MABWELL-B Surges Over 13% in Morning Trade After Two Denosumab Injections Pass Brazilian Regulator GMP Inspection

Deep News

Aug 11

MABWELL-B (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.

According to an official announcement from MABWELL, its wholly-owned subsidiary Taikang Biomedical has successfully passed the Good Manufacturing Practice (GMP) on-site inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) for two denosumab injections: 9MW0311 (a Prolia® biosimilar, domestic brand name: Mailishu®) and 9MW0321 (an Xgeva® biosimilar, domestic brand name: Maiweijian®).

This marks the second time MABWELL has received a GMP certificate from a regulatory authority in a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country, following its earlier success in Jordan. As a PIC/S member, Brazil's ANVISA is known for its rigorous and stringent GMP review standards, which are fully aligned with International Council for Harmonisation (ICH) and World Health Organization (WHO) international guidelines. This certification underscores that MABWELL's quality management system has once again gained recognition from a high-standard overseas regulator, laying a stronger foundation for the company's products to enter more PIC/S member markets.

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.

Most Discussed

1
2
3
4
5
6
7
8
9
10

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers HK | Online Trading in stocks, bonds & ETFS","description":"Discover Tiger Brokers HK, an online trading platform for stocks&ETFs, options&futures, bonds and crypto. Open an account to enjoy low commission trading today!","keywords":"tiger trading,tiger security,tiger broker hk,tigers co ltd,tiger trade hk,tiger brokers hk,stock broker,securities broker,online brokerage,hong kong broker,hk broker,online stock trading,online trading platform,stock trading platforms,trading application,stock trading,stock trading hong kong,buying stocks in hong kong,tiger brokers","social":{"ogDescription":"Discover Tiger Brokers HK, an online trading platform for stocks&ETFs, options&futures, bonds and crypto. Open an account to enjoy low commission trading today!","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.0a0bd8dc.png","ogUrl":"https://www.gotigerhk.com/news/1197905914"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"HKG","license":"TBHK","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"1197905914\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/1197905914?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-08-11 12:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1197905914","market":"nz","top_or_hot":-1,"title":"MABWELL-B Surges Over 13% in Morning Trade After Two Denosumab Injections Pass Brazilian Regulator GMP Inspection","media":"Deep News","content":"<p><b>MABWELL-B</b> (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.<br><br>According to an official announcement from <b>MABWELL</b>, its wholly-owned subsidiary Taikang Biomedical has successfully passed the Good Manufacturing Practice (GMP) on-site inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) for two denosumab injections: 9MW0311 (a Prolia® biosimilar, domestic brand name: Mailishu®) and 9MW0321 (an Xgeva® biosimilar, domestic brand name: Maiweijian®).<br><br>This marks the second time <b>MABWELL</b> has received a GMP certificate from a regulatory authority in a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country, following its earlier success in Jordan. As a PIC/S member, Brazil's ANVISA is known for its rigorous and stringent GMP review standards, which are fully aligned with International Council for Harmonisation (ICH) and World Health Organization (WHO) international guidelines. This certification underscores that <b>MABWELL</b>'s quality management system has once again gained recognition from a high-standard overseas regulator, laying a stronger foundation for the company's products to enter more PIC/S member markets.</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>MABWELL-B Surges Over 13% in Morning Trade After Two Denosumab Injections Pass Brazilian Regulator GMP Inspection</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\">\nMABWELL-B Surges Over 13% in Morning Trade After Two Denosumab Injections Pass Brazilian Regulator GMP Inspection\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1039043262\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/8296859682db4b478146245e72de1922);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Deep News </p>\n<p class=\"h-time\">2026-08-11 12:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p><b>MABWELL-B</b> (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.<br><br>According to an official announcement from <b>MABWELL</b>, its wholly-owned subsidiary Taikang Biomedical has successfully passed the Good Manufacturing Practice (GMP) on-site inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) for two denosumab injections: 9MW0311 (a Prolia® biosimilar, domestic brand name: Mailishu®) and 9MW0321 (an Xgeva® biosimilar, domestic brand name: Maiweijian®).<br><br>This marks the second time <b>MABWELL</b> has received a GMP certificate from a regulatory authority in a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country, following its earlier success in Jordan. As a PIC/S member, Brazil's ANVISA is known for its rigorous and stringent GMP review standards, which are fully aligned with International Council for Harmonisation (ICH) and World Health Organization (WHO) international guidelines. This certification underscores that <b>MABWELL</b>'s quality management system has once again gained recognition from a high-standard overseas regulator, laying a stronger foundation for the company's products to enter more PIC/S member markets.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"","article_id":"1197905914","we_media_id":"1039043262","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1197905914","pubTimestamp":1786420827,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Deep News","introduction":"Global Stock Market Deep Analysis","home_visible":1,"id":"1039043262","head_image":"https://community-static.tradeup.com/news/8296859682db4b478146245e72de1922"},"summary":"MABWELL-B (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.According to an official announcement from MABWELL,...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"159100":"巴西","BK1161":"生物科技","02493":"迈威生物-B"},"translate_title":"两种Denosumab注射液通过巴西监管机构GMP检查后，MABWELL-B早盘飙升超过13%","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"159100":1,"02493":1},"content_text":"MABWELL-B (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.According to an official announcement from MABWELL, its wholly-owned subsidiary Taikang Biomedical has successfully passed the Good Manufacturing Practice (GMP) on-site inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) for two denosumab injections: 9MW0311 (a Prolia® biosimilar, domestic brand name: Mailishu®) and 9MW0321 (an Xgeva® biosimilar, domestic brand name: Maiweijian®).This marks the second time MABWELL has received a GMP certificate from a regulatory authority in a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country, following its earlier success in Jordan. As a PIC/S member, Brazil's ANVISA is known for its rigorous and stringent GMP review standards, which are fully aligned with International Council for Harmonisation (ICH) and World Health Organization (WHO) international guidelines. This certification underscores that MABWELL's quality management system has once again gained recognition from a high-standard overseas regulator, laying a stronger foundation for the company's products to enter more PIC/S member markets.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}