Shanghai Junshi Biosciences Unit Passes US FDA On-Site Inspection; Shares Slide 5%

MT Newswires Live

2025/10/23

Shanghai Junshi Biosciences (HKG:1877) said its wholly owned unit, Suzhou Union Biopharm, has passed an unannounced on-site inspection conducted by the US Food and Drug Administration, according to a Wednesday Hong Kong bourse filing.

Shares of the biopharmaceutical firm were down nearly 5% in Thursday morning trade.

The inspection, held from June 16 to June 24, reviewed compliance with current good manufacturing practice standards at Suzhou Union's Wujiang production base, which manufactures the company's toripalimab injection.

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"澳洲华人首选美澳港股一站式交易平台 | 老虎证券","description":"澳、美、港、A股、ETF、期权一站式在线交易，超低佣金，新手也能轻松开启投资。在老虎证券， 1 美元起投资美股，24/5 无时差交易美股，澳大利亚华人信赖的在线炒股平台。","keywords":"老虎证券,老虎证券澳洲,老虎证券股票,老虎证券开户,老虎证券app,tigertrade老虎证券,股票,asx美股,炒股,券商,澳洲股票交易,澳大利亚炒股","social":{"ogDescription":"澳、美、港、A股、ETF、期权一站式在线交易，超低佣金，新手也能轻松开启投资。在老虎证券， 1 美元起投资美股，24/5 无时差交易美股，澳大利亚华人信赖的在线炒股平台。","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2577294328"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"AUS","license":"TBAU","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2577294328\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2577294328?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-10-23 11:35","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2577294328","market":"sg","top_or_hot":-1,"title":"Shanghai Junshi Biosciences Unit Passes US FDA On-Site Inspection; Shares Slide 5%","media":"MT Newswires Live","content":"<html><body><p> <a href=\"https://laohu8.com/S/SHJBF\">Shanghai Junshi Biosciences</a> (HKG:1877) said its wholly owned unit, Suzhou Union Biopharm, has passed an unannounced on-site inspection conducted by the US Food and Drug Administration, according to a Wednesday Hong Kong bourse filing.</p><p>Shares of the biopharmaceutical firm were down nearly 5% in Thursday morning trade.</p><p>The inspection, held from June 16 to June 24, reviewed compliance with current good manufacturing practice standards at Suzhou Union's Wujiang production base, which manufactures the company's toripalimab injection.</p></body></html>","source":"mtnewswires_news","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>Shanghai Junshi Biosciences Unit Passes US FDA On-Site Inspection; Shares Slide 5%</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: 12.5px; color: #7E829C; margin: 0;}\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\">\nShanghai Junshi Biosciences Unit Passes US FDA On-Site Inspection; Shares Slide 5%\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time smaller\">2025-10-23 11:35</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html><body><p> <a href=\"https://laohu8.com/S/SHJBF\">Shanghai Junshi Biosciences</a> (HKG:1877) said its wholly owned unit, Suzhou Union Biopharm, has passed an unannounced on-site inspection conducted by the US Food and Drug Administration, according to a Wednesday Hong Kong bourse filing.</p><p>Shares of the biopharmaceutical firm were down nearly 5% in Thursday morning trade.</p><p>The inspection, held from June 16 to June 24, reviewed compliance with current good manufacturing practice standards at Suzhou Union's Wujiang production base, which manufactures the company's toripalimab injection.</p></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1161","symbol_name":"生物科技","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2577294328","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2577294328","pubTimestamp":1761190539,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Shanghai Junshi Biosciences  said its wholly owned unit, Suzhou Union Biopharm, has passed an unannounced on-site inspection conducted by the US Food and Drug Administration, according to a Wednesday Hong Kong bourse filing.Shares of the biopharmaceutical firm were down nearly 5% in Thursday morning trade.The inspection, held from June 16 to June 24, reviewed compliance with current good manufacturing practice standards at Suzhou Union's Wujiang production base, which manufactures the company's toripalimab injection.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1161":"生物科技","BK1583":"高瓴概念","BK1515":"抗疫概念","01877":"君实生物"},"translate_title":"上海君实生物子公司通过美国FDA现场检查；股价下跌5%","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01877":1},"content_text":"Shanghai Junshi Biosciences (HKG:1877) said its wholly owned unit, Suzhou Union Biopharm, has passed an unannounced on-site inspection conducted by the US Food and Drug Administration, according to a Wednesday Hong Kong bourse filing.Shares of the biopharmaceutical firm were down nearly 5% in Thursday morning trade.The inspection, held from June 16 to June 24, reviewed compliance with current good manufacturing practice standards at Suzhou Union's Wujiang production base, which manufactures the company's toripalimab injection.","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}