{"id":66080,"date":"2018-10-06T01:00:00","date_gmt":"2018-12-07T03:58:24","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/03c5ba259e\/"},"modified":"2018-12-07T11:58:27","modified_gmt":"2018-12-07T03:58:27","slug":"03c5ba259e","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/66080\/","title":{"rendered":"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01"},"content":{"rendered":"
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2018\u5e74\u4e0a\u534a\u5e74\uff0cFDA\u6279\u51c6\u4e8617\u6b3e\u65b0\u836f\uff0c\u8fd9\u5176\u4e2d\u670912\u4e2a\u836f\u7269\u90fd\u662f\u5168\u7403\u9996\u6279\uff0c\u5176\u4f59\u7684\u5927\u591a\u4e3a\u6b27\u76df\u9996\u6279\u3002<\/span>
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\u5168\u65872289\u5b57\uff0c\u7528\u65f65\u5206\u949f<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u4f5c\u8005\uff1a\u9999\u6797<\/span><\/p>\n

\u56fd\u4ea7\u521b\u65b0\u836f\u9010\u6b65\u8fc8\u5165\u6210\u679c\u5bc6\u96c6\u6536\u83b7\u671f<\/strong><\/span><\/p>\n

2018\u5e74\u4e0a\u534a\u5e74\uff0cFDA\u6279\u51c6\u4e8617\u6b3e\u65b0\u836f\uff0c\u8fd9\u5176\u4e2d\u670912\u4e2a\u836f\u7269\u90fd\u662f\u5168\u7403\u9996\u6279\uff0c\u5176\u4f59\u7684\u5927\u591a\u4e3a\u6b27\u76df\u9996\u6279\u3002\u81f3\u4e8e\u6cbb\u7597\u9886\u57df\u5206\u5e03\u65b9\u9762\uff0c\u6297\u764c\u836f\u70ed\u5ea6\u672a\u51cf\uff0c\u5171\u67097\u4e2a\u4ea7\u54c1\uff1a\u5206\u522b\u662f\u9996\u6b21\u83b7\u6279\u7684\u6768\u68ee\u7684Erleada\u548c\u8bfa\u534e\u7684Lutathera\uff0c\u4ee5\u53ca\u6269\u5927\u9002\u5e94\u75c7\u7684\u6768\u68ee\u7684ZYTIGA\u3001\u963f\u65af\u5229\u5eb7\u7684Imfinzi\u3001\u793c\u6765\u7684Verzenio\u3001\u5b89\u8fdb\u7684Blincyto\u3001Seattle Genetics\u7684Adcetris\u3002<\/span><\/p>\n

\u88681. 2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u768417\u4e2a\u65b0\u836f<\/span><\/p>\n

\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\u6570\u636e\u6765\u6e90\uff1a\u4e2d\u56fd\u65b0\u53d1\u76d1\u6d4b\u6570\u636e\u5e93CPM & FDA\uff0cNovel Drug approvals for 2018<\/span><\/p>\n

2017\u5e74\uff0c\u4e00\u5927\u6ce2\u8fdb\u53e3\u548c\u56fd\u4ea7\u65b0\u836f\u501f\u52a9\u4f18\u5148\u5ba1\u8bc4\u5feb\u901f\u83b7\u6279\u4e0a\u5e02\uff0c\u4e00\u4e9b\u5e78\u8fd0\u8005\u8fd8\u8d76\u4e0a\u4e86\u90e8\u5206\u7701\u5e02\u533b\u4fdd\u8c08\u5224\u7684\u73ed\u8f66\u3002\u805a\u7126\u56fd\u5185\u5e02\u573a\uff0c2018\u5e74\u4e0a\u534a\u5e74\u6709\u4e8c\u5341\u591a\u4e2a\u65b0\u836f\u54c1\u79cd\u4f9d\u6b21\u4e0a\u5e02\u3002\u9664\u4e86\u8bfa\u534e\u3001\u9ed8\u6c99\u4e1c\u3001\u845b\u5170\u7d20\u53f2\u514b\u3001\u793c\u6765\u3001\u62dc\u8033\u7b49\u5236\u836f\u5de8\u5934\u5916\uff0c\u56fd\u5185\u4f01\u4e1a\u4e0d\u65ad\u79ef\u7d2f\u56fd\u9645\u7ade\u4e89\u5b9e\u529b\uff0c\u56fd\u4ea7\u521b\u65b0\u836f\u8fce\u6765\u5927\u7206\u53d1\uff0c\u603b\u8ba17\u4e2a\u4ea7\u54c1\u62ff\u5230\u4e0a\u5e02\u8bb8\u53ef\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c2017\u5e74\u5168\u5e74\u4e0d\u8fc7\u4e00\u4e2a\u56fd\u4ea7\u521b\u65b0\u836f\u83b7\u51c6\u4e0a\u5e02\uff08\u57c3\u535a\u62c9\u75c5\u6bd2\u75ab\u82d7\uff09\u3002<\/span><\/p>\n

\u88682. 2018\u4e0a\u534a\u5e74\u56fd\u5185\u6279\u51c6\u56fd\u4ea7\u4e0a\u5e02\u65b0\u836f<\/span><\/p>\n

\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\u6570\u636e\u6765\u6e90\uff1a\u4e2d\u56fd\u65b0\u53d1\u76d1\u6d4b\u6570\u636e\u5e93CPM<\/span><\/p>\n

\u88683. 2018\u4e0a\u534a\u5e74\u56fd\u5185\u6279\u51c6\u8fdb\u53e3\u4e0a\u5e02\u65b0\u836f<\/span><\/p>\n

\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\u6570\u636e\u6765\u6e90\uff1a\u4e2d\u56fd\u65b0\u53d1\u76d1\u6d4b\u6570\u636e\u5e93CPM<\/span><\/p>\n

\u65b0\u836f\u5ba1\u6279\u52a0\u901f\uff0c\u56fd\u4ea7\u521b\u65b0\u836f\u7533\u62a5\u70ed\u5ea6\u4ecd\u7136\u6301\u7eed\u8d70\u9ad8<\/strong><\/span><\/p>\n

\u57282018\u5e74\u9996\u6b21\u8fdb\u5165\u7533\u62a5\u4e0a\u5e02\u9636\u6bb5\u7684\u54c1\u79cd\u4e2d\uff0c\u521b\u65b0\u836f\u6574\u4f53\u589e\u957f\u6001\u52bf\u8fdc\u8fdc\u4f18\u4e8e\u6539\u826f\u578b\u65b0\u836f\u548c\u751f\u7269\u4eff\u5236\u836f\u3002\u7533\u62a5\u4e0a\u5e02\u65b0\u836f\u4ecd\u4ee5\u8fdb\u53e3\u836f\u4e3a\u4e3b\uff0c\u4f46\u56fd\u4ea7\u521b\u65b0\u836f\u65b9\u9762\u4e5f\u4e0d\u4e4f\u4eae\u70b9\uff0c\u6bd4\u5982\u4e24\u6b3e\u56fd\u4ea7PD-1\/PD-L1\u5355\u6297\u5361\u745e\u5229\u73e0\u5355\u6297\u548c\u7279\u745e\u666e\u5229\u5355\u6297\u7d27\u968f\u8fdb\u53e3\u540c\u7c7b\u4ea7\u54c1\u76f8\u7ee7\u62a5\u4ea7\u3002\u4ece\u76ee\u524d\u5ba1\u8bc4\u5ba1\u6279\u8fdb\u5ea6\u6765\u770b\uff0c\u9884\u8ba12018\u5e74\u4e0b\u534a\u5e74\u8fd8\u5c06\u4f1a\u6709\u5927\u6279\u54c1\u79cd\u901a\u8fc7\u4f18\u5148\u5ba1\u8bc4\u5feb\u901f\u4e0a\u5e02\uff0c\u76f8\u5e94\u4f01\u4e1a\u5c06\u4f18\u5148\u4eab\u53d7\u4ea7\u54c1\u589e\u91cf\u7684\u884c\u4e1a\u7ea2\u5229\u3002<\/span><\/p>\n

\u6211\u4eec\u4ece\u6279\u51c6\u4e0a\u5e02\u53ca\u7533\u62a5\u4e0a\u5e02\u7684\u54c1\u79cd\u4e2d\u53ef\u4ee5\u770b\u5230\uff0c\u5916\u8d44\u521b\u65b0\u836f\u6b63\u52a0\u901f\u8fdb\u5165\u4e2d\u56fd\u5e02\u573a\uff0c\u7ed9\u56fd\u5185\u4f01\u4e1a\u5e26\u6765\u6311\u6218\u540c\u65f6\u4e5f\u7ed9\u56fd\u5185\u4f01\u4e1a\u4ece\u6d77\u5916\u5f15\u5165\u54c1\u79cd\u5e26\u6765\u4e86\u8f83\u597d\u7684\u5951\u673a\u3002\u6b64\u524d\uff0c\u5927\u91cf\u7684\u56fd\u5916\u4e0a\u5e02\u521b\u65b0\u836f\u53d7\u5236\u4e8e\u5ba1\u8bc4\u901f\u5ea6\uff0c\u56fd\u5185\u7684\u4e0a\u5e02\u65f6\u95f4\u5f80\u5f80\u665a\u4e8e\u56fd\u5916\u6570\u5e74\u4e4b\u4e45\uff0c\u65b0\u836f\u8fdb\u5165\u4e2d\u56fd\u4e25\u91cd\u6ede\u540e\uff0c\u5bfc\u81f4\u8bb8\u591a\u60a3\u8005\u5931\u53bb\u6700\u4f73\u6cbb\u7597\u65f6\u95f4\u7a97\u53e3\uff0c\u4e5f\u5f71\u54cd\u5230\u4f01\u4e1a\u7814\u53d1\u521b\u65b0\u7684\u52a8\u529b\u4e0e\u6548\u7387\u3002<\/span><\/p>\n

\u88684. 2018\u4e0a\u534a\u5e74\u9996\u6b21\u7533\u62a5\u4e0a\u5e02\u7684\u56fd\u4ea7\u65b0\u836f<\/span><\/p>\n

\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\u6570\u636e\u6765\u6e90\uff1a\u4e2d\u56fd\u65b0\u53d1\u76d1\u6d4b\u6570\u636e\u5e93CPM<\/span><\/p>\n

\u88685. 2018\u4e0a\u534a\u5e74\u9996\u6b21\u7533\u62a5\u4e0a\u5e02\u7684\u8fdb\u53e3\u65b0\u836f<\/span><\/p>\n

\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\u6570\u636e\u6765\u6e90\uff1a\u4e2d\u56fd\u65b0\u53d1\u76d1\u6d4b\u6570\u636e\u5e93CPM<\/span><\/p>\n

\u7eb5\u89c82018\u4e0a\u534a\u5e74\u56fd\u5185\u65b0\u836f\u7533\u62a5\u60c5\u51b5\u2014\u2014<\/strong><\/span><\/p>\n

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1\u3001\u82cf\u5dde\u76db\u8fea\u4e9a  \u6ce8\u5c04\u7528\u5361\u745e\u5229\u73e0\u5355\u6297<\/span><\/p>\n

\u6ce8\u5c04\u7528\u5361\u745e\u5229\u73e0\u5355\u6297\u662f\u4eba\u6e90\u5316\u6297 PD-1\u5355\u514b\u9686\u6297\u4f53\uff0c\u53ef\u4e0e\u4ebaPD-1\u53d7\u4f53\u7ed3\u5408\u5e76\u963b\u65adPD-1\/PD-L1\u901a\u8def\uff0c\u6062\u590d\u673a\u4f53\u7684\u6297\u80bf\u7624\u514d\u75ab\u529b\uff0c\u4ece\u800c\u5f62\u6210\u764c\u75c7\u514d\u75ab\u6cbb\u7597\u57fa\u7840\u3002\u9002\u7528\u4e8e\u65e2\u5f80\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e8c\u7ebf\u7cfb\u7edf\u6027\u6cbb\u7597\uff08\u542b\u81ea\u4f53\u9020\u8840\u79fb\u690d\uff09\u7684\u590d\u53d1\/\u96be\u6cbb\u6027\u7ecf\u5178\u578b\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u60a3\u8005\u7684\u6cbb\u7597\u3002\u7ecf\u67e5\u8be2\uff0c\u76ee\u524d\u56fd\u5185\u6682\u65e0\u540c\u7c7b\u4ea7\u54c1\u83b7\u6279\u4e0a\u5e02\uff0c\u56fd\u5916\u5df2\u4e0a\u5e02\u7684\u540c\u7c7b\u4ea7\u54c1\u6709\u9ed8\u6c99\u4e1c\u516c\u53f8\u7684Keytruda\uff08\u901a\u7528\u540d\uff1aPembrolizumab\uff09\uff09\u548c\u767e\u65f6\u7f8e\u65bd\u8d35\u5b9d\u516c\u53f8\u7684Opdivo\uff08\u901a\u7528\u540d\uff1aNivolumab\uff09\uff0c\u5747\u4e8e2014\u5e74\u83b7FDA\u6279\u51c6\u4e0a\u5e02\u3002\u9664\u6052\u745e\u533b\u836f\u5916\uff0c\u56fd\u5185\u53e6\u6709\u4fe1\u8fbe\u751f\u7269\u3001\u541b\u5b9e\u751f\u7269\u3001\u767e\u65f6\u7f8e\u65bd\u8d35\u5b9d\u3001\u9ed8\u6c99\u4e1c\u7b49\u4f01\u4e1a\u63d0\u4ea4\u4e86\u540c\u7c7b\u4ea7\u54c1\u7684\u56fd\u5185\u4e0a\u5e02\u7533\u8bf7\u3002<\/span><\/p>\n

2\u3001\u845b\u5170\u7d20\u53f2\u514b  \u6ce8\u5c04\u7528\u8d1d\u5229\u5c24\u5355\u6297<\/span><\/p>\n

2011\u5e743\u67089\u65e5\u7f8e\u56fdFDA\u6279\u51c6\u4e00\u65b0\u578b\u751f\u7269\u5236\u5242\u2014\u2014\u8d1d\u5229\u5355\u6297(Benlysta)\u4e0a\u5e02\uff0c\u6210\u4e3a\u8be5\u5c40\u8fd156\u5e74\u6765\u9996\u6b21\u6279\u51c6\u6cbb\u7597\u7ea2\u6591\u72fc\u75ae\u7684\u65b0\u836f\u3002\u8d1d\u5229\u5355\u6297\u53ef\u4e0eB\u6dcb\u5df4\u7ec6\u80de\u523a\u6fc0\u56e0\u5b50\uff08B-lymphocyte stimulator\uff0cBLyS\uff09\u7ed3\u5408\u5e76\u4ea7\u751f\u6291\u5236\u4f5c\u7528\uff0c\u8fdb\u800c\u4f7f\u5236\u9020\u4f53\u5185\u6297\u4f53\u7684B\u7ec6\u80de\u81ea\u6211\u6bc1\u706d\uff0c\u51cf\u7f13\u514d\u75ab\u7cfb\u7edf\u5bf9\u81ea\u4f53\u7ec4\u7ec7\u7684\u653b\u51fb\uff0c\u9002\u7528\u4e8e\u6cbb\u7597\u6b63\u5728\u63a5\u53d7\u6807\u51c6\u6cbb\u7597\u7684\u6709\u6d3b\u52a8\u6027\u3001\u81ea\u8eab\u6297\u4f53\u9633\u6027\u3001\u5168\u8eab\u6027\u7ea2\u6591\u72fc\u75ae\u6210\u5e74\u60a3\u8005\u3002<\/span><\/p>\n

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3\u3001\u4f18\u65f6\u6bd4   \u6ce8\u5c04\u7528\u57f9\u585e\u5229\u73e0\u5355\u6297<\/span><\/p>\n

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4\u3001\u4f17\u5408\u751f\u7269  \u6ce8\u5c04\u7528\u7279\u745e\u666e\u5229\u5355\u6297<\/span><\/p>\n

\u7279\u745e\u666e\u5229\u5355\u6297\uff08JS001\uff09\u662f\u56fd\u5185\u7b2c4\u4e2a\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\u7684PD-1\/PD-L1\u7c7b\u836f\u7269\uff0c\u4e5f\u662f\u7b2c\u4e00\u5bb6\u83b7\u5f97CDE\uff08\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff09\u53d7\u7406\u7684\u56fd\u5185\u4f01\u4e1a\u3002 BMS\u7684nivolumab\u5df2\u7ecf\u57282017\/11\/2\u7533\u62a5\u4e0a\u5e02\uff0c\u7528\u4e8e\u4e8c\u7ebf\u6cbb\u7597\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff0c\u5e76\u83b7\u5f97\u4e86\u4f18\u5148\u5ba1\u8bc4\u3002\u4fe1\u8fbe\u751f\u7269\u7684\u4fe1\u8fea\u5355\u6297\u57282017\/12\/13\u63d0\u4ea4\u4e0a\u5e02\u7533\u8bf7\uff0c\u7528\u4e8e\u6cbb\u7597\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u3002\u9ed8\u6c99\u4e1c\u7684\u5e15\u535a\u5229\u73e0\u5355\u6297\u57282018\/2\/11\u63d0\u4ea4\u4e86\u4e0a\u5e02\u7533\u8bf7\u3002<\/span><\/p>\n

5\u3001\u9ed8\u6c99\u4e1c  \u6ce8\u5c04\u7528\u5e15\u535a\u5229\u73e0\u5355\u6297<\/span><\/p>\n

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6\u3001\u7f57\u6c0f  \u6ce8\u5c04\u7528\u5e15\u59a5\u73e0\u5355\u6297<\/span><\/p>\n

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\"\u3010\u56fd\u5e86\u7279\u8f91\u3011\u6d6a\u6f6e\u5d1b\u8d77\uff0c\u56fd\u5185\u521b\u65b0\u836f\u8fce\u6765\u53d1\u5c55\u6625\u5929\uff01\"<\/p>\n

\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

2018\u5e74\u4e0a\u534a\u5e74\uff0cFDA\u6279\u51c6\u4e8617\u6b3e\u65b0\u836f\uff0c\u8fd9\u5176\u4e2d\u670912\u4e2a\u836f\u7269\u90fd\u662f\u5168\u7403\u9996\u6279\uff0c\u5176\u4f59\u7684\u5927\u591a\u4e3a\u6b27\u76df\u9996\u6279\u3002 \u5168\u65872289 […]<\/p>\n","protected":false},"author":1,"featured_media":66081,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66080"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=66080"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66080\/revisions"}],"predecessor-version":[{"id":66088,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66080\/revisions\/66088"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/66081"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=66080"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=66080"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=66080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}