{"id":41841,"date":"2018-08-13T01:00:00","date_gmt":"2018-09-17T06:56:14","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e3%80%90%e5%9f%b9%e4%bc%98%e3%80%91%e7%8e%af%e7%90%83%e5%8c%bb%e8%8d%af%e7%ae%80%e8%ae%af%e7%ac%ac70%e6%9c%9f\/"},"modified":"2018-09-17T14:56:15","modified_gmt":"2018-09-17T06:56:15","slug":"%e3%80%90%e5%9f%b9%e4%bc%98%e3%80%91%e7%8e%af%e7%90%83%e5%8c%bb%e8%8d%af%e7%ae%80%e8%ae%af%e7%ac%ac70%e6%9c%9f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/41841\/","title":{"rendered":"\u3010\u57f9\u4f18\u3011\u73af\u7403\u533b\u836f\u7b80\u8baf|\u7b2c70\u671f"},"content":{"rendered":"
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\"\u3010\u57f9\u4f18\u3011\u73af\u7403\u533b\u836f\u7b80\u8baf|\u7b2c70\u671f\"<\/section>\n
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\u4f1a\u8bae\u94fe\u63a5\uff1a9\u67086\u65e5-\u6539\u826f\u521b\u65b0\u4e2d\u7f8e\u53cc\u62a5\u7b56\u7565\u4e0eMAH\u5173\u952e\u95ee\u9898\u7814\u8ba8\u4f1a\u9080\u8bf7\u51fd<\/strong><\/a><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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1\u3001<\/span>\u6052\u745e\u533b\u836f<\/span><\/strong><\/span>\u5411\u7f8e\u56fdFDA\u7533\u62a5\u7684<\/span>\u6258\u4f10\u666e\u5766\u7247<\/span><\/strong>\uff08\u89c4\u683c\u4e3a15mg\u300130mg\uff09\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff0c\u5373\u7f8e\u56fd\u4eff\u5236\u836f\u7533\u8bf7\uff09\u5df2\u83b7\u5f97\u6682\u65f6\u6279\u51c6\u3002<\/span><\/p>\n

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2\u3001FDA\u5ba3\u5e03\u6279\u51c6<\/span>Shionogi<\/span><\/strong>\u7684\u65b0\u836f<\/span>Mulpleta\uff08lusutrombopag\uff09<\/span><\/strong>\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u8ba1\u5212\u63a5\u53d7\u533b\u7597\u6216\u7259\u79d1\u624b\u672f\u7684\u6162\u6027\u809d\u75c5\u6210\u4eba\u60a3\u8005\u7684\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u3002<\/span><\/p>\n

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3\u3001<\/span>\u6d77\u6b63\u836f\u4e1a\uff08\u676d\u5dde\uff09\u6709\u9650\u516c\u53f8<\/strong><\/span>\u6536\u5230\u7f8e\u56fdFDA\u901a\u77e5\uff0c\u5176\u5411\u7f8e\u56fdFDA\u7533\u62a5\u7528\u4e8e\u963f\u5c14\u8328\u6d77\u9ed8\u75c5\u7684<\/span>\u76d0\u9178\u591a\u5948\u54cc\u9f50\u53e3\u5d29\u7247<\/span><\/strong>\u65b0\u836f\u7b80\u7565\u7533\u8bf7\u5df2\u83b7\u5f97\u6279\u51c6\u3002<\/span><\/p>\n

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4\u3001<\/span>Vertex\u5236\u836f<\/span><\/strong>\u8fd1\u65e5\u5ba3\u5e03\u7f8e\u56fdFDA\u5df2\u6279\u51c6\u65d7\u4e0b<\/span>ORKAMBI\uff08lumacaftor \/ ivacaftor\uff09<\/span><\/strong>\u7528\u4e8e2\u81f35\u5c81\u513f\u7ae5\u56ca\u6027\u7ea4\u7ef4\u5316\uff08CF\uff09\uff0c\u4e5f\u4f7f\u5f97\u8be5\u836f\u7269\u6210\u4e3a\u7f8e\u56fd\u9996\u4e2a\u88ab\u6279\u51c6\u7528\u4e8e\u6cbb\u75972\u81f35\u5c81\u513f\u7ae5CF\u7684\u836f\u7269\u3002<\/span><\/p>\n

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5\u3001FDA\u5ba3\u5e03\u6279\u51c6<\/span>Poteligeo<\/span><\/strong>\u4e0a\u5e02\uff0c\u6cbb\u7597\u5df2\u7ecf\u63a5\u53d7\u8fc7\u81f3\u5c11\u4e00\u6b21\u5168\u8eab\u6027\u7597\u6cd5\u7684\u590d\u53d1\u6216\u96be\u6cbb\u6027\u8548\u6837\u771f\u83cc\u75c5\uff08MF\uff09\u6216\u585e\u624e\u91cc\u7efc\u5408\u75c7\uff08SS\uff09\u6210\u5e74\u60a3\u8005\u3002\u8fd9\u662fFDA\u7b2c\u4e00\u6b21\u6279\u51c6\u9488\u5bf9SS\u7684\u836f\u7269\uff0c\u4e5f\u4e3aMF\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u591a\u6cbb\u7597\u9009\u62e9\u3002<\/span><\/p>\n

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6\u3001<\/span>Apotex\u516c\u53f8<\/span><\/strong>\u65d7\u4e0b\u4e0d\u540c\u5242\u91cf\u7684<\/span>\u6c2f\u5316\u94be\u53e3\u670d\u6db2<\/span><\/strong>\u83b7\u5f97\u4e86FDA\u7684\u5ba1\u6279\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u8fd9\u5bb6\u516c\u53f8\u7684\u6c2f\u5316\u94be\u53e3\u670d\u6db2\u6210\u4e3a\u4e86\u9996\u4f8b\u901a\u8fc7\u201c\u7ade\u4e89\u4eff\u5236\u7597\u6cd5\u201d\u6e20\u9053\u6700\u7ec8\u83b7\u5f97\u6279\u51c6\u7684\u4eff\u5236\u836f\u7269\u3002<\/span><\/p>\n

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7\u3001<\/span>Array BioPharma<\/span><\/strong>\u516c\u5e03\u79f0\uff0c\u836f\u7269<\/span>BRAFTOVI\u4e0eMEKTOVI\u3001Cetuximab<\/span><\/strong>\u8054\u7528\u5e94\u7528\uff0c\u6cbb\u7597\u6b64\u524d\u6cbb\u75971-2\u6b21\u5931\u8d25\u7684BRAF-V600E\u7a81\u53d8\u578b\u8f6c\u79fb\u6027\u7ed3\u76f4\u80a0\u764c\uff08mCRC\uff09\u60a3\u8005\u83b7\u5f97\u4e86\u7f8e\u56fdFDA\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u3002<\/span><\/p>\n

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8\u3001<\/span>60\u00b0Pharmaceuticals<\/span><\/strong>\u5ba3\u5e03\uff0cFDA\u6279\u51c6\u4e86\u5176<\/span>ARAKODA\u2122\u7247\u5242<\/span><\/strong>\u7528\u4e8e\u5728\u6210\u4eba\u4e2d\u9884\u9632\u759f\u75be\u3002\u8fd9\u662f18\u5e74\u6765FDA\u6279\u51c6\u7684\u9996\u4f8b\u7528\u4e8e\u9884\u9632\u759f\u75be\u7684\u65b0\u836f\u3002<\/span><\/p>\n

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9\u3001<\/span>Insmed Incorporated<\/span><\/strong>\u5ba3\u5e03\uff0c\u516c\u53f8<\/span>ALIS\uff08\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u60ac\u6d6e\u6db2\uff09<\/span><\/strong>\u7528\u4e8e\u9e1f\u578b\u5206\u679d\u6746\u83cc\uff08MAC\uff09\u5bfc\u81f4\u7684\u975e\u7ed3\u6838\u5206\u679d\u6746\u83cc\uff08NTM\uff09\u80ba\u75c5\u6210\u4eba\u60a3\u8005\u6cbb\u7597\u7684\u5b89\u5168\u548c\u6709\u6548\u6027\u83b7FDA\u836f\u54c1\u54a8\u8be2\u59d4\u5458\u4f1a\u8ba4\u53ef\uff0c\u6216\u53ef9\u6708\u5e95\u83b7\u6279\u4e0a\u5e02\u3002<\/span><\/p>\n

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10\u3001<\/span>Paratek\u5236\u836f<\/span><\/strong>\u516c\u53f8\u65b0\u578b\u6297\u751f\u7d20<\/span>omadacycline<\/span><\/strong>\u9759\u8109\u6ce8\u5c04\u5242\u548c\u53e3\u670d\u5236\u5242\u83b7FDA\u836f\u54c1\u54a8\u8be2\u59d4\u5458\u4f1a\u652f\u6301\u6279\u51c6\u7528\u4e8e\u6025\u6027\u7ec6\u83cc\u6027\u76ae\u80a4\u53ca\u76ae\u80a4\u7ec4\u7ec7\u611f\u67d3\uff08ABSSSI\uff09\u7684\u6cbb\u7597\uff0c\u53ca\u793e\u533a\u83b7\u5f97\u6027\u7ec6\u83cc\u6027\u80ba\u708e\uff08CABP\uff09\u7684\u6cbb\u7597\u3002<\/span><\/p>\n<\/section>\n<\/section>\n

\"\u3010\u57f9\u4f18\u3011\u73af\u7403\u533b\u836f\u7b80\u8baf|\u7b2c70\u671f\"<\/section>\n<\/section>\n<\/section>\n

\u3010\u7f16\u8f91\uff1a\u5f20\u534e\u946b\u3011<\/span>\"\u3010\u57f9\u4f18\u3011\u73af\u7403\u533b\u836f\u7b80\u8baf|\u7b2c70\u671f\"<\/p>\n

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