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Oncology<\/i>\uff09\u548c\u300a\u81ea\u7136\u2022\u764c\u75c7\u300b\uff08<i>Nature 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180\u6642\uff0c\u5c07\u8fd190%\u7684\u554f\u984c\u7b54\u8986\u88abEMA\u5be9\u8a55\u54e1\u4e00\u6b21\u6027\u63a5\u53d7\uff0c\u5269\u9918\u90e8\u5206\u4e5f\u5728\u9032\u4e00\u6b65\u6f84\u6e05\u5f8c\u7372\u5f97\u4e86\u5be9\u8a55\u54e1\u7684\u8a8d\u53ef\u3002\u5728\u5be9\u8a55\u671f\u9593\uff0c\u6211\u5011\u9084\u9806\u5229\u901a\u904e\u4e86EMA\u5c0d\u65bc\u751f\u7522\u5ee0\u7684\u5b9a\u671fGMP\u6838\u67e5\uff0c\u4ee5\u53ca\u5c0d\u5169\u5bb6\u7814\u7a76\u4e2d\u5fc3\u548cCRO\u5171\u70ba\u671f\u4e09\u5468\u7684GCP\u6838\u67e5\u3002\u96a8\u5f8c\uff0c\u6211\u5011\u5728\u4eca\u5e745\u6708\u5e95\u6536\u5230\u4e86EMA\u4eba\u7528\u85e5\u54c1\u59d4\u54e1\u6703\uff08CHMP\uff09\u767c\u4f48\u7684\u63a8\u85a6\u6279\u51c6\u7684\u7a4d\u6975\u610f\u898b\u3002\u9019\u4e00\u8def\u7684\u62ab\u834a\u65ac\u68d8\uff0c\u96e2\u4e0d\u958b\u57fa\u77f3\u5718\u968a\u8fce\u96e3\u800c\u4e0a\u548c\u52c7\u65bc\u5275\u65b0\u7684\u7cbe\u795e\u3002\u300d<\/p>\n<p>\u694a\u535a\u58eb\u9032\u4e00\u6b65\u5f37\u8abf\uff1a\u300c\u8212\u683c\u5229\u55ae\u6297\u5728\u6d77\u5916\u7372\u6279\u4e0a\u5e02\u662f\u57fa\u77f3\u85e5\u696d\u7ba1\u7dda1.0\u6230\u7565\u4e2d\u7684\u91cd\u8981\u91cc\u7a0b\u7891\uff0c\u5370\u8b49\u4e86\u6211\u5011\u5728\u958b\u767c\u540c\u985e\u6700\u4f73\u816b\u7624\u514d\u75ab\u7642\u6cd5\u65b9\u9762\u7684\u5efa\u6a39\uff0c\u4e5f\u70ba\u806f\u5408\u7642\u6cd5\u7684\u958b\u767c\u6253\u4e0b\u4e86\u6df1\u539a\u57fa\u790e\u3002\u5728\u7ba1\u7dda2.0\u4e2d\uff0c\u6211\u5011\u6709\u4e00\u7cfb\u5217\u6975\u5177\u524d\u666f\u7684\u6f5b\u5728\u540c\u985e\u9996\u5275\u6216\u540c\u985e\u6700\u4f73\u5019\u9078\u85e5\u7269\uff0c\u76ee\u524d\u6b63\u5728\u9032\u884c\u570b\u969b\u591a\u4e2d\u5fc3\u81e8\u5e8a\u7814\u7a76\u6216\u5373\u5c07\u9032\u5165\u81e8\u5e8a\u968e\u6bb5\uff0c\u4e26\u4e14\u6211\u5011\u64c1\u6709\u9019\u5019\u9078\u85e5\u7269\u7684\u5168\u7403\u6b0a\u76ca\u3002\u6211\u5011\u4e5f\u5728\u7a4d\u6975\u63a2\u7d22\u8212\u683c\u5229\u55ae\u6297\u8207\u5176\u4ed6\u6cbb\u7642\u624b\u6bb5\u5982\u6297\u9ad4\u5076\u806f\u85e5\u7269\uff08ADC\uff09\u3001\u591a\u7279\u7570\u6027\u6297\u9ad4\u7684\u806f\u5408\u61c9\u7528\uff0c\u4ee5\u9032\u4e00\u6b65\u62d3\u5c55\u5176\u4f5c\u70ba\u816b\u7624\u514d\u75ab\u6cbb\u7642\u9aa8\u67b6\u85e5\u7269\u7684\u81e8\u5e8a\u50f9\u503c\u3002\u300d<\/p>\n<p>\u694a\u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u5728\u8212\u683c\u5229\u55ae\u6297\u8d70\u51fa\u570b\u9580\u6210\u70ba\u6b50\u6d32NSCLC\u7684\u4e00\u7dda\u6cbb\u7642\u4ee5\u53ca\u5728\u4e2d\u570b\u7372\u6279\u591a\u9805\u9069\u61c9\u75c7\u7684\u4e03\u5e74\u6b77\u7a0b\u4e2d\uff0c\u6211\u5011\u898b\u8b49\u4e86\u773e\u591a\u4e2d\u570b\u816b\u7624\u5b78\u5c08\u5bb6\u5728\u8a72\u9818\u57df\u7684\u6df1\u539a\u7a4d\u7d2f\u3001\u6240\u6709\u53c3\u8207\u8212\u683c\u5229\u55ae\u6297\u7814\u7a76\u7684\u60a3\u8005\u7684\u5049\u5927\u5949\u737b\u3001\u4ee5\u53ca\u6211\u5011\u7814\u767c\u5718\u968a\u65e5\u4ee5\u7e7c\u591c\u7684\u4e0d\u61c8\u52aa\u529b\u3002GEMSTONE-302\u512a\u7570\u7684\u7814\u7a76\u6210\u679c\u70ba\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u4f5c\u70baIV\u671fNSCLC\u4e00\u7dda\u6a19\u6e96\u7642\u6cd5\u63d0\u4f9b\u4e86\u5805\u5be6\u7684\u79d1\u5b78\u4f9d\u64da\u3002\u6211\u5011\u671f\u5f85\u9019\u4e00\u300e\u4e2d\u570b\u5275\u65b0\u65b9\u6848\u300f\u80fd\u5920\u5207\u5be6\u70ba\u5168\u7403\u80ba\u764c\u60a3\u8005\u5e36\u4f86\u66f4\u9577\u7684\u751f\u5b58\u7372\u76ca\u548c\u66f4\u597d\u7684\u751f\u547d\u8cea\u91cf\u3002\u300d<\/p>\n<p>\u540c\u6642\uff0c\u57fa\u77f3\u85e5\u696d\u4e5f\u5728\u52a0\u7dca\u7c4c\u5099\u5411EMA\u905e\u4ea4\u8212\u683c\u5229\u55ae\u6297\u5176\u4ed6\u9069\u61c9\u75c7\uff0c\u5982III\u671f\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u3001\u4e00\u7dda\u80c3\u764c\u3001\u4e00\u7dda\u98df\u7ba1\u9c57\u764c\u548c\u5fa9\u767c\u96e3\u6cbb\u6027\u7d50\u5916NK\/T\u7d30\u80de\u6dcb\u5df4\u7624\u7684\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb\uff08MAA\uff09\u3002<\/p>\n<p><b>\u95dc\u65bc\u80ba\u764c<\/b><\/p>\n<p>2020\u5e74\uff0c\u80ba\u764c\u662f\u6b50\u6d32\u7b2c\u4e09\u5927\u78ba\u8a3a\u764c\u75c7\uff0c\u4e5f\u662f\u5c0e\u81f4\u764c\u75c7\u76f8\u95dc\u6b7b\u4ea1\u7684\u4e3b\u8981\u539f\u56e0\uff0c\u5360\u764c\u75c7\u6b7b\u4ea1\u4eba\u6578\u7684\u4e94\u5206\u4e4b\u4e00<sup>[1]<\/sup>\u3002\u5728\u6b50\u6d32\uff0c\u7d0450%\u81f370%\u7684\u80ba\u764c\u60a3\u8005\u78ba\u8a3a\u6642\u5df2\u767c\u5c55\u70baIV\u671f\u968e\u6bb5<sup>[2]<\/sup>\u3002\u5168\u7403\u7bc4\u570d\u5167\uff0cNSCLC\u7d04\u5360\u6240\u6709\u80ba\u764c\u768485%<sup>[3]<\/sup>\u3002<\/p>\n<p><b>\u95dc\u65bc\u8212\u683c\u5229\u55ae\u6297<\/b><\/p>\n<p>\u8212\u683c\u5229\u55ae\u6297\u662f\u7531\u57fa\u77f3\u85e5\u696d\u7814\u767c\u7684\u6297PD-L1\u55ae\u514b\u9686\u6297\u9ad4\uff0c\u8212\u683c\u5229\u55ae\u6297\u7684\u958b\u767c\u662f\u57fa\u65bc\u7f8e\u570bLigand\u516c\u53f8\u6388\u6b0a\u5f15\u9032\u7684OmniRat<sup>\u00ae<\/sup>\u8f49\u57fa\u56e0\u52d5\u7269\u5e73\u53f0\u3002\u8a72\u5e73\u53f0\u53ef\u4e00\u7ad9\u5f0f\u7522\u751f\u5168\u4eba\u6e90\u6297\u9ad4\u3002\u4f5c\u70ba\u4e00\u7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type=\"disc\">\n<li>\u806f\u5408\u5316\u7642\u4e00\u7dda\u6cbb\u7642\u8f49\u79fb\u6027\u9c57\u72c0\u548c\u975e\u9c57\u72c0NSCLC\u60a3\u8005\uff1b<\/li>\n<li>\u6cbb\u7642\u540c\u6b65\u6216\u5e8f\u8cab\u653e\u5316\u7642\u5f8c\u672a\u51fa\u73fe\u75be\u75c5\u9032\u5c55\u7684\u3001\u4e0d\u53ef\u5207\u9664\u3001III\u671fNSCLC\u60a3\u8005\uff1b<\/li>\n<li>\u6cbb\u7642\u5fa9\u767c\u6216\u96e3\u6cbb\u6027\u7d50\u5916NK\/T\u7d30\u80de\u6dcb\u5df4\u7624\u60a3\u8005\uff1b<\/li>\n<li>\u806f\u5408\u6c1f\u5c3f\u5627\u5576\u985e\u548c\u9251\u985e\u5316\u7642\u85e5\u7269\u4e00\u7dda\u6cbb\u7642\u4e0d\u53ef\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\uff0c\u5fa9\u767c\u6216\u8f49\u79fb\u6027\u98df\u7ba1\u9c57\u764c\u60a3\u8005\uff1b<\/li>\n<li>\u806f\u5408\u542b\u6c1f\u5c3f\u5627\u5576\u985e\u548c\u9251\u985e\u85e5\u7269\u5316\u7642\u7528\u65bc\u8868\u9054PD-L1\uff08\u7d9c\u5408\u967d\u6027\u8a55\u5206[CPS]\u22655\uff09\u7684\u4e0d\u53ef\u624b\u8853\u5207\u9664\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u80c3\u53ca\u80c3\u98df\u7ba1\u7d50\u5408\u90e8\u817a\u764c\u7684\u4e00\u7dda\u6cbb\u7642\u3002<\/li>\n<\/ul>\n<p>\u6b50\u76df\u59d4\u54e1\u6703\uff08EC\uff09\u5df2\u6279\u51c6\u8212\u683c\u5229\u55ae\u6297\uff08\u5546\u54c1\u540d\uff1aCejemly<sup>\u00ae<\/sup>\uff09\u806f\u5408\u5316\u7642\u7528\u65bc\u8f49\u79fb\u6027NSCLC\u60a3\u8005\u7684\u4e00\u7dda\u6cbb\u7642\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u82f1\u570b\u85e5\u54c1\u548c\u91ab\u7642\u4fdd\u5065\u7528\u54c1\u7ba1\u7406\u5c40\uff08MHRA\uff09\u5df2\u53d7\u7406\u8212\u683c\u5229\u55ae\u6297\u806f\u5408\u5316\u7642\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u8f49\u79fb\u6027NSCLC\u7684\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb\u3002\u76ee\u524d\uff0c\u8a72\u7533\u8acb\u6b63\u5728\u5be9\u8a55\u904e\u7a0b\u4e2d\u3002<\/p>\n<p><b>\u95dc\u65bc\u57fa\u77f3\u85e5\u696d<\/b><\/p>\n<p>\u57fa\u77f3\u85e5\u696d\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u4ee3\u78bc: 2616\uff09\u6210\u7acb\u65bc2015\u5e74\u5e95\uff0c\u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u6297\u816b\u7624\u85e5\u7269\u7814\u767c\u7684\u5275\u65b0\u9a45\u52d5\u578b\u751f\u7269\u91ab\u85e5\u4f01\u696d\uff0c\u81f4\u529b\u65bc\u6eff\u8db3\u4e2d\u570b\u548c\u5168\u7403\u764c\u75c7\u60a3\u8005\u7684\u6bb7\u5207\u91ab\u7642\u9700\u6c42\u3002\u622a\u81f3\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u6210\u529f\u4e0a\u5e024\u6b3e\u5275\u65b0\u85e5\u3001\u7372\u627915\u9805\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08NDA\uff09\u4ee5\u53ca9\u9805\u9069\u61c9\u75c7\u3002\u7576\u524d\u7814\u767c\u7ba1\u7dda\u5747\u8861\u914d\u7f6e\u4e86\u6f5b\u5728\u540c\u985e\u9996\u5275\u6216\u540c\u985e\u6700\u4f73\u7684\u6297\u9ad4\u5076\u806f\u85e5\u7269\uff08ADC\uff09\u3001\u591a\u7279\u7570\u6027\u6297\u9ad4\u3001\u4ee5\u53ca\u514d\u75ab\u7642\u6cd5\u548c\u7cbe\u6e96\u6cbb\u7642\u85e5\u7269\u5728\u5167\u768412\u6b3e\u5019\u9078\u85e5\u7269\u3002\u540c\u6642\uff0c\u57fa\u77f3\u85e5\u696d\u64c1\u6709\u4e00\u652f\u8cc7\u6df1\u7ba1\u7406\u5718\u968a\uff0c\u300c\u5168\u93c8\u689d\u300d\u8986\u84cb\u81e8\u5e8a\u524d\u63a2\u7d22\u3001\u81e8\u5e8a\u8f49\u5316\u3001\u81e8\u5e8a\u958b\u767c\u3001\u85e5\u7269\u751f\u7522\u3001\u5546\u52d9\u62d3\u5c55\u3001\u5546\u696d\u904b\u71df\u7b49\u95dc\u9375\u74b0\u7bc0\u3002<\/p>\n<p>\u5982\u9700\u77ad\u89e3\u6709\u95dc\u57fa\u77f3\u85e5\u696d\u7684\u66f4\u591a\u4fe1\u606f\uff0c\u8acb\u8a2a\u554f\uff1a<u><a href=\"http:\/\/www.cstonepharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.cstonepharma.com<\/a><\/u>\u3002<\/p>\n<p>\u6295\u8cc7\u8005\u95dc\u4fc2:\u00a0<u><a href=\"mailto:ir@cstonepharma.com\" target=\"_blank\" rel=\"nofollow noopener\">ir@cstonepharma.com<\/a><br \/><\/u>\u5a92\u9ad4\u95dc\u4fc2:\u00a0<u><a href=\"mailto:pr@cstonepharma.com\" target=\"_blank\" rel=\"nofollow noopener\">pr@cstonepharma.com<\/a><\/u><\/p>\n<p><b>\u524d\u77bb\u6027\u8072\u660e<\/b><\/p>\n<p>\u672c\u6587\u6240\u4f5c\u51fa\u7684\u524d\u77bb\u6027\u9673\u8ff0\u50c5\u8207\u672c\u6587\u4f5c\u51fa\u8a72\u9673\u8ff0\u7576\u65e5\u7684\u4e8b\u4ef6\u6216\u8cc7\u6599\u6709\u95dc\u3002\u9664\u6cd5\u5f8b\u898f\u5b9a\u5916\uff0c\u65bc\u4f5c\u51fa\u524d\u77bb\u6027\u9673\u8ff0\u7576\u65e5\u4e4b\u5f8c\uff0c\u7121\u8ad6\u662f\u5426\u51fa\u73fe\u65b0\u8cc7\u6599\u3001\u672a\u4f86\u4e8b\u4ef6\u6216\u5176\u4ed6\u60c5\u6cc1\uff0c\u6211\u5011\u4e26\u7121\u8cac\u4efb\u66f4\u65b0\u6216\u516c\u958b\u4fee\u6539\u4efb\u4f55\u524d\u77bb\u6027\u9673\u8ff0\u53ca\u9810\u6599\u4e4b\u5916\u7684\u4e8b\u4ef6\u3002\u8acb\u7d30\u95b1\u672c\u6587\uff0c\u4e26\u7406\u89e3\u6211\u5011\u7684\u5be6\u969b\u672a\u4f86\u696d\u7e3e\u6216\u8868\u73fe\u53ef\u80fd\u8207\u9810\u671f\u6709\u91cd\u5927\u5dee\u7570\u3002\u672c\u6587\u5167\u6240\u6709\u9673\u8ff0\u4e43\u672c\u6587\u7ae0\u520a\u767c\u65e5\u671f\u4f5c\u51fa\uff0c\u53ef\u80fd\u56e0\u672a\u4f86\u767c\u5c55\u800c\u51fa\u73fe\u8b8a\u52d5\u3002<\/p>\n<p><i>\u8072\u660e\uff1a\u50c5\u4f9b\u91ab\u7642\u885b\u751f\u5c08\u696d\u4eba\u58eb\u4ea4\u6d41\u4f7f\u7528\u3002<\/i><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Dyba T, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[2] van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[3] Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u8212\u683c\u5229\u55ae\u6297\u6210\u70ba\u5168\u7403\u9996\u500b\u5728\u6b50\u6d32\u4e0a&#8230;<\/p>\n","protected":false},"author":16,"featured_media":199219,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-251151","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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\u8072\u660e\uff1a\u50c5\u4f9b\u91ab\u7642\u885b\u751f\u5c08\u696d\u4eba\u58eb\u4ea4\u6d41\u4f7f\u7528\u3002           Dyba T, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.         van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.         Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.         \u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=251151\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u570b\u7522PD-L1\u9996\u5ea6\u6210\u529f\u51fa\u6d77\uff1a\u57fa\u77f3\u85e5\u696d\u5ba3\u4f48\u8212\u683c\u5229\u55ae\u6297\uff08Cejemly\u00ae\uff09\u7372\u6b50\u76df\u59d4\u54e1\u6703\u6279\u51c6\u7528\u65bc\u4e00\u7dda\u6cbb\u7642\u975e\u5c0f\u7d30\u80de\u80ba\u764c - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" 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The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.         van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.         Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. 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The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.         van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.         Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. 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The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.         van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.         Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. 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