石药集团(01093)：注射用西罗莫司(白蛋白结合型)于中国获突破性治疗认定

智通财经2025-02-28

智通财经APP讯，石药集团(01093)发布公告，集团开发的注射用西罗莫司(白蛋白结合型)获中华人民共和国国家药品监督管理局授予突破性治疗认定，拟定适应症为单药用于恶性血管周围上皮样细胞瘤(PEComa)。西罗莫司又称为雷帕霉素，是一种常用的特异性mTOR抑制剂。此前已有口服制剂的西罗莫司获批上市，主要适用于预防接受肾移植患者的器官排斥。该产品采用特殊技术将西罗莫司包裹于人血白蛋白中，克服口服制剂...

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/2514349325?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-02-28 18:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2514349325","market":"us","top_or_hot":-1,"title":"石药集团(01093)：注射用西罗莫司(白蛋白结合型)于中国获突破性治疗认定","media":"智通财经","content":"<div>\n<p>智通财经APP讯，石药集团(01093)发布公告，集团开发的注射用西罗莫司(白蛋白结合型)获中华人民共和国国家药品监督管理局授予突破性治疗认定，拟定适应症为单药用于恶性血管周围上皮样细胞瘤(PEComa)。西罗莫司又称为雷帕霉素，是一种常用的特异性mTOR抑制剂。此前已有口服制剂的西罗莫司获批上市，主要适用于预防接受肾移植患者的器官排斥。该产品采用特殊技术将西罗莫司包裹于人血白蛋白中，克服口服制剂...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1256254.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>石药集团(01093)：注射用西罗莫司(白蛋白结合型)于中国获突破性治疗认定</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石药集团(01093)：注射用西罗莫司(白蛋白结合型)于中国获突破性治疗认定\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-02-28 18:00 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1256254.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，石药集团(01093)发布公告，集团开发的注射用西罗莫司(白蛋白结合型)获中华人民共和国国家药品监督管理局授予突破性治疗认定，拟定适应症为单药用于恶性血管周围上皮样细胞瘤(PEComa)。西罗莫司又称为雷帕霉素，是一种常用的特异性mTOR抑制剂。此前已有口服制剂的西罗莫司获批上市，主要适用于预防接受肾移植患者的器官排斥。该产品采用特殊技术将西罗莫司包裹于人血白蛋白中，克服口服制剂...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1256254.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":"LU1226288253.USD","symbol_name":"UBS (LUX) KEY SELECTION SICAV - CHINA ALLOCATION  OPPORTUNITY (USD) \"P\" (USD) INC","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1256254.html","article_id":"2514349325","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2514349325","pubTimestamp":1740736805,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，石药集团 发布公告，集团开发的注射用西罗莫司获中华人民共和国国家药品监督管理局授予突破性治疗认定，拟定适应症为单药用于恶性血管周围上皮样细胞瘤。此前已有口服制剂的西罗莫司获批上市，主要适用于预防接受肾移植患者的器官排斥。同时，该产品拓展了西罗莫司的应用领域，有望实现治疗mTOR信号通路驱动的一系列疾病。恶性PEComa国内尚无标准治疗，存在未被满足的临床需求。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU1226288253.USD":"UBS (LUX) KEY SELECTION SICAV - CHINA ALLOCATION  OPPORTUNITY (USD) \"P\" (USD) INC","BK1515":"抗疫概念","LU1951186391.HKD":"UBS (LUX) KEY SEL CHINA ALLOCATION OPPORTUNITY (US \"P\" (HKD) INC","IE0008368742.USD":"首域中国增长基金I Acc","IE0008369823.USD":"FSSA HONG KONG GROWTH \"I\" ACC","LU0326950275.SGD":"Schroder ISF China Opportunities A Acc SGD-H","LU1152091168.USD":"UBS (LUX) EQUITY FUND - CHINA OPPORTUNITY (USD) \"PM\" INC","LU1993786604.SGD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (SGD) ACC","LU1807302812.USD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (USD) ACC","LU1960683339.HKD":"UBS (LUX) EQUITY SICAV ALL CHINA \"P\" (HKD) ACC","LU1226287792.SGD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"P\" (SGDHDG) INC","BK1521":"挪威政府全球养老基金持仓","IE00BZ08YR35.GBP":"GUINNESS BEST OF CHINA \"C\" (GBP) ACC","LU0501845795.SGD":"瑞银大中华区股票基金P Acc SGD","01093":"石药集团","LU0067412154.USD":"UBS (LUX) EQUITY FUND -  CHINA OPPORTUNITY \"P\" (USD) ACC","IE00BZ08YS42.EUR":"GUINNESS BEST OF CHINA \"C\" (EUR) ACC","LU0140636845.USD":"施罗德大中华区股票A Acc","LU1152091754.HKD":"UBS (LUX) EQUITY FUND - CHINA OPPORTUNITY (USD) \"PM\" (HKD) INC","IE00BZ08YT58.USD":"GUINNESS BEST OF CHINA \"C\" (USD) ACC","SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","LU1008478684.HKD":"UBS (LUX) EQUITY FUND -  CHINA OPPORTUNITY \"P\" (HKD) ACC","LU0072913022.USD":"UBS (LUX) EQUITY FUND -  GREATER CHINA \"P\" (USD) ACC","IE00B031HY20.USD":"FSSA CHINA GROWTH \"I\" (USD) INC","IE00B543WZ88.USD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (USD) ACC","LU1226288170.HKD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"P6%\"(HK D) INC","LU1226287529.USD":"UBS (LUX) KEY SELECTION SICAV - CHINA ALLOCATION  OPPORTUNITY (USD) \"P\" (USD) ACC","BK1191":"制药","IE00B5MMRT66.SGD":"NEUBERGER BERMAN CHINA EQUITY \"A\" (SGDHDG) ACC","LU1226287875.USD":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"PM\" (USD) INC","LU0880133367.SGD":"UBS (LUX) EQUITY FUND CHINA OPPORTUNITY USD \"P\" (SGD) ACC"},"translate_title":"CSPC Pharmaceutical Group (01093): Sirolimus for injection (albumin-bound type) obtained breakthrough therapy designation in China","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":1},"content_text":"智通财经APP讯，石药集团(01093)发布公告，集团开发的注射用西罗莫司(白蛋白结合型)获中华人民共和国国家药品监督管理局授予突破性治疗认定，拟定适应症为单药用于恶性血管周围上皮样细胞瘤(PEComa)。西罗莫司又称为雷帕霉素，是一种常用的特异性mTOR抑制剂。此前已有口服制剂的西罗莫司获批上市，主要适用于预防接受肾移植患者的器官排斥。该产品采用特殊技术将西罗莫司包裹于人血白蛋白中，克服口服制剂无法向靶部位递送足够浓度药量的缺点，实现了西罗莫司的注射给药，且无需激素预处理。同时，该产品拓展了西罗莫司的应用领域，有望实现治疗mTOR信号通路驱动的一系列疾病。该产品目前正在中国开展用于治疗乳腺癌、软组织肉瘤、肺癌、肾癌等实体瘤及血液瘤的多项II期及III期临床研究。乳腺癌位居女性恶性肿瘤的首位，全球女性乳腺癌新发病例约230万例，经CDK4/6抑制剂治疗失败后的HR+/HER2-晚期乳腺癌患者存在极大未满足的临床需求。该产品与内分泌治疗联合，是国内首款在CDK4/6抑制剂耐药的HR+/HER2-晚期乳腺癌患者中开展临床试验的mTOR抑制剂，集团已向监管部门递交关键III期临床试验沟通交流申请。恶性PEComa国内尚无标准治疗，存在未被满足的临床需求。该产品已有临床数据证实其单药疗效显著优于历史数据，目前已进入关键III期入组阶段。本次获授予的突破性治疗认定，将有助于进一步加快该产品的开发进度，使其有望成为国内首个针对该适应症的标准治疗。","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"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":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.0","shortVersion":"4.36.0","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/2514349325","isCrawlerRequest":true}