劲方医药-B(02595)：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药

智通财经10-22

智通财经APP讯，劲方医药-B(02595)发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督管理局临床试验批准，该研究包含GFH375(口服KRAS G12D抑制剂)联合西妥昔单抗或化疗两项联合疗法;其中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。...

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/2577198386?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-10-22 07:34","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2577198386","market":"hk","top_or_hot":-1,"title":"劲方医药-B(02595)：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药","media":"智通财经","content":"<div>\n<p>智通财经APP讯，劲方医药-B(02595)发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督管理局临床试验批准，该研究包含GFH375(口服KRAS G12D抑制剂)联合西妥昔单抗或化疗两项联合疗法;其中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1357858.html\">网页链接</a>\n\n</div>\n","source":"stock_zhitongcaijing","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>劲方医药-B(02595)：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药</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劲方医药-B(02595)：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-10-22 07:34 北京时间&nbsp;&nbsp;&nbsp;<a href=http://www.zhitongcaijing.com/content/detail/1357858.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯，劲方医药-B(02595)发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督管理局临床试验批准，该研究包含GFH375(口服KRAS G12D抑制剂)联合西妥昔单抗或化疗两项联合疗法;其中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1357858.html\">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":"BK1515","symbol_name":"抗疫概念","start_time":0,"source_url":"http://www.zhitongcaijing.com/content/detail/1357858.html","article_id":"2577198386","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2577198386","pubTimestamp":1761089667,"columns":[],"sourceInfo":{"source_id":"stock_zhitongcaijing","name":"智通财经网"},"weMediaInfo":null,"summary":"智通财经APP讯，劲方医药-B 发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究首例患者在北京大学肿瘤医院完成入组。Ib期试验将首先在北京大学肿瘤医院等约15家中心开展，整体试验的主要研究目的为评估GFH375联合西妥昔单抗或化疗两项联合疗法在实体瘤患者中的安全性╱耐受性、疗效和药代动力学特征。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"159938":"医药","BK1515":"抗疫概念","BK1161":"生物科技","BK1574":"生物医药B类股","02595":"劲方医药-B","09939":"开拓药业-B"},"translate_title":"Jinfang Pharmaceutical-B (02595): Phase Ib/II study of KRAS G12D inhibitor GFH375 combined with cetuximab or chemotherapy for the treatment of advanced solid tumors completed the first patient administration","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"159938":1.5,"02595":1.5,"09939":1.5},"content_text":"智通财经APP讯，劲方医药-B(02595)发布公告，GFH375联合疗法治疗KRAS G12D突变型晚期实体瘤的Ib/II期研究首例患者在北京大学肿瘤医院完成入组。此项研究(GFH375X1202)于9月获得国家药品监督管理局临床试验批准，该研究包含GFH375(口服KRAS G12D抑制剂)联合西妥昔单抗或化疗两项联合疗法;其中GFH375联合化疗方案为一线胰腺导管腺癌(PDAC)治疗方案。Ib期试验将首先在北京大学肿瘤医院等约15家中心开展，整体试验的主要研究目的为评估GFH375联合西妥昔单抗或化疗两项联合疗法在实体瘤患者中的安全性╱耐受性、疗效和药代动力学特征。II期试验中，GFH375联合化疗(白蛋白紫杉醇和吉西他滨)方案将治疗一线晚期PDAC患者，GFH375联合西妥昔单抗(EGFR单抗)方案将治疗晚期PDAC和结直肠癌(CRC)患者。劲方首席医学官汪裕博士表示：“很高兴GFH375两项联合疗法方案进入临床阶段，尤其是一线PDAC治疗将把GFH375临床开发从后线推向前线。GFH375单药治疗PDAC及非小细胞肺癌(NSCLC)的研究数据，近期分别在ESMO和WCLC以突破性研究摘要、口头报告形式展示，优秀疗效提示了该产品治疗多个瘤种的前景。我们期待基于该产品的多项国内外研究能够快速推进，早日造福患者。”GFH375单药疗法于2024年6月获国家药监局批准进入I/II期试验，GFH375/ VS-7375今年已获得FDA快速通道资格认定，可用于一线及后线治疗局部晚期、转移性KRAS G12D突变型PDAC患者。GFH375为口服高活性、高选择性小分子KRAS G12D(ON/OFF)抑制剂，通过非共价形式结合KRAS G12D蛋白，抑制其与下游效应蛋白结合，从而在细胞中破坏 KRAS G12D对下游通路的持续活化，最终高效抑制肿瘤细胞增殖。临床前研究已显示GFH375单药对肿瘤生长的抑制效应随用药剂量和周期增长而提升，且在激酶选择性和安全性靶点测试中显示低脱靶风险。劲方与Verastem就劲方开发的三款有关RAS/MAPK驱动癌症的产品达成了授权及早期合作开发协议。该合作赋予Verastem独家选择权，以就该等三款产品在成功达成I期临床试验预先设定的里程碑后获得各自许可。于2023年12月，Verastem 选择GFH375/VS-7375(一款口服KRAS G12D(ON/OFF)抑制剂)作为其合作的领头项目，就GFH375获得的许可乃该合作诞生的第一个许可。该等许可将赋予 Verastem在大中华区外的开发和商业化权利，而劲方保留中国境内的该等权利。","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":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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.9","shortVersion":"4.35.9","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/2577198386","isCrawlerRequest":true}