百济神州、宜联新药IND！礼来重金加注、AZ联合疗法新进展

医药经济报2025-05-07

百济神州1类新药获批临床日前，CDE官网公示，百济神州申报的1类新药BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4 CDAC），该产品于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。截图来源：CDE官网据百济神州公开资料，BGB-45035具有多个优势，有希望开发成为“best-in-...

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/2533865329?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-05-07 19:02","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2533865329","market":"us","top_or_hot":-1,"title":"百济神州、宜联新药IND！礼来重金加注、AZ联合疗法新进展","media":"医药经济报","content":"<div>\n<p>百济神州1类新药获批临床日前，CDE官网公示，百济神州申报的1类新药BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4 CDAC），该产品于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。截图来源：CDE官网据百济神州公开资料，BGB-45035具有多个优势，有希望开发成为“best-in-...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250507191622a475488d&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>百济神州、宜联新药IND！礼来重金加注、AZ联合疗法新进展</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百济神州、宜联新药IND！礼来重金加注、AZ联合疗法新进展\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-05-07 19:02 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250507191622a475488d&s=b><strong>医药经济报</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>百济神州1类新药获批临床日前，CDE官网公示，百济神州申报的1类新药BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4 CDAC），该产品于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。截图来源：CDE官网据百济神州公开资料，BGB-45035具有多个优势，有希望开发成为“best-in-...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250507191622a475488d&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":"LU0289739699.SGD","symbol_name":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250507191622a475488d&s=b","article_id":"2533865329","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250507191622a475488d&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=2533865329","pubTimestamp":1746615770,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"百济神州1类新药获批临床日前，CDE官网公示，百济神州申报的1类新药BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。本次BGB-45035针对结节性痒疹新适应症获批临床，意味着该产品的临床开发迎来新的进展。此前，Alchemab宣布与礼来达成协议。值得一提的是，根据ECHO的结果，阿可替尼联合苯达莫司汀和利妥昔单抗疗法已于2025年1月17日获FDA批准用于MCL一线治疗。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"688235":"百济神州","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU0203201768.USD":"AB SICAV I - ALL MARKET INCOME PORTFOLIO \"AX\" (USD) INC","LU1720051108.HKD":"ALLIANZ GLOBAL ARTIFICIAL INTELLIGENCE \"AT\" (HKD) ACC","LU2237443978.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc SGD-H","LU1917777945.USD":"安联专题基金Cl AT Acc","LU1720051017.SGD":"Allianz Global Artificial Intelligence AT Acc H2-SGD","SG9999014914.USD":"UNITED GLOBAL QUALITY GROWTH (USDHDG) INC","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","LU1267930730.SGD":"富兰克林美国机遇基金AS Acc SGD (CPF)","LU2491050071.SGD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (SGDHDG) ACC","LU2112291526.USD":"BGF WORLD HEALTHSCIENCE \"A4\" (USD) INC","LU2552382215.SGD":"WELLINGTON US BRAND POWER \"A\" (SGDHDG) ACC","SGXZ99366536.SGD":"United Global Innovation A Acc SGD-H","LU2491050154.USD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (USD) ACC","BK4187":"航天航空与国防","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU2471134952.CNY":"INVESCO GLOBAL EQUITY INCOME ADVANTAGE \"A\" (CNYHDG) INC","LU1868836591.USD":"CT (LUX) I AMERICAN \"1U\"(USD) ACC","LU2264538146.SGD":"Fullerton Lux Funds - Global Absolute Alpha A Acc SGD","LU2237443549.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA SGD-H","IE00BK4W5L77.USD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (USD) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","LU0882574139.USD":"富达环球消费行业基金A ACC","SG9999014906.USD":"大华全球优质成长基金Acc USD","SG9999014880.SGD":"大华全球优质成长基金Acc SGD","LU0266013472.USD":"AXA WF - Framlington Longevity Economy A Cap USD","LU2361044865.SGD":"WELLINGTON US QUALITY GROWTH \"A\" (SGDHDG) ACC","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU0471298777.SGD":"Blackrock Nutrition A2 SGD-H","LU2211815571.USD":"ALLIANZ POSITIVE CHANGE \"AT\" (USD) ACC","SG9999015978.USD":"利安颠覆性创新基金A","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0122379950.USD":"贝莱德世界健康科学A2","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LLY":"礼来","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU2750360641.GBP":"INVESCO GLOBAL EQUITY INCOME ADVANTAGE \"A\" (GBPHDG) INC","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU2237438978.USD":"Amundi Funds US Pioneer A2 (C) USD","AZ":"A2Z Cust2Mate Solutions Corp","LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","06160":"百济神州","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","LU0354030438.USD":"富国美国大盘成长基金Cl A Acc","ONC":"百济神州","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","SG9999001176.USD":"United Global Healthcare Acc USD"},"translate_title":"BeiGene, Yilian new drug IND! Eli Lilly's heavy investment, new progress in AZ combination therapy","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688235":0.9,"ONC":1,"LLY":1,"06160":0.9,"AZ":1},"content_text":"百济神州1类新药获批临床日前，CDE官网公示，百济神州申报的1类新药BGB-45035片就新适应症获得临床试验默示许可，拟开发治疗结节性痒疹。BGB-45035片是一款靶向IRAK4的蛋白降解剂（IRAK4 CDAC），该产品于2024年8月首次在中国获批IND，用于治疗中重度特应性皮炎。截图来源：CDE官网据百济神州公开资料，BGB-45035具有多个优势，有希望开发成为“best-in-class”药物。IRAK4降解更快更深层次，对细胞因子抑制更强，在多种细胞类型中实现了更完全的IRAK4降解；在疾病模型中药效更好；无心血管风险。本次BGB-45035针对结节性痒疹新适应症获批临床，意味着该产品的临床开发迎来新的进展。值得一提的是，IRAK4是近年来颇受业界关注的前沿靶点之一。尤其在靶向IRAK4的蛋白降解剂领域，由Kymera Therapeutics和赛诺菲（Sanofi）共同开发的KT-474（SAR444656）连续两年被知名媒体列入年度十大明星小分子。2023年底，赛诺菲曾在研发日上介绍其管线中具重磅潜力的新药名单，其中就包括这款SAR444656。02宜联生物CDH17 ADC首次在国内获批临床日前，CDE官网显示，宜联生物注射用YL217获批临床，用于经病理学确诊的晚期实体瘤，包括胃肠道、食管、胃食管结合部、胰腺或壶腹部腺癌和神经内分泌肿瘤等。据公开资料，这是该药首次在国内获批临床。截图来源：CDE官网据新闻稿介绍，YL217是一款基于宜联生物TMALIN平台构建的CDH17 ADC，可在肿瘤细胞和肿瘤微环境中释放有效载荷。目前YL217正在美国开展Ⅰ期临床研究。截图来源：2025 AACR Poster据统计，全球范围内共有20款CDH17 ADC在研，其中5款进入临床阶段，分别来自康诺亚（CM518D1）、宜联生物（YL217）、翰森（HS-20110）、普众发现（AMT-676）和 TORL Biotherapeutics（TORL-3-600），但都尚处早期临床阶段。03礼来重金加码神经退行性疾病领域日前，Alchemab Therapeutics宣布，已与礼来就ATLX-1282达成许可协议。公开资料显示，ATLX-1282是Alchemab针对肌萎缩侧索硬化症（ALS）和其他神经退行性疾病开发的创新候选药物。值得注意的是，ATLX-1282是Alchemab利用机器学习和人工智能技术开发的独特平台开发的首个项目，该平台可以对数百万个抗体序列进行测序和分析，发现具有独特作用机制的新型靶点和抗体。截图来源：企业官网据悉，此次交易总价值高达4.15亿美元，包括未披露的预付款、潜在的发现、开发和商业化里程碑付款以及特许权使用费。根据协议条款，Alchemab将负责该项目的早期Ⅰ期临床试验，之后礼来将主导所有进一步的开发和商业化工作。此外，该协议是基于Alchemab和礼来在1月达成合作协议的基础上产生的。此前，Alchemab宣布与礼来达成协议。根据该协议条款，Alchemab将与礼来合作，发现、开发和商业化多达五种用于治疗ALS的新型候选疗法。04阿斯利康BTK抑制剂在欧盟获批新适应症日前，阿斯利康宣布，阿可替尼与苯达莫司汀和利妥昔单抗联合使用已在欧盟获得批准，用于治疗未接受过治疗且不适合接受自体干细胞移植的套细胞淋巴瘤（MCL）成年患者。值得注意的是，这是目前欧盟首个也是唯一一个获批用于该适应症的BTK抑制剂。据悉，阿可替尼是第二代BTK选择性抑制剂。作为广泛临床开发计划的一部分，阿可替尼目前正在以单药或与标准化学免疫疗法相结合的方案，用于治疗多种B细胞血癌患者，包括慢性淋巴细胞白血病（CLL）、MCL和弥漫大B细胞淋巴瘤。截图来源：企业官网此项批准是基于EMACHMP的积极意见，以及Ⅲ期临床试验 ECHO的积极结果。试验旨在评估阿可替尼联合苯达莫司汀和利妥昔单抗治疗的疗效和安全性，并与SoC化学免疫疗法（苯达莫司汀和利妥昔单抗）进行比较，用于治疗65岁及以上、既往未接受过治疗的MCL成年患者。该试验结果显示，阿可替尼的安全性和耐受性与其已知的安全性一致，并且没有发现新的安全信号。值得一提的是，根据ECHO的结果，阿可替尼联合苯达莫司汀和利妥昔单抗疗法已于2025年1月17日获FDA批准用于MCL一线治疗。此外，日本和其他几个国家正在审查该适应症的注册申请。编辑：范晓艳版式编辑：余远泽审校：马飞、张松一季度医药进出口总额超470亿美元！从“中国第一展”看外贸趋势致敬劳动者！2025全国劳模名单揭晓，他们诠释着时代主旋律瞄准艾伯维25亿美元大药！百济、亚盛、诺诚健华竞逐国产桂冠倒计时6天，第36届医药经济信息发布会议程戳这里！www.yyjjb.com.cn洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店","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":"corporation","news_rank":0,"symbols":[],"gpt_button":0,"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/2533865329","isCrawlerRequest":true}