医线药事｜礼来可逆BTK抑制剂在华申报上市 O药新适应症申报上市

每日经济新闻2023-12-06

每经记者：陈星每经编辑：魏官红1.礼来可逆BTK抑制剂在华申报上市12月5日，CDE网站显示，礼来可逆BTK抑制剂匹妥布替尼（pirtobrutinib）在华申报上市，适应症为既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（MCL）成人患者。点评：BTK早已成为内卷赛道之一，全球已有6款BTK抑制剂获批上市，另有6款处于III期研究阶段。除Pirtobrutinib以外，已上市的BTK抑制剂...

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/2389705832?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2023-12-06 09:53","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2389705832","market":"us","top_or_hot":-1,"title":"医线药事｜礼来可逆BTK抑制剂在华申报上市 O药新适应症申报上市","media":"每日经济新闻","content":"<div>\n<p>每经记者：陈星每经编辑：魏官红1.礼来可逆BTK抑制剂在华申报上市12月5日，CDE网站显示，礼来可逆BTK抑制剂匹妥布替尼（pirtobrutinib）在华申报上市，适应症为既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（MCL）成人患者。点评：BTK早已成为内卷赛道之一，全球已有6款BTK抑制剂获批上市，另有6款处于III期研究阶段。除Pirtobrutinib以外，已上市的BTK抑制剂...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202312060953548233440b&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>医线药事｜礼来可逆BTK抑制剂在华申报上市 O药新适应症申报上市</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医线药事｜礼来可逆BTK抑制剂在华申报上市 O药新适应症申报上市\n</h2>\n\n<h4 class=\"meta\">\n\n\n2023-12-06 09:53 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202312060953548233440b&s=b><strong>每日经济新闻</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>每经记者：陈星每经编辑：魏官红1.礼来可逆BTK抑制剂在华申报上市12月5日，CDE网站显示，礼来可逆BTK抑制剂匹妥布替尼（pirtobrutinib）在华申报上市，适应症为既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（MCL）成人患者。点评：BTK早已成为内卷赛道之一，全球已有6款BTK抑制剂获批上市，另有6款处于III期研究阶段。除Pirtobrutinib以外，已上市的BTK抑制剂...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202312060953548233440b&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":"LU0708995401.HKD","symbol_name":"FRANKLIN U.S. OPPORTUNITIES \"A\" (HKD) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202312060953548233440b&s=b","article_id":"2389705832","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202312060953548233440b&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=2389705832","pubTimestamp":1701827603,"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"每经记者：陈星每经编辑：魏官红1.礼来可逆BTK抑制剂在华申报上市12月5日，CDE网站显示，礼来可逆BTK抑制剂匹妥布替尼在华申报上市，适应症为既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤成人患者。点评：BTK早已成为内卷赛道之一，全球已有6款BTK抑制剂获批上市，另有6款处于III期研究阶段。除Pirtobrutinib以外，已上市的BTK抑制剂均为一代BTK抑制剂，不可避免地存在C481S突变导致的获得性耐药问题，令其疗效大打折扣。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0708995401.HKD":"FRANKLIN U.S. OPPORTUNITIES \"A\" (HKD) ACC","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU1267930730.SGD":"富兰克林美国机遇基金AS Acc SGD (CPF)","LU0320765059.SGD":"FTIF - Franklin US Opportunities A Acc SGD","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","SG9999018857.SGD":"United Global Quality Growth Fd Cl Acc SGD-H","LU2264538146.SGD":"Fullerton Lux Funds - Global Absolute Alpha A Acc SGD","LU1988902786.USD":"FULLERTON LUX FUNDS GLOBAL ABSOLUTE ALPHA \"I\" (USD) ACC","BK4007":"制药","SG9999018865.SGD":"United Global Quality Growth Fd Cl Dist SGD-H","LU0122379950.USD":"贝莱德世界健康科学A2","SG9999001176.USD":"United Global Healthcare Acc USD","LU2491050071.SGD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (SGDHDG) ACC","BK4588":"碎股","LU0058720904.USD":"联博国际健康护理基金A","SGXZ31699556.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"C\" (SGDHDG) ACC","LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU1064131342.USD":"Fullerton Lux Funds - Global Absolute Alpha A Acc USD","LU2491050154.USD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (USD) ACC","LU0882574055.USD":"富达全球健康医疗A ACC","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU1814569148.SGD":"WELLINGTON GLOBAL QUALITY GROWTH \"D\" (SGDHDG) ACC","LU0109391861.USD":"富兰克林美国机遇基金A Acc","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","SG9999014906.USD":"大华全球优质成长基金Acc USD","LLY":"礼来","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","LU0061475181.USD":"THREADNEEDLE (LUX) AMERICAN \"AU\" (USD) ACC","SG9999017495.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"B\" (SGD) ACC","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","SG9999014880.SGD":"大华全球优质成长基金Acc SGD","LU0672654240.SGD":"FTIF - Franklin US Opportunities A Acc SGD-H1","LU2491049909.HKD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (HKD) ACC","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","BK4581":"高盛持仓","LU2237438978.USD":"Amundi Funds US Pioneer A2 (C) USD","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD"},"translate_title":"Medical line pharmacy Lilly reversible BTK inhibitor declared for listing in China O drug new indications declared for listing","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LLY":1},"content_text":"每经记者：陈星每经编辑：魏官红1.礼来可逆BTK抑制剂在华申报上市12月5日，CDE网站显示，礼来可逆BTK抑制剂匹妥布替尼（pirtobrutinib）在华申报上市，适应症为既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（MCL）成人患者。点评：BTK早已成为内卷赛道之一，全球已有6款BTK抑制剂获批上市，另有6款处于III期研究阶段。除Pirtobrutinib以外，已上市的BTK抑制剂均为一代BTK抑制剂，不可避免地存在C481S突变导致的获得性耐药问题，令其疗效大打折扣。2.O药新适应症申报上市12月5日，百时美施贵宝（BMS）宣布纳武利尤单抗（Opdivo，O药）联合顺铂化疗一线治疗不可切除或转移性尿路上皮癌（UC）成人患者的补充生物制品许可申请（sBLA）获FDA受理并予以优先审评。点评：尿路上皮癌是世界上第十大癌症，每年有超过57.3万例患者确诊。通常起源于膀胱内部的细胞，约占膀胱癌的90%。除膀胱外，还可能发生在泌尿道的其他部位，包括输尿管和肾盂。3.翰宇药业司美格鲁肽注射液获临床试验通知书翰宇药业（300199.SZ，股价15.2元，市值134.25亿元）公告，获得司美格鲁肽注射液临床试验通知书，适应症为治疗II型糖尿病，不涉及肥胖适应症。点评：“减肥药”概念股中，翰宇药业多次发布相关进展。11月初，公司公告收到合作方的采购订单，美国某大型制药公司向公司合计采购累计金额1408.32万美元【约合人民币1.03亿元（含税）】的利拉鲁肽注射液。4.茅台产业基金投资成都生物医药企业在今年8月完成备案后，近日，公开信息显示，茅台金石基金终于迎来“首投”。茅台金石基金此次所投资公司为成都泰和伟业生物科技有限公司。点评：泰和伟业主要聚焦于保护氨基酸及多肽药物中间体市场，公司在不到半年的时间里完成了两轮合计5亿元的融资。今年8月，泰和伟业宣布完成由高瓴创投作为共同领投方之一的2亿元A轮融资。5.先声药业USP1抑制剂在美获批临床先声药业（02096.HK，股价6.93港元，市值182.33亿港元）发布一则公告，宣布其自主研发的抗肿瘤候选药物泛素特异性肽酶1（USP1）小分子抑制剂SIM0501新药临床试验申请（IND）已获FDA批准，拟开展SIM0501用于晚期实体瘤的临床试验。点评：SIM0501是一种可口服、非共价、高选择性USP1抑制剂。USP1在多种肿瘤中显著过表达，在DNA损伤反应和修复中起到关键作用，阻断USP1可促进肿瘤凋亡，尤其是同源重组缺陷（HRD）肿瘤。每日经济新闻","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.25.1","shortVersion":"4.25.1","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/2389705832"}