FDA Grants Fast Track Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma

Reuters01-28

FDA Grants <a href="https://laohu8.com/S/FTRK">Fast Track</a> Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma

Nanjing Leads Biolabs Co. Ltd. announced that its investigational drug LBL-034, a GPRC5D/CD3 bispecific T-cell engager, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma. The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that address unmet medical needs for serious or life-threatening conditions. The designation provides benefits such as more frequent interactions with the FDA and the possibility of priority and rolling review of marketing applications. No other beneficiary organizations were mentioned in the announcement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nanjing Leads Biolabs Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260128-12002968), on January 28, 2026, and is solely responsible for the information contained therein.

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/2606399754?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-01-28 08:22","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2606399754","market":"fut","top_or_hot":-1,"title":"FDA Grants Fast Track Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Grants <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Nanjing Leads Biolabs Co. Ltd. announced that its investigational drug LBL-034, a GPRC5D/CD3 bispecific T-cell engager, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma. The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that address unmet medical needs for serious or life-threatening conditions. The designation provides benefits such as more frequent interactions with the FDA and the possibility of priority and rolling review of marketing applications. No other beneficiary organizations were mentioned in the announcement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nanjing Leads Biolabs Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260128-12002968), on January 28, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>","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>FDA Grants Fast Track Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma</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\">\nFDA Grants Fast Track Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-01-28 08:22</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Grants <a href=\"https://laohu8.com/S/FTRK\">Fast Track</a> Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Nanjing Leads Biolabs Co. Ltd. announced that its investigational drug LBL-034, a GPRC5D/CD3 bispecific T-cell engager, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma. The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that address unmet medical needs for serious or life-threatening conditions. The designation provides benefits such as more frequent interactions with the FDA and the possibility of priority and rolling review of marketing applications. No other beneficiary organizations were mentioned in the announcement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nanjing Leads Biolabs Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260128-12002968), on January 28, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"HK0000252160.HKD","symbol_name":"易方达 (香港) 中国股票股息基金A 类 (分派) 港元","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260128:nNDL7XdZJg:1","article_id":"2606399754","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2606399754","pubTimestamp":1769559757,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nanjing Leads Biolabs Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange  , on January 28, 2026, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"HK0000252160.HKD":"易方达 (香港) 中国股票股息基金A 类 (分派) 港元","HK0000500386.USD":"易方达 (香港) 中国股票股息基金A 类 (累积) 美元","BK1161":"生物科技","09887":"维立志博-B","HK0000252152.HKD":"易方达 (香港) 中国股票股息基金A 类 (累积) 港元"},"translate_title":"FDA授予南京先导生物实验室的LBL-034治疗复发/难治性多发性骨髓瘤快速通道资格","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09887":0.9},"content_text":"FDA Grants Fast Track Designation to Nanjing Leads Biolabs' LBL-034 for Relapsed/Refractory Multiple Myeloma\n    \n\n        Nanjing Leads Biolabs Co. Ltd. announced that its investigational drug LBL-034, a GPRC5D/CD3 bispecific T-cell engager, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma. The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that address unmet medical needs for serious or life-threatening conditions. The designation provides benefits such as more frequent interactions with the FDA and the possibility of priority and rolling review of marketing applications. No other beneficiary organizations were mentioned in the announcement.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nanjing Leads Biolabs Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260128-12002968), on January 28, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"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":"4.36.2","shortVersion":"4.36.2","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/2606399754","isCrawlerRequest":true}