Shandong Xinhua Pharmaceutical Receives Regulatory Clearance for Clinical Trial of LXH-2103 Injection

Stock News06-22

Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration.

Shandong Xinhua (SEHK: 00719) submitted a request for a pre-clinical trial communication meeting with the Center for Drug Evaluation of the NMPA in November 2025 regarding this product. The CDE provided feedback on the submitted questions in March 2026. The company subsequently filed its clinical trial application for the injection in March 2026, which was accepted in April, leading to the formal approval notice received in June 2026. The review conclusion authorizes the commencement of clinical trials.

The LXH-2103 injection is a Class 1 innovative drug developed by Shandong Xinhua for the treatment of moderate-to-severe post-operative pain. It is a novel analgesic designed to address the variability in efficacy and safety observed with traditional opioids, such as hydrocodone, codeine, and tramadol, which is often caused by CYP2D6 gene polymorphism.

Research indicates that LXH-2103 exhibits properties of a biased μ-opioid receptor agonist. This profile is expected to allow it to bypass the impact of CYP2D6 genetic variations while offering significant potential for effective pain relief and a favorable safety advantage.

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/1183412478?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-06-22 16:42","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1183412478","market":"nz","top_or_hot":-1,"title":"Shandong Xinhua Pharmaceutical Receives Regulatory Clearance for Clinical Trial of LXH-2103 Injection","media":"Stock News","content":"<p>Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration.<br><br>\n<b>Shandong Xinhua</b> (<b>SEHK: 00719</b>) submitted a request for a pre-clinical trial communication meeting with the Center for Drug Evaluation of the NMPA in November 2025 regarding this product. The CDE provided feedback on the submitted questions in March 2026. The company subsequently filed its clinical trial application for the injection in March 2026, which was accepted in April, leading to the formal approval notice received in June 2026. The review conclusion authorizes the commencement of clinical trials.<br><br>\nThe LXH-2103 injection is a Class 1 innovative drug developed by <b>Shandong Xinhua</b> for the treatment of moderate-to-severe post-operative pain. It is a novel analgesic designed to address the variability in efficacy and safety observed with traditional opioids, such as hydrocodone, codeine, and tramadol, which is often caused by CYP2D6 gene polymorphism.<br><br>\nResearch indicates that LXH-2103 exhibits properties of a biased μ-opioid receptor agonist. This profile is expected to allow it to bypass the impact of CYP2D6 genetic variations while offering significant potential for effective pain relief and a favorable safety advantage.</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>Shandong Xinhua Pharmaceutical Receives Regulatory Clearance for Clinical Trial of LXH-2103 Injection</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\">\nShandong Xinhua Pharmaceutical Receives Regulatory Clearance for Clinical Trial of LXH-2103 Injection\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\">2026-06-22 16:42</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration.<br><br>\n<b>Shandong Xinhua</b> (<b>SEHK: 00719</b>) submitted a request for a pre-clinical trial communication meeting with the Center for Drug Evaluation of the NMPA in November 2025 regarding this product. The CDE provided feedback on the submitted questions in March 2026. The company subsequently filed its clinical trial application for the injection in March 2026, which was accepted in April, leading to the formal approval notice received in June 2026. The review conclusion authorizes the commencement of clinical trials.<br><br>\nThe LXH-2103 injection is a Class 1 innovative drug developed by <b>Shandong Xinhua</b> for the treatment of moderate-to-severe post-operative pain. It is a novel analgesic designed to address the variability in efficacy and safety observed with traditional opioids, such as hydrocodone, codeine, and tramadol, which is often caused by CYP2D6 gene polymorphism.<br><br>\nResearch indicates that LXH-2103 exhibits properties of a biased μ-opioid receptor agonist. This profile is expected to allow it to bypass the impact of CYP2D6 genetic variations while offering significant potential for effective pain relief and a favorable safety advantage.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"00719","symbol_name":"山东新华制药股份","start_time":0,"source_url":"","article_id":"1183412478","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1183412478","pubTimestamp":1782117753,"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":"Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration....","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"00719":"山东新华制药股份","BK1515":"抗疫概念","BK1191":"制药"},"translate_title":"山东新华制药获得LXH-2103注射液临床试验监管许可","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00719":1},"content_text":"Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration.\nShandong Xinhua (SEHK: 00719) submitted a request for a pre-clinical trial communication meeting with the Center for Drug Evaluation of the NMPA in November 2025 regarding this product. The CDE provided feedback on the submitted questions in March 2026. The company subsequently filed its clinical trial application for the injection in March 2026, which was accepted in April, leading to the formal approval notice received in June 2026. The review conclusion authorizes the commencement of clinical trials.\nThe LXH-2103 injection is a Class 1 innovative drug developed by Shandong Xinhua for the treatment of moderate-to-severe post-operative pain. It is a novel analgesic designed to address the variability in efficacy and safety observed with traditional opioids, such as hydrocodone, codeine, and tramadol, which is often caused by CYP2D6 gene polymorphism.\nResearch indicates that LXH-2103 exhibits properties of a biased μ-opioid receptor agonist. This profile is expected to allow it to bypass the impact of CYP2D6 genetic variations while offering significant potential for effective pain relief and a favorable safety advantage.","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":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":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,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","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/1183412478","isCrawlerRequest":true}