Henlius Gains NMPA Green Light for Phase 1 Trials of Subcutaneous Pertuzumab-Trastuzumab Biosimilar HLX319

Bulletin Express04-01

Shanghai Henlius Biotech, Inc. (Henlius; 02696) announced that China’s National Medical Products Administration has approved investigational new drug (IND) applications for Phase 1 clinical trials of HLX319, a subcutaneous fixed-dose combination biosimilar of pertuzumab and trastuzumab. The company plans to initiate the trial on the Chinese mainland once operational requirements are met.

HLX319 integrates trastuzumab, pertuzumab and the company’s proprietary recombinant human hyaluronidase (HLXTE-HAase02). The product is being developed for adjuvant and neoadjuvant therapy in early-stage HER2-positive breast cancer as well as for metastatic disease. Preclinical pharmacodynamic, pharmacokinetic and toxicology studies showed high similarity between HLX319 and the reference pertuzumab-trastuzumab subcutaneous formulation, in line with guidance from Chinese, U.S. and EU regulators.

Market data from IQVIA MIDAS indicate that global sales of the reference subcutaneous pertuzumab-trastuzumab combination reached USD3.02 billion in 2025, underscoring the commercial potential if development and registration are successfully completed.

Henlius cautioned that successful development and commercialization of HLX319 remain subject to clinical outcomes and regulatory review, and advised shareholders and potential investors to exercise prudence when dealing in the company’s shares.

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/1159443052?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-04-01 17:08","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1159443052","market":"hk","top_or_hot":-1,"title":"Henlius Gains NMPA Green Light for Phase 1 Trials of Subcutaneous Pertuzumab-Trastuzumab Biosimilar HLX319","media":"Bulletin Express","content":"<p>Shanghai Henlius Biotech, Inc. (Henlius; 02696) announced that China’s National Medical Products Administration has approved investigational new drug (IND) applications for Phase 1 clinical trials of HLX319, a subcutaneous fixed-dose combination biosimilar of pertuzumab and trastuzumab. The company plans to initiate the trial on the Chinese mainland once operational requirements are met.</p>\n<p>HLX319 integrates trastuzumab, pertuzumab and the company’s proprietary recombinant human hyaluronidase (HLXTE-HAase02). The product is being developed for adjuvant and neoadjuvant therapy in early-stage HER2-positive breast cancer as well as for metastatic disease. Preclinical pharmacodynamic, pharmacokinetic and toxicology studies showed high similarity between HLX319 and the reference pertuzumab-trastuzumab subcutaneous formulation, in line with guidance from Chinese, U.S. and EU regulators.</p>\n<p>Market data from IQVIA MIDAS indicate that global sales of the reference subcutaneous pertuzumab-trastuzumab combination reached USD3.02 billion in 2025, underscoring the commercial potential if development and registration are successfully completed.</p>\n<p>Henlius cautioned that successful development and commercialization of HLX319 remain subject to clinical outcomes and regulatory review, and advised shareholders and potential investors to exercise prudence when dealing in the company’s shares.</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>Henlius Gains NMPA Green Light for Phase 1 Trials of Subcutaneous Pertuzumab-Trastuzumab Biosimilar HLX319</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\">\nHenlius Gains NMPA Green Light for Phase 1 Trials of Subcutaneous Pertuzumab-Trastuzumab Biosimilar HLX319\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\">2026-04-01 17:08</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Shanghai Henlius Biotech, Inc. (Henlius; 02696) announced that China’s National Medical Products Administration has approved investigational new drug (IND) applications for Phase 1 clinical trials of HLX319, a subcutaneous fixed-dose combination biosimilar of pertuzumab and trastuzumab. The company plans to initiate the trial on the Chinese mainland once operational requirements are met.</p>\n<p>HLX319 integrates trastuzumab, pertuzumab and the company’s proprietary recombinant human hyaluronidase (HLXTE-HAase02). The product is being developed for adjuvant and neoadjuvant therapy in early-stage HER2-positive breast cancer as well as for metastatic disease. Preclinical pharmacodynamic, pharmacokinetic and toxicology studies showed high similarity between HLX319 and the reference pertuzumab-trastuzumab subcutaneous formulation, in line with guidance from Chinese, U.S. and EU regulators.</p>\n<p>Market data from IQVIA MIDAS indicate that global sales of the reference subcutaneous pertuzumab-trastuzumab combination reached USD3.02 billion in 2025, underscoring the commercial potential if development and registration are successfully completed.</p>\n<p>Henlius cautioned that successful development and commercialization of HLX319 remain subject to clinical outcomes and regulatory review, and advised shareholders and potential investors to exercise prudence when dealing in the company’s shares.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"02696","symbol_name":"复宏汉霖","start_time":0,"source_url":"","article_id":"1159443052","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1159443052","pubTimestamp":1775034490,"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 Henlius Biotech, Inc. (Henlius; 02696) announced that China’s National Medical Products Administration has approved investigational new drug (IND) applications for Phase 1 clinical trials of...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02696":"复宏汉霖"},"translate_title":"复宏汉霖获得NMPA批准皮下注射帕妥珠单抗-曲妥珠单抗生物类似药HLX319的1期试验","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02696":1},"content_text":"Shanghai Henlius Biotech, Inc. (Henlius; 02696) announced that China’s National Medical Products Administration has approved investigational new drug (IND) applications for Phase 1 clinical trials of HLX319, a subcutaneous fixed-dose combination biosimilar of pertuzumab and trastuzumab. The company plans to initiate the trial on the Chinese mainland once operational requirements are met.\nHLX319 integrates trastuzumab, pertuzumab and the company’s proprietary recombinant human hyaluronidase (HLXTE-HAase02). The product is being developed for adjuvant and neoadjuvant therapy in early-stage HER2-positive breast cancer as well as for metastatic disease. Preclinical pharmacodynamic, pharmacokinetic and toxicology studies showed high similarity between HLX319 and the reference pertuzumab-trastuzumab subcutaneous formulation, in line with guidance from Chinese, U.S. and EU regulators.\nMarket data from IQVIA MIDAS indicate that global sales of the reference subcutaneous pertuzumab-trastuzumab combination reached USD3.02 billion in 2025, underscoring the commercial potential if development and registration are successfully completed.\nHenlius cautioned that successful development and commercialization of HLX319 remain subject to clinical outcomes and regulatory review, and advised shareholders and potential investors to exercise prudence when dealing in the company’s shares.","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,SGX","news_rank":0,"isVideo":false,"video":null,"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":"4.40.0","shortVersion":"4.40.0","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/1159443052","isCrawlerRequest":true}