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\u4e0a\u6d77<\/span>2025\u5e741\u67087\u65e5<\/span> \/\u7f8e\u901a\u793e\/ —\u00a02025\u5e741\u67087\u65e5\uff0c\u8fea\u54f2\u533b\u836f\uff08\u80a1\u7968\u4ee3\u7801\uff1a688192.SH\uff09\u5ba3\u5e03\uff0c\u8212\u6c83\u54f2\u00ae\uff08\u901a\u7528\u540d\uff1a\u8212\u6c83\u66ff\u5c3c\u7247\uff09\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08New Drug Application\uff0cNDA\uff09\u5df2\u901a\u8fc7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u7684\u7acb\u5377\u5ba1\u67e5\uff0c\u5e76\u88ab\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff08Priority Review Designation\uff09\uff0c\u7528\u4e8e\u65e2\u5f80\u7ecf\u542b\u94c2\u5316\u7597\u6cbb\u7597\u65f6\u6216\u6cbb\u7597\u540e\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\uff0c\u5e76\u4e14\u7ecfFDA\u6279\u51c6\u7684\u8bd5\u5242\u76d2\u68c0\u6d4b\u786e\u8ba4\uff0c\u5b58\u5728\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08EGFR\uff0920\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\uff08exon20ins\uff09\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u7684\u6210\u4eba\u60a3\u8005\u3002<\/p>\n

\n

<\/a><\/p>\n<\/div>\n

\u6b64\u6b21\u5728\u7f8e\u9012\u4ea4\u7684\u8212\u6c83\u54f2\u00aeNDA\uff0c\u662f\u57fa\u4e8e”\u609f\u7a7a1 B”\uff08WU-KONG1B\uff09\u7684\u79ef\u6781\u7814\u7a76\u6210\u679c\u3002WU-KONG1B\u662f\u4e00\u9879\u5728\u6b27\u7f8e\u3001\u6fb3\u6d32\u3001\u4e9a\u6d32\u7b49\u5168\u740310\u4e2a\u56fd\u5bb6\u548c\u5730\u533a\u5f00\u5c55\u7684\u56fd\u9645\u591a\u4e2d\u5fc3\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u8bc4\u4f30\u8212\u6c83\u54f2\u00ae\u9488\u5bf9\u7ecf\u6cbbEGFR exon20ins NSCLC\u60a3\u8005\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u3002\u8be5\u9879\u8bd5\u9a8c\u5df2\u8fbe\u5230\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\uff0c\u5e76\u4ee5\u53e3\u5934\u62a5\u544a\u5f62\u5f0f\u4eae\u76f82024\u5e74\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u5e74\u4f1a\uff0c\u518d\u8bc1\u8212\u6c83\u54f2\u00ae\u9ad8\u6548\u4f4e\u6bd2\u3001\u5168\u7403\u6f5c\u5728\u540c\u7c7b\u6700\u4f73\u3002\u6b64\u524d\uff0cFDA\u5df2\u6388\u4e88\u8212\u6c83\u54f2\u00ae\u5168\u7ebf<\/span>\u6cbb\u7597\u8be5\u9002\u5e94\u75c7\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08Breakthrough Therapy Designation\uff0cBTD\uff09\u3002<\/p>\n

\u8fea\u54f2\u533b\u836f\u521b\u59cb\u4eba\u3001\u8463\u4e8b\u957f\u517c\u9996\u5e2d\u6267\u884c\u5b98\u5f20\u5c0f\u6797\u535a\u58eb\u8868\u793a\uff1a”EGFR exon20ins\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u9884\u540e\u8f83\u5dee\uff0c\u6cbb\u7597\u9009\u62e9\u6709\u9650\u3002\u8212\u6c83\u54f2\u00ae\u88ab\u7f8e\u56fdFDA\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\uff0c\u4e5f\u610f\u5473\u7740\u5168\u7403\u8303\u56f4\u5185\u8be5\u9886\u57df\u6709\u7740\u5de8\u5927\u7684\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u3002\u57fa\u4e8eWU-KONG1B\u7814\u7a76\u7684\u79ef\u6781\u6210\u679c\uff0c\u6211\u4eec\u76f8\u4fe1\uff0c\u8212\u6c83\u54f2\u00ae\u82e5\u83b7\u5f97\u6279\u51c6\uff0c\u5c06\u91cd\u5851\u8be5\u9886\u57df\u5168\u7403\u6cbb\u7597\u683c\u5c40\uff0c\u4e3a\u66f4\u591a\u60a3\u8005\u5e26\u6765\u7a81\u7834\u6027\u6cbb\u7597\u65b0\u65b9\u6848\u3002”<\/p>\n

FDA\u7684”\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c”\u4e3b\u8981\u6388\u4e88\u5728\u6cbb\u7597\u3001\u8bca\u65ad\u6216\u9884\u9632\u67d0\u4e9b\u4e25\u91cd\u75be\u75c5\u65b9\u9762\u53d6\u5f97\u91cd\u5927\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u7a81\u7834\u7684\u836f\u7269\u3002\u76ee\u524d\uff0c\u6b27\u7f8e<\/span>\u5e02\u573a\u4e0a\u6ca1\u6709\u83b7\u6279\u6cbb\u7597EGFR exon20ins NSCLC\u7684\u5c0f\u5206\u5b50\u9776\u5411\u836f\u3002\u8fea\u54f2\u533b\u836f\u81ea\u4e3b\u7814\u53d1\u7684\u65b0\u578b\u80ba\u764c\u9776\u5411\u836f\u8212\u6c83\u54f2\u00ae\u4e8e2023\u5e748\u6708\u5728\u4e2d\u56fd\u83b7\u6279\uff0c\u662f\u76ee\u524d\u5168\u7403\u552f\u4e00\u83b7\u6279\u6cbb\u7597\u8be5\u9002\u5e94\u75c7\u7684\u53e3\u670d\u5c0f\u5206\u5b50\u9776\u5411\u836f\u3002<\/p>\n

\u5173\u4e8eEGFR exon20ins\u975e\u5c0f\u7ec6\u80de\u80ba\u764c<\/p>\n

\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08EGFR\uff0920\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\uff08exon20ins\uff09\u662f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u7684\u96be\u6cbb\u9776\u70b9\u3002\u7531\u4e8e\u5176\u72ec\u7279\u7684\u7a7a\u95f4\u6784\u8c61\uff0c\u4f20\u7edf\u7684EGFR TKI\u96be\u4ee5\u4e0e\u8be5\u9776\u70b9\u7ed3\u5408\uff0c\u836f\u7269\u7814\u53d1\u56f0\u96be\u3002EGFR exon20ins NSCLC\u60a3\u8005\u9884\u540e\u8f83\u5dee\uff0c\u771f\u5b9e\u4e16\u754c\u4e00\u5e74\u65e0\u8fdb\u5c55\u751f\u5b58\uff08PFS\uff09\u7387\u4ec5\u4e3a13%\uff0c\u4e94\u5e74\u603b\u751f\u5b58\uff08OS\uff09\u7387\u4ec5\u4e3a8%\uff0c\u957f\u671f\u7f3a\u4e4f\u5b89\u5168\u6709\u6548\u7684\u9776\u5411\u6cbb\u7597\u65b9\u6848\uff0c\u662f\u56f0\u6270\u4e34\u5e8a\u591a\u5e74\u4e9f\u9700\u89e3\u51b3\u7684\u75db\u70b9\u3002<\/p>\n

\u5173\u4e8e\u8212\u6c83\u54f2\u00ae\uff08\u8212\u6c83\u66ff\u5c3c\u7247\uff09<\/p>\n

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\u5173\u4e8e\u8fea\u54f2\u533b\u836f<\/p>\n

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\u524d\u77bb\u6027\u58f0\u660e<\/p>\n

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\u66f4\u591a\u4fe1\u606f\uff0c\u656c\u8bf7\u8054\u7cfb
\u6295\u8d44\u8005\u5173\u7cfb\uff1air@dizalpharma.com\u00a0<\/a> \u00a0\u00a0
\u5546\u52a1\u5408\u4f5c\uff1abd@dizalpharma.com\u00a0\u00a0<\/a>
\u5a92\u4f53\u8054\u7edc\uff1apr@dizalpharma.com\u00a0<\/a><\/p>\n

\n<\/div>\n

SOURCE \u8fea\u54f2\u533b\u836f<\/p>","protected":false},"excerpt":{"rendered":"

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\u8fea\u54f2\u533b\u836f<\/p>\n","protected":false},"author":0,"featured_media":6370,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25],"tags":[],"class_list":["post-6369","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"\n\u8fea\u54f2\u533b\u836f\u8212\u6c83\u54f2\u4e0a\u5e02\u7533\u8bf7\u83b7\u7f8e\u56fdFDA\u53d7\u7406\u5e76\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c - Money Compass CN<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/moneycompass.com.my\/cn\/\u8fea\u54f2\u533b\u836f\u8212\u6c83\u54f2\u4e0a\u5e02\u7533\u8bf7\u83b7\u7f8e\u56fdfda\u53d7\u7406\u5e76\u6388\u4e88\u4f18\u5148\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u8fea\u54f2\u533b\u836f\u8212\u6c83\u54f2\u4e0a\u5e02\u7533\u8bf7\u83b7\u7f8e\u56fdFDA\u53d7\u7406\u5e76\u6388\u4e88\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c - Money Compass CN\" \/>\n<meta property=\"og:description\" content=\"\u8212\u6c83\u54f2\u00ae\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u57fa\u4e8e\u56fd\u9645\u591a\u4e2d\u5fc3\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76”\u609f\u7a7a1 B“\uff08WU-KONG1B\uff09\u7684\u79ef\u6781\u6210\u679c\u82e5\u83b7\u5f97\u6279\u51c6\uff0c\u8212\u6c83\u54f2\u00ae\u5c06\u4e3a\u5168\u7403\u66f4\u591aEGFR exon20ins\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u5e26\u6765\u7a81\u7834\u6027\u6cbb\u7597\u65b0\u9009\u62e9 \u4e0a\u6d772025\u5e741\u67087\u65e5 \/\u7f8e\u901a\u793e\/ 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