科济药业-B(02171)：首批临床批次从北卡罗来纳州的RTP GMP生产工厂放行

智通财经2022-09-01

智通财经APP讯，科济药业-B(02171)发布公告，该公司位于美国北卡罗来纳州的三角研究园(RTP)区域符合现行药品生产质量管理规范(CGMP)的生产工厂(RTP GMP生产工厂)已经开始了自体CAR-T细胞产品的 GMP生产，并成功放行了首批用于临床试验的 GMP批次。RTP GMP生产工厂，总建筑面积约为3300平方米，将为科济药业提供每年为700名患者生产自体CAR-T细胞产品的额外产能，...

网页链接

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

我们需要你的真知灼见来填补这片空白

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/2264985202?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2022-09-01 18:04","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2264985202","market":"hk","top_or_hot":-1,"title":"科济药业-B(02171)：首批临床批次从北卡罗来纳州的RTP GMP生产工厂放行","media":"智通财经","content":"<div>\n<p>智通财经APP讯，科济药业-B(02171)发布公告，该公司位于美国北卡罗来纳州的三角研究园(RTP)区域符合现行药品生产质量管理规范(CGMP)的生产工厂(RTP GMP生产工厂)已经开始了自体CAR-T细胞产品的 GMP生产，并成功放行了首批用于临床试验的 GMP批次。RTP GMP生产工厂，总建筑面积约为3300平方米，将为科济药业提供每年为700名患者生产自体CAR-T细胞产品的额外产能，...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/786259.html\">网页链接</a>\n\n</div>\n","source":"stock_zhitongcaijing","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>科济药业-B(02171)：首批临床批次从北卡罗来纳州的RTP GMP生产工厂放行</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\">\n科济药业-B(02171)：首批临床批次从北卡罗来纳州的RTP GMP生产工厂放行\n</h2>\n\n<h4 class=\"meta\">\n\n\n2022-09-01 18:04 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/786259.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，科济药业-B(02171)发布公告，该公司位于美国北卡罗来纳州的三角研究园(RTP)区域符合现行药品生产质量管理规范(CGMP)的生产工厂(RTP GMP生产工厂)已经开始了自体CAR-T细胞产品的 GMP生产，并成功放行了首批用于临床试验的 GMP批次。RTP GMP生产工厂，总建筑面积约为3300平方米，将为科济药业提供每年为700名患者生产自体CAR-T细胞产品的额外产能，...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/786259.html\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1585","symbol_name":"昨日强势股","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/786259.html","article_id":"2264985202","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2264985202","pubTimestamp":1662026657,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，科济药业-B 发布公告，该公司位于美国北卡罗来纳州的三角研究园区域符合现行药品生产质量管理规范的生产工厂已经开始了自体CAR-T细胞产品的 GMP生产，并成功放行了首批用于临床试验的 GMP批次。成功放行首例在RTP GMP生产工厂生产的用于美国患者的产品对于科济药业而言是一个重大里程碑。在RTP GMP生产工厂开始临床生产将大大降低目前全球供应链短缺的风险并且增强科济药业的价值链。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK1585":"昨日强势股","BK1161":"生物科技","BK1574":"生物医药B类股","02171":"科济药业-B","BK1587":"次新股"},"translate_title":"Keji Pharmaceutical-B (02171): The first clinical batches were released from the RTP GMP production plant in North Carolina","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02171":1,"RTP":1},"content_text":"智通财经APP讯，科济药业-B(02171)发布公告，该公司位于美国北卡罗来纳州的三角研究园(RTP)区域符合现行药品生产质量管理规范(CGMP)的生产工厂(RTP GMP生产工厂)已经开始了自体CAR-T细胞产品的 GMP生产，并成功放行了首批用于临床试验的 GMP批次。RTP GMP生产工厂，总建筑面积约为3300平方米，将为科济药业提供每年为700名患者生产自体CAR-T细胞产品的额外产能，用于支援在北美和欧洲的临床研究和早期商业化。除在中国正在进行的数项临床研究外，该公司还有两项获得了美国FDA和加拿大卫生部批准的IND试验正在进行中，包括CT053用于治疗复发/难治多发性骨髓瘤的关键2期临床试验和CT041用于治疗晚期胃癌和胰腺癌的1b期临床试验。科济药业正在快速扩展在美国的自主生产和质量测试能力。该公司将加速推进临床研究为全球患者提供更多有前景的CAR-T细胞产品。成功放行首例在RTP GMP生产工厂生产的用于美国患者的产品对于科济药业而言是一个重大里程碑。通过利用科济药业垂直一体化生产优势，我们的世界级CMC团队高效完成了从中国生产工厂的全球技术转移，以有效推进临床生产。在RTP GMP生产工厂开始临床生产将大大降低目前全球供应链短缺的风险并且增强科济药业的价值链。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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":false,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"laohu8","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/2264985202"}