CLOUDBREAK-B (02592) Voluntarily Withdraws China IND for CBT-009; Other Core Pipelines Stay on Track

Bulletin Express03-19

Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating juvenile myopia.

The decision follows China’s recent approval of a comparable product and subsequent discussions with the Center for Drug Evaluation (CDE) indicating divergent regional regulatory requirements, which would complicate inclusion of China in a multi-regional Phase 3 trial. Management stated that reallocating resources and mitigating development risk underpin the withdrawal.

Cloudbreak will maintain investment in its semi-fluorinated alkane (SFA+) platform and intends to reassess CBT-009’s clinical strategy. Options include additional supplementary studies, protocol adjustments, pre-submission consultations with the CDE, or a future resubmission of the IND.

Pipeline Status • CBT-004 and CBT-199: Research and development activities, including IND preparations, remain on schedule. • CBT-001: The Phase 3 multi-regional clinical trial (MRCT) is expected to complete in 3Q 2026.

The company reiterated that there is no guarantee of ultimate approval or commercialisation for CBT-009 or any other core product. Shareholders and potential investors are advised to exercise caution 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/1199098192?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-03-19 19:22","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1199098192","market":"us","top_or_hot":-1,"title":"CLOUDBREAK-B (02592) Voluntarily Withdraws China IND for CBT-009; Other Core Pipelines Stay on Track","media":"Bulletin Express","content":"<p>Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating juvenile myopia.</p>\n<p>The decision follows China’s recent approval of a comparable product and subsequent discussions with the Center for Drug Evaluation (CDE) indicating divergent regional regulatory requirements, which would complicate inclusion of China in a multi-regional Phase 3 trial. Management stated that reallocating resources and mitigating development risk underpin the withdrawal.</p>\n<p>Cloudbreak will maintain investment in its semi-fluorinated alkane (SFA+) platform and intends to reassess CBT-009’s clinical strategy. Options include additional supplementary studies, protocol adjustments, pre-submission consultations with the CDE, or a future resubmission of the IND.</p>\n<p>Pipeline Status  \n• CBT-004 and CBT-199: Research and development activities, including IND preparations, remain on schedule.  \n• CBT-001: The Phase 3 multi-regional clinical trial (MRCT) is expected to complete in 3Q 2026.</p>\n<p>The company reiterated that there is no guarantee of ultimate approval or commercialisation for CBT-009 or any other core product. Shareholders and potential investors are advised to exercise caution 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>CLOUDBREAK-B (02592) Voluntarily Withdraws China IND for CBT-009; Other Core Pipelines Stay on Track</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\">\nCLOUDBREAK-B (02592) Voluntarily Withdraws China IND for CBT-009; Other Core Pipelines Stay on Track\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\">2026-03-19 19:22</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating juvenile myopia.</p>\n<p>The decision follows China’s recent approval of a comparable product and subsequent discussions with the Center for Drug Evaluation (CDE) indicating divergent regional regulatory requirements, which would complicate inclusion of China in a multi-regional Phase 3 trial. Management stated that reallocating resources and mitigating development risk underpin the withdrawal.</p>\n<p>Cloudbreak will maintain investment in its semi-fluorinated alkane (SFA+) platform and intends to reassess CBT-009’s clinical strategy. Options include additional supplementary studies, protocol adjustments, pre-submission consultations with the CDE, or a future resubmission of the IND.</p>\n<p>Pipeline Status  \n• CBT-004 and CBT-199: Research and development activities, including IND preparations, remain on schedule.  \n• CBT-001: The Phase 3 multi-regional clinical trial (MRCT) is expected to complete in 3Q 2026.</p>\n<p>The company reiterated that there is no guarantee of ultimate approval or commercialisation for CBT-009 or any other core product. Shareholders and potential investors are advised to exercise caution 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":"02592","symbol_name":"拨康视云-B","start_time":0,"source_url":"","article_id":"1199098192","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1199098192","pubTimestamp":1773919373,"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":"Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02592":"拨康视云-B"},"translate_title":"CLOUDBREAK-B(02592)主动撤回CBT-009的中国IND；其他核心管道仍按计划进行","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02592":1},"content_text":"Cloudbreak Pharma Inc. (CLOUDBREAK-B, 02592) has voluntarily withdrawn its Investigational New Drug (IND) application in China for CBT-009, an SFA+ atropine ophthalmic emulsion aimed at treating juvenile myopia.\nThe decision follows China’s recent approval of a comparable product and subsequent discussions with the Center for Drug Evaluation (CDE) indicating divergent regional regulatory requirements, which would complicate inclusion of China in a multi-regional Phase 3 trial. Management stated that reallocating resources and mitigating development risk underpin the withdrawal.\nCloudbreak will maintain investment in its semi-fluorinated alkane (SFA+) platform and intends to reassess CBT-009’s clinical strategy. Options include additional supplementary studies, protocol adjustments, pre-submission consultations with the CDE, or a future resubmission of the IND.\nPipeline Status  \n• CBT-004 and CBT-199: Research and development activities, including IND preparations, remain on schedule.  \n• CBT-001: The Phase 3 multi-regional clinical trial (MRCT) is expected to complete in 3Q 2026.\nThe company reiterated that there is no guarantee of ultimate approval or commercialisation for CBT-009 or any other core product. Shareholders and potential investors are advised to exercise caution 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":"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":"4.39.0","shortVersion":"4.39.0","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/1199098192","isCrawlerRequest":true}