{"id":112520,"date":"2024-04-26T20:39:00","date_gmt":"2024-04-26T13:39:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/20240426203900112520"},"modified":"2024-04-27T00:28:33","modified_gmt":"2024-04-26T16:28:33","slug":"%e5%91%8b%e5%96%b9%e6%9b%bf%e5%b0%bc%e8%8e%b7%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80chmp%e7%a7%af%e6%9e%81%e6%84%8f%e8%a7%81%e7%94%a8%e4%ba%8e%e7%bb%93%e7%9b%b4%e8%82%a0","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/20240426203900112520","title":{"rendered":"\u544b\u55b9\u66ff\u5c3c\u83b7\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40CHMP\u79ef\u6781\u610f\u89c1\u7528\u4e8e\u7ed3\u76f4\u80a0\u764c"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/www.xinwengao.com\/cn\/wp-content\/uploads\/HUTCHMED_Logo_Logo-8.jpg\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><p><b><span id=\"spanHghlt9bdd\">\u548c\u9ec4\u533b\u836f\u5ba3\u4f48\u6b66\u7530\u83b7\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a (CHMP) \u79ef\u6781\u610f\u89c1 \u652f\u6301\u544b\u55b9\u66ff\u5c3c (fruquintinib) \u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c<\/span><\/b><\/p>\n<p><i>\u2014 <\/i><i>\u82e5\u4e8e\u6b27\u76df\u83b7\u6279\uff0c\u544b\u55b9\u66ff\u5c3c\u5c06\u6210\u4e3a\u8d85\u8fc7\u5341\u5e74\u6765\u7b2c\u4e00\u4e2a\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u7684\u521b\u65b0\u9776\u5411\u7597\u6cd5\uff0c\u65e0\u8bba\u60a3\u8005\u7684\u751f\u7269\u6807\u5fd7\u7269\u72b6\u6001\u5982\u4f55<\/i><i>&nbsp;\u2014<\/i><\/p>\n<p><i>\u2014 <\/i><i>\u57fa\u4e8e<\/i><i>FRESCO<\/i><i>\u2011<\/i><i>2&nbsp; III <\/i><i>\u671f\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\u7ed9\u51fa\u79ef\u6781\u610f\u89c1<\/i><i>&nbsp;\u2014<\/i><\/p>\n<p><span class=\"legendSpanClass\">\u9999\u6e2f\u3001\u4e0a\u6d77\u548c\u65b0\u6cfd\u897f\u5dde\u5f17\u6d1b\u52d2\u59c6\u516c\u56ed<\/span><span class=\"legendSpanClass\">2024\u5e744\u670826\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; <b>\u548c\u9ec4\u533b\u836f\uff08\u4e2d\u56fd\uff09\u6709\u9650\u516c\u53f8<\/b>\uff08\u7b80\u79f0&quot;<a href=\"https:\/\/www.hutch-med.com\/sc\/home\/\" target=\"_blank\" rel=\"nofollow noopener\">\u548c\u9ec4\u533b\u836f<\/a>&quot;\u6216&quot;HUTCHMED&quot;\uff09\uff08\u7eb3\u65af\u8fbe\u514b\/\u4f26\u6566\u8bc1\u4ea4\u6240\uff1aHCM\uff1b\u9999\u6e2f\u4ea4\u6613\u6240\uff1a13\uff09\u4eca\u65e5\u5ba3\u5e03\u5176<span id=\"spanHghlt824a\">\u5408\u4f5c\u4f19\u4f34<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&amp;esheet=52286207&amp;newsitemid=20200915005224&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=2&amp;md5=b7076f2bbb02ad331cdf76657f8aa07f\" target=\"_blank\" rel=\"nofollow noopener\">\u6b66\u7530<\/a><\/span>\u53d6\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08&quot;EMA&quot;\uff09\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08&quot;CHMP&quot;\uff09\u5efa\u8bae\u6279\u51c6\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u7684\u6210\u4eba\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u3002<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<\/p><\/div>\n<p>\u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u5728\u51b3\u5b9a\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u5728\u6574\u4e2a\u6b27\u76df\u3001\u632a\u5a01\u3001\u5217\u652f\u6566\u58eb\u767b\u548c\u51b0\u5c9b\u7684\u4e0a\u5e02\u8bb8\u53ef\u65f6\uff0c\u5c06\u4f1a\u628aCHMP\u7684\u79ef\u6781\u610f\u89c1\u7eb3\u5165\u8003\u8651\u3002&nbsp;\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff0c\u544b\u55b9\u66ff\u5c3c\u5c06\u6210\u4e3a\u6b27\u76df\u6279\u51c6\u7528\u4e8e\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u7684\u7b2c\u4e00\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u6240\u6709\u4e09\u79cd\u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08&quot;VEGFR&quot;\uff09\u7684\u9009\u62e9\u6027\u6291\u5236\u5242\u3002&nbsp;<sup>[1]<sup>,<\/sup>[2]<\/sup>&nbsp;\u6b66\u7530\u62e5\u6709\u5728\u4e2d\u56fd\u5185\u5730\u3001\u9999\u6e2f\u548c\u6fb3\u95e8\u4ee5\u5916\u8fdb\u4e00\u6b65\u5f00\u53d1\u3001\u5546\u4e1a\u5316\u548c\u751f\u4ea7\u544b\u55b9\u66ff\u5c3c\u7684\u5168\u7403\u72ec\u5bb6\u8bb8\u53ef\u3002<\/p>\n<p><b>\u6b66\u7530\u80bf\u7624\u90e8\u9996\u5e2d\u533b\u5b66\u5b98<\/b><b>Awny Farajallah <\/b><b>\u533b\u5b66\u535a\u58eb<\/b>\u8868\u793a\uff1a&quot;\u900f\u8fc7\u4e0e\u548c\u9ec4\u533b\u836f\u7684\u5408\u4f5c\uff0c\u6211\u4eec\u5728\u6269\u5927\u544b\u55b9\u66ff\u5c3c\u5728\u9002\u7528\u60a3\u8005\u4e2d\u7684\u53ef\u53ca\u6027\u65b9\u9762\u53d6\u5f97\u4e86\u957f\u8db3\u8fdb\u5c55\u3002&nbsp;\u968f\u7740CHMP \u5bf9\u544b\u55b9\u66ff\u5c3c\u7ed9\u51fa\u79ef\u6781\u610f\u89c1\uff0c\u6211\u4eec\u8ddd\u79bb\u4e3a\u6b27\u76df\u60a3\u8005\u63d0\u4f9b\u4e00\u79cd\u6709\u671b\u5e26\u6765\u663e\u8457\u7684\u751f\u5b58\u83b7\u76ca\u7684\u53e3\u670d\u3001\u975e\u5316\u7597\u6cbb\u7597\u9009\u62e9\u53c8\u8fd1\u4e86\u4e00\u6b65\u3002\u6211\u4eec\u671f\u5f85\u6b27\u76df\u59d4\u5458\u4f1a\u5728\u4e0d\u4e45\u7684\u5c06\u6765\u505a\u51fa\u6b63\u5f0f\u51b3\u5b9a\u3002&quot;<\/p>\n<p><b>\u548c\u9ec4\u533b\u836f\u9996\u5e2d\u6267\u884c\u5b98\u517c\u9996\u5e2d\u79d1\u5b66\u5b98\u82cf\u6170\u56fd\u535a\u58eb<\/b>\u8868\u793a\uff1a&quot;\u548c\u9ec4\u533b\u836f\u5728\u4e3a\u6709\u9700\u8981\u7684\u60a3\u8005\u5f00\u53d1\u521b\u65b0\u80bf\u7624\u836f\u7269\u65b9\u9762\u62e5\u6709\u826f\u597d\u7684\u5f80\u7ee9\u3002&nbsp;\u76ee\u524d\uff0c\u6b27\u76df\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u53ef\u7528\u7684\u6cbb\u7597\u9009\u62e9\u6709\u9650\uff0c\u5bfc\u81f4\u6cbb\u7597\u7ed3\u679c\u4e0d\u4f73\u3002&nbsp;\u6211\u4eec\u5bf9\u5408\u4f5c\u4f19\u4f34\u6b66\u7530\u5728\u91cd\u65b0\u5b9a\u4e49\u6cbb\u7597\u683c\u5c40\uff0c\u5e76\u89e3\u51b3\u6b27\u6d32\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u91cd\u5927\u672a\u88ab\u6ee1\u8db3\u7684\u9700\u6c42\u9886\u57df\u53d6\u5f97\u8fdb\u5c55\u611f\u5230\u5341\u5206\u9ad8\u5174\u3002\u5728\u8fc7\u53bb\u7684\u4e94\u5e74\u95f4\uff0c\u8fd9\u79cd\u521b\u65b0\u80bf\u7624\u836f\u7269\u4e3a\u4e2d\u56fd\u60a3\u8005\u5e26\u6765\u4e86\u6df1\u8fdc\u7684\u5f71\u54cd\u3002\u81ea\u4ece\u4e0e\u6b66\u7530\u8fbe\u6210\u5408\u4f5c\u4ee5\u6765\uff0c\u6211\u4eec\u770b\u5230\u8fd9\u4e00\u5f71\u54cd\u7684\u8303\u56f4\u5f97\u4ee5\u8fdb\u4e00\u6b65\u6269\u5927\uff0c\u5728\u7f8e\u56fd\u83b7\u5f97\u6279\u51c6\u548c\u4e0a\u5e02\uff0c\u73b0\u5728\u5219\u662f\u7b49\u5f85\u6b27\u76df\u59d4\u5458\u4f1a\u7684\u6279\u51c6\uff0c\u6211\u4eec\u671f\u5f85\u8be5\u836f\u7269\u4e5f\u4e3a\u6b27\u6d32\u60a3\u8005\u5e26\u6765\u79ef\u6781\u7684\u5f71\u54cd\u3002&nbsp;&quot;<\/p>\n<p>CHMP \u7684\u79ef\u6781\u610f\u89c1\u4e3b\u8981\u57fa\u4e8e&nbsp;FRESCO-2\u56fd\u9645\u591a\u4e2d\u5fc3III \u671f\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7ed3\u679c\u4ea6\u652f\u6301\u4e86\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u7684\u63d0\u4ea4\u3002&nbsp;\u8be5\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u5df2\u4e8e&nbsp;2023 \u5e74&nbsp;6 \u6708\u83b7EMA<a href=\"https:\/\/www.hutch-med.com\/sc\/fruquintinib-ema-validation\/\" target=\"_blank\" rel=\"nofollow noopener\">\u786e\u8ba4\u53ca\u53d7\u7406<\/a>\u3002<\/p>\n<p><b>\u5173\u4e8e\u7ed3\u76f4\u80a0\u764c<br \/><\/b>\u7ed3\u76f4\u80a0\u764c\u662f\u59cb\u4e8e\u7ed3\u80a0\u6216\u76f4\u80a0\u7684\u764c\u75c7\u3002\u6839\u636e\u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784\uff08IARC\uff09\u7684\u6570\u636e\uff0c\u7ed3\u76f4\u80a0\u764c\u662f\u5168\u7403\u7b2c\u4e09\u5927\u5e38\u89c1\u764c\u75c7\u3002\u57282020\u5e74\u4f30\u8ba1\u9020\u6210\u8d85\u8fc793.5\u4e07\u4eba\u6b7b\u4ea1\u3002\u5728\u6b27\u6d32\uff0c\u7ed3\u76f4\u80a0\u764c\u662f\u7b2c\u4e8c\u5927\u5e38\u89c1\u764c\u75c7\uff0c2020\u5e74\u7ea6\u670952\u4e07\u4f8b\u65b0\u589e\u75c5\u4f8b\u548c24.5\u4e07\u4f8b\u6b7b\u4ea1\u3002<sup>[3]<\/sup>&nbsp;\u5728\u7f8e\u56fd\uff0c2024\u5e74\u4f30\u8ba1\u5c06\u65b0\u589e15.3\u4e07\u4f8b\u7ed3\u76f4\u80a0\u764c\u65b0\u75c7\u4ee5\u53ca5.3\u4e07\u4f8b\u6b7b\u4ea1\u3002<sup>[4]<\/sup> \u5728\u65e5\u672c\uff0c\u7ed3\u76f4\u80a0\u764c\u662f\u6700\u5e38\u89c1\u7684\u764c\u75c7\uff0c2020\u5e74\u4f30\u8ba1\u670914.8\u4e07\u4f8b\u65b0\u589e\u75c5\u4f8b\u548c6\u4e07\u4f8b\u6b7b\u4ea1\u3002<sup>[3]<\/sup>&nbsp;\u5c3d\u7ba1\u65e9\u671f\u7ed3\u76f4\u80a0\u764c\u80fd\u591f\u901a\u8fc7\u624b\u672f\u5207\u9664\uff0c\u4f46\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u76ee\u524d\u6cbb\u7597\u7ed3\u679c\u4e0d\u4f73\u4e14\u6cbb\u7597\u65b9\u6848\u6709\u9650\uff0c\u4ecd\u7136\u5b58\u5728\u5927\u91cf\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u867d\u7136\u90e8\u5206\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u6216\u53ef\u53d7\u76ca\u4e8e\u57fa\u4e8e\u5206\u5b50\u7279\u5f81\u7684\u4e2a\u6027\u5316\u6cbb\u7597\u7b56\u7565\uff0c\u7136\u800c\u5927\u90e8\u5206\u60a3\u8005\u672a\u643a\u5e26\u53ef\u4f5c\u4e3a\u6cbb\u7597\u9776\u70b9\u7684\u7a81\u53d8\u3002&nbsp;<sup>[5]<sup>,<\/sup>[6]<sup>,<\/sup>[7]<sup>,<\/sup>[8]<sup>,<\/sup>[9]&nbsp;<\/sup><\/p>\n<p><b>\u5173\u4e8e<\/b><b>FRESCO<\/b><b>\u2011<\/b><b>2 III<\/b><b>\u671f\u7814\u7a76<br \/><\/b>FRESCO\u20112\u7814\u7a76\u662f\u4e00\u9879\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u3001\u65e5\u672c\u53ca\u6fb3\u5927\u5229\u4e9a\u5f00\u5c55\u7684\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65e8\u5728\u63a2\u7d22\u544b\u55b9\u66ff\u5c3c\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u5bf9\u6bd4\u5b89\u6170\u5242\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\uff08<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04322539\" target=\"_blank\" rel=\"nofollow noopener\">NCT04322539<\/a>\uff09\u3002FRESCO\u20112\u7814\u7a76\u8fbe\u5230\u4e86\u6240\u6709\u4e3b\u8981\u7ec8\u70b9\u53ca\u5173\u952e\u6b21\u8981\u7ec8\u70b9\uff0c\u5728\u603b\u751f\u5b58\u671f\uff08OS\uff09\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u65b9\u9762\u5747\u663e\u793a\u51fa\u8fbe\u5230\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u548c\u4e34\u5e8a\u610f\u4e49\u7684\u663e\u8457\u6539\u5584\uff0c\u5e76\u5728\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u5c55\u73b0\u51fa\u4e00\u81f4\u7684\u83b7\u76ca\uff0c\u65e0\u8bba\u60a3\u8005\u65e2\u5f80\u63a5\u53d7\u8fc7\u4f55\u79cd\u6cbb\u7597\u3002\u544b\u55b9\u66ff\u5c3c\u5728FRESCO-2\u7814\u7a76\u4e2d\u663e\u793a\u51fa\u53ef\u63a7\u7684\u5b89\u5168\u6027\uff0c\u4e0e\u4e4b\u524d\u516c\u5e03\u7684\u544b\u55b9\u66ff\u5c3c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6240\u62a5\u544a\u7684\u4e00\u81f4\u3002\u5728\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c&nbsp;20%\u51fa\u73b0\u5bfc\u81f4\u6cbb\u7597\u505c\u6b62\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c\u8be5\u6bd4\u4f8b\u4e3a&nbsp;21%\u3002\u8be5\u7814\u7a76\u7684\u7ed3\u679c\u4e8e2022\u5e749\u6708\u7684\u6b27\u6d32\u80bf\u7624\u5185\u79d1\u5b66\u4f1a\uff08ESMO\uff09\u5e74\u4f1a\u4e0a<a href=\"https:\/\/oncologypro.esmo.org\/meeting-resources\/esmo-congress-2022\/fresco-2-a-global-phase-iii-multiregional-clinical-trial-mrct-evaluating-the-efficacy-and-safety-of-fruquintinib-in-patients-with-refractory-met\" target=\"_blank\" rel=\"nofollow noopener\">\u516c\u5e03<\/a>\uff0c\u5e76\u968f\u540e\u57282023\u5e746\u6708\u4e8e\u300a\u67f3\u53f6\u5200\uff08The Lancet\uff09\u300b<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(23)00772-9\/fulltext\" target=\"_blank\" rel=\"nofollow noopener\">\u53d1\u8868<\/a>\u3002<sup>[10]<sup>,<\/sup>[11]<\/sup>&nbsp;<\/p>\n<p><b>\u5173\u4e8e\u544b\u55b9\u66ff\u5c3c<br \/><\/b>\u544b\u55b9\u66ff\u5c3c\u662f\u4e00\u79cd\u9009\u62e9\u6027\u7684\u53e3\u670dVEGFR-1\u3001-2\u53ca-3\u6291\u5236\u5242\u3002VEGFR\u6291\u5236\u5242\u5728\u6291\u5236\u80bf\u7624\u7684\u8840\u7ba1\u751f\u6210\u4e2d\u8d77\u5230\u81f3\u5173\u91cd\u8981\u7684\u4f5c\u7528\u3002\u544b\u55b9\u66ff\u5c3c\u88ab\u8bbe\u8ba1\u4e3a\u62e5\u6709\u66f4\u9ad8\u7684\u6fc0\u9176\u9009\u62e9\u6027\uff0c\u65e8\u5728\u964d\u4f4e\u8131\u9776\u6fc0\u9176\u6d3b\u6027\uff0c\u4ece\u800c\u5b9e\u73b0\u66f4\u9ad8\u7684\u836f\u7269\u66b4\u9732\u3001\u5bf9\u9776\u70b9\u7684\u6301\u7eed\u8986\u76d6\u4ee5\u53ca\u5f53\u6f5c\u5728\u4f5c\u4e3a\u8054\u5408\u7597\u6cd5\u65f6\u62e5\u6709\u66f4\u9ad8\u7684\u7075\u6d3b\u5ea6\u3002\u8fc4\u4eca\u4e3a\u6b62\uff0c\u544b\u55b9\u66ff\u5c3c\u5c55\u793a\u51fa\u53ef\u63a7\u7684\u5b89\u5168\u6027\u7279\u5f81\uff0c\u5176\u4e0e\u5176\u4ed6\u6297\u80bf\u7624\u7597\u6cd5\u8054\u5408\u4f7f\u7528\u7684\u7814\u7a76\u6b63\u5728\u8fdb\u884c\u4e2d\u3002<\/p>\n<p><b>\u5173\u4e8e\u6b66\u7530\u548c<\/b><b>FRUZAQLA<sup>&reg;<br \/><\/sup><\/b>\u6b66\u7530\u62e5\u6709\u5728\u4e2d\u56fd\u5185\u5730\u3001\u9999\u6e2f\u548c\u6fb3\u95e8\u4ee5\u5916\u8fdb\u4e00\u6b65\u5f00\u53d1\u3001\u5546\u4e1a\u5316\u548c\u751f\u4ea7\u544b\u55b9\u66ff\u5c3c\u7684\u5168\u7403\u72ec\u5bb6\u8bb8\u53ef\u3002\u544b\u55b9\u66ff\u5c3c\u4e8e2023\u5e7411\u6708<a href=\"https:\/\/www.hutch-med.com\/sc\/us-fda-approval-of-fruzaqla-fruquintinib\/\" target=\"_blank\" rel=\"nofollow noopener\">\u4e8e\u7f8e\u56fd\u83b7\u5f97\u6279\u51c6<\/a>\uff0c\u5e76\u7531\u6b66\u7530\u4ee5\u5546\u54c1\u540dFRUZAQLA<sup>&reg;<\/sup>\u4e0a\u5e02\u9500\u552e\u3002\u7f8e\u56fd\u7684\u83b7\u6279\u662f\u57fa\u4e8e\u4e24\u9879\u5927\u578b\u3001\u968f\u673a\u5bf9\u7167III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6570\u636e\uff0c\u5373\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8cFRESCO-2\u7814\u7a76\u4ee5\u53ca\u4e8e\u4e2d\u56fd\u5f00\u5c55\u7684FRESCO\u7814\u7a76\uff0c\u5728\u603b\u5171734\u540d\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u5c55\u73b0\u51fa\u4e86\u4e00\u81f4\u7684\u83b7\u76ca\u3002\u5404\u9879\u7814\u7a76\u7684\u5b89\u5168\u6027\u7279\u5f81\u4ea6\u4fdd\u6301\u4e00\u81f4\u3002<\/p>\n<p>\u9664\u4e86\u5411EMA\u63d0\u4ea4\u7684\u7533\u8bf7\u5916\uff0c\u4e00\u9879\u5411\u65e5\u672c\u533b\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5c40\uff08PMDA\uff09\u7684\u7533\u8bf7\u4ea6\u4e8e2023\u5e749\u6708\u63d0\u4ea4\u3002<\/p>\n<p><b>\u5173\u4e8e\u544b\u55b9\u66ff\u5c3c\u5728\u4e2d\u56fd\u83b7\u6279<br \/><\/b>\u544b\u55b9\u66ff\u5c3c\u5df2\u4e8e\u4e2d\u56fd\u83b7\u6279\u4e0a\u5e02\uff0c\u5e76\u7531\u548c\u9ec4\u533b\u836f\u53ca\u793c\u6765\u5408\u4f5c\u4ee5\u5546\u54c1\u540d\u7231\u4f18\u7279<sup>&reg;<\/sup>\u4e0a\u5e02\u9500\u552e\u3002\u5176\u4e8e2020\u5e741\u6708\u83b7\u7eb3\u5165\u4e2d\u56fd\u56fd\u5bb6\u533b\u4fdd\u836f\u54c1\u76ee\u5f55\u3002\u5728\u4e2d\u56fd416\u4f8b\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\u5f00\u5c55\u7684\u544b\u55b9\u66ff\u5c3cIII\u671f\u5173\u952e\u6027\u6ce8\u518c\u7814\u7a76FRESCO\u7684\u7814\u7a76\u652f\u6301\u4e86\u544b\u55b9\u66ff\u5c3c\u5728\u4e2d\u56fd\u7684\u83b7\u6279\uff0c\u8be5\u7814\u7a76\u7684\u7ed3\u679c\u5df2\u4e8e\u300a\u7f8e\u56fd\u533b\u5b66\u4f1a\u6742\u5fd7\uff08JAMA\uff09\u300b\u4e0a<a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2685988\" target=\"_blank\" rel=\"nofollow noopener\">\u53d1\u8868<\/a>\u3002\u81ea\u544b\u55b9\u66ff\u5c3c\u5728\u4e2d\u56fd\u4e0a\u5e02\u4ee5\u6765\uff0c\u622a\u81f32023\u5e74\u5e74\u4e2d\u5df2\u6709\u8d85\u8fc78\u4e07\u540d\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u6cbb\u7597\u3002<\/p>\n<p><b>\u5173\u4e8e\u548c\u9ec4\u533b\u836f<br \/><\/b>\u548c\u9ec4\u533b\u836f\uff08\u7eb3\u65af\u8fbe\u514b\/\u4f26\u6566\u8bc1\u4ea4\u6240\uff1aHCM\uff1b\u9999\u6e2f\u4ea4\u6613\u6240\uff1a13\uff09\u662f\u4e00\u5bb6\u5904\u4e8e\u5546\u4e1a\u5316\u9636\u6bb5\u7684\u521b\u65b0\u578b\u751f\u7269\u533b\u836f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u53d1\u73b0\u3001\u5168\u7403\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u6cbb\u7597\u764c\u75c7\u548c\u514d\u75ab\u6027\u75be\u75c5\u7684\u9776\u5411\u836f\u7269\u548c\u514d\u75ab\u7597\u6cd5\u3002\u96c6\u56e2\u65d7\u4e0b\u516c\u53f8\u5171\u6709\u7ea65,000\u540d\u5458\u5de5\uff0c\u5176\u4e2d\u6838\u5fc3\u7684\u80bf\u7624\/\u514d\u75ab\u4e1a\u52a1\u62e5\u6709\u7ea61,800\u4eba\u7684\u56e2\u961f\u3002\u81ea\u6210\u7acb\u4ee5\u6765\uff0c\u548c\u9ec4\u533b\u836f\u81f4\u529b\u4e8e\u5c06\u81ea\u4e3b\u53d1\u73b0\u7684\u6297\u80bf\u7624\u5019\u9009\u836f\u7269\u5e26\u5411\u5168\u7403\u60a3\u8005\uff0c\u9996\u4e09\u4e2a\u836f\u7269\u73b0\u5df2\u5728\u4e2d\u56fd\u4e0a\u5e02\uff0c\u5176\u4e2d\u9996\u4e2a\u836f\u7269\u4ea6\u4e8e\u7f8e\u56fd\u4e0a\u5e02\u3002\u6b32\u4e86\u89e3\u66f4\u591a\u8be6\u60c5\uff0c\u8bf7\u8bbf\u95ee\uff1a<a href=\"https:\/\/www.hutch-med.com\/sc\/home\/\" target=\"_blank\" rel=\"nofollow noopener\">www.hutch\u2011med.com<\/a>\u6216\u5173\u6ce8\u6211\u4eec\u7684<a href=\"https:\/\/www.linkedin.com\/company\/hutchmed\/\" target=\"_blank\" rel=\"nofollow noopener\">\u9886\u82f1<\/a>\u4e13\u9875\u3002<\/p>\n<p><b>\u7f8e\u56fd\u91cd\u8981\u5b89\u5168\u6027\u4fe1\u606f<br \/><\/b><b>\u8b66\u544a\u53ca\u6ce8\u610f\u4e8b\u9879<\/b><\/p>\n<ul type=\"disc\">\n<li>\u5728\u63a5\u53d7FRUZAQLA \u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c49%\u51fa\u73b0\u9ad8\u8840\u538b\uff0c\u5176\u4e2d19%\u51fa\u73b03-4\u7ea7\u4e8b\u4ef6\uff0c3 \u540d\u60a3\u8005\uff080.3%\uff09\u51fa\u73b0\u9ad8\u8840\u538b\u5371\u8c61\u3002\u9664\u975e\u8840\u538b\u5f97\u5230\u826f\u597d\u63a7\u5236\uff0c\u5426\u5219\u4e0d\u8981\u5f00\u59cb\u4f7f\u7528FRUZAQLA\u3002 \u7b2c\u4e00\u4e2a\u6708\u6bcf\u5468\u76d1\u6d4b\u4e00\u6b21\u8840\u538b\uff0c\u6b64\u540e\u6839\u636e\u4e34\u5e8a\u6307\u5f81\u81f3\u5c11\u6bcf\u6708\u76d1\u6d4b\u4e00\u6b21\u3002 \u89c6\u60c5\u51b5\u5f00\u59cb\u6216\u8c03\u6574\u964d\u538b\u6cbb\u7597\u3002 \u6839\u636e\u9ad8\u8840\u538b\u7684\u4e25\u91cd\u7a0b\u5ea6\uff0c\u6682\u505c\u3001\u51cf\u5c11\u5242\u91cf\u6216\u6c38\u4e45\u505c\u7528 FRUZAQLA\u3002<\/li>\n<li>\u51fa\u8840\u4e8b\u4ef6\u53ef\u80fd\u4e8eFRUZAQLA\u6cbb\u7597\u671f\u95f4\u51fa\u73b0\uff0c\u5305\u62ec\u4e25\u91cd\u3001\u81f4\u547d\u7684\u4e8b\u4ef6\u3002 \u5728\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c6%\u7684\u60a3\u8005\u51fa\u73b0\u80c3\u80a0\u9053\u51fa\u8840\uff0c\u5176\u4e2d1%\u51fa\u73b0\u22653\u7ea7\u4e8b\u4ef6\uff0c2\u540d\u60a3\u8005\u51fa\u73b0\u81f4\u547d\u6027\u51fa\u8840\u3002 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\u53ef\u80fd\u589e\u52a0\u611f\u67d3\u98ce\u9669\uff0c\u5305\u62ec\u81f4\u547d\u611f\u67d3\u3002\u5728911\u540d\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c\u6700\u5e38\u89c1\u7684\u611f\u67d3\u662f\u5c3f\u8def\u611f\u67d3\uff086.8%\uff09\u3001\u4e0a\u547c\u5438\u9053\u611f\u67d3\uff083.2%\uff09\u548c\u80ba\u708e\uff082.5%\uff09\uff1b\u81f4\u547d\u611f\u67d3\u5305\u62ec\u80ba\u708e\uff080.4%\uff09\u3001\u8d25\u8840\u75c7\uff080.2%\uff09\u3001\u7ec6\u83cc\u611f\u67d3\uff080.1%\uff09\u3001\u4e0b\u547c\u5438\u9053\u611f\u67d3\uff080.1%\uff09\u548c\u611f\u67d3\u6027\u4f11\u514b\uff080.1%\uff09\u3002\u82e5\u51fa\u73b03\u7ea7\u62164\u7ea7\u611f\u67d3\u6216\u4efb\u4f55\u7b49\u7ea7\u7684\u611f\u67d3\u6076\u5316\uff0c\u9700\u6682\u505cFRUZAQLA\u3002\u5f85\u611f\u67d3\u5f97\u5230\u63a7\u5236\u540e\uff0c\u518d\u6062\u590d\u539f\u5242\u91cf\u7684FRUZAQLA\u6cbb\u7597\u3002<\/li>\n<li>\u80c3\u80a0\u7a7f\u5b54\u53ef\u80fd\u4e8e\u63a5\u53d7FRUZAQLA \u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u51fa\u73b0\u3002\u5728\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c1.3%\u51fa\u73b0\u22653\u7ea7\u80c3\u80a0\u9053\u7a7f\u5b54\uff0c\u5305\u62ec1\u4f8b\u81f4\u547d\u4e8b\u4ef6\u3002\u51fa\u73b0\u751f\u80c3\u80a0\u7a7f\u5b54\u6216\u7618\u7ba1\u7684\u60a3\u8005\u5e94\u6c38\u4e45\u505c\u7528FRUZAQLA\u3002<\/li>\n<li>\u809d\u6bd2\u6027\u3002FRUZAQLA \u53ef\u5bfc\u81f4\u809d\u635f\u4f24\u3002\u5728\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c48%\u7684\u60a3\u8005\u51fa\u73b0\u4e19\u6c28\u9178\u8f6c\u6c28\u9176\uff08&quot;ALT&quot;\uff09\u6216\u5929\u95e8\u51ac\u6c28\u9178\u8f6c\u6c28\uff08&quot;AST&quot;\uff09\u5347\u9ad8\uff0c\u5176\u4e2d5%\u7684\u60a3\u8005\u51fa\u73b0\u22653\u7ea7\u4e8b\u4ef6\uff0c0.2%\u7684\u60a3\u8005\u51fa\u73b0\u81f4\u547d\u4e8b\u4ef6\u3002\u5728\u5f00\u59cb\u4f7f\u7528FRUZAQLA\u4e4b\u524d\u548c\u6574\u4e2a\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u5e94\u5b9a\u671f\u76d1\u6d4b\u809d\u529f\u80fd\uff08ALT\u3001AST \u548c\u80c6\u7ea2\u7d20\uff09\u3002\u5e94\u6839\u636e\u809d\u529f\u80fd\u68c0\u6d4b\u5347\u9ad8\u6240\u663e\u793a\u7684\u809d\u6bd2\u6027\u7684\u4e25\u91cd\u7a0b\u5ea6\u548c\u6301\u7eed\u6027\uff0c\u6682\u505c\u3001\u51cf\u91cf\u6216\u6c38\u4e45\u505c\u7528FRUZAQLA\u3002<\/li>\n<li>\u86cb\u767d\u5c3f\u3002FRUZAQLA\u53ef\u80fd\u5f15\u8d77\u86cb\u767d\u5c3f\u3002\u5728\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c36%\u51fa\u73b0\u86cb\u767d\u5c3f\uff0c2.5%\u7684\u60a3\u8005\u51fa\u73b0\u22653\u7ea7\u4e8b\u4ef6\u3002\u5728\u5f00\u59cb\u4f7f\u7528FRUZAQLA\u4e4b\u524d\u548c\u6574\u4e2a\u6cbb\u7597\u8fc7\u7a0b\u4e2d\u5e94\u5b9a\u671f\u76d1\u6d4b\u86cb\u767d\u5c3f\u3002\u82e524\u5c0f\u65f6\u86cb\u767d\u5c3f\u5b9a\u91cf\u22652g\uff0c\u5e94\u6682\u505cFRUZAQLA\u76f4\u81f3\u6539\u5584\u81f3\u22641\u7ea7\u86cb\u767d\u5c3f\u5e76\u4e0b\u8c03\u5242\u91cf\u7ee7\u7eedFRUZAQLA\u6cbb\u7597\u3002\u51fa\u73b0\u80be\u75c5\u7efc\u5408\u5f81\u7684\u60a3\u8005\u5e94\u505c\u7528 FRUZAQLA\u3002<\/li>\n<li>\u5728911\u540d\u63a5\u53d7FRUZAQLA\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c35%\u51fa\u73b0\u638c\u8dd6\u7ea2\u80bf\u611f\u89c9\uff08&quot;PPE&quot;\uff09\uff0c\u5176\u4e2d8%\u51fa\u73b03\u7ea7\u4e8b\u4ef6\u3002\u6839\u636ePPE \u7684\u4e25\u91cd\u7a0b\u5ea6\uff0c\u6682\u505cFRUZAQLA\u7528\u836f\uff0c\u7136\u540e\u4ee5\u539f\u5242\u91cf\u6216\u964d\u4f4e\u5242\u91cf\u6062\u590d\u7528\u836f\u3002<\/li>\n<li>\u53ef\u9006\u6027\u540e\u90e8\u8111\u75c5\u53d8\u7efc\u5408\u5f81\uff08&quot;PRES&quot;\uff09\uff0c\u5728 911 \u540d\u63a5\u53d7FRUZAQLA \u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u66fe\u51fa\u73b0\u4e00\u4f8b\uff0c\u8fd9\u662f\u4e00\u79cd\u901a\u8fc7MRI\u7279\u5f81\u6027\u53d1\u73b0\u8bca\u65ad\u7684\u76ae\u8d28\u4e0b\u8840\u7ba1\u6e90\u6027\u6c34\u80bf\u7efc\u5408\u5f81\u3002 \u4efb\u4f55\u51fa\u73b0\u766b\u75eb\u3001\u5934\u75db\u3001\u89c6\u529b\u969c\u788d\u3001\u7cbe\u795e\u9519\u4e71\u6216\u7cbe\u795e\u529f\u80fd\u6539\u53d8\u7684\u60a3\u8005\u5e94\u8fdb\u884cPRES\u8bc4\u4f30\u3002 \u5bf9\u4e8e\u51fa\u73b0PRES \u7684\u60a3\u8005\u5e94\u505c\u7528FRUZAQLA\u3002<\/li>\n<li>\u4f24\u53e3\u6108\u5408\u5ef6\u8fdf\u3002\u5728FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c1\u540d\u60a3\u8005\u51fa\u73b02\u7ea7\u4f24\u53e3\u88c2\u5f00\u4e8b\u4ef6\u3002\u5927\u624b\u672f\u524d\u81f3\u5c112\u5468\u4e0d\u8981\u670d\u7528 FRUZAQLA\u3002\u5927\u624b\u672f\u540e\u81f3\u5c112\u5468\u5185\u8bf7\u52ff\u4f7f\u7528FRUZAQLA\uff0c\u76f4\u5230\u4f24\u53e3\u5145\u5206\u6108\u5408\u3002\u4f24\u53e3\u6108\u5408\u5e76\u53d1\u75c7\u89e3\u51b3\u540e\u6062\u590d FRUZAQLA\u6cbb\u7597\u7684\u5b89\u5168\u6027\u5c1a\u672a\u786e\u5b9a\u3002<\/li>\n<li>\u52a8\u8109\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u3002\u5728\u63a5\u53d7 FRUZAQLA\u6cbb\u7597\u7684911\u540d\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u4e2d\uff0c0.8%\u7684\u60a3\u8005\u51fa\u73b0\u52a8\u8109\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u3002\u5bf9\u4e8e\u8fd1\u671f\u6709\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53f2\u7684\u60a3\u8005\uff0c\u9700\u614e\u7528 FRUZAQLA\u3002\u5bf9\u4e8e\u51fa\u73b0\u52a8\u8109\u8840\u6813\u6813\u585e\u7684\u60a3\u8005\uff0c\u5e94\u505c\u7528FRUZAQLA\u3002<\/li>\n<li>\u5bf9FD&amp;C\u9ec4\u82725 \u53f7\uff08\u67e0\u6aac\u9ec4\uff09\u53ca6 \u53f7\uff08\u65e5\u843d\u9ec4FCF\uff09\u7684\u8fc7\u654f\u53cd\u5e94\u3002FRUZAQLA 1mg \u80f6\u56ca\u542b\u6709FD&amp;C\u9ec4\u82725\u53f7\uff08\u67e0\u6aac\u9ec4\uff09\uff0c\u53ef\u80fd\u4f1a\u5728\u67d0\u4e9b\u6613\u611f\u4eba\u7fa4\u4e2d\u5f15\u8d77\u8fc7\u654f\u578b\u53cd\u5e94\uff08\u5305\u62ec\u652f\u6c14\u7ba1\u6c14\u5598\uff09\u3002FRUZAQLA 1mg \u542b\u6709FD&amp;C\u9ec4\u82726\u53f7\uff08\u65e5\u843d\u9ec4FCF\uff09\uff0c\u53ef\u80fd\u4f1a\u5f15\u8d77\u8fc7\u654f\u53cd\u5e94\u3002<\/li>\n<li>\u80da\u80ce\u2013\u80ce\u4ed4\u6bd2\u6027\u3002\u6839\u636e\u52a8\u7269\u7814\u7a76\u7684\u7ed3\u679c\u53ca\u5176\u4f5c\u7528\u673a\u5236\uff0c\u5b55\u5987\u670d\u7528FRUZAQLA\u53ef\u80fd\u4f1a\u5bf9\u80ce\u513f\u9020\u6210\u4f24\u5bb3\u3002\u5e94\u544a\u77e5\u5b55\u5987\u5bf9\u80ce\u513f\u7684\u6f5c\u5728\u98ce\u9669\u3002\u5efa\u8bae\u80b2\u9f84\u5973\u6027\u548c\u6709\u80b2\u9f84\u5973\u6027\u4f34\u4fa3\u7684\u7537\u6027\u5728FRUZAQLA\u6cbb\u7597\u671f\u95f4\u548c\u6700\u540e\u4e00\u6b21\u7ed9\u836f\u540e2\u5468\u5185\u4f7f\u7528\u6709\u6548\u7684\u907f\u5b55\u63aa\u65bd\u3002<\/li>\n<\/ul>\n<p><b>\u4e0d\u826f\u53cd\u5e94<br \/><\/b>FRUZAQLA\u6cbb\u7597\u540e\u6700\u5e38\u89c1\uff08\u53d1\u751f\u7387\u226520%\uff09\u7684\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u9ad8\u8840\u538b\u3001\u638c\u8dd6\u7ea2\u80bf\u611f\u89c9\uff08\u624b\u8db3\u76ae\u80a4\u53cd\u5e94\uff09\u3001\u86cb\u767d\u5c3f\u3001\u53d1\u58f0\u56f0\u96be\u3001\u8179\u75db\u3001\u8179\u6cfb\u548c\u4e4f\u529b\u3002<\/p>\n<p>\u836f\u7269\u76f8\u4e92\u4f5c\u7528\uff1a\u907f\u514dFRUZAQLA\u4e0e\u5f3a\u6548\u6216\u4e2d\u5ea6CYP3A\u8bf1\u5bfc\u5242\u540c\u65f6\u7ed9\u836f\u3002<\/p>\n<p><b>\u5728\u7279\u5b9a\u4eba\u7fa4\u4e2d\u7684\u4f7f\u7528<\/b><\/p>\n<ul type=\"disc\">\n<li><span id=\"spanHghlt6287\">\u54fa\u4e73\uff1a\u5efa\u8bae\u5973\u6027\u5728FRUZAQLA\u6cbb\u7597\u671f\u95f4\u4ee5\u53ca\u6700\u540e\u4e00\u6b21\u7528\u836f\u540e2 \u5468\u5185\u4e0d\u8981\u54fa\u4e73\u3002<\/span><\/li>\n<\/ul>\n<p><span id=\"spanHghltb4fe\">\u5982\u9700\u62a5\u544a\u7591\u4f3c\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u8bf7\u81f4\u75351-844-662-8532\u8054\u7edc\u6b66\u7530\uff08Takeda Pharmaceuticals\uff09\u6216\u81f4\u75351-800-FDA-1088\u6216\u8bbf\u95ee<a href=\"http:\/\/www.fda.gov\/medwatch\" target=\"_blank\" rel=\"nofollow noopener\">www.fda.gov\/medwatch<\/a>\u8054\u7edcFDA\u3002<\/span><\/p>\n<p>\u8bf7\u53c2\u9605FRUZAQLA\uff08\u544b\u55b9\u66ff\u5c3c\uff09\u7684\u5b8c\u6574<a href=\"https:\/\/takeda.info\/Fruzaqla-Prescribing-Information\" target=\"_blank\" rel=\"nofollow noopener\">\u5904\u65b9\u4fe1\u606f<\/a>\u3002<\/p>\n<p><b><i>\u524d\u77bb\u6027\u9648\u8ff0<br \/><\/i><\/b><i>\u672c\u516c\u544a\u5305\u542b<\/i><i>1995<\/i><i>\u5e74\u300a\u7f8e\u56fd\u79c1\u4eba\u8bc1\u5238\u8bc9\u8bbc\u6539\u9769\u6cd5\u6848\u300b<\/i><i>&quot;<\/i><i>\u5b89\u5168\u6e2f<\/i><i>&quot;<\/i><i>\u6761\u6b3e\u4e2d\u5b9a\u4e49\u7684\u524d\u77bb\u6027\u9648\u8ff0\u3002\u8fd9\u4e9b\u524d\u77bb\u6027\u9648\u8ff0\u53cd\u6620\u4e86\u548c\u9ec4\u533b\u836f\u76ee\u524d\u5bf9\u672a\u6765\u4e8b\u4ef6\u7684\u9884\u671f\uff0c\u5305\u62ec<\/i><i>EMA <\/i><i>\u662f\u5426\u6279\u51c6\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u7ed3\u76f4\u80a0\u764c\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u4ee5\u53ca\u6279\u51c6\u65f6\u95f4\u7684\u9884\u671f\uff0c\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u7684\u6cbb\u7597\u6f5c\u529b\u7684\u9884\u671f\u4ee5\u53ca\u544b\u55b9\u66ff\u5c3c\u9488\u5bf9\u6b64\u9002\u5e94\u75c7\u53ca\u5176\u4ed6\u9002\u5e94\u75c7\u7684\u8fdb\u4e00\u6b65\u4e34\u5e8a\u7814\u7a76\u8ba1\u5212\u3002\u524d\u77bb\u6027\u9648\u8ff0\u6d89\u53ca\u98ce\u9669\u548c\u4e0d\u786e\u5b9a\u6027\u3002\u6b64\u7c7b\u98ce\u9669\u548c\u4e0d\u786e\u5b9a\u6027\u5305\u62ec\u4e0b\u5217\u5047\u8bbe\uff1a\u652f\u6301\u544b\u55b9\u66ff\u5c3c\u4e8e\u6b27\u76df\u6216\u5176\u4ed6\u5730\u533a\uff08\u4f8b\u5982\uff1a\u65e5\u672c\uff09\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u7ed3\u76f4\u80a0\u764c\u6216\u5176\u4ed6\u9002\u5e94\u75c7\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u7684\u6570\u636e\u5145\u8db3\u6027\u3001\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u5ba1\u6279\u7684\u6f5c\u529b\uff0c\u544b\u55b9\u66ff\u5c3c\u7684\u5b89\u5168\u6027\u3001\u548c\u9ec4\u533b\u836f\u4e3a\u544b\u55b9\u66ff\u5c3c\u8fdb\u4e00\u6b65\u4e34\u5e8a\u5f00\u53d1\u8ba1\u5212\u53ca\u5546\u4e1a\u5316\u63d0\u4f9b\u8d44\u91d1\u5e76\u5b9e\u73b0\u53ca\u5b8c\u6210\u7684\u80fd\u529b\uff0c\u6b64\u7c7b\u4e8b\u4ef6\u53d1\u751f\u7684\u65f6\u95f4\uff0c\u5404\u65b9\u6ee1\u8db3\u8bb8\u53ef\u534f\u8bae\u7684\u6761\u6b3e\u548c\u6761\u4ef6\u7684\u80fd\u529b\uff0c\u76d1\u7ba1\u673a\u6784\u7684\u884c\u52a8\u6216\u53ef\u5f71\u54cd\u4e34\u5e8a\u8bd5\u9a8c\u7684\u542f\u52a8\u3001\u65f6\u95f4\u548c\u8fdb\u5c55\u53ca\u544b\u55b9\u66ff\u5c3c\u7684\u6ce8\u518c\u8def\u5f84\uff0c\u4ee5\u53ca\u6b66\u7530\u6210\u529f\u5f00\u53d1\u3001\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u544b\u55b9\u66ff\u5c3c\u7684\u80fd\u529b\u7b49\u3002\u6b64\u5916\uff0c\u7531\u4e8e\u90e8\u5206\u7814\u7a76\u4f9d\u8d56\u4e0e\u5176\u4ed6\u836f\u7269\u4ea7\u54c1\u4e0e\u544b\u55b9\u66ff\u5c3c\u8054\u5408\u4f7f\u7528\uff0c\u56e0\u6b64\u6b64\u7c7b\u98ce\u9669\u548c\u4e0d\u786e\u5b9a\u6027\u5305\u62ec\u6709\u5173\u8fd9\u4e9b\u6cbb\u7597\u836f\u7269\u7684\u5b89\u5168\u6027\u3001\u7597\u6548\u3001\u4f9b\u5e94\u548c\u6301\u7eed\u76d1\u7ba1\u6279\u51c6\u7684\u5047\u8bbe\u3002\u5f53\u524d\u548c\u6f5c\u5728\u6295\u8d44\u8005\u8bf7\u52ff\u8fc7\u5ea6\u4f9d\u8d56\u8fd9\u4e9b\u524d\u77bb\u6027\u9648\u8ff0\uff0c\u8fd9\u4e9b\u9648\u8ff0\u4ec5\u5728\u622a\u81f3\u672c\u516c\u544a\u53d1\u5e03\u5f53\u65e5\u6709\u6548\u3002\u6709\u5173\u8fd9\u4e9b\u98ce\u9669\u548c\u5176\u4ed6\u98ce\u9669\u7684\u8fdb\u4e00\u6b65\u8ba8\u8bba\uff0c\u8bf7\u67e5\u9605\u548c\u9ec4\u533b\u836f\u5411\u7f8e\u56fd\u8bc1\u5238\u4ea4\u6613\u59d4\u5458\u4f1a\u3001<\/i><i>AIM<\/i><i>\u4ee5\u53ca\u9999\u6e2f\u8054\u5408\u4ea4\u6613\u6240\u6709\u9650\u516c\u53f8\u63d0\u4ea4\u7684\u6587\u4ef6\u3002\u65e0\u8bba\u662f\u5426\u51fa\u73b0\u65b0\u8baf\u606f\u3001\u672a\u6765\u4e8b\u4ef6\u6216\u60c5\u51b5\u6216\u5176\u4ed6\u56e0\u7d20\uff0c\u548c\u9ec4\u533b\u836f\u5747\u4e0d\u627f\u62c5\u66f4\u65b0\u6216\u4fee\u8ba2\u672c\u516c\u544a\u6240\u542b\u8baf\u606f\u7684\u4e49\u52a1\u3002<\/i><\/p>\n<p><b><i>\u533b\u7597\u4fe1\u606f<br \/><\/i><\/b><i>\u672c\u516c\u544a\u6240\u63d0\u5230\u7684\u4ea7\u54c1\u53ef\u80fd\u5e76\u672a\u5728\u6240\u6709\u56fd\u5bb6\u4e0a\u5e02\uff0c\u6216\u53ef\u80fd\u4ee5\u4e0d\u540c\u7684\u5546\u6807\u8fdb\u884c\u9500\u552e\uff0c\u6216\u7528\u4e8e\u4e0d\u540c\u7684\u75c5\u75c7\uff0c\u6216\u91c7\u7528\u4e0d\u540c\u7684\u5242\u91cf\uff0c\u6216\u62e5\u6709\u4e0d\u540c\u7684\u6548\u529b\u3002\u672c\u6587\u4e2d\u6240\u5305\u542b\u7684\u4efb\u4f55\u4fe1\u606f\u90fd\u4e0d\u5e94\u88ab\u770b\u4f5c\u662f\u4efb\u4f55\u5904\u65b9\u836f\u7684\u7533\u8bf7\u3001\u63a8\u5e7f\u6216\u5e7f\u544a\uff0c\u5305\u62ec\u90a3\u4e9b\u6b63\u5728\u7814\u53d1\u7684\u836f\u7269\u3002<\/i><\/p>\n<p><b><i>\u5185\u5e55\u6d88\u606f<br \/><\/i><\/b><i>\u672c\u516c\u544a\u5305\u542b\uff08\u6b27\u76df\uff09\u7b2c<\/i><i>596\/2014<\/i><i>\u53f7\u6761\u4f8b\uff08\u8be5\u6761\u4f8b\u6784\u6210\u300a<\/i><i>2018<\/i><i>\u5e74\u6b27\u6d32\u8054\u76df\uff08\u9000\u51fa\uff09\u6cd5\u300b\u5b9a\u4e49\u7684\u6b27\u76df\u4fdd\u7559\u6cd5\u5f8b\u7684\u4e00\u90e8\u5206\uff09\u7b2c<\/i><i>7<\/i><i>\u6761\u89c4\u5b9a\u7684\u5185\u5e55\u6d88\u606f\u3002<\/i><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prnpr2 prnpl2 prnvab prnsbtb0 prnrbrb0 prnsbbb0 prnsblb0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[1]<\/sup><\/span>&nbsp;&nbsp; Xu X<i>, et al<\/i>. Efficacy and safety of regorafenib and fruquintinib as third\u2011line treatment for colorectal cancer: a narrative review. <i>Transl Cancer Res<\/i> 2022;11(1):276\u2011287. doi: 10.21037\/tcr\u201120\u20113539.<br \/><span class=\"prnews_span\"><sup>[2]<\/sup><\/span>&nbsp;&nbsp; Sun Q<i>, et al<\/i>. (2014) Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy, <i>Cancer Biol Ther.<\/i> 2014 15:12, 1635\u20111645. doi: 10.4161\/15384047.2014.964087.<br \/><span class=\"prnews_span\"><sup>[3]<\/sup><\/span>&nbsp;&nbsp; Sung H<i>, et al<\/i>. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. <i>CA Cancer J Clin.<\/i> 2021;71(3):209\u2011249. doi:10.3322\/caac.21660.<br \/><span class=\"prnews_span\"><sup>[4]<\/sup><\/span>&nbsp;&nbsp; American Cancer Society. Cancer Facts &amp; Figures 2024. Atlanta, <i>American Cancer Society<\/i>; 2024.<br \/><span class=\"prnews_span\"><sup>[5]<\/sup><\/span>&nbsp;&nbsp; Bando H<i>, et al<\/i>. Therapeutic landscape and future direction of metastatic colorectal cancer. <i>Nat Rev Gastroenterol Hepatol<\/i> 2023; 20(5)306\u2011322. doi:10.1038\/s41575\u2011022\u201100736\u20111.<br \/><span class=\"prnews_span\"><sup>[6]<\/sup><\/span>&nbsp;&nbsp; D&#8217;Haene N<i>, et al<\/i>. Clinical application of targeted next\u2011generation sequencing for colorectal cancer patients: a multicentric Belgian experience. <i>Oncotarget.<\/i> 2018;9(29):20761\u201120768. Published 2018 Apr 17. doi:10.18632\/oncotarget.25099.<br \/><span class=\"prnews_span\"><sup>[7]<\/sup><\/span>&nbsp;&nbsp; Venderbosch S<i>, et al<\/i>. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: A pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS Studies. <i>Clinical Cancer Res.<\/i> 2014; 20(20):5322\u20135330. doi:10.1158\/1078\u20110432.ccr\u201114\u20110332.<br \/><span class=\"prnews_span\"><sup>[8]<\/sup><\/span>&nbsp;&nbsp; Koopman M<i>, et al<\/i>. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. <i>Br J Cancer.<\/i> 2009;100(2), 266\u2013273. doi:10.1038\/sj.bjc.6604867.<br \/><span class=\"prnews_span\"><sup>[9]<\/sup><\/span>&nbsp;&nbsp; Ahcene Djaballah S<i>, et al<\/i>. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. <i>Am Soc Clin Oncol Educ Book.<\/i> 2022;42:1\u201114. doi:10.1200\/EDBK_351354.<br \/><span class=\"prnews_span\"><sup>[10]<\/sup><\/span> Dasari NA<i>, et al<\/i>. LBA25 \u2013 FRESCO\u20112: A global Phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. <i>Ann Oncol.<\/i> 2022 Sep;33(suppl_7): S808\u2011S869. doi:10.1016\/annonc\/annonc1089.<br \/><span class=\"prnews_span\"><sup>[11]<\/sup><\/span>&nbsp;Dasari NA<i>, et al<\/i>. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO\u20112): an international, multicentre, randomised, double\u2011blind, Phase III study. <i>Lancet.<\/i> 2023;402(10395):41\u201153. doi:10.1016\/S0140\u20116736(23)00772\u20119.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u548c\u9ec4\u533b\u836f\u5ba3\u4f48\u6b66\u7530\u83b7\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a (CHMP) \u79ef\u6781\u610f\u89c1 \u652f\u6301\u544b\u55b9\u66ff\u5c3c (fruquintinib) \u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c \u2014 \u82e5\u4e8e\u6b27\u76df\u83b7\u6279\uff0c\u544b\u55b9\u66ff\u5c3c\u5c06\u6210\u4e3a\u8d85\u8fc7\u5341\u5e74\u6765\u7b2c\u4e00\u4e2a\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u7684\u521b\u65b0\u9776\u5411\u7597\u6cd5\uff0c\u65e0\u8bba\u60a3\u8005\u7684\u751f\u7269\u6807\u5fd7\u7269\u72b6\u6001\u5982\u4f55&nbsp;\u2014 \u2014 \u57fa\u4e8eFRESCO\u20112&nbsp; III \u671f\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\u7ed9\u51fa\u79ef\u6781\u610f\u89c1&nbsp;\u2014 \u9999\u6e2f\u3001\u4e0a\u6d77\u548c\u65b0\u6cfd\u897f\u5dde\u5f17\u6d1b\u52d2\u59c6\u516c\u56ed2024\u5e744\u670826\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u548c\u9ec4\u533b\u836f\uff08\u4e2d\u56fd\uff09\u6709\u9650\u516c\u53f8\uff08\u7b80\u79f0&quot;\u548c\u9ec4\u533b\u836f&quot;\u6216&quot;HUTCHMED&quot;\uff09\uff08\u7eb3\u65af\u8fbe\u514b\/\u4f26\u6566\u8bc1\u4ea4\u6240\uff1aHCM\uff1b\u9999\u6e2f\u4ea4\u6613\u6240\uff1a13\uff09\u4eca\u65e5\u5ba3\u5e03\u5176\u5408\u4f5c\u4f19\u4f34\u6b66\u7530\u53d6\u5f97\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08&quot;EMA&quot;\uff09\u4eba\u7528\u836f\u54c1\u59d4\u5458\u4f1a\uff08&quot;CHMP&quot;\uff09\u5efa\u8bae\u6279\u51c6\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u7684\u6210\u4eba\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u3002 \u6b27\u76df\u59d4\u5458\u4f1a\uff08EC\uff09\u5728\u51b3\u5b9a\u544b\u55b9\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u5728\u6574\u4e2a\u6b27\u76df\u3001\u632a\u5a01\u3001\u5217\u652f\u6566\u58eb\u767b\u548c\u51b0\u5c9b\u7684\u4e0a\u5e02\u8bb8\u53ef\u65f6\uff0c\u5c06\u4f1a\u628aCHMP\u7684\u79ef\u6781\u610f\u89c1\u7eb3\u5165\u8003\u8651\u3002&nbsp;\u5982\u679c\u83b7\u5f97\u6279\u51c6\uff0c\u544b\u55b9\u66ff\u5c3c\u5c06\u6210\u4e3a\u6b27\u76df\u6279\u51c6\u7528\u4e8e\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u7684\u7b2c\u4e00\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u6240\u6709\u4e09\u79cd\u8840\u7ba1\u5185\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08&quot;VEGFR&quot;\uff09\u7684\u9009\u62e9\u6027\u6291\u5236\u5242\u3002&nbsp;[1],[2]&nbsp;\u6b66\u7530\u62e5\u6709\u5728\u4e2d\u56fd\u5185\u5730\u3001\u9999\u6e2f\u548c\u6fb3\u95e8\u4ee5\u5916\u8fdb\u4e00\u6b65\u5f00\u53d1\u3001\u5546\u4e1a\u5316\u548c\u751f\u4ea7\u544b\u55b9\u66ff\u5c3c\u7684\u5168\u7403\u72ec\u5bb6\u8bb8\u53ef\u3002 \u6b66\u7530\u80bf\u7624\u90e8\u9996\u5e2d\u533b\u5b66\u5b98Awny Farajallah \u533b\u5b66\u535a\u58eb\u8868\u793a\uff1a&quot;\u900f\u8fc7\u4e0e\u548c\u9ec4\u533b\u836f\u7684\u5408\u4f5c\uff0c\u6211\u4eec\u5728\u6269\u5927\u544b\u55b9\u66ff\u5c3c\u5728\u9002\u7528\u60a3\u8005\u4e2d\u7684\u53ef\u53ca\u6027\u65b9\u9762\u53d6\u5f97\u4e86\u957f\u8db3\u8fdb\u5c55\u3002&nbsp;\u968f\u7740CHMP \u5bf9\u544b\u55b9\u66ff\u5c3c\u7ed9\u51fa\u79ef\u6781\u610f\u89c1\uff0c\u6211\u4eec\u8ddd\u79bb\u4e3a\u6b27\u76df\u60a3\u8005\u63d0\u4f9b\u4e00\u79cd\u6709\u671b\u5e26\u6765\u663e\u8457\u7684\u751f\u5b58\u83b7\u76ca\u7684\u53e3\u670d\u3001\u975e\u5316\u7597\u6cbb\u7597\u9009\u62e9\u53c8\u8fd1\u4e86\u4e00\u6b65\u3002\u6211\u4eec\u671f\u5f85\u6b27\u76df\u59d4\u5458\u4f1a\u5728\u4e0d\u4e45\u7684\u5c06\u6765\u505a\u51fa\u6b63\u5f0f\u51b3\u5b9a\u3002&quot; \u548c\u9ec4\u533b\u836f\u9996\u5e2d\u6267\u884c\u5b98\u517c\u9996\u5e2d\u79d1\u5b66\u5b98\u82cf\u6170\u56fd\u535a\u58eb\u8868\u793a\uff1a&quot;\u548c\u9ec4\u533b\u836f\u5728\u4e3a\u6709\u9700\u8981\u7684\u60a3\u8005\u5f00\u53d1\u521b\u65b0\u80bf\u7624\u836f\u7269\u65b9\u9762\u62e5\u6709\u826f\u597d\u7684\u5f80\u7ee9\u3002&nbsp;\u76ee\u524d\uff0c\u6b27\u76df\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u53ef\u7528\u7684\u6cbb\u7597\u9009\u62e9\u6709\u9650\uff0c\u5bfc\u81f4\u6cbb\u7597\u7ed3\u679c\u4e0d\u4f73\u3002&nbsp;\u6211\u4eec\u5bf9\u5408\u4f5c\u4f19\u4f34\u6b66\u7530\u5728\u91cd\u65b0\u5b9a\u4e49\u6cbb\u7597\u683c\u5c40\uff0c\u5e76\u89e3\u51b3\u6b27\u6d32\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\u91cd\u5927\u672a\u88ab\u6ee1\u8db3\u7684\u9700\u6c42\u9886\u57df\u53d6\u5f97\u8fdb\u5c55\u611f\u5230\u5341\u5206\u9ad8\u5174\u3002\u5728\u8fc7\u53bb\u7684\u4e94\u5e74\u95f4\uff0c\u8fd9\u79cd\u521b\u65b0\u80bf\u7624\u836f\u7269\u4e3a\u4e2d\u56fd\u60a3\u8005\u5e26\u6765\u4e86\u6df1\u8fdc\u7684\u5f71\u54cd\u3002\u81ea\u4ece\u4e0e\u6b66\u7530\u8fbe\u6210\u5408\u4f5c\u4ee5\u6765\uff0c\u6211\u4eec\u770b\u5230\u8fd9\u4e00\u5f71\u54cd\u7684\u8303\u56f4\u5f97\u4ee5\u8fdb\u4e00\u6b65\u6269\u5927\uff0c\u5728\u7f8e\u56fd\u83b7\u5f97\u6279\u51c6\u548c\u4e0a\u5e02\uff0c\u73b0\u5728\u5219\u662f\u7b49\u5f85\u6b27\u76df\u59d4\u5458\u4f1a\u7684\u6279\u51c6\uff0c\u6211\u4eec\u671f\u5f85\u8be5\u836f\u7269\u4e5f\u4e3a\u6b27\u6d32\u60a3\u8005\u5e26\u6765\u79ef\u6781\u7684\u5f71\u54cd\u3002&nbsp;&quot; CHMP \u7684\u79ef\u6781\u610f\u89c1\u4e3b\u8981\u57fa\u4e8e&nbsp;FRESCO-2\u56fd\u9645\u591a\u4e2d\u5fc3III \u671f\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u8be5\u7814\u7a76\u7ed3\u679c\u4ea6\u652f\u6301\u4e86\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u7684\u63d0\u4ea4\u3002&nbsp;\u8be5\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u5df2\u4e8e&nbsp;2023 \u5e74&nbsp;6 \u6708\u83b7EMA\u786e\u8ba4\u53ca\u53d7\u7406\u3002 \u5173\u4e8e\u7ed3\u76f4\u80a0\u764c\u7ed3\u76f4\u80a0\u764c\u662f\u59cb\u4e8e\u7ed3\u80a0\u6216\u76f4\u80a0\u7684\u764c\u75c7\u3002\u6839\u636e\u56fd\u9645\u764c\u75c7\u7814\u7a76\u673a\u6784\uff08IARC\uff09\u7684\u6570\u636e\uff0c\u7ed3\u76f4\u80a0\u764c\u662f\u5168\u7403\u7b2c\u4e09\u5927\u5e38\u89c1\u764c\u75c7\u3002\u57282020\u5e74\u4f30\u8ba1\u9020\u6210\u8d85\u8fc793.5\u4e07\u4eba\u6b7b\u4ea1\u3002\u5728\u6b27\u6d32\uff0c\u7ed3\u76f4\u80a0\u764c\u662f\u7b2c\u4e8c\u5927\u5e38\u89c1\u764c\u75c7\uff0c2020\u5e74\u7ea6\u670952\u4e07\u4f8b\u65b0\u589e\u75c5\u4f8b\u548c24.5\u4e07\u4f8b\u6b7b\u4ea1\u3002[3]&nbsp;\u5728\u7f8e\u56fd\uff0c2024\u5e74\u4f30\u8ba1\u5c06\u65b0\u589e15.3\u4e07\u4f8b\u7ed3\u76f4\u80a0\u764c\u65b0\u75c7\u4ee5\u53ca5.3\u4e07\u4f8b\u6b7b\u4ea1\u3002[4] 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III\u671f\u7814\u7a76FRESCO\u20112\u7814\u7a76\u662f\u4e00\u9879\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u3001\u65e5\u672c\u53ca\u6fb3\u5927\u5229\u4e9a\u5f00\u5c55\u7684\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65e8\u5728\u63a2\u7d22\u544b\u55b9\u66ff\u5c3c\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u5bf9\u6bd4\u5b89\u6170\u5242\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7528\u4e8e\u6cbb\u7597\u7ecf\u6cbb\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\u60a3\u8005\uff08NCT04322539\uff09\u3002FRESCO\u20112\u7814\u7a76\u8fbe\u5230\u4e86\u6240\u6709\u4e3b\u8981\u7ec8\u70b9\u53ca\u5173\u952e\u6b21\u8981\u7ec8\u70b9\uff0c\u5728\u603b\u751f\u5b58\u671f\uff08OS\uff09\u548c\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u65b9\u9762\u5747\u663e\u793a\u51fa\u8fbe\u5230\u5177\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u548c\u4e34\u5e8a\u610f\u4e49\u7684\u663e\u8457\u6539\u5584\uff0c\u5e76\u5728\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\u5c55\u73b0\u51fa\u4e00\u81f4\u7684\u83b7\u76ca\uff0c\u65e0\u8bba\u60a3\u8005\u65e2\u5f80\u63a5\u53d7\u8fc7\u4f55\u79cd\u6cbb\u7597\u3002\u544b\u55b9\u66ff\u5c3c\u5728FRESCO-2\u7814\u7a76\u4e2d\u663e\u793a\u51fa\u53ef\u63a7\u7684\u5b89\u5168\u6027\uff0c\u4e0e\u4e4b\u524d\u516c\u5e03\u7684\u544b\u55b9\u66ff\u5c3c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u6240\u62a5\u544a\u7684\u4e00\u81f4\u3002\u5728\u63a5\u53d7\u544b\u55b9\u66ff\u5c3c\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c&nbsp;20%\u51fa\u73b0\u5bfc\u81f4\u6cbb\u7597\u505c\u6b62\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u800c\u63a5\u53d7\u5b89\u6170\u5242\u8054\u5408\u6700\u4f73\u652f\u6301\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff0c\u8be5\u6bd4\u4f8b\u4e3a&nbsp;21%\u3002\u8be5\u7814\u7a76\u7684\u7ed3\u679c\u4e8e2022\u5e749\u6708\u7684\u6b27\u6d32\u80bf\u7624\u5185\u79d1\u5b66\u4f1a\uff08ESMO\uff09\u5e74\u4f1a\u4e0a\u516c\u5e03\uff0c\u5e76\u968f\u540e\u57282023\u5e746\u6708\u4e8e\u300a\u67f3\u53f6\u5200\uff08The Lancet\uff09\u300b\u53d1\u8868\u3002[10],[11]&nbsp; 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