{"id":61023,"date":"2018-10-12T01:00:00","date_gmt":"2018-12-07T03:03:53","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/8a7f7bd07c\/"},"modified":"2018-12-07T11:03:55","modified_gmt":"2018-12-07T03:03:55","slug":"8a7f7bd07c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/61023\/","title":{"rendered":"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09"},"content":{"rendered":"
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\u56fd\u5916\u836f\u7269\u7814\u53d1\u52a8\u6001<\/section>\n<\/section>\n
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1\u3001\u7f8e\u56fd\u751f\u7269\u5236\u836f\u516c\u53f8Ionis Pharmaceuticals\u53ca\u65d7\u4e0b\u516c\u53f8Akcea Therapeutics\u8fd1\u65e5\u8054\u5408\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6279\u51c6Tegsedi\uff08inotersen\uff09\u7528\u4e8e<\/span>\u9057\u4f20\u6027\u8f6c\u7532\u72b6\u817a\u7d20\u86cb\u767d\u6dc0\u7c89\u6837\u53d8\u6027\uff08hATTR\uff09<\/strong><\/span>\u6210\u4eba\u60a3\u8005\uff0c\u6cbb\u7597\u7b2c1\u9636\u6bb5\u6216\u7b2c2\u9636\u6bb5\u591a\u53d1\u6027\u795e\u7ecf\u75c5\u53d8\u3002\u4e4b\u524d\uff0cFDA\u5df2\u6388\u4e88Tegsedi\u5b64\u513f\u836f\u8d44\u683c\u548c\u5feb\u901f\u901a\u9053\u5730\u4f4d\u3002\u6b64\u6b21\u6279\u51c6\uff0c\u4f7fTegsedi\u6210\u4e3a\u7f8e\u56fd\u5e02\u573a\u9996\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u76ae\u4e0b\u6ce8\u5c04\u7684RNA\u9776\u5411\u836f\u7269\uff0c\u53ef\u5927\u5e45\u964d\u4f4e\u4ebaTTR\u86cb\u767d\u7684\u4ea7\u751f\u3002\u800c\u7f8e\u56fd\u4e5f\u662f\u7ee7\u6b27\u76df\u3001\u52a0\u62ff\u5927\u4e4b\u540eTegsedi\u83b7\u6279\u7684\u7b2c\u4e09\u4e2a\u5e02\u573a\u3002<\/span><\/p>\n

2\u3001\u7f8e\u56fd\u57fa\u56e0\u6cbb\u7597\u516c\u53f8\u84dd\u9e1f\u751f\u7269\uff08Bluebird Bio\uff09\u8fd1\u65e5\u5ba3\u5e03\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5df2\u53d7\u7406\u57fa\u56e0\u7597\u6cd5LentiGlobin\u6cbb\u7597<\/span>\u8f93\u8840\u4f9d\u8d56\u578b\u03b2\u5730\u4e2d\u6d77\u8d2b\u8840<\/span><\/strong>\uff08TDT\uff09\u548c<\/span>\u975e-\u03b20\/\u03b20\u57fa\u56e0\u578bTDT\u9752\u5c11\u5e74\u53ca\u6210\u4eba\u60a3\u8005<\/span><\/strong>\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u3002\u8be5\u836f\u662f\u4e00\u79cd\u6f5c\u5728\u7684\u4e00\u6b21\u6027\u57fa\u56e0\u7597\u6cd5\uff0c\u53ef\u89e3\u51b3\u5bfc\u81f4TDT\u7684\u6839\u672c\u9057\u4f20\u75c5\u56e0\uff0c\u6709\u671b\u4e3aTDT\u7684\u4e34\u5e8a\u6cbb\u7597\u5e26\u6765\u4e00\u573a\u9769\u547d\u3002\u6b64\u524d\uff0cEMA\u5df2\u6388\u4e88LentiGlobin\u52a0\u901f\u8bc4\u4f30\u8d44\u683c\uff0c\u5176\u5ba1\u67e5\u65f6\u95f4\u5c06\u75317\u4e2a\u6708\uff08210\u5929\uff09\u7f29\u77ed\u81f35\u4e2a\u6708\uff08150\u5929\uff09\u3002<\/span><\/p>\n

\"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09\"<\/p>\n

3\u3001VistaGen Therapeutics\u662f\u4e00\u5bb6\u4e34\u5e8a\u9636\u6bb5\u7684\u751f\u7269\u5236\u836f\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u5f00\u53d1\u65b0\u4e00\u4ee3\u7597\u6cd5\u6cbb\u7597\u591a\u79cd\u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\u548c\u533b\u7597\u9700\u6c42\u9ad8\u5ea6\u672a\u6ee1\u8db3\u7684\u75be\u75c5\u3002\u8fd1\u65e5\uff0c\u8be5\u516c\u53f8\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6388\u4e88\u5b9e\u9a8c\u6027\u836f\u7269AV-101\u4f5c\u4e3a\u4e00\u79cd\u975e\u963f\u7247\u7c7b\u975e\u9547\u9759\u5242\u6cbb\u7597\u795e\u7ecf\u75c5\u7406\u6027\u75bc\u75db\u7684\u5feb\u901f\u901a\u9053\u5730\u4f4d\u3002\u8fd9\u4e5f\u662f\u81ea2017\u5e7412\u6708\u4ee5\u6765VistaGen\u516c\u53f8\u83b7\u5f97\u7684\u7b2c2\u4e2aFDA\u5feb\u901f\u901a\u9053\u5730\u4f4d\u3002\u4e4b\u524d\uff0cFDA\u5df2\u6388\u4e88AV-101\u6cbb\u7597\u91cd\u5ea6\u6291\u90c1\u75c7\uff08MDD\uff09\u7684\u5feb\u901f\u901a\u9053\u5730\u4f4d\u3002<\/span><\/p>\n

4\u3001Chimerix\u662f\u4e00\u5bb6\u4f4d\u4e8e\u7f8e\u56fd\u5317\u5361\u7f57\u6765\u7eb3\u5dde\u7684\u5c0f\u578b\u751f\u7269\u6280\u672f\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u53d1\u73b0\u3001\u5f00\u53d1\u3001\u5546\u4e1a\u5316\u521b\u65b0\u6027\u7684\u6297\u75c5\u6bd2\u836f\u7269\uff0c\u4ee5\u89e3\u51b3\u672a\u6ee1\u8db3\u7684\u533b\u7597\u9700\u6c42\u3002\u8fd1\u65e5\uff0c\u8be5\u516c\u53f8\u5728\u7f8e\u56fd\u65e7\u91d1\u5c71\u4e3e\u884c\u76842018\u5e74\u7f8e\u56fd\u611f\u67d3\u6027\u75be\u75c5\u5468\uff08IDWEEK2018\uff09\u4e0a\u516c\u5e03\u4e86\u5b9e\u9a8c\u6027\u6297\u75c5\u6bd2\u836f\u7269brincidofovir\uff08BCV\uff09\u591a\u6b21\u5242\u91cf\u9012\u589e\uff08MAD\uff09I\u671f\u4e34\u5e8a\u7814\u7a76\u7684\u6570\u636e\u3002<\/span><\/p>\n

5\u3001\u65e5\u672c\u836f\u4f01\u7b2c\u4e00\u4e09\u5171\u5236\u836f\uff08Daiichi Sankyo\uff09\u8fd1\u65e5\u5ba3\u5e03\uff0c\u65e5\u672c\u536b\u751f\u52b3\u52a8\u798f\u5229\u90e8\uff08MHLW\uff09\u5df2\u6388\u4e88CAR-T\u7ec6\u80de\u7597\u6cd5axicabtagene ciloleucel\uff08\u524d\u79f0KTE-C19\uff09\u6cbb\u7597\u5f25\u6f2b\u6027\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08DLBCL\uff09\u3001\u539f\u53d1\u6027\u7eb5\u8188\uff08\u80f8\u817a\uff09\u5927B\u7ec6\u80de\u6dcb\u5df4\u7624\uff08PMBCL\uff09\u3001\u9ad8\u7ea7\u522bB\u7ec6\u80de\u6dcb\u5df4\u7624\uff08HGBL\uff09\u3001\u8f6c\u5316\u6ee4\u6ce1\u6027\u6dcb\u5df4\u7624\uff08TFL\uff09\u7684\u5b64\u513f\u836f\u8d44\u683c\uff0c\u4e0a\u8ff04\u79cd\u6dcb\u5df4\u7624\u5747\u4e3a\u4fb5\u88ad\u6027\u7684\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\uff08NHL\uff09\u3002<\/span><\/p>\n

6\u3001\u7eff\u53f6\u5236\u836f\u96c6\u56e2\u5ba3\u5e03\uff1a\u7531\u5176\u81ea\u4e3b\u7814\u53d1\u7684\u3001\u7528\u4e8e\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u548c\u5206\u88c2\u60c5\u611f\u6027\u969c\u788d\u7684\u65b0\u836f — \u5e15\u5229\u54cc\u916e\u7f13\u91ca\u6df7\u60ac\u808c\u8089\u6ce8\u5c04\u5242\uff08LY03010\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u6279\u51c6\uff0c\u53ef\u5728\u7f8e\u8fdb\u5165\u4e34\u5e8a\u7814\u7a76\u3002FDA\u5df2\u5728pre-IND\u4f1a\u8bae\u7eaa\u8981\u4e2d\u786e\u8ba4\uff1a\u53ea\u8981\u8bc1\u660e\u591a\u6b21\u7ed9\u836f\u80fd\u8fbe\u5230\u7a33\u6001\u7684\u751f\u7269\u7b49\u6548\u6027\uff0c\u5373\u53ef\u652f\u6301LY03010\u7684505 (b) (2) NDA\u4e0a\u5e02\u7533\u8bf7\u3002<\/span><\/p>\n

7\u3001\u4fe1\u8fbe\u751f\u7269\u8fd1\u65e5\u5ba3\u5e03\uff0c\u516c\u53f8\u5f00\u53d1\u7684\u91cd\u7ec4\u5168\u4eba\u6e90\u6297CD47\u5355\u514b\u9686\u6297\u4f53\uff08\u7814\u53d1\u4ee3\u53f7\uff1aIBI-188\uff09\uff0c\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u9881\u53d1\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\uff0c\u62df\u5f00\u5c55\u5728\u5b9e\u4f53\u7624\u548c\u8840\u6db2\u80bf\u7624\u60a3\u8005\u8eab\u4e0a\u7684\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/p>\n

8\u30019\u670829\u65e5\uff0c\u7f8e\u56fdFDA\u5ba3\u5e03\u6279\u51c6\u8d5b\u8bfa\u83f2\uff08Sanofi\uff09\u548c\u518d\u751f\u5143\uff08Regeneron\uff09\u8054\u5408\u5f00\u53d1\u7684Libtayo\uff08cemiplimab-rwlc\uff09\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u8f6c\u79fb\u6027\u76ae\u80a4\u9cde\u72b6\u7ec6\u80de\u764c\uff08CSCC\uff09\u6216\u4e0d\u80fd\u63a5\u53d7\u6cbb\u6108\u6027\u624b\u672f\u6216\u653e\u7597\u7684\u5c40\u90e8\u665a\u671fCSCC\u60a3\u8005\u3002\u8fd9\u662fFDA\u6279\u51c6\u7684<\/span>\u7b2c\u4e00\u4f8b\u9488\u5bf9\u665a\u671fCSCC\u7684\u7597\u6cd5<\/span><\/strong>\u3002\u5b83\u540c\u65f6\u662f\u7b2c\u4e09\u6b3e\u83b7\u5f97FDA\u6279\u51c6\u7684\u6297PD-1\u6297\u4f53\u3002<\/span><\/p>\n

9\u3001Arrowhead Pharmaceuticals\u5ba3\u5e03\u4e0e\u5f3a\u751f\uff08Johnson & Johnson\uff09\u65d7\u4e0b\u6768\u68ee\uff08Janssen Pharmaceuticals\uff09\u516c\u53f8\u8fbe\u6210\u4e86\u6388\u6743\u5408\u4f5c\u534f\u8bae\uff0c\u5171\u540c\u5f00\u53d1\u548c\u63a8\u5e7f\u4e59\u809dRNAi\u7597\u6cd5ARO-HBV\u3002\u6b64\u5916\u6768\u68ee\u53ef\u4ee5\u9009\u62e9\u6700\u591a\u4e09\u79cd\u9488\u5bf9\u5176\u5b83\u75be\u75c5\u7684RNAi\u836f\u7269\u4e0eArrowhead\u5c55\u5f00\u7814\u53d1\u5408\u4f5c\u3002\u5408\u4f5c\u534f\u8bae\u7684\u603b\u91d1\u989d\u53ef\u9ad8\u8fbe37\u4ebf\u7f8e\u5143\u3002<\/span><\/p>\n

10\u3001\u793c\u6765GIP\/GLP\u53cc\u6fc0\u52a8\u5242\u663e\u793a\u964d\u7cd6\u3001\u51cf\u80a5\u7597\u6548\u3002\u793c\u6765\u5728\u300a\u67f3\u53f6\u5200\u300b\u6742\u5fd7\u53d1\u8868\u4e86\u5176GIP\/GLP\u53cc\u6fc0\u52a8\u5242LY3298176\u5728\u4e00\u4e2a\u4e8c\u671f\u4e34\u5e8a\u7684\u964d\u7cd6\u3001\u51cf\u80a5\u7597\u6548\u3002\u8fd9\u4e2a\u8bd5\u9a8c\u62db\u52df316\u4f4d\u7cd6\u5c3f\u75c5\u60a3\u8005\uff0c\u5728\u53e3\u670d\u6807\u51c6\u7597\u6cd5\u80cc\u666f\u4e0a\u52066\u7ec4\uff0c\u5206\u522b\u4e3a\u5b89\u6170\u5242\u3001\u6bcf\u5468\u6ce8\u5c041\u30015\u300110\u300115\u6beb\u514b\u56db\u4e2a\u5242\u91cfLY3298176\u3001\u548c\u6bcf\u5468\u6ce8\u5c041.5\u6beb\u514b\uff08\u6700\u9ad8\u6279\u51c6\u5242\u91cf\uff09\u7684GLP\u6fc0\u52a8\u5242Trulicity\u3002\u89c2\u5bdf26\u5468LY3298176\u663e\u793a\u5242\u91cf\u76f8\u5173\u964d\u7cd6\u3001\u51cf\u80a5\u7597\u6548\uff0c15\u6beb\u514b\u7ec4\u670977%\u60a3\u8005A1c\u4f4e\u4e8e7%\u300110\u6beb\u514b\u7ec4\u670990%\u60a3\u8005\u8fbe\u5230\u8fd9\u4e2a\u63a7\u5236\u76ee\u6807\uff0c\u800cTrulicity\u548c\u5b89\u6170\u5242\u7ec4\u53ea\u670955%\u548c12%\u60a3\u8005\u8fbe\u6807\u3002\u4e24\u4e2a\u9ad8\u5242\u91cf\u7ec4\u7edd\u5bf9A1C\u4e0b\u964d2.4%\u30012.0%\uff0c\u663e\u8457\u9ad8\u4e8eTrulicity\u76841.2%\u3002\u4e24\u4e2a\u9ad8\u5242\u91cf\u7ec4\u7684\u4f53\u91cd\u4e0b\u964d\u5206\u522b11.3\u548c8.7\u516c\u65a4\uff0c\u800cTrulicity\u53ea\u964d\u4f4e2.7\u516c\u65a4\u3002\u5f53\u7136\u526f\u4f5c\u7528\u53d1\u751f\u7387\u4e5f\u9ad8\u4e8eTrulicity\uff0c\u636e\u6211\u76ee\u6d4b1.5\u6beb\u514bTrulicity\u4e0e5\u6beb\u514bLY3298176\u526f\u4f5c\u7528\u76f8\u5f53\u3002\u793c\u6765\u51c6\u5907\u5f00\u59cb\u4e00\u4e2a\u53eb\u505aSURPASS\u7684\u4e09\u671f\u4e34\u5e8a\u7ee7\u7eed\u7814\u7a76\u8fd9\u4e2a\u836f\u7269\u3002<\/span><\/p>\n

11\u3001\u4f4d\u4e8e\u9a6c\u8428\u8bf8\u585e\u5dde\u5251\u6865\u5e02\u7684Sarepta Therapeutics\u4e00\u76f4\u81f4\u529b\u4e8e\u53d1\u73b0\u548c\u5f00\u53d1\u9488\u5bf9\u7f55\u89c1\u795e\u7ecf\u808c\u8089\u75be\u75c5\u7684\u7cbe\u51c6\u57fa\u56e0\u7597\u6cd5\u3002\u8be5\u516c\u53f8\u65e5\u524d\u5ba3\u5e03\uff0c\u5176\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\uff08DMD\uff09\u7684\u5728\u7814\u57fa\u56e0\u7597\u6cd5AAVrh74.MHCK7.micro-Dystrophin\uff08\u4ee5\u4e0b\u7b80\u79f0AAVrh74\uff09\uff0c\u5728\u62e5\u6709\u56db\u540dDMD\u60a3\u8005\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u83b7\u5f97\u79ef\u6781\u7ed3\u679c\u3002\u901a\u8fc7\u514d\u75ab\u7ec4\u5316\u4e0e\u514d\u75ab\u5370\u8ff9\u68c0\u6d4b\uff0c\u53c2\u4e0e\u8bd5\u9a8c\u7684\u56db\u540d\u60a3\u8005\u5747\u663e\u793a\u51fa\u4e86\u660e\u663e\u7684\u5fae\u6297\u808c\u840e\u7f29\u86cb\u767d\uff08micro-dystrophin\uff09\u6c34\u5e73\uff0c\u5e76\u83b7\u5f97\u4e86\u826f\u597d\u7684\u529f\u80fd\u6027\u6539\u826f\u7ed3\u679c\uff0c\u4e14\u672a\u51fa\u73b0\u4efb\u4f55\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff08SAEs\uff09\u3002<\/span><\/p>\n

12\u3001\u7f57\u6c0f\uff08Roche\uff09\u96c6\u56e2\u65e5\u524d\u5ba3\u5e03\uff0cFDA\u6279\u51c6\u5176\u6cbb\u7597A\u578b\u8840\u53cb\u75c5\u7684\u91cd\u78c5\u836fHemlibra\uff08emicizumab-kxwh\uff09\uff0c\u4f5c\u4e3a\u65e5\u5e38\u9884\u9632\u6027\u7597\u6cd5\uff0c\u6cbb\u7597\u4f53\u5185\u4e0d\u542b\u56e0\u5b50VIII\u6291\u5236\u7269\u7684A\u578b\u8840\u53cb\u75c5\u60a3\u8005\uff0c\u4e3a\u60a3\u8005\u9884\u9632\u6216\u51cf\u8f7b\u9891\u7e41\u51fa\u8840\u72b6\u51b5\u3002Hemlibra\u662f\u76ee\u524d\u552f\u4e00\u4e00\u6b3e\u9762\u5411\u4f53\u5185\u542b\u6709\u6216\u4e0d\u542b\u56e0\u5b50VIII\u6291\u5236\u7269\u7684A\u578b\u8840\u53cb\u75c5\u60a3\u8005\uff0c\u4e14\u8ba9\u60a3\u8005\u53ef\u4ee5\u6bcf\u5468\u3001\u6bcf\u4e24\u5468\u6216\u6bcf\u56db\u5468\u4e00\u6b21\u63a5\u53d7\u76ae\u4e0b\u6ce8\u5c04\u7684\u9884\u9632\u6027\u7597\u6cd5\u3002<\/span><\/p>\n

13\u3001\u82f1\u56fd\u5236\u836f\u5de8\u5934\u845b\u5170\u7d20\u53f2\u514b\uff08GSK\uff09\u4e0e\u675c\u514b\u4e34\u5e8a\u7814\u7a76\u6240\uff08DCRI\uff09\u8fd1\u65e5\u5728\u5fb7\u56fd\u67cf\u6797\u4e3e\u884c\u7684\u7b2c54\u5c4a\u6b27\u6d32\u7cd6\u5c3f\u75c5\u7814\u7a76\u534f\u4f1a\uff08EASD\uff09\u5e74\u5ea6\u4f1a\u8bae\u4e0a\u516c\u5e03\u4e86\u7cd6\u5c3f\u75c5\u836f\u7269albiglutide\uff08\u54c1\u724c\u540dTanzeum\/Eperzan\uff09\u5fc3\u8840\u7ba1\u9884\u540e\u4e34\u5e8a\u7814\u7a76Harmony Outcomes\uff08NCT02465515\uff09\u7684\u6570\u636e\u3002\u845b\u5170\u7d20\u53f2\u514bGLP-1\u964d\u7cd6\u836falbiglutide\u53ef\u663e\u8457\u964d\u4f4e\u4e3b\u8981\u4e0d\u826f\u5fc3\u8840\u7ba1\u4e8b\u4ef6\uff08MACE\uff09\u98ce\u9669\u3002<\/span><\/p>\n

14\u3001Orchard Therapeutics\u662f\u82f1\u56fd\u7684\u4e00\u5bb6\u751f\u7269\u6280\u672f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u901a\u8fc7\u521b\u65b0\u7684\u57fa\u56e0\u7597\u6cd5\u6539\u53d8\u7f55\u89c1\u75c5\u60a3\u8005\u7684\u751f\u6d3b\u3002\u8fd1\u65e5\uff0c\u8be5\u516c\u53f8\u5ba3\u5e03\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5df2\u6388\u4e88OTL-300\u4f18\u5148\u836f\u7269\u8d44\u683c\uff08PRIME\uff09\u3002OTL-300\u662f\u4e00\u79cd\u5b9e\u9a8c\u6027\u81ea\u4f53\u4f53\u5916\u6162\u75c5\u6bd2\u57fa\u56e0\u7597\u6cd5\uff0c\u5f00\u53d1\u7528\u4e8e\u8f93\u8840\u4f9d\u8d56\u6027\u03b2\u5730\u4e2d\u6d77\u8d2b\u8840\uff08TDBT\uff09\u7684\u6cbb\u7597\uff0c\u8be5\u75c5\u662fHBB\u57fa\u56e0\uff08\u03b2\u73e0\u86cb\u767d\u57fa\u56e0\uff09\u4e2d200\u591a\u79cd\u7a81\u53d8\u4e2d\u7684\u4e00\u79cd\u6240\u5f15\u8d77\u7684\u7f55\u89c1\u9057\u4f20\u6027\u8840\u6db2\u75c5\uff0c\u4e5f\u662f\u6700\u4e25\u91cd\u7c7b\u578b\u7684\u03b2\u5730\u4e2d\u6d77\u8d2b\u8840\uff0c\u76ee\u524d\u552f\u4e00\u7684\u6cbb\u7597\u65b9\u6cd5\u662f\u5f02\u57fa\u56e0\u9020\u8840\u79fb\u690d\uff0c\u4f46\u5b58\u5728\u975e\u5e38\u9ad8\u7684\u79fb\u690d\u76f8\u5173\u53d1\u75c5\u7387\u548c\u6b7b\u4ea1\u7387\u3002<\/span><\/p>\n

\"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09\"<\/p>\n

15\u3001Paratek\u5236\u836f\u516c\u53f8\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u57fa\u4e8e\u5176\u65b0\u578b\u56db\u73af\u7d20\u5316\u5b66\u4e13\u957f\u7684\u521b\u65b0\u7597\u6cd5\u3002\u8fd1\u65e5\uff0c\u8be5\u516c\u53f8\u5ba3\u5e03\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u5df2\u53d7\u7406\u6297\u751f\u7d20omadacycline\u6cbb\u7597\u793e\u533a\u83b7\u5f97\u6027\u7ec6\u83cc\u6027\u80ba\u708e\uff08CABP\uff09\u548c\u6025\u6027\u7ec6\u83cc\u6027\u76ae\u80a4\u548c\u76ae\u80a4\u7ed3\u6784\u611f\u67d3\uff08ABSSSI\uff09\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\uff08MAA\uff09\u3002\u5728\u7f8e\u56fd\u5e02\u573a\uff0comadacycline\u5df2\u4e8e\u8fd1\u65e5\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u4ee5\u54c1\u724c\u540dNuzyra\u4e0a\u5e02\uff0c\u7528\u4e8eCABP\u548cABSSSI\u7684\u6cbb\u7597\u3002<\/span><\/p>\n

\"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09\"<\/p>\n

16\u3001\u65e5\u672c\u836f\u4f01\u536b\u6750\uff08Eisai\uff09\u8fd1\u65e5\u5728\u5fb7\u56fd\u67cf\u6797\u4e3e\u884c\u7684\u7b2c54\u5c4a\u6b27\u6d32\u7cd6\u5c3f\u75c5\u7814\u7a76\u534f\u4f1a\uff08EASD\uff09\u5e74\u5ea6\u4f1a\u8bae\u4e0a\u516c\u5e03\u4e86\u51cf\u80a5\u836fBelviq\uff08lorcaserin\uff0c\u6d1b\u5361\u897f\u6797\uff09\u957f\u671f\u5fc3\u8840\u7ba1\u9884\u540e\u7814\u7a76\uff08CAMELLIA-TIMI61\uff09\u4e2d\u9884\u9632\u548c\u7f13\u89e32\u578b\u7cd6\u5c3f\u75c5\uff08T2DM\uff09\u7684\u65b0\u7684\u5206\u6790\u6570\u636e\u3002Belviq\u4e8e2012\u5e746\u6708\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\uff0c\u7ed3\u5408\u4f4e\u70ed\u91cf\u996e\u98df\u53ca\u589e\u52a0\u4f53\u529b\u52b3\u52a8\uff0c\u7528\u4e8e\u80a5\u80d6\u75c7\u6210\u4eba\u60a3\u8005\u7ba1\u7406\u4f53\u91cd\u3002<\/span><\/p>\n

17\u3001\u5236\u836f\u5de8\u5934\u9ed8\u6c99\u4e1c\uff08Merck & Co\uff09\u8fd1\u65e5\u5728\u7f8e\u56fd\u65e7\u91d1\u5c71\u4e3e\u884c\u76842018\u5e74\u7f8e\u56fd\u611f\u67d3\u6027\u75be\u75c5\u5468\uff08IDWEEK2018\uff09\u4e0a\u516c\u5e03\u4e86\u4e09\u5408\u4e00HIV\u590d\u65b9\u65b0\u836fDelstrigo\uff08doravirine 100mg\/\u62c9\u7c73\u592b\u5b9a[3TC]300mg\/tenofovir disoproxil fumarate[TDF]300mg\uff09III\u671f\u4e34\u5e8a\u7814\u7a76DRIVE-SHIFT\u7684\u9996\u6279\u6570\u636e\u3002\u6cbb\u7597\u7b2c48\u5468\u7684\u6570\u636e\u663e\u793a\uff0c\u8be5\u7814\u7a76\u8fbe\u5230\u4e86\u975e\u52a3\u6548\u6027\u4e3b\u8981\u7ec8\u70b9\uff0cDelstrigo\u540c\u65f6\u8868\u73b0\u51fa\u4e86\u66f4\u4f18\u7684\u8840\u8102\u53c2\u6570\u3002<\/span><\/p>\n

18\u3001Almirall\u662f\u603b\u90e8\u4f4d\u4e8e\u897f\u73ed\u7259\u7684\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u76ae\u80a4\u5065\u5eb7\u7684\u5168\u7403\u533b\u836f\u516c\u53f8\uff0c\u81f4\u529b\u4e8e\u5e94\u7528\u79d1\u5b66\u4e3a\u60a3\u8005\u53ca\u540e\u4ee3\u63d0\u4f9b\u533b\u7597\u89e3\u51b3\u65b9\u6848\uff0c\u5176\u5de5\u4f5c\u91cd\u70b9\u662f\u5bf9\u6297\u76ae\u80a4\u75be\u75c5\uff0c\u5e2e\u52a9\u4eba\u4eec\u611f\u53d7\u548c\u5c55\u73b0\u81ea\u5df1\u7684\u6700\u4f73\u72b6\u6001\u3002\u8fd1\u65e5\uff0c\u8be5\u516c\u53f8\u5ba3\u5e03\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6279\u51c6Seysara\uff08sarecycline\uff09\u7247\u5242\uff0c\u7528\u4e8e9\u5c81\u53ca\u4ee5\u4e0a\u975e\u7ed3\u8282\u6027\u4e2d\u5ea6\u81f3\u91cd\u5ea6\u5bfb\u5e38\u75e4\u75ae\u60a3\u8005\u6cbb\u7597\u708e\u6027\u75c5\u53d8\u3002Seysara\u662f\u4e00\u79cd\u9996\u521b\uff08first-in-class\uff09\u3001\u7a84\u8c31\u56db\u73af\u7d20\u884d\u751f\u6297\u751f\u7d20\uff0c\u5177\u6709\u6297\u708e\u4f5c\u7528\uff0cSeysara\u662f40\u5e74\u6765\u9996\u4e2a\u6cbb\u7597\u76ae\u80a4\u75c5\u53e3\u670d\u6297\u751f\u7d20\u3002<\/span><\/p>\n

\"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09\"<\/p>\n

19\u3001\u4fe1\u8fbe\u751f\u7269\u5236\u836f\u6709\u9650\u516c\u53f8\uff08\u4ee5\u4e0b\u7b80\u79f0\u4fe1\u8fbe\u751f\u7269\uff0cInnovent Biologics\uff09\u8fd1\u65e5\u5ba3\u5e03\uff0c\u516c\u53f8\u5f00\u53d1\u7684\u91cd\u7ec4\u5168\u4eba\u6e90\u6297CD47\u5355\u514b\u9686\u6297\u4f53\uff08\u7814\u53d1\u4ee3\u53f7\uff1aIBI188\uff09\uff0c\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u9881\u53d1\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\uff0c\u62df\u7528\u4e8e\u6cbb\u7597\u665a\u671f\u6076\u6027\u80bf\u7624\u548c\u6dcb\u5df4\u7624\u3002<\/span><\/p>\n

20\u3001\u65e5\u672c\u836f\u4f01\u536b\u6750\uff08Eisai\uff09\u8fd1\u65e5\u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6279\u51c6\u6269\u5927\u65b0\u4e00\u4ee3\u6297\u766b\u75eb\u836fFycompa\uff08perampanel\uff0c\u5421\u4ed1\u5e15\u5948\uff09\u7684\u9002\u5e94\u75c7\uff0c\u4f5c\u4e3a\u5355\u836f\u7597\u6cd5\u4ee5\u53ca\u4f5c\u4e3a\u8f85\u52a9\u7597\u6cd5\u7528\u4e8e4\u5c81\u53ca\u4ee5\u4e0a\u513f\u79d1\u766b\u75eb\u60a3\u8005\u90e8\u5206\u53d1\u4f5c\u6027\u766b\u75eb\uff08POS\uff0c\u6709\u6216\u65e0\u7ee7\u53d1\u6027\u5168\u8eab\u6027\u766b\u75eb\u53d1\u4f5c\uff09\u7684\u6cbb\u7597\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0c\u6b64\u6b21\u513f\u79d1\u6269\u5927\u9002\u5e94\u75c7\u83b7\u5f97\u4e86FDA\u7684\u4f18\u5148\u5ba1\u67e5\uff0c\u5e76\u5728\u63d0\u4ea4\u7533\u8bf7\u540e6\u4e2a\u6708\u4fbf\u83b7\u5f97\u4e86\u6279\u51c6\u3002\u6b64\u6b21\u6279\u51c6\u5305\u62ecFycompa\u7247\u5242\u548c\u53e3\u670d\u6df7\u60ac\u6db2\u3002<\/span><\/p>\n

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\u56fd\u5185\u836f\u7269\u7814\u53d1\u52a8\u6001<\/section>\n<\/section>\n
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\"\u6bcf\u5468\u836f\u8baf\uff082018\u5e74\u7b2c35\u671f\uff09\"<\/p>\n

3\u3001\u5728\u4e00\u9879\u65b0\u7684\u7814\u7a76\u4e2d\uff0c\u901a\u8fc7\u5206\u6790\u5168\u7403\u6700\u5927\u7684\u6d89\u53ca141431\u540d\u6765\u81ea\u4e2d\u56fd\u5404\u5730\u7684\u5b55\u5987\u7684\u57fa\u56e0\u7ec4\u6570\u636e\uff0c\u6765\u81ea\u4e2d\u56fd\u6df1\u5733\u534e\u5927\u57fa\u56e0\u7b49\u7814\u7a76\u673a\u6784\u7684\u7814\u7a76\u4eba\u5458\u53d1\u73b0\u4e86\u57fa\u56e0\u4e0e\u51fa\u751f\u7ed3\u679c\uff08\u5305\u62ec\u53cc\u80ce\u598a\u5a20\u548c\u5973\u6027\u7b2c\u4e00\u6b21\u6000\u5b55\u65f6\u7684\u5e74\u9f84\uff09\u4e4b\u95f4\u5b58\u5728\u610f\u60f3\u4e0d\u5230\u7684\u5173\u8054\u3002\u8fd9\u79cd\u5206\u6790\u8fd8\u5141\u8bb8\u8fd9\u4e9b\u7814\u7a76\u4eba\u5458\u91cd\u5efa\u4e2d\u56fd\u4e0d\u540c\u79cd\u65cf\u7fa4\u4f53\u5728\u8fd1\u4ee3\u7684\u4eba\u53e3\u6d41\u52a8\u548c\u901a\u5a5a\uff0c\u5e76\u6709\u671b\u6709\u52a9\u4e8e\u9274\u5b9a\u51fa\u8ba9\u4eba\u4eec\u5bb9\u6613\u60a3\u4e0a\u4f20\u67d3\u75c5\u7684\u57fa\u56e0\u3002\u76f8\u5173\u7814\u7a76\u7ed3\u679c\u53d1\u8868\u57282018\u5e7410\u67084\u65e5\u7684\u671f\u520a\u4e0a\uff0c\u8bba\u6587\u6807\u9898\u4e3a\u201cGenomic Analyses from Non-invasive Prenatal Testing Reveal Genetic Associations, Patterns of Viral Infections, and Chinese Population History\u201d\u3002<\/span><\/p>\n

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