirmation and regulatory approvals are required before the new indication can be brought to market.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"02196","symbol_name":"复星医药","start_time":0,"source_url":"","article_id":"1147082994","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1147082994","pubTimestamp":1772013861,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Bulletin Express","introduction":"Full Coverage of HK & US Stock Announcements","home_visible":1,"id":"1053168898","head_image":"https://community-static.tradeup.com/news/ed558ed0402cbe7d1ef4d150458f2b2e"},"summary":"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02196":"复星医药"},"translate_title":"上海复星医药（集团）股份有限公司（02196.HK，600196.SH）Luvometinib治疗KRAS突变型非小细胞肺癌II期临床试验获NMPA批准","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02196":1},"content_text":"Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the National Medical Products Administration to conduct a Phase II clinical trial of 复迈宁® (Luvometinib Tablets) in combination with Anlotinib for patients with KRAS-mutant advanced non-small cell lung cancer.\nLuvometinib, an innovative MEK1/2 selective inhibitor developed by the Company, is already approved in China for two indications: adult patients with Langerhans cell histiocytosis and histiocytic neoplasms, and pediatric patients aged two years or above with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection. Two further indications have been accepted by the regulator and included in the Priority Review list, and additional trials are ongoing in children’s low-grade glioma and extracranial arteriovenous malformations.\nAs of January 2026, research and development investment in Luvometinib had reached approximately 668.00 million renminbi. According to IQVIA MIDAS™, sales of MEK1/2 selective inhibitors globally amounted to around US$2,068 million in 2024.\nThe Company highlighted that further clinical confirmation and regulatory approvals are required before the new indication can be brought to market.","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":"policyRegulatory,SGX","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":"4.36.2","shortVersion":"4.36.2","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/1147082994","isCrawlerRequest":true}