2026开年已经有3款创新药密集获批上市，来自恒瑞、百济、赛诺菲

制药网01-08

2026新年伊始，医药行业便传来阵阵暖意，根据国家药品监督管理局网站消息，2026开年已经有三款创新药获批上市，其中包含2个国产创新药，分别来自恒瑞医药、百济神州；1个进口产品，来自赛诺菲。其中，恒瑞医药子公司苏州盛迪亚生物医药有限公司申报的瑞拉芙普α注射液(商品名：艾泽利)于1月7日获批上市，该品种联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、...

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/2601356555?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2026-01-08 13:44","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2601356555","market":"hk","top_or_hot":-1,"title":"2026开年已经有3款创新药密集获批上市，来自恒瑞、百济、赛诺菲","media":"制药网","content":"<div>\n<p>2026新年伊始，医药行业便传来阵阵暖意，根据国家药品监督管理局网站消息，2026开年已经有三款创新药获批上市，其中包含2个国产创新药，分别来自恒瑞医药、百济神州；1个进口产品，来自赛诺菲。其中，恒瑞医药子公司苏州盛迪亚生物医药有限公司申报的瑞拉芙普α注射液(商品名：艾泽利)于1月7日获批上市，该品种联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260108134829a4aaa790&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>2026开年已经有3款创新药密集获批上市，来自恒瑞、百济、赛诺菲</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\">\n2026开年已经有3款创新药密集获批上市，来自恒瑞、百济、赛诺菲\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-01-08 13:44 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260108134829a4aaa790&s=b><strong>制药网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>2026新年伊始，医药行业便传来阵阵暖意，根据国家药品监督管理局网站消息，2026开年已经有三款创新药获批上市，其中包含2个国产创新药，分别来自恒瑞医药、百济神州；1个进口产品，来自赛诺菲。其中，恒瑞医药子公司苏州盛迪亚生物医药有限公司申报的瑞拉芙普α注射液(商品名：艾泽利)于1月7日获批上市，该品种联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260108134829a4aaa790&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":"LU1303224171.USD","symbol_name":"NINETY ONE GSF ALL CHINA EQUITY \"A\" (USD) INC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260108134829a4aaa790&s=b","article_id":"2601356555","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260108134829a4aaa790&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=2601356555","pubTimestamp":1767851095,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"2026新年伊始，医药行业便传来阵阵暖意，根据国家药品监督管理局网站消息，2026开年已经有三款创新药获批上市，其中包含2个国产创新药，分别来自恒瑞医药、百济神州；1个进口产品，来自赛诺菲。业内表示，本次普乐司兰钠注射液的获批，回应了临床在甘油三酯管理方面的迫切患者需求。开年三款创新药的密集获批，离不开国家利好政策的支持。回顾刚刚过去的2025年，我国有76个创新药获批上市，与2024年48个相比，大幅增长58.33%。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU1303224171.USD":"NINETY ONE GSF ALL CHINA EQUITY \"A\" (USD) INC","BK1161":"生物科技","BK1500":"做空集合股","BK1583":"高瓴概念","LU0307460666.USD":"EASTSPRING INVESTMENTS CHINA EQUITY \"A\" ACC","06978":"永泰生物-B","06160":"百济神州","LU1719994722.HKD":"NINETY ONE GSF ALL CHINA EQUITY \"A\" (HKD) ACC","LU1251922891.USD":"NINETY ONE GSF ALL CHINA EQUITY \"A\" (USD) ACC","BK1588":"回港中概股","LU1969619763.USD":"EASTSPRING INV CHINA A SHARES GROWTH \"A\" (USD) ACC","LU2328871848.SGD":"Eastspring Investments - China A Shares Growth AS SGD","LU0588546209.SGD":"Eastspring Investments - China Equity Fund AS SGD","LU1770034418.SGD":"ALL CHINA EQUITY \"A\" (SGDHDG) ACC","BK1574":"生物医药B类股"},"translate_title":"At the beginning of 2026, three innovative drugs have been intensively approved for marketing, from Hengrui, Baekje, and Sanofi","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"06160":0.9,"06978":1.5},"content_text":"2026新年伊始，医药行业便传来阵阵暖意，根据国家药品监督管理局网站消息，2026开年已经有三款创新药获批上市，其中包含2个国产创新药，分别来自恒瑞医药、百济神州；1个进口产品，来自赛诺菲。其中，恒瑞医药子公司苏州盛迪亚生物医药有限公司申报的瑞拉芙普α注射液(商品名：艾泽利)于1月7日获批上市，该品种联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗。百济神州申报的1类创新药索托克拉片(商品名：百悦达)于1月6日获批上市。该药适用于既往经过至少包含布鲁顿酪氨酸激酶(BTK)抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)患者、既往接受过至少两种系统性治疗(含布鲁顿氏酪氨酸激酶[BTK]抑制剂)的复发或难治性套细胞淋巴瘤(MCL)成人患者，为临床提供新的治疗选择。赛诺菲申报的1类创新药普乐司兰钠注射液(商品名：瑞达普)于1月7日获批上市，该药品在饮食控制基础上，用于降低家族性乳糜微粒血症综合征(FCS)成人患者的甘油三酯水平。FCS是一种高甘油三酯水平相关的遗传性疾病。作为作用于创新靶点APOC3(载脂蛋白C-III) mRNA的小干扰RNA(siRNA)药物，普乐司兰钠注射液能够将FCS患者空腹甘油三酯水平较基线降低80%、急性胰腺炎发生率较安慰剂降低80%，且仅需一年四次给药。业内表示，本次普乐司兰钠注射液的获批，回应了临床在甘油三酯管理方面的迫切患者需求。随着创新疗法的问世以及围绕甘油三酯的多方位管理体系完善，未来血脂管理有望迈入更规范化、精准化的新阶段，推动心血管疾病防治进程，为中国慢病防治体系建设提供坚实助力。开年三款创新药的密集获批，离不开国家利好政策的支持。如我国医保“双目录”协同发力，通过政策引导保障创新药可及性，2025年版国家医保目录新增50种1类创新药，头版商保创新药目录纳入19种高价值创新药，形成基本医保与商保的互补衔接。这种政策支持体系不仅让创新药更快惠及患者，也为药企研发创新提供了明确导向。2026开年的创新药“开门红”，为医药行业发展定下创新驱动的基调。而这股创新热潮更延续了2025年的强劲势头。回顾刚刚过去的2025年，我国有76个创新药获批上市，与2024年48个相比，大幅增长58.33%。近年来，国内创新药逐渐迎来收获期，展望未来，随着药品审评审批改革的持续深化和医保政策的精准赋能，预计将有更多国内外创新药加速落地。这些创新成果不仅将不断提升我国疑难重症和罕见病的诊疗水平，更将推动医药产业向高质量创新转型，让更多患者在创新药的加持下获得更好的治疗体验。","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":"4.36.2","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/2601356555","isCrawlerRequest":true}