诺诚健华、鞍石药业、福泰制药新药多点发力

医药经济报2025-04-16

诺诚健华1类新药申报上市今日，CDE官网显示，已受理诺诚健华新一代泛TRK抑制剂Zurletrectinib（ICP-723）用于治疗携带NTRK融合基因的晚期实体瘤成人和青少年（12周岁≤年龄<18周岁）患者的新药上市申请（NDA）。此外，卓乐替尼针对儿童患者（2周岁≤年龄<12周岁）的注册临床试验正在进行中。公司资料显示，NTRK融合基因可见于各种类型的成人及儿童肿瘤。在部分罕见肿瘤中，例如...

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/2527299736?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-04-16 14:01","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2527299736","market":"us","top_or_hot":-1,"title":"诺诚健华、鞍石药业、福泰制药新药多点发力","media":"医药经济报","content":"<div>\n<p>诺诚健华1类新药申报上市今日，CDE官网显示，已受理诺诚健华新一代泛TRK抑制剂Zurletrectinib（ICP-723）用于治疗携带NTRK融合基因的晚期实体瘤成人和青少年（12周岁≤年龄<18周岁）患者的新药上市申请（NDA）。此外，卓乐替尼针对儿童患者（2周岁≤年龄<12周岁）的注册临床试验正在进行中。公司资料显示，NTRK融合基因可见于各种类型的成人及儿童肿瘤。在部分罕见肿瘤中，例如...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250416183133a45afd98&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>诺诚健华、鞍石药业、福泰制药新药多点发力</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诺诚健华、鞍石药业、福泰制药新药多点发力\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-04-16 14:01 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250416183133a45afd98&s=b><strong>医药经济报</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>诺诚健华1类新药申报上市今日，CDE官网显示，已受理诺诚健华新一代泛TRK抑制剂Zurletrectinib（ICP-723）用于治疗携带NTRK融合基因的晚期实体瘤成人和青少年（12周岁≤年龄<18周岁）患者的新药上市申请（NDA）。此外，卓乐替尼针对儿童患者（2周岁≤年龄<12周岁）的注册临床试验正在进行中。公司资料显示，NTRK融合基因可见于各种类型的成人及儿童肿瘤。在部分罕见肿瘤中，例如...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250416183133a45afd98&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":"IE00B19Z3B42.SGD","symbol_name":"Legg Mason ClearBridge - Value A Acc SGD","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250416183133a45afd98&s=b","article_id":"2527299736","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250416183133a45afd98&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=2527299736","pubTimestamp":1744783286,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"诺诚健华1类新药申报上市今日，CDE官网显示，已受理诺诚健华新一代泛TRK抑制剂Zurletrectinib用于治疗携带NTRK融合基因的晚期实体瘤成人和青少年患者的新药上市申请。在部分罕见肿瘤中，例如唾液腺癌、分泌型乳腺癌、婴儿纤维肉瘤等，发生率超过90%。福泰制药小核酸药物探索神经肌肉疾病近日，福泰制药在ClinicalTrials网站登记一项Ⅱ期临床试验，评估VX-670对Ⅰ型强直性肌营养不良症患者的长期安全性和耐受性、疗效和药代动力学。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4532":"文艺复兴科技持仓","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU2417539215.USD":"ALLIANZ GLOBAL INCOME \"AMF\" (USD) INC","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","IE00B894F039.SGD":"Legg Mason ClearBridge - US Aggressive Growth A Acc SGD-H","IE00B19Z9P08.USD":"LEGG MASON CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (USD) INC","VRTX":"福泰制药","BK4585":"ETF&股票定投概念","LU2237438978.USD":"Amundi Funds US Pioneer A2 (C) USD","LU1069344957.HKD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (HKD) INC","BK4139":"生物科技","LU0058720904.USD":"联博国际健康护理基金A","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU2362541273.HKD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (HKD) ACC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","SG9999001176.USD":"United Global Healthcare Acc USD","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","LU2362541513.USD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (USD) ACC","IE00BZ9MQY76.HKD":"FTGF CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (HKD) ACC","09969":"诺诚健华","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","LU2362540622.SGD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (SGDHDG) ACC","LU0234570918.USD":"高盛全球核心股票组合Acc Close","LU0061475181.USD":"THREADNEEDLE (LUX) AMERICAN \"AU\" (USD) ACC","BK4588":"碎股","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0079474960.USD":"联博美国增长基金A","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","IE00B19Z9Z06.USD":"Legg Mason ClearBridge - US Aggressive Growth A Acc USD","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC"},"translate_title":"Nuocheng Jianhua, Anshi Pharmaceutical and Futai Pharmaceutical are making more efforts in new drugs","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09969":0.9,"VRTX":1},"content_text":"诺诚健华1类新药申报上市今日，CDE官网显示，已受理诺诚健华新一代泛TRK抑制剂Zurletrectinib（ICP-723）用于治疗携带NTRK融合基因的晚期实体瘤成人和青少年（12周岁≤年龄<18周岁）患者的新药上市申请（NDA）。此外，卓乐替尼针对儿童患者（2周岁≤年龄<12周岁）的注册临床试验正在进行中。公司资料显示，NTRK融合基因可见于各种类型的成人及儿童肿瘤。在部分罕见肿瘤中，例如唾液腺癌、分泌型乳腺癌、婴儿纤维肉瘤等，发生率超过90%。鞍石药业小分子抑制剂拟纳入优先审评日前，CDE官网公示，鞍石药业申报的苯甲酸安达替尼胶囊（PLB1004胶囊）拟纳入优先审评，用于治疗既往经含铂化疗和/或PD-1/PD-L1免疫治疗时或治疗后出现疾病进展，或不耐受，并且经检测确认存在表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）的患者。安达替尼是鞍石生物自主研发的新型小分子酪氨酸激酶不可逆抑制剂，具有高选择性，可以透过血脑屏障。非临床药效实验表明该化合物对EGFR 20号外显子插入（ex20 ins）突变、HER2 20号外显子插入（ex20 ins）突变、EGFR敏感突变、EGFR耐药突变和EGFR罕见突变均有效。Insight数据库显示，公司已针对该药开展多适应症研究，包括非鳞状非小细胞肺癌（临床Ⅲ期）、非小细胞肺癌（临床Ⅱ期）和非小细胞肺癌脑转移（临床Ⅱ期）。福泰制药小核酸药物探索神经肌肉疾病近日，福泰制药在ClinicalTrials网站登记一项Ⅱ期临床试验，评估VX-670对Ⅰ型强直性肌营养不良症（DM1）患者的长期安全性和耐受性、疗效和药代动力学。这项开放标签扩展研究试验拟招募36名患者，预计2028年7月完成。VX-670是一种磷酰二胺基吗啉寡核苷酸（PMO），系该公司于2023年2月从Entrada Therapeutics公司获得项目授权的产品。其靶向DM1致病因素DMPK，与一个环肽（称为内体逃逸载体）连接，该环肽包含一个基序，可有效递送至细胞内并转移到CUG重复序列所在的细胞核。来源：CDE、ClinicalTrials网站编辑：李咏诗版式编辑：余远泽审校：马飞、张松辉瑞再终止GLP-1药物开发！罗氏、艾伯维等弯道超车？支付宝上线肿瘤、慢病AI名医！蚂蚁、华为、苹果等大厂开卷？“猴茅”昭衍新药暴跌！FDA计划放弃动物实验，CRO价值逻辑生变？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":"","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":"4.36.0","shortVersion":"4.36.0","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/2527299736","isCrawlerRequest":true}