康哲药业(00867)：拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL中国上市许可申请已获受理

智通财经2025-07-28

智通财经APP讯，康哲药业(00867)公布，改良型新药ZUNVEYL(拟定通用名：葡萄糖酸苯加兰他敏肠溶片)(ZUNVEYL)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。ZUNVEYL于2024年7月获得美国食品和药物管理局(FDA)批准上市用于治疗成人轻度至中度阿尔茨海默型痴呆症状，属于新一代...

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/2554854727?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-07-28 17:34","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2554854727","market":"hk","top_or_hot":-1,"title":"康哲药业(00867)：拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL中国上市许可申请已获受理","media":"智通财经","content":"<div>\n<p>智通财经APP讯，康哲药业(00867)公布，改良型新药ZUNVEYL(拟定通用名：葡萄糖酸苯加兰他敏肠溶片)(ZUNVEYL)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。ZUNVEYL于2024年7月获得美国食品和药物管理局(FDA)批准上市用于治疗成人轻度至中度阿尔茨海默型痴呆症状，属于新一代...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1322649.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>康哲药业(00867)：拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL中国上市许可申请已获受理</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康哲药业(00867)：拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL中国上市许可申请已获受理\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-07-28 17:34 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1322649.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，康哲药业(00867)公布，改良型新药ZUNVEYL(拟定通用名：葡萄糖酸苯加兰他敏肠溶片)(ZUNVEYL)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。ZUNVEYL于2024年7月获得美国食品和药物管理局(FDA)批准上市用于治疗成人轻度至中度阿尔茨海默型痴呆症状，属于新一代...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1322649.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":"IE00BGHQDM52.EUR","symbol_name":"GUINNESS ASIAN EQUITY INCOME \"C\" (EUR) ACC","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1322649.html","article_id":"2554854727","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2554854727","pubTimestamp":1753695273,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。加兰他敏自2001年获FDA批准以来，在轻度至中度阿尔茨海默型痴呆症状治疗中已积累了丰富的疗效证据并展现出长期临床获益。与ZUNVEYL相关的用途专利，已在中国获得授权。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IE00BGHQDM52.EUR":"GUINNESS ASIAN EQUITY INCOME \"C\" (EUR) ACC","IE00BMCWC346.EUR":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (EUR) ACC","00867":"康哲药业","SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","BK1191":"制药","IE00BVYPNQ40.USD":"GUINNESS ASIAN EQUITY INCOME \"C\" (USD) ACC","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","IE00BYV24P56.USD":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (USD) ACC","SG9999015978.USD":"利安颠覆性创新基金A","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","BK1593":"医美概念股","IE00BVYPNP33.GBP":"GUINNESS ASIAN EQUITY INCOME \"C\" (GBP) ACC"},"translate_title":"CMS (00867): The Chinese marketing authorization application for ZUNVEYL, an improved new drug intended to be used to treat mild to moderate Alzheimer's dementia symptoms in adults, has been accepted","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00867":1},"content_text":"智通财经APP讯，康哲药业(00867)公布，改良型新药ZUNVEYL(拟定通用名：葡萄糖酸苯加兰他敏肠溶片)(ZUNVEYL)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。ZUNVEYL于2024年7月获得美国食品和药物管理局(FDA)批准上市用于治疗成人轻度至中度阿尔茨海默型痴呆症状，属于新一代乙酰胆硷酯酶抑制剂(AChEI)，通过抑制乙酰胆硷酯酶活性、提高中枢乙酰胆硷水平从而改善阿尔茨海默病患者的认知和记忆功能。ZUNVEYL为加兰他敏的前体药物，以惰性形式经过胃部和肠道，在肝脏代谢成活性成分并释放到血液中。ZUNVEYL通过这种作用机制达到与加兰他敏相同的治疗效果，并潜在地降低胃肠道不良反应、改善耐受性。加兰他敏自2001年获FDA批准以来，在轻度至中度阿尔茨海默型痴呆症状治疗中已积累了丰富的疗效证据并展现出长期临床获益。此外，ZUNVEYL所有研究中记录的胃肠道不良事件低于2%，并且未观察到失眠。ZUNVEYL作为近十年来FDA批准的第二个阿尔茨海默病口服疗法的药品，具有潜在更优的胃肠道安全性，有望提高阿尔茨海默病患者的用药依从性，从而使患者获益。与ZUNVEYL相关的用途专利，已在中国获得授权。ZUNVEYL将使该集团创新药产品矩阵更加多元化，提升集团综合竞争实力，且产品可与集团在售创新药维图可(地西泮鼻喷雾剂)、原研品牌药黛力新(氟哌噻吨美利曲辛片)以及在研创新产品注射用Y-3等系列中枢神经品种在专家网络与市场资源方面协同。凭借集团成功的商业化经验、合规高效的商业化体系，ZUNVEYL如获批上市，将为中国阿尔茨海默病患者的认知障碍治疗带来新的用药选择，满足兼具疗效与安全性药物的临床需求，提升疾病诊疗和操作实践，从而使患者受益，并预期对本集团业绩产生积极正面影响。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":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,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","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/2554854727","isCrawlerRequest":true}