【重磅】济川药业创新研发新突破！1类新药小儿便通颗粒上市申请获受理

米内网2025-07-08

精彩内容近日，济川药业收到国家药监局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。资料显示，小儿便通颗粒来源于名医验方，具有健脾和胃、行气导滞的功效，用于小儿便秘，中医辨证属食积证者。来源：CDE官网根据公开信息，中国境内（不包括港澳台地区）暂无与其处方一致的药品上市或注册申报信息，小儿便通颗粒有望成为《小儿便秘中药新药临床研发技术指导原则（试行）》（2024年）发布后的首个...

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/2549519746?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-07-08 16:08","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2549519746","market":"sh","top_or_hot":-1,"title":"【重磅】济川药业创新研发新突破！1类新药小儿便通颗粒上市申请获受理","media":"米内网","content":"<div>\n<p>精彩内容近日，济川药业收到国家药监局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。资料显示，小儿便通颗粒来源于名医验方，具有健脾和胃、行气导滞的功效，用于小儿便秘，中医辨证属食积证者。来源：CDE官网根据公开信息，中国境内（不包括港澳台地区）暂无与其处方一致的药品上市或注册申报信息，小儿便通颗粒有望成为《小儿便秘中药新药临床研发技术指导原则（试行）》（2024年）发布后的首个...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250708161737a43d91a3&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>【重磅】济川药业创新研发新突破！1类新药小儿便通颗粒上市申请获受理</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【重磅】济川药业创新研发新突破！1类新药小儿便通颗粒上市申请获受理\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-07-08 16:08 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250708161737a43d91a3&s=b><strong>米内网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>精彩内容近日，济川药业收到国家药监局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。资料显示，小儿便通颗粒来源于名医验方，具有健脾和胃、行气导滞的功效，用于小儿便秘，中医辨证属食积证者。来源：CDE官网根据公开信息，中国境内（不包括港澳台地区）暂无与其处方一致的药品上市或注册申报信息，小儿便通颗粒有望成为《小儿便秘中药新药临床研发技术指导原则（试行）》（2024年）发布后的首个...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250708161737a43d91a3&s=b\">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":"BK0187","symbol_name":"一线龙头","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250708161737a43d91a3&s=b","article_id":"2549519746","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250708161737a43d91a3&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2549519746","pubTimestamp":1751962113,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"精彩内容近日，济川药业收到国家药监局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。据悉，济川药业将继续以“共创幸福精彩的生命体验”为愿景，秉承“引领前沿、创新精品”的研发理念，紧跟医药市场变化，从患者用药需求出发，聚焦中长期发展战略，以科研创新驱动企业高质量、可持续发展，履行好上市医药企业应有的社会责任，为大众健康护航。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"561510":"中药ETF华泰柏瑞","562390":"中药50ETF","600566":"济川药业","BK0187":"一线龙头","BK0028":"国家队","BK0239":"医药制造","BK0201":"可转债","BK0188":"融资融券","BK0012":"证金概念","BK0077":"质押式回购"},"translate_title":"[Blockbuster] Jichuan Pharmaceutical's new breakthrough in innovative research and development! Class 1 new drug Xiaoer Biantong Granules marketing application accepted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"561510":0.9,"562390":0.9,"600566":1},"content_text":"精彩内容近日，济川药业收到国家药监局签发的1.1类中药创新药小儿便通颗粒申报上市许可的《受理通知书》。资料显示，小儿便通颗粒来源于名医验方，具有健脾和胃、行气导滞的功效，用于小儿便秘，中医辨证属食积证者。来源：CDE官网根据公开信息，中国境内（不包括港澳台地区）暂无与其处方一致的药品上市或注册申报信息，小儿便通颗粒有望成为《小儿便秘中药新药临床研发技术指导原则（试行）》（2024年）发布后的首个用于小儿便秘的中药1.1类新药。作为国内拥有儿科品种、剂型最多的制药企业之一，济川药业深耕儿科优势领域多年，先后培育了蒲地蓝消炎口服液、同贝®小儿豉翘清热颗粒、健胃消食口服液、黄龙止咳颗粒、盛雪元®蛋白琥珀酸铁口服溶液等品牌产品。同时，公司不断加强上市品种的二次开发、中药新药和高端化药研发，一举拿下新版《药品注册管理办法》实施以来首个中药改良型新药金同贝®小儿豉翘清热糖浆；成为国内首家获批敏菲乐®盐酸非索非那定干混悬剂和贝罗南®小儿法罗培南钠颗粒的药企，进一步提升了儿科领域的核心竞争力。此外，济川药业以商业拓展赋能外延式扩张，形成了自主创新和合作研发相结合的研发体系。公司联合征祥医药开发出流感1类创新药玛硒洛沙韦片，该新药是一款具有全球自主知识产权的新一代靶向流感病毒RNA聚合酶PA抑制剂，全疗程仅需用药一次，其上市申请已获CDE受理，目前在审评审批阶段；与天境生物合作开发的1类创新药融合蛋白型长效生长激素的生物制品上市申请也已获CDE受理，每周给药一次，该创新疗法有望为儿童生长激素缺乏症患者带来有效且便捷的治疗方案。据悉，济川药业将继续以“共创幸福精彩的生命体验”为愿景，秉承“引领前沿、创新精品”的研发理念，紧跟医药市场变化，从患者用药需求出发，聚焦中长期发展战略，以科研创新驱动企业高质量、可持续发展，履行好上市医药企业应有的社会责任，为大众健康护航。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","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/2549519746","isCrawlerRequest":true}