Chinese Regulator Accepts NDA for Sino Biopharm's Breast Cancer Drug

MT Newswires Live

Yesterday

Sino Biopharmaceutical (HKG:1177) said China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.

The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.

TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.

The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments for

the company.

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

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.0a0bd8dc.png","ogUrl":"https://sg.tigerfiesta.com/news/2667675725"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2667675725\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2667675725?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-09-16 09:35","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2667675725","market":"sg","top_or_hot":-1,"title":"Chinese Regulator Accepts NDA for Sino Biopharm's Breast Cancer Drug","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/SBHMY\">Sino Biopharmaceutical</a> (HKG:1177) said China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.</p><p>The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.</p><p>TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.</p><p>The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments for</p><p>the company.</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>Chinese Regulator Accepts NDA for Sino Biopharm's Breast Cancer Drug</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\">\nChinese Regulator Accepts NDA for Sino Biopharm's Breast Cancer Drug\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2026-09-16 09:35</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/SBHMY\">Sino Biopharmaceutical</a> (HKG:1177) said China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.</p><p>The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.</p><p>TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.</p><p>The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments for</p><p>the company.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SIL","symbol_name":"Silver Miners Etf","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2667675725","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2667675725","pubTimestamp":1789522517,"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":"Sino Biopharmaceutical  said China's Center for Drug Evaluation  has officially accepted the New Drug Application  for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments forthe company.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"SIL":"Silver Miners Etf","BK4017":"黄金","LU1223082519.USD":"SCHRODER ISF GLOBAL GOLD \"A\" (USD) INC AV","BK1191":"制药","SGDM":"Sprott Gold Miners ETF","LU1223083913.SGD":"Schroder ISF Global Gold A Acc SGD-H","CDE":"科尔黛伦矿业","BK7050":"调查和咨询服务","HK0000165453.HKD":"华夏精选大中华科技基金 A类港币","LU1223082196.USD":"施罗德环球黄金A Acc","BK1515":"抗疫概念","CDE.AU":"Codeifai Limited","XME":"金属与采矿指数ETF-SPDR","BK1521":"挪威政府全球养老基金持仓","IE00BZ08YR35.GBP":"GUINNESS BEST OF CHINA \"C\" (GBP) ACC","01177":"中国生物制药","IE00BZ08YS42.EUR":"GUINNESS BEST OF CHINA \"C\" (EUR) ACC","GDXJ":"小型黄金矿业ETF(Market Vectors)","IE00BZ08YT58.USD":"GUINNESS BEST OF CHINA \"C\" (USD) ACC","BK1589":"北水核心资产"},"translate_title":"中国监管机构接受中国生物制药乳腺癌药物NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CDE":1,"01177":1,"SGDM":0.6,"XME":0.6,"SIL":0.6,"CDE.AU":1,"GDXJ":0.6},"content_text":"Sino Biopharmaceutical (HKG:1177) said China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments forthe company.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}