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rel=\"noopener\">[\u93c8\u63a5]<\/a>\u00a0<\/p>\n<p>\u6b64\u524d\uff0c\u9054\u4f2f\u6a02\u00ae\u5df2\u7372\u5f97NMPA\u6279\u51c6\u7528\u65bc\u7d93ROS1-TKI\u6cbb\u7642\u5f8c\u9032\u5c55\u7684ROS1\u967d\u6027\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\uff08NSCLC\uff09\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7642\u3002\u9054\u4f2f\u6a02\u00ae\u662f\u4fe1\u9054\u751f\u7269\u7b2c13\u6b3e\u5546\u696d\u5316\u7522\u54c1\uff0c\u9019\u4e00\u5275\u65b0\u7cbe\u6e96\u7642\u6cd5\u5c07\u60e0\u53ca ROS1 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(NCT04919811)\u3002<\/p>\n<p>\u9054\u4f2f\u6a02\u00ae\u7372\u4e2d\u570b\u570b\u5bb6\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u7528\u65bc\uff1a1\uff09\u7d93ROS1-TKI\u6cbb\u7642\u5f8c\u9032\u5c55\u7684ROS1\u967d\u6027\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\uff08NSCLC\uff09\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7642\uff1b\u53ca2\uff09<span>ROS1\u967d\u6027\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\uff08NSCLC\uff09\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7642\u3002<\/span><\/p>\n<p>\u4ed6\u96f7\u66ff\u5c3c\u65bc 2022 \u5e74\u88ab CDE \u6388\u4e88\u7a81\u7834\u6027\u7642\u6cd5\u8a8d\u5b9a\uff08BTD\uff09\uff0c\u7528\u65bc\u6cbb\u7642\u65e2\u5f80\u7d93 ROS1 TKI \u6cbb\u7642\u7684\u665a\u671f\u6216\u8f49\u79fb\u6027 ROS1 \u967d\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u6210\u4eba\u60a3\u8005\u4ee5\u53ca\u672a\u7d93 ROS1 TKI \u6cbb\u7642\u7684 ROS1 \u967d\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u60a3\u8005\u3002 \u9664\u6b64\u4e4b\u5916\uff0c\u4ed6\u96f7\u66ff\u5c3c\u9084\u7372\u5f97\u7f8e\u570bFDA\u6388\u4e88\u7684\u7528\u65bc\u6cbb\u7642 ROS1 \u967d\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\u7684\u5b64\u5152\u85e5\u8a8d\u5b9a\uff08ODD\uff09\u548c\u7a81\u7834\u6027\u7642\u6cd5\u8a8d\u5b9a\uff08BTD\uff09\u3002\u57fa\u65bcTRUST-I\u548cTRUST-II\u7814\u7a76\u7d50\u679c\uff0cNuvation Bio\u5411\u7f8e\u570bFDA\u905e\u4ea4\u4ed6\u96f7\u66ff\u5c3c\u7684NDA\uff0c\u7528\u65bcROS1\u967d\u6027\u665a\u671fNSCLC\u60a3\u8005\u7684\u6cbb\u7642\uff08\u4e0d\u8ad6\u6cbb\u7642\u7dda\u6578\uff0c\u5b8c\u5168\u5be9\u6279\uff09\u3002FDA\u65bc2024\u5e7412\u6708\u53d7\u7406\u4e86\u6b64\u9805NDA\u4e26\u6388\u4e88\u512a\u5148\u5be9\u8a55\u3002<\/p>\n<p>2021 \u5e74 6 \u6708\uff0c\u4fe1\u9054\u751f\u7269\u8207\u8446\u5143\u91ab\u85e5\u2014 \u73fe\u70ba Nuvation Bio (NYSE: NUVB) \u65d7\u4e0b\u516c\u53f8\uff0c \u7c3d\u8a02\u4e86\u7368\u5bb6\u8a31\u53ef\u5354\u8b70\uff0c\u5728\u5927\u4e2d\u83ef\u5340\uff08\u5305\u62ec\u4e2d\u570b\u5927\u9678\u3001\u9999\u6e2f\u3001\u6fb3\u9580\u548c\u53f0\u7063\uff09\u5171\u540c\u958b\u767c\u548c\u5546\u696d\u5316\u4ed6\u96f7\u66ff\u5c3c\u3002<\/p>\n<p>\u95dc\u65bc\u4fe1\u9054\u751f\u7269<\/p>\n<p>\u300c\u59cb\u65bc\u4fe1\uff0c\u9054\u65bc\u884c\u300d\uff0c\u958b\u767c\u51fa\u8001\u767e\u59d3\u7528\u5f97\u8d77\u7684\u9ad8\u8cea\u91cf\u751f\u7269\u85e5\uff0c\u662f\u4fe1\u9054\u751f\u7269\u7684\u4f7f\u547d\u548c\u76ee\u6a19\u3002\u4fe1\u9054\u751f\u7269\u6210\u7acb\u65bc2011\u5e74\uff0c\u81f4\u529b\u65bc\u7814\u767c\u3001\u751f\u7522\u548c\u92b7\u552e\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u3001\u4ee3\u8b1d\u3001\u773c\u79d1\u7b49\u91cd\u5927\u75be\u75c5\u9818\u57df\u7684\u5275\u65b0\u85e5\u7269\uff0c\u8b93\u6211\u5011\u7684\u5de5\u4f5c\u60e0\u53ca\u66f4\u591a\u7684\u751f\u547d\u3002\u516c\u53f8\u5df2\u670913\u500b\u7522\u54c1\u7372\u5f97\u6279\u51c6\u4e0a\u5e02\uff0c\u5b83\u5011\u5206\u5225\u662f\u4fe1\u8fea\u5229\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u9054\u4f2f\u8212\u00ae\uff09\uff0c\u8c9d\u4f10\u73e0\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u9054\u6538\u540c\u00ae\uff09\uff0c\u963f\u9054\u6728\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u8607\u7acb\u4fe1\u00ae\uff09\uff0c\u5229\u59a5\u6614\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u9054\u4f2f\u83ef\u00ae\uff09\uff0c\u4f69\u7c73\u66ff\u5c3c\u7247\uff08\u9054\u4f2f\u5766\u00ae\uff09\uff0c\u5967\u96f7\u5df4\u66ff\u5c3c\u7247\uff08\u8010\u7acb\u514b\u00ae\uff09\uff0c \u96f7\u83ab\u897f\u5c24\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u5e0c\u5189\u64c7\u00ae\uff09\uff0c\u585e\u666e\u66ff\u5c3c\u81a0\u56ca\uff08\u777f\u59a5\u00ae\uff09\uff0c\u4f0a\u57fa\u5967\u4f96\u8cfd\u6ce8\u5c04\u6db2\uff08\u798f\u53ef\u8607\u00ae\uff09\uff0c\u6258\u840a\u897f\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u4fe1\u5fc5\u6a02\u00ae\uff09, \u6c1f\u6fa4\u96f7\u585e\u7247\uff08\u9054\u4f2f\u7279\u00ae\uff09\uff0c\u5339\u59a5\u5e03\u66ff\u5c3c\u7247\uff08\u6377\u5e15\u529b\u00ae\uff09\u548c\u5df1\u4e8c\u9178\u4ed6\u96f7\u66ff\u5c3c\u81a0\u56ca\uff08\u9054\u4f2f\u6a02\u00ae\uff09\u3002\u76ee\u524d\uff0c\u540c\u6642\u9084\u67094\u500b\u54c1\u7a2e\u5728NMPA\u5be9\u8a55\u4e2d\uff0c3\u500b\u65b0\u85e5\u5206\u5b50\u9032\u5165III\u671f\u6216\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u53e6\u5916\u9084\u670917\u500b\u65b0\u85e5\u54c1\u7a2e\u5df2\u9032\u5165\u81e8\u5e8a\u7814\u7a76\u3002<\/p>\n<p>\u516c\u53f8\u5df2\u8207\u79ae\u4f86\u3001\u7f85\u6c0f\u3001\u8cfd\u8afe\u83f2\u3001Adimab\u3001Incyte\u548cMD Anderson \u764c\u75c7\u4e2d\u5fc3\u7b49\u570b\u969b\u5408\u4f5c\u65b9\u9054\u621030\u591a\u9805\u6230\u7565\u5408\u4f5c\u3002\u4fe1\u9054\u751f\u7269\u5728\u4e0d\u65b7\u81ea\u7814\u5275\u65b0\u85e5\u7269\u3001\u8b00\u6c42\u81ea\u8eab\u767c\u5c55\u7684\u540c\u6642\uff0c\u79c9\u627f\u7d93\u6fdf\u5efa\u8a2d\u4ee5\u4eba\u6c11\u70ba\u4e2d\u5fc3\u7684\u767c\u5c55\u601d\u60f3\u3002\u591a\u5e74\u4f86\uff0c\u59cb\u7d42\u5fc3\u61f7\u79d1\u5b78\u5584\u5ff5\uff0c\u5805\u5b88\u300c\u4ee5\u60a3\u8005\u70ba\u4e2d\u5fc3\u300d\uff0c\u5fc3\u7e6b\u60a3\u8005\u4e26\u95dc\u6ce8\u60a3\u8005\u5bb6\u5ead\uff0c\u7a4d\u6975\u5c65\u884c\u793e\u6703\u8cac\u4efb\u3002\u516c\u53f8\u9678\u7e8c\u767c\u8d77\u3001\u53c3\u8207\u4e86\u591a\u9805\u85e5\u54c1\u516c\u76ca\u63f4\u52a9\u9805\u76ee\uff0c\u8b93\u8d8a\u4f86\u8d8a\u591a\u7684\u60a3\u8005\u80fd\u5920\u5f97\u76ca\u65bc\u751f\u547d\u79d1\u5b78\u7684\u9032\u6b65\uff0c\u8cb7\u5f97\u5230\u3001\u7528\u5f97\u8d77\u9ad8\u8cea\u91cf\u7684\u751f\u7269\u85e5\u3002\u622a\u81f3\u76ee\u524d\uff0c\u4fe1\u9054\u751f\u7269\u60a3\u8005\u63f4\u52a9\u9805\u76ee\u5df2\u60e0\u53ca20\u9918\u842c\u666e\u901a\u60a3\u8005\uff0c\u85e5\u7269\u6350\u8d08\u7e3d\u50f9\u503c36\u5104\u5143\u4eba\u6c11\u5e63\u3002\u4fe1\u9054\u751f\u7269\u5e0c\u671b\u548c\u5927\u5bb6\u4e00\u8d77\u52aa\u529b\uff0c\u63d0\u9ad8\u4e2d\u570b\u751f\u7269\u88fd\u85e5\u7522\u696d\u7684\u767c\u5c55\u6c34\u5e73\uff0c\u4ee5\u6eff\u8db3\u767e\u59d3\u7528\u85e5\u53ef\u53ca\u6027\u548c\u4eba\u6c11\u5c0d\u751f\u547d\u5065\u5eb7\u7f8e\u597d\u9858\u671b\u7684\u8ffd\u6c42\u3002<\/p>\n<p>\u8a73\u60c5\u8acb\u8a2a\u554f\u516c\u53f8\u7db2\u7ad9\uff1awww.innoventbio.com\u6216\u516c\u53f8\u9818\u82f1\u8cec\u865f<a href=\"http:\/\/www.linkedin.com\/company\/innovent-biologics\/\" target=\"_blank\" rel=\"noopener\">www.linkedin.com\/company\/innovent-biologics\/<\/a>\u3002<\/p>\n<p>\u8072\u660e\uff1a1.\u4fe1\u9054\u751f\u7269\u4e0d\u63a8\u85a6\u672a\u7372\u6279\u7684\u85e5\u54c1\/\u9069\u61c9\u75c7\u7684\u4f7f\u7528\u3002<\/p>\n<p>2.\u96f7\u83ab\u897f\u5c24\u55ae\u6297\u6ce8\u5c04\u6db2\uff08\u5e0c\u5189\u64c7\u00ae\uff09\u585e\u666e\u66ff\u5c3c\u81a0\u56ca\uff08\u777f\u59a5\u00ae\uff09\u548c\u5339\u59a5\u5e03\u66ff\u5c3c\u7247\uff08\u6377\u5e15\u529b\u00ae\uff09\u7531\u79ae\u4f86\u516c\u53f8\u7814\u767c<\/p>\n<p>\u524d\u77bb\u6027\u8072\u660e<\/p>\n<p>\u672c\u65b0\u805e\u7a3f\u6240\u767c\u4f48\u7684\u4fe1\u606f\u4e2d\u53ef\u80fd\u6703\u5305\u542b\u67d0\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u3002\u9019\u4e9b\u8868\u8ff0\u672c\u8cea\u4e0a\u5177\u6709\u76f8\u7576\u98a8\u96aa\u548c\u4e0d\u78ba\u5b9a\u6027\u3002\u5728\u4f7f\u7528\u300c\u9810\u671f\u300d\u3001\u300c\u76f8\u4fe1\u300d\u3001\u300c\u9810\u6e2c\u300d\u3001\u300c\u671f\u671b\u300d\u3001\u300c\u6253\u7b97\u300d\u53ca\u5176\u4ed6\u985e\u4f3c\u8a5e\u8a9e\u9032\u884c\u8868\u8ff0\u6642\uff0c\u51e1\u8207\u672c\u516c\u53f8\u6709\u95dc\u7684\uff0c\u76ee\u7684\u5747\u662f\u8981\u6307\u660e\u5176\u5c6c\u524d\u77bb\u6027\u8868\u8ff0\u3002\u672c\u516c\u53f8\u4e26\u7121\u7fa9\u52d9\u4e0d\u65b7\u5730\u66f4\u65b0\u9019\u4e9b\u9810\u6e2c\u6027\u9673\u8ff0\u3002<\/p>\n<p>\u9019\u4e9b\u524d\u77bb\u6027\u8868\u8ff0\u4e43\u57fa\u65bc\u672c\u516c\u53f8\u7ba1\u7406\u5c64\u5728\u505a\u51fa\u8868\u8ff0\u6642\u5c0d\u672a\u4f86\u4e8b\u52d9\u7684\u73fe\u6709\u770b\u6cd5\u3001\u5047\u8a2d\u3001\u671f\u671b\u3001\u4f30\u8a08\u3001\u9810\u6e2c\u548c\u7406\u89e3\u3002\u9019\u4e9b\u8868\u8ff0\u4e26\u975e\u5c0d\u672a\u4f86\u767c\u5c55\u7684\u4fdd\u8b49\uff0c\u6703\u53d7\u5230\u98a8\u96aa\u3001\u4e0d\u78ba\u6027\u53ca\u5176\u4ed6\u56e0\u7d20\u7684\u5f71\u97ff\uff0c\u6709\u4e9b\u4e43\u8d85\u51fa\u672c\u516c\u53f8\u7684\u63a7\u5236\u7bc4\u570d\uff0c\u96e3\u4ee5\u9810\u8a08\u3002\u56e0\u6b64\uff0c\u53d7\u6211\u5011\u7684\u696d\u52d9\u3001\u7af6\u722d\u74b0\u5883\u3001\u653f\u6cbb\u3001\u7d93\u6fdf\u3001\u6cd5\u5f8b\u548c\u793e\u6703\u60c5\u6cc1\u7684\u672a\u4f86\u8b8a\u5316\u53ca\u767c\u5c55\u7684\u5f71\u97ff\uff0c\u5be6\u969b\u7d50\u679c\u53ef\u80fd\u6703\u8207\u524d\u77bb\u6027\u8868\u8ff0\u6240\u542b\u8cc7\u6599\u6709\u8f03\u5927\u5dee\u5225\u3002<\/p>\n<p>\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4 (a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002<\/p>\n<p>\u53c3\u8003\u6587\u737b<\/p>\n<p>[i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u820a\u91d1\u5c71\u548c\u4e2d\u570b\u8607\u5dde2025\u5e741\u67083\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u4fe1\u9054\u751f\u7269\u88fd\u85e5\u96c6\u5718\uff08\u9999\u6e2f\u806f\u4ea4\u6240\u80a1\u7968\u4ee3\u78bc\uff1a01801\uff09\uff0c\u4e00\u5bb6\u81f4\u529b\u65bc\u7814\u767c\u3001\u751f\u7522\u548c\u92b7\u552e\u816b\u7624\u3001\u81ea\u8eab\u514d\u75ab\u3001\u4ee3\u8b1d\u3001\u773c\u79d1\u7b49\u91cd\u5927\u75be\u75c5\u9818\u57df\u5275\u65b0\u85e5\u7269\u7684\u751f\u7269\u88fd\u85e5\u516c\u53f8\u5ba3\u4f48\uff0c\u65b0\u4e00\u4ee3 ROS1 \u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5291\uff08TKI\uff09\u9054\u4f2f\u6a02\u00ae\uff08\u5df1\u4e8c\u9178\u4ed6\u96f7\u66ff\u5c3c\u81a0\u56ca\uff09\u7684\u7b2c\u4e8c\u9805\u65b0\u85e5\u4e0a\u5e02\u7533\u8acb\uff08NDA\uff09\u7372\u4e2d\u570b\u570b\u5bb6\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u65bcROS1\u967d\u6027\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f49\u79fb\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u764c\uff08NSCLC\uff09\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7642\u3002 \u672c\u6b21\u7372\u6279\u662f\u57fa\u65bc\u4e00\u9805\u81e8\u5e8aII\u671f\u7814\u7a76TRUST-I (NCT04395677) \u7684\u7a4d\u6975\u7d50\u679c\u3002\u8a72\u8a66\u9a57\u662f\u4e00\u9805\u5728\u4e2d\u570b\u958b\u5c55\u7684\u591a\u4e2d\u5fc3\u3001\u958b\u653e\u6a19\u7c64\u3001\u55ae\u81c2\u8a66\u9a57\uff0c\u65e8\u5728\u8a55\u4f30\u9054\u4f2f\u6a02\u00ae\u5728\u4e2d\u570b ROS1 \u967d\u6027\u975e\u5c0f\u7d30\u80de\u764c\u60a3\u8005\u4e2d\u7684\u7684\u5b89\u5168\u6027\u3001\u8010\u53d7\u6027\u548c\u7642\u6548\u3002 TRUST-I \u81e8\u5e8a\u7814\u7a76\u7684\u7d50\u679c\u65bc\u7f8e\u570b\u300a\u81e8\u5e8a\u816b\u7624\u5b78\u96dc\u8a8c\u300b\uff08Journal of Clinical Oncology, JCO\uff09\u767c\u8868\uff0c\u4e26\u5728 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\u672c\u516c\u53f8\u3001\u672c\u516c\u53f8\u8463\u4e8b\u53ca\u50f1\u54e1\u4ee3\u7406\u6982\u4e0d\u627f\u64d4 (a) \u66f4\u6b63\u6216\u66f4\u65b0\u672c\u7db2\u7ad9\u6240\u8f09\u524d\u77bb\u6027\u8868\u8ff0\u7684\u4efb\u4f55\u7fa9\u52d9;\u53ca (b) \u82e5\u56e0\u4efb\u4f55\u524d\u77bb\u6027\u8868\u8ff0\u4e0d\u80fd\u5be6\u73fe\u6216\u8b8a\u6210\u4e0d\u6b63\u78ba\u800c\u5f15\u81f4\u7684\u4efb\u4f55\u8cac\u4efb\u3002 \u53c3\u8003\u6587\u737b [i] Zhang et al. Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. Thorac Cancer. 2019 Jan;10(1):47-53.<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_generate-full-width-content":"","spay_email":"","footnotes":""},"categories":[1],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u4fe1\u9054\u751f\u7269\u5ba3\u4f48ROS1\u6291\u5236\u5291\u9054\u4f2f\u6a02\u00ae\uff08\u5df1\u4e8c\u9178\u4ed6\u96f7\u66ff\u5c3c\u81a0\u56ca\uff09\u7372\u6279\u7b2c\u4e8c\u9805\u9069\u61c9\u75c7\uff0c\u7528\u65bc\u5168\u7dda\u6cbb\u7642 ROS1 \u967d\u6027\u80ba\u764c - \u9999\u6e2f\u7279\u8a31\u7d93\u71df<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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Prevalence of ROS1 fusion in Chinese patients with non-small cell lung cancer. 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