康哲药业阿尔茨海默病新药在中国申报上市

药渡2025-07-31

7月28日，康哲药业宣布，改良型新药ZUNVEYL（拟定通用名：葡萄糖酸苯加兰他敏肠溶片）的新药上市许可申请（NDA）已获得中国国家药品监督管理局（NMPA）受理。该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，属于新一代乙酰胆碱酯酶抑制剂（AChEI），通过抑制乙酰胆碱酯酶活性、提高中枢乙酰胆碱...

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/2555795078?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-07-31 07:32","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2555795078","market":"hk","top_or_hot":-1,"title":"康哲药业阿尔茨海默病新药在中国申报上市","media":"药渡","content":"<div>\n<p>7月28日，康哲药业宣布，改良型新药ZUNVEYL（拟定通用名：葡萄糖酸苯加兰他敏肠溶片）的新药上市许可申请（NDA）已获得中国国家药品监督管理局（NMPA）受理。该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，属于新一代乙酰胆碱酯酶抑制剂（AChEI），通过抑制乙酰胆碱酯酶活性、提高中枢乙酰胆碱...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250731074110a6ca5ac8&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>康哲药业阿尔茨海默病新药在中国申报上市</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康哲药业阿尔茨海默病新药在中国申报上市\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-07-31 07:32 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250731074110a6ca5ac8&s=b><strong>药渡</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>7月28日，康哲药业宣布，改良型新药ZUNVEYL（拟定通用名：葡萄糖酸苯加兰他敏肠溶片）的新药上市许可申请（NDA）已获得中国国家药品监督管理局（NMPA）受理。该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，属于新一代乙酰胆碱酯酶抑制剂（AChEI），通过抑制乙酰胆碱酯酶活性、提高中枢乙酰胆碱...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250731074110a6ca5ac8&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":"SG9999004220.SGD","symbol_name":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250731074110a6ca5ac8&s=b","article_id":"2555795078","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250731074110a6ca5ac8&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=2555795078","pubTimestamp":1753918339,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"目前阿尔茨海默病临床用药主要分为改善认知症状及延缓疾病进展两类，AChEI属于前者，但较高的副作用发生率是阿尔茨海默病现有药物的主要痛点之一。ZUNVEYL作为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。康哲药业于2025年1月8日通过全资附属公司与Alpha Cognition就用于治疗轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL签订许可、合作与经销协议。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"SG9999004220.SGD":"Nikko AM Shenton Asia Dividend Equity Fund  SGD","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","IE00BVYPNQ40.USD":"GUINNESS ASIAN EQUITY INCOME \"C\" (USD) ACC","SG9999015978.USD":"利安颠覆性创新基金A","LU2488822045.USD":"ALLIANZ CHINA HEALTHY LIVING \"AT\" (USD) ACC","IE00BYV24P56.USD":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (USD) ACC","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","00867":"康哲药业","IE00BGHQDM52.EUR":"GUINNESS ASIAN EQUITY INCOME \"C\" (EUR) ACC","BK1593":"医美概念股","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","IE00BVYPNP33.GBP":"GUINNESS ASIAN EQUITY INCOME \"C\" (GBP) ACC","IE00BMCWC346.EUR":"GUINNESS EMERGING MARKETS EQUITY INCOME \"C\" (EUR) ACC","BK1191":"制药"},"translate_title":"CMS's new Alzheimer's disease drug applies for listing in China","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00867":1},"content_text":"7月28日，康哲药业宣布，改良型新药ZUNVEYL（拟定通用名：葡萄糖酸苯加兰他敏肠溶片）的新药上市许可申请（NDA）已获得中国国家药品监督管理局（NMPA）受理。该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，属于新一代乙酰胆碱酯酶抑制剂（AChEI），通过抑制乙酰胆碱酯酶活性、提高中枢乙酰胆碱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。阿尔茨海默病是一种慢性进行性神经退行性疾病，表现为记忆力及其他认知功能的进行性减退，其中部分病人进展为痴呆。目前阿尔茨海默病临床用药主要分为改善认知症状及延缓疾病进展两类，AChEI属于前者，但较高的副作用发生率是阿尔茨海默病现有药物的主要痛点之一。耐受性会影响治疗依从性。停药可能会给患者自身带来风险，并会给患者家属、医生和护理人员带来不满和负担。公开资料显示，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。康哲药业于2025年1月8日通过全资附属公司与Alpha Cognition就用于治疗轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL签订许可、合作与经销协议。根据协议，康哲药业获得了在亚洲（除日本、中东地区）、澳洲、新西兰开发、注册、生产、进口、出口和商业化产品的独家权利，Alpha保留在上述区域内生产供应的权利。参考资料：[1]康哲药业（867.HK，8A8.SG）改良型阿尔茨海默病新药ZUNVEYL中国NDA已获受理. From https://www.prnasia.com/story/497951-1.shtml内容来源：医药观澜","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":"","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":"4.36.2","shortVersion":"4.36.2","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/2555795078","isCrawlerRequest":true}