{"id":83530,"date":"2019-04-17T00:00:50","date_gmt":"2019-04-17T03:04:02","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/83530\/"},"modified":"2019-04-17T11:04:08","modified_gmt":"2019-04-17T03:04:08","slug":"a25b7d05f2","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/83530\/","title":{"rendered":"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269"},"content":{"rendered":"
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\u70b9\u51fb\u4e0a\u65b9\u7684<\/span>  \u25b2<\/span> \u6dfb\u52a0\u5173\u6ce8<\/span><\/span><\/p>\n


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2018\u5e74\uff0cFDA\u5171\u6279\u51c6\u4e8659\u6b3e\u65b0\u836f\u3002\u5176\u4e2d19\u6b3e\uff08\u5360\u603b\u91cf\u768432%\uff09\u662ffirst-in-class\u836f\u7269\u3002\u672c\u6587\u5bf9\u8fd919\u6b3e\u65b0\u836f\u8fdb\u884c\u8be6\u7ec6\u4ecb\u7ecd\u300211\u79cd\u836f\u7269\uff08\u7ea2\u8272\u52a0\u7c97\u90e8\u5206\uff09\u4e3a\u9996\u6b21\u83b7FDA\u6279\u51c6\u7684first-in-class\u836f\u7269\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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1.Aimovig<\/span><\/strong><\/section>\n
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Aimovig(erenumab)\u662f\u7531\u5b89\u8fdb\u7814\u53d1\u7684\u4e00\u6b3e\u9776\u5411CGRP\u53d7\u4f53\u7684\u5355\u514b\u9686\u6297\u4f53\u836f\u7269\uff0c\u4e8e2018\u5e745\u670817\u65e5\u83b7FDA\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u4e8e\u9884\u9632\u548c\u6cbb\u7597\u6210\u4eba\u504f\u5934\u75db\u3002\u540c\u5e747\u6708\u4efd\uff0c\u8be5\u836f\u5728\u6b27\u76df\u83b7\u6279\u4e0a\u5e02\uff0c\u7528\u6765\u9884\u9632\u6bcf\u6708\u51fa\u73b04\u6b21\u4ee5\u4e0a\u504f\u5934\u75db\u7684\u6210\u4eba\u60a3\u8005\uff0c\u76ee\u524d\u9488\u5bf9\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5c1a\u5904\u4e8e\u2160\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n


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2015\u5e74\uff0c\u5b89\u8fdb\u548c\u8bfa\u534e\u7b7e\u7f72\u4e86\u5171\u540c\u5f00\u53d1\u534f\u8bae\u3002\u8bfa\u534e\u56e0\u6b64\u83b7\u5f97\u4e86\u5728\u7f8e\u56fd\u548c\u65e5\u672c\u4ee5\u5916\u7684\u5171\u540c\u9500\u552e\u6743\u30022017\u5e74\uff0c\u534f\u8bae\u7a0d\u4f5c\u4fee\u6539\uff0c\u8bfa\u534e\u83b7\u5f97\u4e86\u5728\u7f8e\u56fd\u7684\u9500\u552e\u6743\u4ee5\u53ca\u5728\u52a0\u62ff\u5927\u7684\u72ec\u5bb6\u9500\u552e\u6743\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1a WO 2010075238\uff1bUS 2016311913\uff1bWO 2016171742<\/span><\/p>\n


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2.Crysvita<\/span><\/span><\/strong><\/section>\n
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Crysvita(Burosumab)\u7531\u534f\u548c\u53d1\u9175\u9e92\u9e9f\u682a\u5f0f\u4f1a\u793e\u7814\u53d1\uff0c\u6700\u5148\u5728\u6b27\u76df\u83b7\u6279\u30022018\u5e744\u670817\u65e5\u83b7\u5f97FDA\u6279\u51c6\u4e0a\u5e02\u3002\u4f5c\u4e3a\u4e00\u6b3e\u6297FGF23\u5355\u6297\uff0cCrysvita\u7528\u4e8e\u6cbb\u7597X\u8fde\u9501\u4f4e\u78f7\u9178\u8840\u75c7\u4f5d\u507b\u75c5\uff08XLH\uff09\u30022019\u5e741\u6708\uff0c\u8be5\u836f\u83b7\u51c6\u5728\u65e5\u672c\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597FGF23\u76f8\u5173\u7684\u4f4e\u78f7\u8840\u75c7\u4f5d\u507b\u75c5\u548c\u8f6f\u9aa8\u75c5\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aUS2015353633<\/span><\/p>\n


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3.Elzonris<\/span><\/strong><\/section>\n
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\u8be5\u836f\u7531Stemline Therapeutics\u7814\u53d1\uff0c\u4e8e2018\u5e7412\u670821\u65e5\u83b7FDA\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u5e74\u6216\u4e24\u5c81\u4ee5\u4e0a\u513f\u7ae5\u7684\u539f\u4ee3\u6d46\u7ec6\u80de\u6837\u6811\u7a81\u72b6\u7ec6\u80de\u7624(BPDCN)\u3002\u4f5c\u4e3a\u4e00\u79cd\u878d\u5408\u86cb\u767d\uff0cElzonris(Tagraxofusp)\u5305\u542b\u4e86\u767d\u5589\u6bd2\u7d20(DT388)\u7684\u50ac\u5316\u548c\u8f6c\u4f4d\u7ed3\u6784\u57df\u5e76\u878d\u5408\u4e86\u4ebaIL-3\uff0c\u901a\u8fc7\u9776\u5411CD123(IL-3\u53d7\u4f53\u4e9a\u57fa\u03b1)\uff0c\u5c06DT388\u8f6c\u8fd0\u8fdb\u5165\u7ec6\u80de\u5185\u4ece\u800c\u6740\u4f24\u80bf\u7624\u7ec6\u80de\u3002\u6b64\u5916\uff0c\u8be5\u516c\u53f8\u6b63\u5f00\u5c55\u8be5\u836f\u4e0epomalidomide\u548c\u5730\u585e\u7c73\u677e\u8054\u7528\u6cbb\u7597\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u53ca\u6cbb\u7597\u6025\u6027\u9ad3\u6027\u767d\u8840\u75c5\u3001\u7cfb\u7edf\u6027\u80a5\u5927\u7ec6\u80de\u589e\u591a\u75c7\u3001\u9aa8\u9ad3\u7ea4\u7ef4\u5316\u7b49\u75be\u75c5\u3002<\/span><\/p>\n


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4.Galafold<\/span><\/span><\/strong><\/section>\n
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Galafold(migalastat)\u7531Amicus Pharmaceuticals\u7814\u53d1\uff0c\u6700\u65e9\u4e8e2016\u5e74\u5728\u5fb7\u56fd\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u759716\u5c81\u53ca\u4ee5\u4e0a\u7684\u6cd5\u5e03\u745e\u6c0f\u75c7\uff08\u03b1-\u7cd6\u82f7\u9176 A \u7f3a\u9677\uff09\u60a3\u8005\u30022018\u5e748\u670810\u65e5\u83b7\u5f97FDA\u6279\u51c6\u4e0a\u5e02\u3002\u6cd5\u5e03\u745e\u6c0f\u75c7\u662f\u7531\u4e8e\u57fa\u56e0\u7a81\u53d8\u5bfc\u81f4\u03b1-\u7cd6\u82f7\u9176A\u9519\u8bef\u6298\u53e0\u3002Migalastat\u53ef\u4ee5\u4e0e\u9519\u8bef\u6298\u53e0\u7684\u03b1-\u7cd6\u82f7\u9176A\u7ed3\u5408\uff0c\u4ece\u800c\u8f6c\u53d8\u4e3a\u6b63\u786e\u7684\u6784\u8c61\uff0c\u6700\u7ec8\u4f7f\u5176\u53d1\u6325\u6b63\u5e38\u7684\u529f\u80fd\u3002\u8fd9\u7c7b\u5c0f\u5206\u5b50\u836f\u7269\u88ab\u6210\u4e3a\u836f\u7406\u4f34\u4fa3(pharmacological chaperones)\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2012154681\uff1bWO 2014014938\uff1bWO 2014055988\uff1bWO 2018017721\uff1bWO 2018222655\uff1bWO 2018230628\uff1bUS 2019000819\uff1bWO 2019017938\uff1bWO 2019020362\uff1bWO 2019046244<\/span><\/p>\n


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\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


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\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n


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5.Gamifant<\/span><\/strong><\/section>\n
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Gamifant(emapalumab)\u662f\u6297IFN\u03b3\u5355\u6297\uff0c\u7531NovImmune\u7814\u53d1\u3002\u8be5\u836f\u4e8e2018\u5e7411\u670820\u65e5\u83b7\u6279\uff0c\u7528\u4e8e\u6cbb\u7597\u539f\u53d1\u6027\u566c\u8840\u7ec6\u80de\u6dcb\u5df4\u7ec4\u7ec7\u7ec6\u80de\u589e\u751f\u75c7(HLH)\u3002Gamifant\u5206\u522b\u4e8e2010\u5e74\u548c2016\u5e74\u83b7\u5f97\u5b64\u513f\u836f\u548c\u7a81\u7834\u7597\u6cd5\u8ba4\u8bc1\u3002\u76ee\u524d\u88ab\u62a5\u9053\u6700\u591a\u7684\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\uff1a\u611f\u67d3\u3001\u9ad8\u8840\u538b\u7b49\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2006109191\u3001WO 2016177913\u3001WO 2018078442<\/span><\/p>\n

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6.Lucemyra<\/span><\/span><\/strong><\/section>\n
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\u76d0\u9178\u6d1b\u975e\u897f\u4e01\u662f\u7531Britannia\u7814\u53d1\u7684\u9009\u62e9\u6027\u03b12\u80be\u4e0a\u817a\u7d20\u80fd\u53d7\u4f53\u6fc0\u52a8\u5242\uff0c\u6700\u521d\u4e8e1991\u5e74\u5728\u82f1\u56fd\u4e0a\u5e02\u7528\u4e8e\u6cbb\u7597\u963f\u7247\u6212\u65ad\u7efc\u5408\u5f81\u30022018\u5e745\u670816\u65e5\u83b7\u5f97FDA\u6279\u51c6\u6cbb\u7597\u6210\u4eba\u7684\u963f\u7247\u6212\u65ad\u75c7\u72b6\u3002<\/span><\/p>\n


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\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


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\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aUS 3966757\uff1bWO 1998016226\uff1bWO 1999055334\uff1bWO 2005107806\uff1bWO 2009120735\uff1bWO 2009158477\uff1bWO 2010016844<\/span><\/p>\n


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7.Lutathera<\/span><\/span><\/strong><\/section>\n
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\u4e2d\u6587\u540d\uff1a\u9565[177Lu]\u5965\u7d22\u5ea6\u66f2\u80bd\u6216\u5965\u7d22\u745e\u80bd\u9565[177Lu]\u3002<\/span><\/p>\n


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CASNo.: 177943-88-3 \u5206\u5b50\u91cf\uff1a1609.542<\/span><\/p>\n


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\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n


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Lutathera\u662f\u4e00\u79cd\u751f\u957f\u6fc0\u7d20\u6291\u5236\u7d20\u4e8c\u578b\u53d7\u4f53\u914d\u4f53\uff0c\u7531Metronic\u516c\u53f8\u7814\u53d1\u3002\u8be5\u836f\u6700\u521d\u4e8e2017\u5e74\u5728\u4e39\u9ea6\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u80c3\u80a0\u80f0\u817a\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\uff08GEP NETs\uff09\u30022018\u5e741\u670826\u65e5\u83b7FDA\u6279\u51c6\u3002\u76ee\u524d\uff0c\u8be5\u836f\u8fd8\u6709\u4e00\u9879\u2160\/\u2161\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597\u63a5\u53d7\u8fc7\u4e00\u7ebf\u7597\u6cd5\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u6269\u6563\u6027\u5c0f\u7ec6\u80de\u80ba\u764c\uff08ES-SCLC\uff09\u6216\u8005\u975e\u8fdb\u5c55\u6027ES-SCLC\u6216\u8005\u8054\u7528\u7eb3\u6b66\u5355\u6297\u665a\u671f\/\u4e0d\u80fd\u52a8\u624b\u672f\u7684\u2160-\u2161\u80baNETs\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2016135214\uff1bWO 2016207732<\/span><\/p>\n


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8.Onpattro<\/span><\/strong><\/section>\n
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Onpattro(Patisiran)\u662f\u53cc\u94feRNA\uff0c\u662f\u7b2c\u4e00\u4e2a\u88abFDA\u6279\u51c6\u7684RNAi\u7597\u6cd5\uff0c\u7531AlnylamPharmaceuticals\u7814\u53d1\uff0c\u9776\u5411\u7a81\u53d8\u578b\u7532\u72b6\u817a\u7d20\u8fd0\u8f7d\u86cb\u767d(TTR)\uff0c2018\u5e748\u670810\u65e5\u83b7\u6279\u7528\u4ee5\u6cbb\u7597\u5bb6\u65cf\u6027\u6dc0\u7c89\u6837\u795e\u7ecf\u75c5\u53d8\u3002<\/span><\/p>\n


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Sense strand: <\/span><\/p>\n

GUAACCAAGAGUAUUCCAUdTdT<\/span><\/p>\n


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Anti-sense strand:<\/span><\/p>\n

AUGGAAUACUCUUGGUUACdTdT<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2001075164\uff1bWO 2002044321\uff1bWO 2008042973\uff1bWO 2009082817\uff1bWO 2009127060\uff1bWO 2010048228\uff1bWO 2010144740\uff1bWO 2016033326<\/span><\/p>\n

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9.Orilissa<\/span><\/strong><\/section>\n
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Orilissa(elagolix sodium)\u4e8e2018\u5e747\u670823\u65e5\u83b7\u6279\u4e0a\u5e02\uff0c\u6cbb\u7597\u5b50\u5bab\u5185\u819c\u5f02\u4f4d\u76f8\u5173\u7684\u4e2d\u91cd\u5ea6\u75bc\u75db\u3002elagolix sodium\u662f\u53e3\u670d\u4fc3\u6027\u817a\u6fc0\u7d20\u91ca\u653e\u6fc0\u7d20\u53d7\u4f53(GnRH)\u62ee\u6297\u5242\uff0c\u7531Neurocrine Biosciences\u7814\u53d1\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO 2005007165\uff1bUS 2017056403<\/span><\/p>\n


<\/p>\n

\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


<\/p>\n

\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n


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10.Oxervate<\/span><\/span><\/strong><\/section>\n
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Oxervate(cenegermin-bkbj)\u4e8e2018\u5e748\u670822\u65e5\u83b7FDA\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u795e\u7ecf\u8425\u517b\u6027\u89d2\u819c\u708e\u3002\u7531Dompe\u7814\u53d1\uff0c\u6700\u521d\u5728\u6b27\u6d32\u4e0a\u5e02\uff0c\u662f\u4e00\u79cd\u91cd\u7ec4\u03b2-\u795e\u7ecf\u751f\u957f\u56e0\u5b50\uff0c\u662fTrkA\u548cLNGFR\u7684\u5916\u5468\u9009\u62e9\u6027\u6fc0\u52a8\u5242\u3002\u76ee\u524d\u8fd8\u6709\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597\u9ec4\u6591\u56ca\u6837\u6c34\u80bf\u3001\u8272\u7d20\u6027\u89c6\u7f51\u819c\u708e\u4ee5\u53ca\u5e72\u773c\u75c7\u7b49\u75be\u75c5\u3002<\/span><\/p>\n


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11.Palynziq<\/span><\/strong><\/section>\n
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Palynziq(Pegvaliase)\u662f\u4e00\u79cd\u9176\u66ff\u4ee3\u7597\u6cd5\uff0c\u4e8e2018\u5e745\u670824\u65e5\u83b7\u6279\u7528\u4e8e\u6cbb\u7597\u82ef\u4e19\u916e\u5c3f\u75c7\u3002Pegvaliase\u662f\u4e00\u79cd\u91cd\u7ec4\u805a\u4e59\u4e8c\u9187\u5316\u7684\u82ef\u4e19\u6c28\u9178\u89e3\u6c28\u9176\u7a81\u53d8\u86cb\u767d(S503, S565)\u3002\u6700\u521d\u7531Ibex\u7814\u53d1\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO 2006034373\u3001WO 2009025760\u3001WO 2011097335<\/span><\/p>\n


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12.  Poteligeo<\/span><\/span><\/strong><\/section>\n
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Poteligeo(mogamulizumab-kpkc)\u4e8e2018\u5e748\u67088\u65e5\u83b7\u6279\uff0c\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027CCR\u9633\u6027\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u3002\u8be5\u836f\u6700\u5148\u4e8e2012\u5e74\u5728\u65e5\u672c\u4e0a\u5e02\uff0c\u7531Kyowa Hakko Kirin\u7814\u53d1\u3002\u8be5\u836f\u57282010\u5e74\u83b7\u5f97FDA\u7684\u5b64\u513f\u836f\u8ba4\u8bc1\uff0c\u7528\u4e8e\u6cbb\u7597\u76ae\u80a4T\u7ec6\u80de\u6dcb\u5df4\u7624\u4ee5\u53ca\u5916\u5468T\u7ec6\u80de\u6dcb\u5df4\u7624\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO 2003018635\uff1bWO 2015179236\uff1bWO 2017010106\uff1bWO 2017127707\uff1bWO 2018101448\uff1bWO 2018159845<\/span><\/p>\n


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13.Tavalisse<\/span><\/strong><\/section>\n
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Tavalisse(fostamatinib)\u4e8e2018\u5e744\u670817\u65e5\u83b7\u5f97FDA\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u6301\u7eed\u6027\u6216\u6162\u6027\u514d\u75ab\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u3002Tavalisse\u7531Rigel\u7814\u53d1\uff0c\u662fR-406\u7684\u524d\u836f\u3002\u76ee\u524d\u8be5\u836f\u6b63\u8fdb\u884c\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597IgA\u80be\u75c5\u4ee5\u53ca\u81ea\u8eab\u514d\u75ab\u6027\u6eb6\u8840\u6027\u8d2b\u8840\uff0c\u8fd8\u6709\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597\u7c7b\u98ce\u6e7f\u6027\u5173\u8282\u708e\u3002\u6b64\u5916\uff0c\u8fd8\u6709\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\u6cbb\u7597\u5b9e\u4f53\u7624\u548c\u6dcb\u5df4\u7624\uff0c\u4f46\u662f\u76ee\u524d\u5c1a\u65e0\u66f4\u591a\u8fdb\u5c55\u88ab\u62a5\u9053\u3002\u4f5c\u4e3aSyk(Spleen tyrosine kinase)\u6291\u5236\u5242\uff0cfostamatinib\u53ef\u4ee5\u6291\u5236\u80a5\u5927\u7ec6\u80de\u3001\u5de8\u566c\u7ec6\u80de\u548cB\u7ec6\u80de\u6d3b\u5316\uff0c\u4ece\u800c\u6291\u5236\u5305\u62ecTNF\u3001\u767d\u4ecb\u7d20\u5728\u5185\u7684\u591a\u79cd\u708e\u6027\u4ecb\u8d28\u3002\u6b64\u5916\u8be5\u836f\u8fd8\u4f5c\u7528\u4e8eFlt3\u4ee5\u53caABCB1\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aUS 2006047135\u3001WO 2006078846\u3001US 2006276459\u3001WO 2008064274\u3001WO 2009061909\u3001WO 2011002999\u3001WO 2013014454\u3001WO 2015095765\u3001US 2015246125\u3001US 2018000837 <\/span><\/p>\n


<\/p>\n

\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


<\/p>\n

\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n

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14.Tegsedi<\/span><\/span><\/strong><\/section>\n
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Tegsedi(Inotersen)\u662f\u4e00\u79cd\u8f6c\u7532\u72b6\u817a\u7d20\u6dc0\u7c89\u6837\u86cb\u767d\u6291\u5236\u5242\uff0c\u7531Ionis Pharmaceuticals(\u539f\u540dIsis Pharmaceuticals)\u7814\u53d1\u30022018\u5e74\u6700\u5148\u5728\u6b27\u6d32\u4e0a\u5e02\u7528\u4e8e\u6cbb\u7597\u9057\u4f20\u6027\u60a3\u6709\u8f6c\u7532\u72b6\u817a\u7d20\u6dc0\u7c89\u6837\u53d8\u6027\u7684\u6210\u5e74\u75c5\u4eba\u7684\u76ae\u4e0b\u591a\u53d1\u6027\u795e\u7ecf\u75c5\u3002\u968f\u540e\u4e8e2018\u5e7410\u67085\u65e5\u83b7\u6279\u5728\u7f8e\u56fd\u4e0a\u5e02\u3002\u4f5c\u4e3a\u4e00\u79cd\u53cd\u4e49\u7597\u6cd5\uff0cInotersen\u76ee\u524d\u8fd8\u6709\u4e8c\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597\u5bb6\u65cf\u6027\u6dc0\u7c89\u6837\u5fc3\u808c\u75c5\u3002<\/span><\/p>\n


<\/p>\n

\u5176\u6838\u9178\u5e8f\u5217\u4e3a\uff1aTCTTGGTTACATGAAATCCC<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO2011139917\u3001WO 2013173789<\/span><\/p>\n


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15.Tibsovo<\/span><\/strong><\/section>\n
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Tibsovo(Ivosidenib)\u662f\u53e3\u670d\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176(IDH1)\u6291\u5236\u5242\uff0c\u7531Agios Pharmaceuticals\u7814\u53d1\u30022018\u5e747\u670820\u65e5\uff0cFDA\u6279\u51c6\u5176\u4e0a\u5e02\u7528\u4e8e\u6cbb\u7597\u4e0e\u7a81\u53d8\u578bIDH1\u6709\u5173\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u6025\u6027\u9ad3\u6027\u767d\u8840\u75c5\u3002\u76ee\u524d\u4ecd\u5728\u5f00\u5c55\u4e09\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7528\u4e8e\u6cbb\u7597\u5177\u6709\u7a81\u53d8\u578bIDH1\u4e0d\u53ef\u5207\u9664\u6216\u8f6c\u79fb\u6027\u80c6\u7ba1\u764c\u3002\u6b64\u5916\uff0cAgios\u8fd8\u5f00\u5c55\u4e86\u65e9\u671f\u6cbb\u7597IDH1\u7a81\u53d8\u7684\u5b9e\u4f53\u7624\u6216\u8005\u665a\u671f\u767d\u8840\u75c5\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO 2013107291\u3001WO 2015010626\u3001WO 2015127173\u3001WO 2015138837\u3001WO 2015138839\u3001CN 106496090\u3001WO 2017066566\u3001WO 2017066571\u3001WO 2017096309\u3001WO  2017146795\u3001 US 2018353491<\/span><\/p>\n


<\/p>\n

\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


<\/p>\n

\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n

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16.TOPXX \u8fd9\u4e2a\u836f\u4e19\u73af\u7684\u4e24\u4fa7\u7684\u6c22\u539f\u5b50\u662f\u6709\u624b\u6027\u7684\uff0c\u8def\u7ebf\u4e2d\u6ca1\u6709<\/span><\/strong><\/section>\n
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TOPXX(tecovirimat)\u7531SIGA Technologies\u7814\u53d1\u7684\u6297\u5929\u82b1\u53e3\u670d\u5c0f\u5206\u5b50\u836f\u7269\uff0c\u4e8e2018\u5e747\u670813\u65e5\u83b7FDA\u6279\u51c6\u3002Tecovirimat\u5bf9\u6b63\u75d8\u75c5\u6bd2\u5177\u6709\u6297\u75c5\u6bd2\u6d3b\u6027\uff0c\u4e5f\u662f\u7f8e\u56fd\u552f\u4e00\u4e00\u4e2a\u83b7\u6279\u7684\u6297\u5929\u82b1\u836f\u7269\u3002\u5176\u4f5c\u7528\u673a\u7406\u662f\u6291\u5236\u4e86\u6240\u6709\u6b63\u75d8\u75c5\u6bd2\u91cc\u9ad8\u5ea6\u4fdd\u5b88\u7684p37\u86cb\u767d\uff0c\u4ece\u800c\u963b\u6b62\u4e86\u5305\u819c\u75c5\u6bd2\u7684\u5f62\u6210\u3002\u7531\u4e8e\u5929\u82b1\u75c5\u6bd2\u65e9\u5728\u4e0a\u4e16\u7eaa\u5c31\u5df2\u88ab\u5f7b\u5e95\u6d88\u706d\uff0c\u56e0\u6b64\u8fd9\u4e00\u836f\u7269\u7684\u83b7\u6279\u662f\u57fa\u4e8e\u975e\u4eba\u7c7b\u7075\u957f\u7c7b\u52a8\u7269\u7684\u75be\u75c5\u6a21\u578b\u7684\u8bd5\u9a8c\u7ed3\u679c\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO 2004112718\u3001US 2007287735\u3001US 2008004452\u3001WO 2011119698\u3001WO 2012018810\u3001WO 2014028545\u3001WO 2015009566\u3001 WO 2017142910<\/span><\/p>\n


<\/p>\n

\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


<\/p>\n

\"2018\u5e74FDA\u6279\u51c6\u768419\u6b3efirst-in-class\u836f\u7269\"<\/p>\n


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17.Trogarzo<\/span><\/strong><\/section>\n
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Trogarzo(ibalizumab)\u4e8e2018\u5e743\u67086\u65e5\u83b7FDA\u6279\u51c6\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6cbb\u7597\u65b9\u6848\u5931\u8d25\u7684\u591a\u836f\u8010\u836f\u7684HIV-1\u611f\u67d3\u3002Trogarzo\u4f5c\u4e3a\u5355\u6297\u836f\u7269\uff0c\u4e0e\u7ec6\u80de\u819c\u7684CD4\u53d7\u4f53\u7ed3\u5408\uff0c\u963b\u6b62\u75c5\u6bd2\u8fdb\u5165\u4ece\u800c\u963b\u65ad\u611f\u67d3\u3002\u4e34\u5e8a\u524d\u7814\u7a76\u7ed3\u679c\u8868\u660e\u5176\u5e76\u4e0d\u4f1a\u6291\u5236\u514d\u75ab\u529f\u80fd\u4ee5\u53ca\u6d88\u8017CD4\u7ec6\u80de\u3002<\/span><\/p>\n


<\/p>\n

Trogarzo\u6700\u5148\u7531Biogen\u7814\u53d1\uff0c1998\u5e74\u8f6c\u8ba9\u7ed9TaiMed Biologics\u30022016\u5e74\uff0cThertechnologies\u83b7\u8bb8\u5728\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u7684\u72ec\u5bb6\u7ecf\u8425\u6743\uff0c\u4e00\u5e74\u540e\u8303\u56f4\u6269\u5927\u81f3\u6b27\u76df\u3001\u4ee5\u8272\u5217\u3001\u632a\u5a01\u3001\u4fc4\u7f57\u65af\u548c\u745e\u58eb\u3002<\/span><\/p>\n


<\/p>\n

\u4e3b\u8981\u4e13\u5229\uff1aWO1992009305<\/span><\/p>\n


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18.Vitrakvi<\/span><\/strong><\/section>\n
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Vitrakvi(Larotrectinib sulfate)\u662f\u7531Array BioPharma\u539f\u7814\u7684\u53e3\u670d\u539f\u808c\u7403\u86cb\u767d\u6fc0\u9176\u6291\u5236\u5242\uff0c\u8be5\u516c\u53f8\u4e8e2013\u5e747\u6708\u4e0eLoxo Oncology\u8fbe\u6210\u5408\u4f5c\u534f\u8bae\u30022016\u5e74\uff0cLarotrectinib\u83b7\u5f97\u4e86FDA\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u8bc1\u30022018\u5e7411\u670826\u65e5\u83b7\u6279\uff0c\u7528\u4e8e\u6cbb\u7597\u5177\u6709\u795e\u7ecf\u8425\u517b\u53d7\u4f53\u916a\u6c28\u9178\u6fc0\u9176(NTRK)\u57fa\u56e0\u878d\u5408\u7684\u5b9e\u4f53\u7624\u548c\u8f6f\u7ec4\u7ec7\u8089\u7624\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2010048314\u3001WO 2010048314\u3001US 2017281632\u3001WO 2017176751\u3001US 2018207162<\/span><\/p>\n


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19.  Xofluza<\/span><\/span><\/strong><\/section>\n
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Xofluza(Baloxavir marboxil)\u662f\u4e00\u6b3e\u6297\u6d41\u611f\u75c5\u6bd2\u836f\u7269\uff08cap-\u4f9d\u8d56\u578b\u6838\u9178\u5185\u5207\u9176\uff09\uff0c\u7531\u65e5\u672c\u76d0\u91ce\u4e49\u516c\u53f8\u7814\u53d1\u3002\u8be5\u836f\u6700\u5148\u5728\u65e5\u672c\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u548c\u513f\u7ae5\u7684\u7532\u578b\u548c\u4e59\u578b\u6d41\u611f\u75c5\u6bd2\u30022018\u5e7410\u670824\u65e5\u83b7FDA\u6279\u51c6\u4e0a\u5e02\u3002\u4e0d\u540c\u4e0e\u5965\u53f8\u4ed6\u97e6\u4ee5\u53ca\u624e\u7eb3\u7c73\u97e6\u7684\u4f5c\u7528\u673a\u5236\uff0cXofluza\u6291\u5236\u4e86\u75c5\u6bd2\u8f6c\u5f55\u7684\u7b2c\u4e00\u6b65\uff0c\u4ece\u800c\u6291\u5236\u75c5\u6bd2\u3002<\/span><\/p>\n


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\u4e3b\u8981\u4e13\u5229\uff1aWO 2016175224\u3001WO 2017104691\u3001WO 2017221869\u3001WO 2018030463<\/span><\/p>\n


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\u5408\u6210\u8def\u7ebf\uff1a<\/span><\/p>\n


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\u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

[1] https:<\/span>\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DrugInnovation\/ucm592464.htm<\/span><\/p>\n

[2] Goadsby; et al.(2017). “A Controlled Trial of Erenumab for Episodic Migraine”. N.Engl. J. Med. (377:<\/span>2123\u20132132).<\/span><\/p>\n

[3]https:<\/span>\/\/www.fda.gov\/newsevents\/newsroom\/pressannouncements\/ucm604810.htm<\/span><\/p>\n

[4]Lamb YN (2018). “Elagolix:<\/span> First Global Approval”. Drugs. 78 (14):<\/span>1501\u20131508.<\/span><\/p>\n

[5]Chen C et al. (2008). “Discovery of sodiumR-(+)-4-{2-[5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-[trifluoromethyl]benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenylethylamino}butyrate(elagolix), a potent and orally available nonpeptide antagonist of the human gonadotropin-releasing hormone receptor”. J. Med. Chem. 51 (23):<\/span> 7478\u201385.<\/span><\/p>\n

[6]S.P. McAdoo; F.W.K. Tam (2011). “Fostamatinib Disodium”. Drugs of the Future. 36 (4):<\/span> 273\u2013280.<\/span><\/p>\n

[7]Grosenbach, Douglas W.; Honeychurch, Kady; Rose, Eric A.; Chinsangaram,Jarasvech; Frimm, Annie; Maiti, Biswajit; Lovejoy, Candace; Meara, Ingrid;Long, Paul; Hruby, Dennis E. (2018). “Oral Tecovirimat for the Treatment of Smallpox”. N Engl J Med. 379:<\/span> 44\u201353.<\/span><\/p>\n


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\u6587\u7ae0\u4fe1\u606f\u6e90\u4e8e\u516c\u4f17\u53f7<\/span>\u6297\u4f53\u5708<\/span>\uff0c<\/span>\u767b\u8f7d\u8be5\u6587\u7ae0\u76ee\u7684\u4e3a\u66f4\u5e7f\u6cdb\u7684\u4f20\u9012\u884c\u4e1a\u4fe1\u606f\uff0c\u4e0d\u4ee3\u8868\u8d5e\u540c\u5176\u89c2\u70b9\u6216\u5bf9\u5176<\/span>\u771f\u5b9e\u6027\u8d1f\u8d23\u3002\u6587\u7ae0\u7248\u6743\u5f52\u539f\u4f5c\u8005\u53ca\u539f\u51fa\u5904\u6240\u6709\uff0c\u6587\u7ae0\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\u3002\u672c\u7f51\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5fc3\u4f3c\u5e73\u539f\u8d70\u9a6c\uff0c\u6613\u653e\u96be\u6536\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u533b\u836f\u5927\u6570\u636e|\u884c\u4e1a\u52a8\u6001|\u653f\u7b56\u89e3\u8bfb<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u70b9\u51fb\u4e0a\u65b9\u7684  \u25b2 \u6dfb\u52a0\u5173\u6ce8 2018\u5e74\uff0cFDA\u5171\u6279\u51c6\u4e8659\u6b3e\u65b0\u836f\u3002\u5176\u4e2d19\u6b3e\uff08\u5360 […]<\/p>\n","protected":false},"author":1,"featured_media":83531,"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\/83530"}],"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=83530"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/83530\/revisions"}],"predecessor-version":[{"id":83542,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/83530\/revisions\/83542"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/83531"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=83530"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=83530"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=83530"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}