Gan&Lee Pharmaceuticals (603087.SH): CHMP Grants Positive Opinion for Marketing Authorization Application (MAA) of Insulin Glargine Injection (Ondibta®) in EU

Stock News11-13

Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).

CHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.

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/1189004134?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-11-13 17:20","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1189004134","market":"nz","top_or_hot":-1,"title":"Gan&Lee Pharmaceuticals (603087.SH): CHMP Grants Positive Opinion for Marketing Authorization Application (MAA) of Insulin Glargine Injection (Ondibta®) in EU","media":"Stock News","content":"<p>Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).</p>\n<p>CHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.</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>Gan&Lee Pharmaceuticals (603087.SH): CHMP Grants Positive Opinion for Marketing Authorization Application (MAA) of Insulin Glargine Injection (Ondibta®) in EU</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\">\nGan&Lee Pharmaceuticals (603087.SH): CHMP Grants Positive Opinion for Marketing Authorization Application (MAA) of Insulin Glargine Injection (Ondibta®) in EU\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\">2025-11-13 17:20</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).</p>\n<p>CHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4585","symbol_name":"ETF&股票定投概念","start_time":0,"source_url":"","article_id":"1189004134","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1189004134","pubTimestamp":1763025640,"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":"Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"603087":"甘李药业","BK4585":"ETF&股票定投概念","BK4087":"商业印刷","CHMP":"冠军工业","BK4215":"住宅房地产投资信托","BK0239":"医药制造","MAA":"MAA房产信托","BK4588":"碎股"},"translate_title":"甘李药业（603087.SH）：CHMP授予甘精胰岛素注射液（Ondibta）上市许可申请（MAA）积极意见®）在欧盟","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"603087":1,"FSXEmain":1,"FESXmain":1,"CHMP":1,"MAA":1},"content_text":"Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).\nCHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.","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,"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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","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/1189004134","isCrawlerRequest":true}