{"id":1448,"date":"2022-07-06T07:32:52","date_gmt":"2022-07-06T07:32:52","guid":{"rendered":"https:\/\/www.junshipharma.com\/?p=1448"},"modified":"2023-01-10T07:09:18","modified_gmt":"2023-01-10T07:09:18","slug":"%e7%be%8e%e5%9b%bdfda%e5%8f%97%e7%90%86%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e9%87%8d%e6%96%b0%e6%8f%90%e4%ba%a4%e7%9a%84%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97","status":"publish","type":"post","link":"https:\/\/www.junshipharma.com\/%e7%be%8e%e5%9b%bdfda%e5%8f%97%e7%90%86%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e9%87%8d%e6%96%b0%e6%8f%90%e4%ba%a4%e7%9a%84%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97\/","title":{"rendered":"\u7f8e\u56fdFDA\u53d7\u7406\u541b\u5b9e\u751f\u7269\u91cd\u65b0\u63d0\u4ea4\u7684\u7279\u745e\u666e\u5229\u5355\u6297\u6cbb\u7597\u9f3b\u54bd\u764c\u4e0a\u5e02\u7533\u8bf7"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><em>FDA\u5df2\u5c06\u7279\u745e\u666e\u5229\u5355\u6297BLA\u7684\u76ee\u6807\u5ba1\u8bc4\u65e5\u671f\u5b9a\u4e3a2022\u5e7412\u670823\u65e5<\/em><\/li>\n\n\n\n<li><em>\u5982\u82e5\u83b7\u6279\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u5c06\u6210\u4e3a\u7f8e\u56fd\u9996\u4e2a\u4e14\u552f\u4e00\u7528\u4e8e\u9f3b\u54bd\u764c\u6cbb\u7597\u7684\u80bf\u7624\u514d\u75ab\u836f\u7269<\/em><\/li>\n<\/ul>\n\n\n\n<p>\u5317\u4eac\u65f6\u95f42022\u5e747\u67086\u65e5\uff0c\u541b\u5b9e\u751f\u7269\uff081877.HK\uff0c688180.SH\uff09\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d7\u7406\u4e86\u91cd\u65b0\u63d0\u4ea4\u7684\u7279\u745e\u666e\u5229\u5355\u6297\u8054\u5408\u5409\u897f\u4ed6\u6ee8\/\u987a\u94c2\u4f5c\u4e3a\u665a\u671f\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\uff08NPC\uff09\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\u548c\u5355\u836f\u7528\u4e8e\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\u542b\u94c2\u6cbb\u7597\u540e\u7684\u4e8c\u7ebf\u53ca\u4ee5\u4e0a\u6cbb\u7597\u7684\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\u3002FDA\u5df2\u5c06\u5904\u65b9\u836f\u7528\u6237\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09\u7684\u76ee\u6807\u5ba1\u8bc4\u65e5\u671f\u5b9a\u4e3a2022\u5e7412\u670823\u65e5\u3002<\/p>\n\n\n\n<p>2021\u5e743\u6708\uff0c\u541b\u5b9e\u751f\u7269\u5ba3\u5e03\u5411FDA\u6eda\u52a8\u63d0\u4ea4\u7279\u745e\u666e\u5229\u5355\u6297\u6cbb\u7597\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\u7684BLA\u5e76\u83b7\u5f97\u6eda\u52a8\u5ba1\u8bc4\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u6210\u4e3a\u9996\u4e2a\u5411FDA\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\u7684\u56fd\u4ea7\u6297PD-1\u5355\u6297\u3002\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u80ba\u708e\uff08COVID-19\uff09\u75ab\u60c5\u76f8\u5173\u7684\u65c5\u884c\u9650\u5236\u963b\u788d\u4e86FDA\u524d\u6765\u5b8c\u6210\u5fc5\u8981\u7684\u73b0\u573a\u6838\u67e5\u5de5\u4f5c\u3002FDA\u65e9\u524d\u8868\u793a\uff0c\u7531\u4e8e\u5176\u9700\u8981\u5728\u4e2d\u56fd\u8fdb\u884c\u73b0\u573a\u6838\u67e5\uff0c\u91cd\u65b0\u63d0\u4ea4BLA\u7684\u5ba1\u8bc4\u65f6\u9650\u5c06\u4e3a6\u4e2a\u6708\u3002<\/p>\n\n\n\n<p>\u5982\u82e5\u6279\u51c6\uff0c\u541b\u5b9e\u751f\u7269\u7684\u5317\u7f8e\u5408\u4f5c\u4f19\u4f34Coherus BioSciences\u8ba1\u5212\u4e8e2023\u5e74\u7b2c\u4e00\u5b63\u5ea6\u5728\u7f8e\u56fd\u63a8\u51fa\u7279\u745e\u666e\u5229\u5355\u6297\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u4e5f\u5c06\u6210\u4e3a\u7f8e\u56fd\u9996\u4e2a\u4e14\u552f\u4e00\u7528\u4e8e\u9f3b\u54bd\u764c\u6cbb\u7597\u7684\u80bf\u7624\u514d\u75ab\u836f\u7269\u3002<\/p>\n\n\n\n<p><strong>\u541b\u5b9e\u751f\u7269\u9996\u5e2d\u533b\u5b66\u5b98Patricia Keegan\u535a\u58eb<\/strong>\u8868\u793a\uff1a\u201c\u5c3d\u7ba1\u65b0\u51a0\u75ab\u60c5\u7ed9\u6bcf\u4e2a\u4eba\u90fd\u5e26\u6765\u4e86\u5de8\u5927\u6311\u6218\uff0c\u4f46\u6211\u4eec\u81f4\u529b\u4e3a\u5168\u7403\u60a3\u8005\u63d0\u4f9b\u6548\u679c\u66f4\u597d\u7684\u6cbb\u7597\u9009\u62e9\u7684\u51b3\u5fc3\u4f9d\u65e7\u575a\u5b9a\u3002\u901a\u8fc7\u541b\u5b9e\u751f\u7269\u4e0e\u5408\u4f5c\u4f19\u4f34Coherus\u7684\u5171\u540c\u52aa\u529b\uff0c\u53cc\u65b9\u5c31\u7279\u745e\u666e\u5229\u5355\u6297\u5728\u4e2d\u56fd\u4ee5\u5916\u5730\u533a\u7684\u9996\u4e2a\u4e0a\u5e02\u7533\u8bf7\u53d6\u5f97\u4e86\u6301\u7eed\u6027\u7684\u8fdb\u5c55\u3002\u5728\u63a5\u4e0b\u6765\u7684\u51e0\u4e2a\u6708\u5185\uff0c\u6211\u4eec\u5c06\u4e0eFDA\u5bc6\u5207\u5408\u4f5c\uff0c\u63a8\u52a8\u8fd9\u9879\u521b\u65b0\u7597\u6cd5\u7684\u5ba1\u8bc4\u5de5\u4f5c\u3002\u201d<\/p>\n\n\n\n<p><strong>Coherus<\/strong><strong>\u9996\u5e2d\u5f00\u53d1\u5b98Theresa LaVallee\u535a\u58eb<\/strong>\u8868\u793a\uff1a\u201c\u9f3b\u54bd\u764c\u662f\u4e00\u79cd\u4fb5\u88ad\u6027\u6781\u5f3a\u7684\u764c\u75c7\uff0c\u76ee\u524dFDA\u5c1a\u672a\u6279\u51c6\u8fc7\u4efb\u4f55\u514d\u75ab\u7597\u6cd5\u7528\u4e8e\u8be5\u9886\u57df\u6cbb\u7597\u3002\u7279\u745e\u666e\u5229\u5355\u6297\u5c06\u89e3\u51b3\u9f3b\u54bd\u764c\u60a3\u8005\u4e25\u91cd\u672a\u88ab\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u6211\u4eec\u4e0e\u5408\u4f5c\u4f19\u4f34\u541b\u5b9e\u751f\u7269\u7d27\u5bc6\u5408\u4f5c\uff0c\u5df2\u5b8c\u6210FDA\u8981\u6c42\u7684\u8d28\u91cf\u6d41\u7a0b\u53d8\u66f4\uff0c\u4ece\u800c\u63a8\u52a8\u4e86\u7279\u745e\u666e\u5229\u5355\u6297BLA\u7684\u5feb\u901f\u91cd\u65b0\u63d0\u4ea4\u3002\u201d<\/p>\n\n\n\n<p><strong>Coherus<\/strong><strong>\u9996\u5e2d\u6267\u884c\u5b98Denny Lanfear<\/strong>\u8868\u793a\uff1a\u201c\u7279\u745e\u666e\u5229\u5355\u6297\u7684\u91cd\u65b0\u63d0\u4ea4\u662f\u6211\u4eec\u5728\u672a\u676512\u4e2a\u6708\u5927\u529b\u5173\u6ce8\u7684\u5173\u952e\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u91cc\u7a0b\u7891\u4e4b\u4e00\uff0c\u6211\u4eec\u5bf9\u516c\u53f8\u5728\u8fd9\u4e9b\u9886\u57df\u7684\u6267\u884c\u548c\u8fdb\u5c55\u611f\u5230\u9ad8\u5174\u3002\u7279\u745e\u666e\u5229\u5355\u6297\u7684PDUFA\u65e5\u671f\u5b9a\u57282022\u5e7412\u6708\uff0c\u968f\u540e\u9884\u8ba1\u57282023\u5e74\u7b2c\u4e00\u5b63\u5ea6\u4e0a\u5e02\uff0c\u5c06\u6b63\u5f0f\u6807\u5fd7\u7740\u6211\u4eec\u8fdb\u5165\u80bf\u7624\u514d\u75ab\u9886\u57df\u3002\u5728\u8be5\u9886\u57df\uff0cCoherus\u5c06\u6210\u4e3a\u5c11\u6570\u51e0\u5bb6\u62e5\u6709PD-1\u4e13\u6709\u6743\u76ca\u5e76\u5c06\u5176\u4f5c\u4e3a\u57fa\u77f3\u5efa\u7acb\u8d77\u80bf\u7624\u4e1a\u52a1\u7684\u516c\u53f8\u4e4b\u4e00\u3002\u201d<\/p>\n\n\n\n<p>\u5728\u7279\u745e\u666e\u5229\u5355\u6297\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u9f3b\u54bd\u764c\u540e\uff0cCoherus\u5728\u7f8e\u56fd\u7684\u7b56\u7565\u5c06\u5305\u62ec\u901a\u8fc7\u5171\u540c\u5f00\u53d1\u534f\u8bae\u8bc4\u4f30\u7279\u745e\u666e\u5229\u5355\u6297\u8054\u5408\u5176\u4ed6\u80bf\u7624\u836f\u7269\u548c\u514d\u75ab\u7597\u6cd5\u5728\u91cd\u5927\u9002\u5e94\u75c7\u4e2d\u4ea7\u751f\u663e\u8457\u4e34\u5e8a\u83b7\u76ca\u7684\u80fd\u529b\u3002<\/p>\n\n\n\n<p>\u7279\u745e\u666e\u5229\u5355\u6297\u7684BLA\u662f\u57fa\u4e8eJUPITER-02\uff08\u4e00\u9879\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u56fd\u9645\u591a\u4e2d\u5fc3III\u671f\u4e34\u5e8a\u7814\u7a76\uff09\u53caPOLARIS-02\uff08\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u5f00\u653e\u6807\u7b7e\u3001II\u671f\u5173\u952e\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\uff09\u7684\u7814\u7a76\u7ed3\u679c\u3002JUPITER-02\u7814\u7a76\u7ed3\u679c\u4e8e2021\u5e746\u6708\u5728\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08ASCO\uff09\u5e74\u4f1a\u7684\u5168\u4f53\u5927\u4f1a\uff08#LBA2\uff09\u4e0a\u9996\u6b21\u53d1\u8868\uff0c\u968f\u540e\u4f5c\u4e3a<a href=\"https:\/\/www.nature.com\/articles\/s41591-021-01444-0\">\u300a\u81ea\u7136-\u533b\u5b66\u300b<\/a>\uff08<em>Nature Medicine<\/em>\uff0cIF=87.241\uff092021\u5e749\u6708\u520a\u7684\u5c01\u9762\u6587\u7ae0\u53d1\u8868\u3002POLARIS-02\u7814\u7a76\u7ed3\u679c\u5df2\u4e8e2021\u5e741\u6708\u5728\u7ebf\u53d1\u8868\u4e8e<a href=\"https:\/\/ascopubs.org\/doi\/full\/10.1200\/JCO.20.02712\">\u300a\u4e34\u5e8a\u80bf\u7624\u5b66\u6742\u5fd7\u300b<\/a>\uff08<em>Journal of Clinical Oncology<\/em>\uff0cIF=50.717\uff09\u3002<\/p>\n\n\n\n<p>\u6b64\u524d\uff0cFDA\u5df2\u6388\u4e88\u7279\u745e\u666e\u5229\u5355\u6297\u6cbb\u7597\u9f3b\u54bd\u764c2\u9879\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u548c1\u9879\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\u3002\u5728\u4e2d\u56fd\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u5df2\u4e8e2021\u5e74\u6279\u51c6\u7279\u745e\u666e\u5229\u5355\u62972\u9879\u9f3b\u54bd\u764c\u9886\u57df\u65b0\u9002\u5e94\u75c7\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u6210\u4e3a\u5168\u7403\u9996\u4e2a\u83b7\u6279\u9f3b\u54bd\u764c\u6cbb\u7597\u7684\u514d\u75ab\u68c0\u67e5\u70b9\u6291\u5236\u5242\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h6 class=\"wp-block-heading\"><em>1. \u672c\u6750\u6599\u65e8\u5728\u4f20\u9012\u524d\u6cbf\u4fe1\u606f\uff0c\u65e0\u610f\u5411\u60a8\u505a\u4efb\u4f55\u4ea7\u54c1\u7684\u63a8\u5e7f\uff0c\u4e0d\u4f5c\u4e3a\u4e34\u5e8a\u7528\u836f\u6307\u5bfc\u3002<\/em><\/h6>\n\n\n\n<h6 class=\"wp-block-heading\"><em>2. \u82e5\u60a8\u60f3\u4e86\u89e3\u5177\u4f53\u75be\u75c5\u8bca\u7597\u4fe1\u606f\uff0c\u8bf7\u9075\u4ece\u533b\u7597\u536b\u751f\u4e13\u4e1a\u4eba\u58eb\u7684\u610f\u89c1\u4e0e\u6307\u5bfc\u3002<\/em><\/h6>\n\n\n\n\n\n<p><strong>\u5173\u4e8e\u9f3b\u54bd\u764c<\/strong><\/p>\n\n\n\n<p>\u9f3b\u54bd\u764c\u662f\u4e00\u79cd\u539f\u53d1\u4e8e\u9f3b\u54bd\u90e8\u9ecf\u819c\u4e0a\u76ae\u7684\u6076\u6027\u80bf\u7624\uff0c\u662f\u5e38\u89c1\u7684\u5934\u9888\u90e8\u80bf\u7624\u4e4b\u4e00\u3002\u636e\u7edf\u8ba1\uff0c2020\u5e74\u5168\u7403\u9f3b\u54bd\u764c\u65b0\u53d1\u75c5\u4f8b\u6570\u8d85\u8fc713\u4e07<a id=\"_ftnref1\" href=\"#_ftn1\"><sup>[1]<\/sup><\/a>\u3002\u7531\u4e8e\u539f\u53d1\u80bf\u7624\u4f4d\u7f6e\u7684\u539f\u56e0\uff0c\u5f88\u5c11\u91c7\u7528\u624b\u672f\u6cbb\u7597\uff0c\u5c40\u90e8\u75be\u75c5\u60a3\u8005\u4e3b\u8981\u91c7\u7528\u5316\u7597\u53ca\u653e\u7597\u6cbb\u7597\u3002\u5728\u7f8e\u56fd\uff0c\u5c1a\u65e0\u514d\u75ab\u7597\u6cd5\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u9f3b\u54bd\u764c\u3002<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">\u53c2\u8003\u6587\u732e<\/h5>\n\n\n\n<h5 class=\"wp-block-heading\"><a href=\"https:\/\/www.junshipharma.com\/wp-admin\/post-new.php?lang=zh-hans#_ftnref1\">[1]<\/a> https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/4-Nasopharynx-fact-sheet.pdf.<\/h5>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>\u5173\u4e8e\u7279\u745e\u666e\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff08\u62d3\u76ca<sup>\u00ae<\/sup>\uff09<\/strong><\/p>\n\n\n\n<p>\u7279\u745e\u666e\u5229\u5355\u6297\u6ce8\u5c04\u6db2\uff08\u62d3\u76ca<sup>\u00ae<\/sup>\uff09\u4f5c\u4e3a\u6211\u56fd\u6279\u51c6\u4e0a\u5e02\u7684\u9996\u4e2a\u56fd\u4ea7\u4ee5PD-1\u4e3a\u9776\u70b9\u7684\u5355\u6297\u836f\u7269\uff0c\u83b7\u5f97\u56fd\u5bb6\u79d1\u6280\u91cd\u5927\u4e13\u9879\u9879\u76ee\u652f\u6301\uff0c\u5e76\u8363\u81ba\u56fd\u5bb6\u4e13\u5229\u9886\u57df\u6700\u9ad8\u5956\u9879\u201c\u4e2d\u56fd\u4e13\u5229\u91d1\u5956\u201d\u3002<\/p>\n\n\n\n<p>\u7279\u745e\u666e\u5229\u5355\u6297\u81f3\u4eca\u5df2\u5728\u5168\u7403\uff08\u5305\u62ec\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u4e1c\u5357\u4e9a\u53ca\u6b27\u6d32\u7b49\u5730\uff09\u5f00\u5c55\u4e86\u8986\u76d6\u8d85\u8fc715\u4e2a\u9002\u5e94\u75c7\u768430\u591a\u9879\u7531\u516c\u53f8\u53d1\u8d77\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u6b63\u5728\u8fdb\u884c\u6216\u5df2\u5b8c\u6210\u7684\u5173\u952e\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76\u5728\u591a\u4e2a\u7624\u79cd\u8303\u56f4\u5185\u8bc4\u4f30\u7279\u745e\u666e\u5229\u5355\u6297\u7684\u5b89\u5168\u6027\u53ca\u7597\u6548\uff0c\u5305\u62ec\u80ba\u764c\u3001\u9f3b\u54bd\u764c\u3001\u98df\u7ba1\u764c\u3001\u80c3\u764c\u3001\u8180\u80f1\u764c\u3001\u4e73\u817a\u764c\u3001\u809d\u764c\u3001\u80be\u764c\u53ca\u76ae\u80a4\u764c\u7b49\u3002<\/p>\n\n\n\n<p>\u622a\u81f3\u76ee\u524d\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u5df2\u5728\u4e2d\u56fd\u83b7\u62795\u9879\u9002\u5e94\u75c7\uff1a\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u5168\u8eab\u7cfb\u7edf\u6cbb\u7597\u5931\u8d25\u7684\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u9ed1\u8272\u7d20\u7624\u7684\u6cbb\u7597\uff082018\u5e7412\u6708\uff09\uff1b\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u4e8c\u7ebf\u53ca\u4ee5\u4e0a\u7cfb\u7edf\u6cbb\u7597\u5931\u8d25\u7684\u590d\u53d1\/\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\u60a3\u8005\u7684\u6cbb\u7597\uff082021\u5e742\u6708\uff09\uff1b\u7528\u4e8e\u542b\u94c2\u5316\u7597\u5931\u8d25\u5305\u62ec\u65b0\u8f85\u52a9\u6216\u8f85\u52a9\u5316\u759712\u4e2a\u6708\u5185\u8fdb\u5c55\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u5c3f\u8def\u4e0a\u76ae\u764c\u7684\u6cbb\u7597\uff082021\u5e744\u6708\uff09\uff1b\u8054\u5408\u987a\u94c2\u548c\u5409\u897f\u4ed6\u6ee8\u7528\u4e8e\u5c40\u90e8\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\uff082021\u5e7411\u6708\uff09\uff1b\u8054\u5408\u7d2b\u6749\u9187\u548c\u987a\u94c2\u7528\u4e8e\u4e0d\u53ef\u5207\u9664\u5c40\u90e8\u665a\u671f\/\u590d\u53d1\u6216\u8fdc\u5904\u8f6c\u79fb\u6027\u98df\u7ba1\u9cde\u764c\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\uff082022\u5e745\u6708\uff09\u30022020\u5e7412\u6708\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u9996\u6b21\u901a\u8fc7\u56fd\u5bb6\u533b\u4fdd\u8c08\u5224\uff0c\u76ee\u524d\u5df2\u67093\u9879\u9002\u5e94\u75c7\u7eb3\u5165\u300a2021\u5e74\u836f\u54c1\u76ee\u5f55\u300b\uff0c\u662f\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\u4e2d\u552f\u4e00\u7528\u4e8e\u6cbb\u7597\u9ed1\u8272\u7d20\u7624\u548c\u9f3b\u54bd\u764c\u7684\u6297PD-1\u5355\u6297\u836f\u7269\u3002\u6b64\u5916\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u8054\u5408\u5316\u7597\u7528\u4e8e\u4e00\u7ebf\u6cbb\u7597\u65e0EGFR\u6216ALK\u7a81\u53d8\u7684\u665a\u671f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u60a3\u8005\u7684\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u7533\u8bf7\u76ee\u524d\u6b63\u5728\u63a5\u53d7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u7684\u5ba1\u8bc4\u3002<\/p>\n\n\n\n<p>\u5728\u56fd\u9645\u5316\u5e03\u5c40\u65b9\u9762\uff0c\u7279\u745e\u666e\u5229\u5355\u6297\u5df2\u5728\u9ecf\u819c\u9ed1\u8272\u7d20\u7624\u3001\u9f3b\u54bd\u764c\u3001\u8f6f\u7ec4\u7ec7\u8089\u7624\u3001\u98df\u7ba1\u764c\u3001\u5c0f\u7ec6\u80de\u80ba\u764c\u9886\u57df\u83b7\u5f97FDA\u6388\u4e882\u9879\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u30011\u9879\u5feb\u901f\u901a\u9053\u8ba4\u5b9a\u30011\u9879\u4f18\u5148\u5ba1\u8bc4\u8ba4\u5b9a\u548c5\u9879\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\u3002<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"<p>\u5317\u4eac\u65f6\u95f42022\u5e747\u67086\u65e5\uff0c\u541b\u5b9e\u751f\u7269\uff081877.HK\uff0c688180.SH\uff09\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d7\u7406\u4e86\u91cd\u65b0\u63d0\u4ea4\u7684\u7279\u745e\u666e\u5229\u5355\u6297\u8054\u5408\u5409\u897f\u4ed6\u6ee8\/\u987a\u94c2\u4f5c\u4e3a\u665a\u671f\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\uff08NPC\uff09\u60a3\u8005\u7684\u4e00\u7ebf\u6cbb\u7597\u548c\u5355\u836f\u7528\u4e8e\u590d\u53d1\u6216\u8f6c\u79fb\u6027\u9f3b\u54bd\u764c\u542b\u94c2\u6cbb\u7597\u540e\u7684\u4e8c\u7ebf\u53ca\u4ee5\u4e0a\u6cbb\u7597\u7684\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\u3002FDA\u5df2\u5c06\u5904\u65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