Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) Subsidiary Receives Clinical Trial Approval Notice

Stock News08-22

Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. received a Study May Proceed Letter (SMP) from the U.S. Food and Drug Administration (FDA) for 225Ac-LNC1011 injection, with Phase I clinical trials set to commence in the near future. The FDA has completed its safety review of the 225Ac-LNC1011 injection application and determined that the proposed prostate cancer clinical study may proceed. According to U.S. drug registration legal and regulatory requirements, 225Ac-LNC1011 injection must still undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States.

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/1102185198?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-08-22 11:56","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1102185198","market":"other","top_or_hot":-1,"title":"Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) Subsidiary Receives Clinical Trial Approval Notice","media":"Stock News","content":"<p>Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. received a Study May Proceed Letter (SMP) from the U.S. Food and Drug Administration (FDA) for 225Ac-LNC1011 injection, with Phase I clinical trials set to commence in the near future. The FDA has completed its safety review of the 225Ac-LNC1011 injection application and determined that the proposed prostate cancer clinical study may proceed. According to U.S. drug registration legal and regulatory requirements, 225Ac-LNC1011 injection must still undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States.</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>Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) Subsidiary Receives Clinical Trial Approval Notice</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\">\nYantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) Subsidiary Receives Clinical Trial Approval Notice\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\">2025-08-22 11:56</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. received a Study May Proceed Letter (SMP) from the U.S. Food and Drug Administration (FDA) for 225Ac-LNC1011 injection, with Phase I clinical trials set to commence in the near future. The FDA has completed its safety review of the 225Ac-LNC1011 injection application and determined that the proposed prostate cancer clinical study may proceed. According to U.S. drug registration legal and regulatory requirements, 225Ac-LNC1011 injection must still undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"002675","symbol_name":"东诚药业","start_time":0,"source_url":"","article_id":"1102185198","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1102185198","pubTimestamp":1755834991,"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":"Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. received a Study May Proceed Letter (SMP) from the U.S. Food and Drug...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"002675":"东诚药业","BK0239":"医药制造"},"translate_title":"烟台东诚生物化工有限公司。(002675.SZ)子公司收到临床试验批准通知书","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"002675":1},"content_text":"Yantai Dongcheng Biochemicals Co.,Ltd. (002675.SZ) announced that on August 22, 2025, its subsidiary LNC PHARMA PTE. LTD. received a Study May Proceed Letter (SMP) from the U.S. Food and Drug Administration (FDA) for 225Ac-LNC1011 injection, with Phase I clinical trials set to commence in the near future. The FDA has completed its safety review of the 225Ac-LNC1011 injection application and determined that the proposed prostate cancer clinical study may proceed. According to U.S. drug registration legal and regulatory requirements, 225Ac-LNC1011 injection must still undergo clinical trials and receive FDA review and approval before it can be marketed and sold in the United States.","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":"","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/1102185198","isCrawlerRequest":true}