從康辰藥業KC1086看KAT6靶向藥潛力：輝瑞、恒瑞等藥企搶灘，或攻克CDK4/6耐藥

CPHI製藥在線

2025/07/01

關注並星標CPHI製藥在線日前，北京康辰藥業股份有限公司（簡稱：康辰藥業）1類新藥KC1086片在國內獲得臨床試驗默示許可，擬用於晚期復發或轉移性實體瘤。KC1086是康辰藥業完全自主研發的一款具有全新結構的強效、高選擇性賴氨酸乙酰轉移酶6（KAT6）的小分子抑制劑。臨床前研究顯示：在ER+/HER2-的乳腺癌藥效模型中，同等劑量水平下KC1086對腫瘤生長具有更強的抑制作用，且在其他實體瘤藥效...

網頁鏈接

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2548003569"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2548003569\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2548003569?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":false,"pubTime":"2025-07-01 18:35","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2548003569","market":"us","top_or_hot":-1,"title":"從康辰藥業KC1086看KAT6靶向藥潛力：輝瑞、恒瑞等藥企搶灘，或攻克CDK4/6耐藥","media":"CPHI製藥在線","content":"<div>\n<p>關注並星標CPHI製藥在線日前，北京康辰藥業股份有限公司（簡稱：康辰藥業）1類新藥KC1086片在國內獲得臨床試驗默示許可，擬用於晚期復發或轉移性實體瘤。KC1086是康辰藥業完全自主研發的一款具有全新結構的強效、高選擇性賴氨酸乙酰轉移酶6（KAT6）的小分子抑制劑。臨床前研究顯示：在ER+/HER2-的乳腺癌藥效模型中，同等劑量水平下KC1086對腫瘤生長具有更強的抑制作用，且在其他實體瘤藥效...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250701185313a4c8d3e0&s=b\">網頁鏈接</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>從康辰藥業KC1086看KAT6靶向藥潛力：輝瑞、恒瑞等藥企搶灘，或攻克CDK4/6耐藥</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: 12.5px; color: #7E829C; margin: 0;}\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從康辰藥業KC1086看KAT6靶向藥潛力：輝瑞、恒瑞等藥企搶灘，或攻克CDK4/6耐藥\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">CPHI製藥在線</strong><span class=\"h-time small\">2025-07-01 18:35</span>\n</p>\n</h4>\n</header>\n<article>\n<div>\n<p>關注並星標CPHI製藥在線日前，北京康辰藥業股份有限公司（簡稱：康辰藥業）1類新藥KC1086片在國內獲得臨床試驗默示許可，擬用於晚期復發或轉移性實體瘤。KC1086是康辰藥業完全自主研發的一款具有全新結構的強效、高選擇性賴氨酸乙酰轉移酶6（KAT6）的小分子抑制劑。臨床前研究顯示：在ER+/HER2-的乳腺癌藥效模型中，同等劑量水平下KC1086對腫瘤生長具有更強的抑制作用，且在其他實體瘤藥效...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250701185313a4c8d3e0&s=b\">網頁鏈接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250701185313a4c8d3e0&s=b\">CPHI製藥在線</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0170899867.USD","symbol_name":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250701185313a4c8d3e0&s=b","article_id":"2548003569","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250701185313a4c8d3e0&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=2548003569","pubTimestamp":1751366118,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"因此，KAT6被認為是腫瘤藥研發的潛力靶點。此外，KAT6靶向藥領域已有BD交易達成。總結整體來看，KAT6靶向藥大多處於早期階段，輝瑞的PF-07248144預計有望最先進入3期臨床。適應症上看，當前KAT6靶向藥主要集中在乳腺癌，有望攻克CDK4/6抑制劑耐藥問題。期待KAT6靶向藥早日迎來重大突破，造福廣大腫瘤患者。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"600276":"恒瑞医药","603590":"康辰药业","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4568":"美国抗疫概念","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","PFE":"辉瑞","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4550":"红杉资本持仓","BK4592":"伊斯兰概念","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","BK4588":"碎股","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0234572021.USD":"高盛美国核心股票组合Acc","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","LU0122379950.USD":"贝莱德世界健康科学A2","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU0058720904.USD":"联博国际健康护理基金A","BK4534":"瑞士信贷持仓","BK4007":"制药","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","SG9999001176.USD":"United Global Healthcare Acc USD","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","BK4599":"减肥药","BK4581":"高盛持仓","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","01276":"恒瑞医药","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","BK4585":"ETF&股票定投概念","SG9999002232.USD":"Allianz Global High Payout USD"},"translate_title":"Looking at the potential of KAT6 targeted drugs from Kangchen Pharmaceutical KC1086: Pfizer, Hengrui and other pharmaceutical companies seize the beach, or overcome CDK4/6 drug resistance","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600276":0.9,"603590":0.9,"01276":0.9,"PFE":1},"content_text":"關注並星標CPHI製藥在線日前，北京康辰藥業股份有限公司（簡稱：康辰藥業）1類新藥KC1086片在國內獲得臨床試驗默示許可，擬用於晚期復發或轉移性實體瘤。KC1086是康辰藥業完全自主研發的一款具有全新結構的強效、高選擇性賴氨酸乙酰轉移酶6（KAT6）的小分子抑制劑。臨床前研究顯示：在ER+/HER2-的乳腺癌藥效模型中，同等劑量水平下KC1086對腫瘤生長具有更強的抑制作用，且在其他實體瘤藥效模型中顯示出類似的效果。此外，KC1086的ADME特性和安全性評價結果顯示可有效解決此類化合物的蓄積問題，無明顯的種屬差異。康辰藥業是集研產銷於一體的創新藥企業，除了KC1086，公司還有多款在研項目，其中ZY5301（「金草片」）是NMPA批准的針對「盆腔炎性疾病後遺症慢性盆腔痛」的唯一中藥，其3期臨床試驗已達到主要研究終點，完成遞交Pre-NDA並已獲得受理。ZY5301屬於我國在研中藥1.2類新藥，其主要成分是總環烯醚萜苷，由筋骨草全草提取獲得。2024年3月，公司宣佈該藥在女性盆腔炎性疾病後遺症慢性盆腔痛患者中開展的3期臨床試驗（CTR20222693）已達到主要研究終點。統計分析結果顯示：ZY5301在為期12周治療期內VAS評分的疼痛消失率達到主要研究終點，其安全性及耐受性表現良好，且不良事件發生率低。KC1036進展也較快，是其公司自主研發且具有完全自主知識產權的II型非競爭性AXL、VEGFR多靶點受體酪氨酸激酶抑制劑，通過抑制AXL、VEGFR2等靶點實現抗腫瘤活性，被開發針對消化系統腫瘤、胸腺腫瘤等多個適應症。已公布的臨床試驗結果顯示：截至2023年7月31日，KC1036單藥治療晚期食管鱗癌（ESCC）的ORR為26.1%，疾病控制率DCR為69.6%，中位OS為7.1月，明顯優於現有臨床結果。關於KAT6及其靶向藥進展KAT6屬於MYST家族組蛋白乙酰化酶，在調節轉錄、發育、造血細胞分化、細胞周期進程和有絲分裂方面發揮關鍵作用。KAT6 包括 KAT6A、KAT6B兩種亞型其中KAT6A於1996年在急性髓系白血病（AML）的染色體異位中首次被發現。KAT6B於1999年被鑑定為KAT6A的旁系同源物。研究發現，KAT6通過對組蛋白H3和非組蛋白進行乙酰化修飾，在細胞周期調控、幹細胞自我更新等方面發揮着重要作用，其異常表達（包括突變、基因組擴增、缺失或融合）往往會導致乳腺癌、卵巢癌、宮頸癌、膠質母細胞瘤、白血病等多種疾病的發生。因此，KAT6被認為是腫瘤藥研發的潛力靶點。據不完全統計，全球還有多款在研KAT6靶向藥，詳見下表。在研KAT6靶向藥大多處於早期臨床，恒瑞醫藥的HRS-2189進展較快，其前列腺癌適應症已進入2期階段。輝瑞的PF-07248144是全球最先開展臨床研究的KAT6抑制劑，通過與KAT6A/B選擇性結合，抑制組蛋白H3第23位賴氨酸乙酰化修飾（H3K23Ac），從而影響基因轉錄發揮治療作用。2025 ASCO大會上公布的PF-07248144作為單藥療法，以及與氟維司羣治療曾接受過大量治療的ER+/HER2-轉移性乳腺癌的首次人體 1期劑量遞增/擴展研究結果顯示：1mg、5mgPF-07248144+氟維司羣治療組的ORR分別為24.1%、37.2%，CBR分別為37.9%、55.8%，mDOR分別為4.6個月、15.8個月，mPFS分別為3.6個月、10.7個月。安全性方面，最常見的3級及以上副作用為中性粒細胞貧血，該副作用可以逆轉且可以通過劑量調整來控制，未發生肺炎副作用。輝瑞計劃今年開展該藥的關鍵3期臨床，進一步鞏固公司在乳腺癌領域的優勢。Olema Oncology的OP-3136在臨床前研究中顯示出顯著的抗腫瘤活性，無論單藥使用還是與palazestrant（一款雌激素受體完全拮抗劑）聯合。齊魯製藥的QLS1304在ER+/HER2-乳腺癌體內模型中無論單藥還是與SoC聯用均展示出了強勁的抗腫瘤療效，今年5月被FDA授予快速通道資格認定。復宏漢霖的HLX97-053在對CDK4/6抑制劑耐藥患者來源的異種移植瘤模型中表現出與氟維司羣和哌柏西利明顯更強的協同作用，且其血液學毒性也顯著降低，具有同類最佳的潛力。此外，KAT6靶向藥領域已有BD交易達成。2024年1月，英硅智能將ISM5043的全球獨家開發和商業化權益授予給美納里尼，總金額高達5億美元。總結整體來看，KAT6靶向藥大多處於早期階段，輝瑞的PF-07248144預計有望最先進入3期臨床。適應症上看，當前KAT6靶向藥主要集中在乳腺癌，有望攻克CDK4/6抑制劑耐藥問題。期待KAT6靶向藥早日迎來重大突破，造福廣大腫瘤患者。","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"}}}