CSPC Pharma (01093) Obtains U.S. FDA Approval for Clinical Trials of Highly Selective PDE4B Inhibitor

Bulletin Express03-06

CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration approval to commence clinical trials in the United States. The product, a novel and highly selective phosphodiesterase 4B (PDE4B) inhibitor, has demonstrated in preclinical studies the ability to increase pulmonary drug concentrations and reduce systemic exposure, thereby lowering gastrointestinal side effects. Animal models have also shown efficacy that surpasses existing drugs, supported by favorable pharmacokinetic properties and a broad safety margin.

The approved clinical indication targets pulmonary fibrosis, specifically idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These conditions currently have limited treatment options available on the market. The approval showcases CSPC Pharma’s high-end innovative inhalation technology platform and establishes a foundation for further development of subsequent inhalation formulations in the company’s pipeline.

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/1137757729?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-03-06 19:42","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1137757729","market":"us","top_or_hot":-1,"title":"CSPC Pharma (01093) Obtains U.S. FDA Approval for Clinical Trials of Highly Selective PDE4B Inhibitor","media":"Bulletin Express","content":"<p>CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration approval to commence clinical trials in the United States. The product, a novel and highly selective phosphodiesterase 4B (PDE4B) inhibitor, has demonstrated in preclinical studies the ability to increase pulmonary drug concentrations and reduce systemic exposure, thereby lowering gastrointestinal side effects. Animal models have also shown efficacy that surpasses existing drugs, supported by favorable pharmacokinetic properties and a broad safety margin.</p>\n<p>The approved clinical indication targets pulmonary fibrosis, specifically idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These conditions currently have limited treatment options available on the market. The approval showcases CSPC Pharma’s high-end innovative inhalation technology platform and establishes a foundation for further development of subsequent inhalation formulations in the company’s pipeline.</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>CSPC Pharma (01093) Obtains U.S. FDA Approval for Clinical Trials of Highly Selective PDE4B Inhibitor</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\">\nCSPC Pharma (01093) Obtains U.S. FDA Approval for Clinical Trials of Highly Selective PDE4B Inhibitor\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\">2026-03-06 19:42</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration approval to commence clinical trials in the United States. The product, a novel and highly selective phosphodiesterase 4B (PDE4B) inhibitor, has demonstrated in preclinical studies the ability to increase pulmonary drug concentrations and reduce systemic exposure, thereby lowering gastrointestinal side effects. Animal models have also shown efficacy that surpasses existing drugs, supported by favorable pharmacokinetic properties and a broad safety margin.</p>\n<p>The approved clinical indication targets pulmonary fibrosis, specifically idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These conditions currently have limited treatment options available on the market. The approval showcases CSPC Pharma’s high-end innovative inhalation technology platform and establishes a foundation for further development of subsequent inhalation formulations in the company’s pipeline.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"01093","symbol_name":"石药集团","start_time":0,"source_url":"","article_id":"1137757729","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1137757729","pubTimestamp":1772797372,"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":"CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"01093":"石药集团"},"translate_title":"石药集团(01093)高选择性PDE4B抑制剂获美国FDA临床试验批件","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":1},"content_text":"CSPC Pharmaceutical Group Limited (CSPC Pharma, 01093) announced that SYH2059 powder for inhalation, categorized as a new Class 1 chemical drug, has received U.S. Food and Drug Administration approval to commence clinical trials in the United States. The product, a novel and highly selective phosphodiesterase 4B (PDE4B) inhibitor, has demonstrated in preclinical studies the ability to increase pulmonary drug concentrations and reduce systemic exposure, thereby lowering gastrointestinal side effects. Animal models have also shown efficacy that surpasses existing drugs, supported by favorable pharmacokinetic properties and a broad safety margin.\nThe approved clinical indication targets pulmonary fibrosis, specifically idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These conditions currently have limited treatment options available on the market. The approval showcases CSPC Pharma’s high-end innovative inhalation technology platform and establishes a foundation for further development of subsequent inhalation formulations in the company’s pipeline.","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":"dataReport,SGX","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/1137757729","isCrawlerRequest":true}