{"id":2332,"date":"2018-07-03T01:00:00","date_gmt":"2018-07-27T06:35:55","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/2018%e4%b8%8a%e5%8d%8a%e5%b9%b4fda%e6%89%b9%e5%87%86%e7%9a%84%e6%96%b0%e8%8d%af\/"},"modified":"2018-07-27T14:35:58","modified_gmt":"2018-07-27T06:35:58","slug":"2018%e4%b8%8a%e5%8d%8a%e5%b9%b4fda%e6%89%b9%e5%87%86%e7%9a%84%e6%96%b0%e8%8d%af","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/2332\/","title":{"rendered":"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f"},"content":{"rendered":"
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2018\u4e0a\u534a\u5e74\uff0cFDA\u5171\u6279\u51c620\u4e2a\u65b0\u5206\u5b50\u5b9e\u4f53\u548c\u65b0\u751f\u7269\u5236\u54c1\uff0c\u5305\u62ec15\u4e2a\u65b0\u5206\u5b50\u5b9e\u4f53\u548c5\u4e2a\u65b0\u751f\u7269\u5236\u54c1\u3002<\/span><\/p>\n


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\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

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1. Lutathera\uff08lutetium Lu 177 dotatate\uff09<\/p>\n<\/section>\n<\/section>\n<\/section>\n


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1\u670826\u65e5\uff0cFDA\u6279\u51c6\u4e86\u8bfa\u534e\u5b50\u516c\u53f8\u6cd5\u56fdAdvanced Accelerator Applications \u516c\u53f8\uff08\u5148\u8fdb\u52a0\u901f\u5668\u5e94\u7528\u516c\u53f8\uff09Lutathera\u7528\u4e8e\u6cbb\u7597\u80c3\u80a0\u80f0\u817a\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\uff08GEP-NETs\uff09\uff0c\u8fd9\u4e5f\u662f<\/span>\u653e\u5c04\u6027\u836f\u7269\u9996\u6b21\u88abFDA\u6279\u51c6\u7528\u4e8e\u6cbb\u7597GEP-NETs\u3002<\/strong><\/span>
<\/span><\/p>\n


<\/p>\n

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/strong><\/p>\n

Lutathera\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/strong><\/p>\n

Lutathera\u662f\u4e00\u79cdLu-177\u6807\u8bb0\u7684\u751f\u957f\u6291\u7d20\u7c7b\u4f3c\u7269\uff0c\u5c5e\u4e8e\u65b0\u5174\u7684\u80bd\u53d7\u4f53\u653e\u5c04\u6027\u6838\u7d20\u7597\u6cd5\uff08PRRT\uff09\uff0c\u901a\u8fc7\u4e0e\u4e00\u79cd\u79f0\u4e3a\u751f\u957f\u6fc0\u7d20\u6291\u5236\u7d20\u53d7\u4f53\u7684\u7ec6\u80de\u7ed3\u5408\u800c\u8d77\u4f5c\u7528\uff0c\u8be5\u751f\u957f\u6291\u7d20\u53d7\u4f53\u53ef\u80fd\u5b58\u5728\u4e8e\u67d0\u4e9b\u80bf\u7624\u4e0a\u3002\u5728\u4e0e\u53d7\u4f53\u7ed3\u5408\u4e4b\u540e\uff0c\u836f\u7269\u8fdb\u5165\u7ec6\u80de\uff0c\u91ca\u653e\u8f90\u5c04\u6765\u635f\u4f24\u80bf\u7624\u7ec6\u80de\u3002<\/span><\/p>\n


<\/p>\n

\u80c3\u80a0\u80f0\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\u662f\u4e00\u7ec4\u8d77\u6e90\u4e8e\u795e\u7ecf\u5916\u80da\u5c42\u3001\u542b\u795e\u7ecf\u5185\u5206\u6ccc\u9897\u7c92\u7684\u80bf\u7624\u3002\u53ef\u5b58\u5728\u4e8e\u80f0\u817a\u548c\u80c3\u80a0\u9053\u7684\u4e0d\u540c\u90e8\u4f4d\uff0c\u5982\u80c3\uff0c\u80a0\uff0c\u7ed3\u80a0\u548c\u76f4\u80a0\u3002\u636e\u4f30\u8ba1\uff0c\u6bcf\u5e74\u7ea6\u670927,000\u4eba\u4e2d\u6709\u4e00\u4eba\u88ab\u8bca\u65ad\u4e3a\u80c3\u80a0\u80f0\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\u3002<\/span><\/p>\n


<\/p>\n

Lutathera\u7684\u6279\u51c6\u5f97\u5230\u4e86\u4e24\u9879\u7814\u7a76\u7684\u652f\u6301\u3002\u9996\u5148\u662f\u4e00\u9879\u5173\u952e\u6027\u968f\u673aIII\u671f\u4e34\u5e8a\u7814\u7a76NETTER-1\u7684\u6570\u636e\uff0c\u6d89\u53ca229\u4f8b\u60a3\u6709\u67d0\u79cd\u665a\u671f\u751f\u957f\u6291\u7d20\u53d7\u4f53\u9633\u6027GEP-NET\u7684\u60a3\u8005\u3002\u8bd5\u9a8c\u4e2d\u7684\u60a3\u8005\u5728\u6b63\u63a5\u53d7\u8bfa\u534e\u5df2\u4e0a\u5e02\u836f\u7269Sandosatin\u6cbb\u7597\u4e14\u8fc7\u8868\u8fbe\u751f\u957f\u6291\u7d20\u53d7\u4f53\u7684\u4e0d\u53ef\u624b\u672f\u6cbb\u6108\u7684\u4e2d\u80a0\u795e\u7ecf\u5185\u5206\u6ccc\u80bf\u7624\u60a3\u8005\u4e2d\u5f00\u5c55\uff0c\u5c06Lutathera\u4e0e\u53cc\u5242\u91cfSandosatin\u8fdb\u884c\u4e86\u5bf9\u6bd4\u3002\u6570\u636e\u663e\u793a\uff0cLutathera\u4f7f\u75be\u75c5\u8fdb\u5c55\u6216\u6b7b\u4ea1\u98ce\u9669\u5927\u5e45\u964d\u4f4e79%\u3002<\/span><\/p>\n


<\/p>\n

\u7b2c\u4e8c\u9879\u7814\u7a76\u57fa\u4e8e\u6765\u81ea\u751f\u957f\u6291\u7d20\u53d7\u4f53\u9633\u6027\u80bf\u7624\u60a3\u8005\u76841214\u540d\u60a3\u8005\u7684\u8d44\u6599\uff0c\u5305\u62ecGEP-NETS\u3002\u7ed3\u679c\u663e\u793a\uff1a\u6ce8\u5c04Lutathera\u7684360\u540dGEP-NETs\u60a3\u8005\uff0c16%\u51fa\u73b0\u90e8\u5206\u80bf\u7624\u7f29\u5c0f\u3002<\/span><\/p>\n

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2. Biktarvy<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

Biktarvy\u662f\u4e00\u79cd\u4e09\u5408\u4e00\u590d\u65b9\u5242\u578b\uff0c\u7531HIV-1\u6574\u5408\u9176\u94fe\u8f6c\u79fb\u6291\u5236\u5242\uff08INSTI\uff09bictegravir\uff0850mg\uff09\u4ee5\u53ca\u4e24\u79cdHIV-1\u6838\u82f7\u7c7b\u4f3c\u7269\u9006\u8f6c\u5f55\u9176\u6291\u5236\u5242\uff08NRTIs\uff09emtricitabine\uff08200mg\uff09\u548ctenofovir alafenamide\uff0825mg\uff09\u7ec4\u6210\u3002<\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

bictegravir\u94a0\u76d0\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

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

Biktarvy\u9002\u5e94\u75c7\u4e3a\u5728\u6ca1\u6709\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u6cbb\u7597\u53f2\u7684\u6210\u5e74\u4eba\u4e2d\u7528\u4e8e\u6cbb\u7597HIV-1\u611f\u67d3\u7684\u5b8c\u6574\u65b9\u6848\uff0c\u6216\u8005\u5728\u63a5\u53d7\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\u5c11\u4e8e3\u4e2a\u6708\u3001\u4e14\u53d6\u4ee3\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\u75c5\u6bd2\u5b66\u6291\u5236\uff08HIV-1 RNA\u8f7d\u91cf\u4f4e\u4e8e50\u4e2a\u62f7\u8d1d\/ mL\uff09\u3001\u6ca1\u6709\u5931\u8d25\u7684\u6cbb\u7597\u53f2\uff0c\u5e76\u4e14\u6ca1\u6709\u5bf9Biktarvy\u4e2a\u4f53\u7ec4\u5206\u7684\u6297\u6027\u76f8\u5173\u8054\u7684\u65e2\u5f80\u53cd\u5e94\u3002<\/span><\/p>\n


<\/p>\n

Biktarvy\u7684\u4e3b\u8981\u5b89\u5168\u6027\u8bc4\u4f30\u57fa\u4e8e\u6765\u81ea\u4e24\u4e2a\u968f\u673a\u53cc\u76f2\u4e3b\u52a8\u5bf9\u7167\u8bd5\u9a8c\uff08\u8bd5\u9a8c1489\u548c\u8bd5\u9a8c1490\uff09\u768448\u5468\u6570\u636e\uff0c\u5171\u62db\u52df\u4e861274\u540dHIV-1\u611f\u67d3\u3001\u6ca1\u6709\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u6cbb\u7597\u53f2\u7684\u6210\u5e74\u53d7\u8bd5\u8005\uff0c\u5176\u4e2d\u6709634\u540d\u53d7\u8bd5\u8005\u63a5\u53d7\u6bcf\u5929\u4e00\u6b21\u4e00\u7247Biktarvy\u3002<\/span><\/p>\n


<\/p>\n

\u5728\u8bd5\u9a8c1489\u548c1490\u8bd5\u9a8c\u4e2d\uff0cBiktarvy\u7ec4\u4e2d\u81f3\u5c11\u67095\uff05\u7684\u53d7\u8bd5\u8005\u62a5\u544a\u6700\u5e38\u89c1\u7684\u4e0d\u826f\u53cd\u5e94\uff08\u6240\u6709\u6210\u7ee9\uff09\u4e3a\u8179\u6cfb\uff0c\u6076\u5fc3\u548c\u5934\u75db\u3002\u505c\u7528Biktarvy\uff0cabacavir [ABC] \/ dolutegravir [DTG] \/ lamivudine [3TC]\uff09\u6216DTG + FTC \/ TAF\u6cbb\u7597\uff0c\u53d7\u8bd5\u8005\u4e25\u91cd\u7a0b\u5ea6\u4e0d\u826f\u4e8b\u4ef6\u6bd4\u4f8b\u4f9d\u6b211\uff05\uff0c1\uff05 \uff0c<1\uff05\u3002<\/span><\/p>\n


<\/p>\n

BIKTARVY\u53e6\u5916\u7684\u5b89\u5168\u6027\u4f7f\u57fa\u4e8e282\u540d\u75c5\u6bd2\u5b66\u5f97\u5230\u6291\u5236\u7684\u53d7\u8bd5\u800548\u5468\u6570\u636e\u3002\u8fd9\u9879\u968f\u673a\u53cc\u76f2\u4e3b\u52a8\u5bf9\u7167\u8bd5\u9a8c\uff08\u8bd5\u9a8c1844\uff09\u4e2d\u75c5\u6bd2\u6291\u5236\u53d7\u8bd5\u8005\u4eceDTG + ABC \/ 3TC\u6216 \uff08ATV\uff09\uff08\u7ed9\u4e88cobicistat\u6216ritonavir\uff09\u6216\u5730\u745e\u90a3\u97e6\uff08darunavir\uff09\u7684\u65b9\u6848\u5176\u4e2d\u75c5\u6bd2\u5b66\u6291\u5236\u7684\u53d7\u8bd5\u8005\u4ece\u542b\u6709\u963f\u624e\u90a3\u97e6\uff08ATV\uff09\u7684\u65b9\u6848\u8f6c\u6362\u4e3a\u5f00\u653e\u6807\u7b7e\uff0c\u4e3b\u52a8\u4e0e\u5bf9\u7167\u8bd5\u9a8c\u7684290\u540d\u53d7\u8bd5\u8005\u7684\u7b2c48\u5468\u6570\u636e DRV\uff08\u4e0ecobicistat\u6216ritonavir\u4e00\u8d77\u7ed9\u836f\uff09\u52a0FTC \/ TDF\u6216ABC \/ 3TC\u81f3BIKTARVY\uff08\u8bd5\u9a8c1878\uff09\u8fdb\u884c\u5bf9\u6bd4\u3002\u603b\u7684\u6765\u8bf4\uff0c1844\u548c1878\u5e74\u8bd5\u9a8c\u4e2d\u75c5\u6bd2\u5f97\u5230\u6291\u5236\u7684\u6210\u5e74\u53d7\u8bd5\u8005\u7684\u5b89\u5168\u6027\u4e0e\u6ca1\u6709\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u6cbb\u7597\u53f2\u7684\u53d7\u8bd5\u8005\u76f8\u4f3c\u3002<\/span><\/p>\n

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3. Symdeko\uff08tezacaftor+ ivacaftor\uff09<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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

\u56ca\u6027\u7ea4\u7ef4\u5316\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u4f1a\u7f29\u77ed\u5bff\u547d\u7684\u9057\u4f20\u75be\u75c5\uff0c\u5f71\u54cd\u4e86\u5317\u7f8e\u3001\u6b27\u6d32\u548c\u6fb3\u5927\u5229\u4e9a\u7ea6 75000 \u540d\u60a3\u8005\uff0c\u7531\u57fa\u56e0\u7a81\u53d8\u5bfc\u81f4\u7684CFTR\u86cb\u767d\u7f3a\u9677\u6216\u7f3a\u5931\u5f15\u8d77\u3002\u513f\u7ae5\u5fc5\u987b\u9057\u4f20\u5230\u5206\u522b\u6765\u81ea\u7236\u6bcd\u7684\u4e24\u4e2a\u6709\u7f3a\u9677\u7684CFTR\u57fa\u56e0\uff0c\u624d\u4f1a\u60a3\u56ca\u6027\u7ea4\u7ef4\u5316\u3002<\/span><\/p>\n


<\/p>\n

Symdeko\u7528\u4e8e\u6cbb\u759712\u5c81\u53ca\u4ee5\u4e0a\u7684\u56ca\u6027\u7ea4\u7ef4\u5316\u60a3\u8005\uff0c\u662ftezacaftor\u548civacaftor\u7684\u590d\u5408\u5242\uff0c\u4e5f\u662fVertex\u83b7\u5f97FDA\u6279\u51c6\u7684\u7b2c3\u79cd\u9488\u5bf9\u56ca\u6027\u7ea4\u7ef4\u5316\u6839\u672c\u75c5\u56e0\u7684\u6cbb\u7597\u836f\u7269\u3002<\/span><\/p>\n


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

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

tezacaftor\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

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

Symdeko\u662f\u83b7\u6279\u4e3b\u8981\u57fa\u4e8e\u540d\u4e3aEVOLVE\u548cEXPAND\u7684\u4e24\u4e2a\u2162\u671f\u7814\u7a76\u3002\u7814\u7a76\u5171\u62db\u52df\u4e86\u7ea6750\u540d\u5e74\u9f84\u572812\u5c81\u53ca\u4ee5\u4e0a\u7684\u56ca\u6027\u7ea4\u7ef4\u5316\u60a3\u8005\uff0c\u4ed6\u4eec\u643a\u5e26\u4e24\u4e2a F508del\u7a81\u53d8\uff0c\u6216\u8005\u643a\u5e26\u4e00\u4e2a F508del\u7a81\u53d8\u548c\u5e26\u6709\u6b8b\u4f59CFTR\u529f\u80fd\u7684\u7a81\u53d8\u3002\u5728\u8fd9\u4e24\u9879\u7814\u7a76\u4e2d\uff0c\u63a5\u53d7 SYMDEKO \u6cbb\u7597\u7684\u60a3\u8005\u80ba\u529f\u80fd\u548c\u5176\u4ed6\u6307\u6807\u5f97\u5230\u6709\u7edf\u8ba1\u5b66\u610f\u4e49\u548c\u4e34\u5e8a\u610f\u4e49\u7684\u6539\u5584\uff0c\u5e76\u4e14\u8bc1\u5b9e\u5177\u6709\u5b89\u5168\u6027\u3002<\/span><\/p>\n

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4. Erleada\uff08apalutamide\uff09<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

Erleada\uff08apalutamide\uff09\u5c5e\u4e8e\u7b2c\u4e8c\u4ee3\u9ad8\u9009\u62e9\u6027\u96c4\u6fc0\u7d20\u53d7\u4f53\uff08AR\uff09\u62ee\u6297\u5242\uff0c\u4e0e\u96c4\u6fc0\u7d20\u53d7\u4f53\u7684\u4eb2\u548c\u529b\u662f\u7b2c\u4e00\u4ee3AR\u62ee\u6297\u5242\u76845\u500d\u4ee5\u4e0a\u3002\u5f3a\u751f\u57282013\u5e748\u6708\u4ee510\u4ebf\u7f8e\u5143\uff086.5\u4ebf\u7f8e\u5143\u9996\u4ed8\u6b3e+3.5\u4ebf\u7f8e\u5143\u91cc\u7a0b\u91d1\uff09\u6536\u8d2dArgon\u516c\u53f8\u5c06ARN-509\uff08JNJ-56021927\uff0capalutamide\uff09\u6536\u5165\u56ca\u4e2d\uff0c\u4f5c\u4e3a\u5bf9\u81ea\u5df1\u524d\u5217\u817a\u764c\u4ea7\u54c1\u7ebf\u7684\u8865\u5145\u3002<\/span><\/p>\n


<\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

apalutamide\u7ed3\u6784\u5f0f<\/span>
<\/p>\n

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

apalutamide\u7684\u5b89\u5168\u6027\u53ca\u7597\u6548\u5728\u6d89\u53ca1207\u4f8b\u975e\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u524d\u5217\u817a\u764c\u7684\u968f\u673a\u7814\u7a76\u4e2d\u5f97\u5230\u8bc1\u5b9e\u3002\u60a3\u8005\u968f\u673a\u7ed9\u4e88apalutamide\u6216\u5b89\u6170\u5242\uff0c\u5e76\u63a5\u53d7\u5185\u5206\u6ccc\u6cbb\u7597\uff0c\u5305\u62ec\u63a5\u53d7\u4fc3\u6027\u817a\u6fc0\u7d20\u91ca\u653e\u6fc0\u7d20\uff08GnRH\uff09\u7c7b\u4f3c\u7269\uff0c\u6216\u8005\u624b\u672f\u53bb\u52bf\uff08\u5207\u9664\u53cc\u4fa7\u777e\u4e38\uff09\u4ee5\u964d\u4f4e\u4f53\u5185\u96c4\u6fc0\u7d20\u6c34\u5e73\u3002\u7ed3\u679c\u663e\u793a\uff0capalutamide\u6cbb\u7597\u7ec4\u65e0\u8f6c\u79fb\u751f\u5b58\u671f\u76f8\u6bd4\u5b89\u6170\u5242\u7ec4\u663e\u8457\u5ef6\u957f\uff0840.5 vs 16.2\u4e2a\u6708\uff09\u3002<\/span><\/p>\n


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

Erleada\u83b7\u5f97\u8fc7FDA\u7684\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u662fFDA\u6279\u51c6\u7684\u9996\u4e2a\u6cbb\u7597\u975e\u8f6c\u79fb\u6027\u53bb\u52bf\u62b5\u6297\u524d\u5217\u817a\u764c\u7684\u836f\u7269\uff0c\u4e5f\u662f<\/span>\u9996\u4e2a\u51ed\u501f\u65e0\u8f6c\u79fb\u751f\u5b58\u671f\uff08metastasis-free survival\uff0cMFS\uff09\u7684\u4e34\u5e8a\u7ec8\u70b9\u83b7\u6279\u4e0a\u5e02\u7684\u80bf\u7624\u65b0\u836f<\/span>\u3002\u6240\u8c13\u65e0\u8f6c\u79fb\u751f\u5b58\u671f\uff0c\u662f\u6307\u4ece\u975e\u8f6c\u79fb\u6027\u80bf\u7624\u60a3\u8005\u4ece\u5f00\u59cb\u6cbb\u7597\u5230\u80bf\u7624\u7ec6\u80de\u8f6c\u79fb\u81f3\u8eab\u4f53\u5176\u4ed6\u5668\u5b98\u6216\u6b7b\u4ea1\u7684\u65f6\u95f4\u3002<\/span><\/span><\/p>\n


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

\u524d\u5217\u817a\u764c\u662f\u4e00\u79cd\u96c4\u6fc0\u7d20\u4f9d\u8d56\u7684\u80bf\u7624\uff0c\u96c4\u6fc0\u7d20\u53ef\u4ee5\u523a\u6fc0\u524d\u5217\u817a\u764c\u7ec6\u80de\u7684\u751f\u957f\u548c\u75be\u75c5\u8fdb\u5c55\u3002<\/span>\u524d\u5217\u817a\u764c\u7684\u6cbb\u7597\u9009\u62e9\u76f8\u5bf9\u6709\u9650\uff0c\u76ee\u524d\u5168\u7403\u6700\u7545\u9500\u7684\u524d\u5217\u817a\u764c\u836f\u7269\u662fZytiga\uff08\u963f\u6bd4\u7279\u9f99\uff0cCYP17A1\u6291\u5236\u5242\uff09\u3001Xtandi\uff08\u6069\u6742\u9c81\u80fa\uff0c\u96c4\u6fc0\u7d20\u53d7\u4f53\u62ee\u6297\u5242\uff09\u3002\u524d\u80052017\u5e74\u5168\u7403\u9500\u552e\u989d\u8fbe\u523025\u4ebf\u7f8e\u5143\uff0c\u540e\u8005\u66f4\u662f\u5438\u5f15\u8f89\u745e\u82b1\u8d39140\u4ebf\u7f8e\u5143\u7684\u5927\u4ee3\u4ef7\u6536\u8d2d\u4e86Medivation\u3002<\/span><\/span><\/p>\n


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

\u8be6\u89c1\uff1a<\/span>FDA\u6279\u51c6\u5f3a\u751f\u524d\u5217\u817a\u764c\u65b0\u836fErleada<\/a><\/span><\/p>\n

\n
\n
\n

5. Trogarzo\uff08ibalizumab-uiyk\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

Trogarzo (ibalizumab-uiyk)\u662f\u4e00\u79cd\u9759\u8109\u6ef4\u6ce8\u7684\u4eba\u6e90\u5316\u514d\u75ab\u7403\u86cb\u767dG4\u5355\u514b\u9686\u6297\u4f53\uff0c\u5b83\u4e0eCD4+T\u7ec6\u80de\u53d7\u4f53\u7684\u7b2c\u4e8c\u4e2a\u80de\u5916\u533a\u57df\u7ed3\u5408\uff0c\u963b\u6b62HIV\u75c5\u6bd2\u5165\u4fb5\u8fd9\u4e9b\u7ec6\u80de\uff0c\u548cPRO140\u7c7b\u4f3c\u90fd\u662f\u4e00\u79cd\u201c\u75c5\u6bd2\u4fb5\u5165\u6291\u5236\u5242\u201d\u3002\u5b83<\/span>\u662f<\/span>10\u591a\u5e74\u6765\u9996\u6b3e\u5177\u6709\u5168\u65b0\u4f5c\u7528\u673a\u5236\u7684\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\uff0c\u4e5f\u662f<\/span>\u9996\u4f8b\u5728\u4e2d\u56fd\u751f\u4ea7\u3001\u5e76\u5f97\u5230\u7f8e\u56fdFDA\u6279\u51c6\u8fdb\u5165\u7f8e\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7684\u65e0\u83cc\u751f\u7269\u5236\u5242\u3002<\/span><\/span><\/strong><\/span><\/p>\n


<\/p>\n

Trogarzo\u662f\u4e00\u79cd\u5168\u65b0\u7684\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\uff0c\u7528\u4e8e\u6cbb\u7597\u73b0\u6709\u591a\u79cd\u7597\u6cd5\u5747\u65e0\u6cd5\u8d77\u6548\u7684\u6210\u4eba\u827e\u6ecb\u75c5\u75c5\u6bd2\uff08HIV\uff09\u611f\u67d3\u8005\u3002\u4f7f\u7528\u7528\u65b9\u6cd5\u662f\uff0c\u60a3\u8005\u6bcf14\u5929\u9759\u8109\u5185\u6ce8\u5c04\u4e00\u6b21\uff0c\u4e5f\u53ef\u4e0e\u5176\u4ed6\u540c\u7c7b\u836f\u7269\u8054\u5408\u4f7f\u7528\u3002<\/span><\/p>\n


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

Trogarzo\u7684\u5b89\u5168\u6027\u4e0e\u7597\u6548\u5728\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5df2\u5f97\u5230\u4e86\u9a8c\u8bc1\u3002\u8be5\u8bd5\u9a8c\u62db\u52df\u4e8640\u540d\u611f\u67d3\u6709\u591a\u91cd\u8010\u836f\u6027HIV\u7684\u60a3\u8005\uff0c\u4ed6\u4eec\u5747\u91cd\u5ea6\u7ecf\u6cbb\uff0c\u6709\u4e9b\u60a3\u8005\u751a\u81f3\u5df2\u7ecf\u63a5\u53d7\u8fc710\u79cd\u6216\u66f4\u591a\u7684\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\u3002\u7136\u800c\uff0c\u7814\u7a76\u4eba\u5458\u53d1\u73b0\uff0c\u60a3\u8005\u5373\u4fbf\u63a5\u53d7\u4e86\u5927\u91cf\u6cbb\u7597\uff0c\u4ed6\u4eec\u8840\u6db2\u4e2d\u7684\u75c5\u6bd2\u6c34\u5e73\uff08HIV-RNA\uff09\u4f9d\u65e7\u5f88\u9ad8\u3002\u4f46\u5728\u539f\u6709\u7597\u6cd5\u4e2d\uff0c\u52a0\u5165Trogarzo\u7684\u6cbb\u7597\u4e00\u5468\u540e\uff0c\u5927\u90e8\u5206\u60a3\u8005\u8840\u6db2\u4e2d\u7684HIV-RNA\u6c34\u5e73\u5c31\u6709\u663e\u8457\u4e0b\u964d\u300224\u5468\u540e\uff0c43%\u7684\u60a3\u8005\u5176HIV-RNA\u6c34\u5e73\u5f97\u5230\u4e86\u6291\u5236\u3002<\/span><\/p>\n


<\/p>\n

\u8be6\u89c1\uff1aFDA\u6279\u51c6HIV\u6cbb\u7597\u836f\u7269Trogarzo\uff0c\u6bcf14\u5929\u6ce8\u5c04\u4e00\u6b21<\/a><\/span><\/p>\n

\n
\n
\n

 6. <\/span>Ilumya\uff08tildrakizumab\uff09<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u94f6\u5c51\u75c5\u662f\u76ae\u80a4\u4e0a\u51fa\u73b0\u7684\u975e\u4f20\u67d3\u6027\u6162\u6027\u514d\u75ab\u6027\u75be\u75c5\uff0c\u53ef\u52a0\u901f\u76ae\u80a4\u7ec6\u80de\u7684\u751f\u957f\u5468\u671f\uff0c\u5e76\u5bfc\u81f4\u76ae\u80a4\u51fa\u73b0\u539a\u539a\u7684\u9cde\u5c51\u533a\u57df\u3002\u6700\u5e38\u89c1\u7684\u94f6\u5c51\u75c5\u5f62\u5f0f\u4e3a\u6591\u5757\u578b\u94f6\u5c51\u75c5\uff0c\u5f71\u54cd\u4e86\u5927\u7ea6 80%\u81f390%\u7684\u94f6\u5c51\u75c5\u60a3\u8005\u3002<\/span><\/p>\n


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

Ilumya\uff08tildrakizumab\uff09\u53ef\u4ee5\u9009\u62e9\u6027\u7ed3\u5408IL-23\u7684p19\u4e9a\u57fa\uff0c\u5e76\u6291\u5236\u5176\u4e0e IL-23 \u53d7\u4f53\u4f5c\u7528\uff0c\u4ece\u800c\u6291\u5236\u4fc3\u708e\u7ec6\u80de\u56e0\u5b50\u548c\u8d8b\u5316\u56e0\u5b50\u7684\u91ca\u653e\u3002\u5728\u5b8c\u6210\u521d\u59cb\u5242\u91cf\u7684\u7b2c0\u5468\u548c\u7b2c4\u5468\uff0cIlumya\u6bcf12\u5468\u901a\u8fc7\u76ae\u4e0b\u6ce8\u5c04\u4ee5100mg\u7684\u5242\u91cf\u65bd\u7528\u3002Ilumya\u4e0d\u9002\u5408\u5bf9tildrakizumab \u4e25\u91cd\u8fc7\u654f\u7684\u60a3\u8005\u3002<\/span><\/p>\n


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

FDA\u6279\u51c6\u57fa\u4e8e\u5173\u952e\u2162\u671f\u4e34\u5e8a\u9879\u76eereSURFACE\u7684\u6570\u636e\u652f\u6301\u3002\u5728\u4e24\u9879\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u8bd5\u9a8c\uff08reSURFACE 1 \u548c reSURFACE 2\uff09\u4e2d\uff0c926\u540d\u6210\u4eba\u60a3\u8005\u63a5\u53d7 ILUMYA\uff08N=616\uff09\u6216\u5b89\u6170\u5242\uff08N=310\uff09\u6cbb\u7597\u3002\u8fd9\u4e24\u9879\u7814\u7a76\u5747\u8fbe\u5230\u4e86\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\uff0c\u8bc1\u660e\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\uff0c\u65bd\u7528Ilumya 100mg\u80fd\u53d6\u5f97\u663e\u8457\u7684\u4e34\u5e8a\u6539\u5584\u3002<\/span><\/p>\n


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

\u5176\u4e2d\uff0creSURFACE1\u7814\u7a76\u670974%\uff08229\u4eba\uff09\u7684\u60a3\u8005\u57283\u6b21\u7528\u836f\u540e\u7b2c 28 \u5468\u8fbe\u523075%\u7684\u76ae\u80a4\u6e05\u9664\u7387\uff0c84%\u6301\u7eed\u4f7f\u7528 ILUMYA100 mg\u7684\u60a3\u8005\u5728\u7b2c64\u5468\u80fd\u7ef4\u6301 PASI 75\uff0c\u800c\u91cd\u65b0\u968f\u673a\u5206\u914d\u4f7f\u7528\u5b89\u6170\u5242\u7684\u60a3\u8005\u53ea\u670922%\u7684\u4eba\u80fd\u7ef4\u6301\u8fd9\u4e00\u6548\u679c\u3002\u63a5\u53d7 ILUMYA 100 mg \u6cbb\u7597\u4e14\u5728\u7b2c28\u5468\u65f6PGA\u8bc4\u5206\u4e3a\u201c\u6e05\u9664\u201d\u6216\u201c\u6700\u5c0f\u201d\u7684\u60a3\u8005\u4e2d\uff0c\u670969%\u7684\u4eba\u5728\u7b2c64\u5468\u65f6\u80fd\u7ef4\u6301\u8fd9\u4e00\u53cd\u5e94\uff0c\u800c\u88ab\u91cd\u65b0\u968f\u673a\u5206\u914d\u63a5\u53d7\u5b89\u6170\u5242\u7684\u60a3\u8005\u4e2d\u53ea\u670914%\u7684\u4eba\u80fd\u7ef4\u6301\u8fd9\u4e00\u53cd\u5e94\u3002<\/span><\/p>\n

\n
\n
\n

7. Tavalisse\uff08fostamatinib\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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

Tavalisse (fostamatinib disodium hexahydrate)\u662f\u4e00\u79cd\u53e3\u670d\u7684\u813e\u810f\u916a\u6c28\u9178\u6fc0\u9176(SYK)\u6291\u5236\u5242\uff0c\u901a\u8fc7\u963b\u6b62\u8840\u5c0f\u677f\u7684\u7834\u574f\u6765\u5e94\u5bf9\u75be\u75c5\u7684\u6f5c\u5728\u81ea\u8eab\u514d\u75ab\u539f\u56e0\uff0c\u4e3a\u6210\u5e74\u6162\u6027ITP\u60a3\u8005\u63d0\u4f9b\u4e86\u4e00\u4e2a\u91cd\u8981\u7684\u65b0\u7684\u6cbb\u7597\u65b9\u6848\u3002<\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

<\/span>fostamatinib\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

\u6162\u6027ITP\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5176\u4e2d\u514d\u75ab\u7cfb\u7edf\u7834\u574f\u8840\u5c0f\u677f\uff0c\u8fd9\u662f\u6b63\u5e38\u8840\u6db2\u51dd\u56fa\u6240\u5fc5\u9700\u7684\u3002\u8fd9\u79cd\u75be\u75c5\u5f88\u96be\u6cbb\u7597\uff0c\u56e0\u4e3a\u4e0d\u53ef\u80fd\u9884\u6d4b\u4eba\u4eec\u5982\u4f55\u56de\u5e94\u53ef\u7528\u7684\u6cbb\u7597\u65b9\u6cd5\u3002Tavalisse\u7528\u4e8e\u5bf9\u4e4b\u524d\u6cbb\u7597\u7f13\u89e3\u4e0d\u4f73\u7684\u6210\u5e74\u6162\u6027\u514d\u75ab\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\uff08ITP\uff09\u60a3\u8005\u8840\u5c0f\u677f\u51cf\u5c11\u7684\u6cbb\u7597\u3002<\/span><\/p>\n


<\/p>\n

Tavalisse\u7684\u6279\u51c6\u4f9d\u8d56\u4e8eFIT\u4e34\u5e8a\u7814\u7a76\u9879\u76ee\u7684\u6570\u636e\uff0cFIT\u5305\u542b\u4e24\u9879\u968f\u673a\u5b89\u6170\u5242\u5bf9\u7167\u7684\u2162\u671f\u4e34\u5e8a\u7814\u7a76047\u548c048\u3001\u4e00\u9879\u5f00\u6807\u6269\u5c55\u8bd5\u9a8c049\u4ee5\u53ca\u6700\u521d\u7684\u6982\u5ff5\u9a8c\u8bc1\u8bd5\u9a8c\u3002\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u5305\u62ec\u4e86163\u4f8bITP\u60a3\u8005\u7684\u6570\u636e\uff0c\u5e76\u5f97\u5230\u4e86\u4e00\u9879\u5b89\u5168\u6570\u636e\u96c6\u7684\u652f\u6301\uff0c\u8be5\u6570\u636e\u96c6\u5305\u542b4600\u591a\u540d\u6d89\u53ca\u5176\u5b83\u9002\u5e94\u75c7\u7684\u5df2\u63a5\u53d7TAVALISSE\u8bc4\u4f30\u7684\u53d7\u8bd5\u8005\u3002<\/span><\/p>\n

\n
\n
\n

8. Crysvita\uff08burosumab-twza\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

X-\u8fde\u9501\u4f4e\u78f7\u6027\u4f5d\u507b\u75c5\uff08XLH\uff09\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u9057\u4f20\u6027\u75be\u75c5\uff0c\u4e5f\u662f\u6700\u5e38\u89c1\u7684\u4f4e\u8840\u78f7\u9178\u4f5d\u507b\u75c5\uff0c\u6bcf20000\u4eba\u4e2d\u5c31\u6709\u4e00\u4eba\u53d7\u6b64\u75c5\u5f71\u54cd\u3002XLH\u643a\u5e26\u5728X\u67d3\u8272\u4f53\u4e0a\uff0c\u867d\u7136\u51e0\u4e4e\u6240\u6709\u7684X\u8fde\u9501\u75be\u75c5\u90fd\u662f\u9690\u6027\u7684\uff0c\u4f46\u662fXLH\u662f\u5176\u4e2d\u5c11\u6570\u663e\u6027\u9057\u4f20\u7684\u75be\u75c5\u4e4b\u4e00\u3002<\/span><\/p>\n


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

4\u670818\u65e5\uff0cFDA\u6279\u51c6\u4e86\u5355\u514b\u9686\u6297\u4f53\u836f\u7269Crysvita\uff08burosumab-twza\uff09\u7684\u4e0a\u5e02\u7533\u8bf7\uff0c\u7528\u4e8e\u6cbb\u75971\u5c81\u53ca\u4ee5\u4e0a\u513f\u7ae5\u548c\u6210\u5e74\u4eba\u7684XLH\u3002Burosumab\u7531\u65e5\u672c\u836f\u4f01\u534f\u548c\u9e92\u9e9f\uff08Kyowa Kirin\uff09\u548cUltragenyx\u5408\u4f5c\u5f00\u53d1\uff0c\u662f\u9488\u5bf9\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b5023\uff08FGF23\uff09\u7684\u91cd\u7ec4\u5b8c\u5168\u4eba\u6e90\u5316\u5355\u514b\u9686IgG1\u6297\u4f53\uff0c\u662f<\/span>\u5168\u7403\u7b2c\u4e00\u4e2a\u83b7\u6279\u6cbb\u7597XLH\u7684\u836f\u7269\u3002<\/strong><\/p>\n


<\/p>\n

\u5728\u4e00\u9879\u62db\u52df\u4e86134\u540d\u60a3\u8005\u7684\u2162\u671f\u4e34\u5e8a\u4e2d\uff0c\u4ee51:1\u968f\u673a\u5206\u914d1 mg\/kg\u5242\u91cfburosumab\u6216\u5b89\u6170\u5242\uff0c\u6bcf4\u54681\u6b21\uff0c\u7597\u7a0b24\u5468\u300224\u5468\u540e\uff0c\u6765\u81ea\u4e24\u7ec4\u7684\u60a3\u8005\u7ee7\u7eed\u5f00\u653e\u6807\u7b7e\u8bd5\u9a8c\uff0c\u5728\u6b64\u671f\u95f4\uff0c\u4ed6\u4eec\u6bcf4\u54681\u6b21\u63a5\u53d71mg\/kg\u7684Burosumab\u3002<\/span><\/p>\n


<\/p>\n

\u5728\u6cbb\u759724\u81f348\u5468\u540e\uff0c\u81ea\u7814\u7a76\u5f00\u59cb\u4ee5\u6765\u63a5\u53d7Burosumab\u6cbb\u7597\u7684\u60a3\u8005\u4e2d\uff08n = 68\uff09\uff0c84\uff05\u8fbe\u5230\u5e76\u7ef4\u6301\u4e86\u8840\u6e05\u78f7\u6c34\u5e73\u9ad8\u4e8e\u6b63\u5e38\u503c\u4e0b\u9650\uff082.5 mg\/dL\uff09\u300289\uff05\u4ece\u5b89\u6170\u5242\u4ea4\u53c9\u5230\u63a5\u53d724\u5468Burosumab\u6cbb\u7597\u7684\u60a3\u8005\uff08n = 66\uff09\uff0c\u8fbe\u5230\u5e76\u7ef4\u6301\u4e86\u8840\u6e05\u78f7\u6c34\u5e73\u9ad8\u4e8e\u6b63\u5e38\u503c\u4e0b\u9650\u3002<\/span><\/p>\n

\n
\n
\n

9. Akynzeo\uff08fosnetupitant \/palonosetron\uff09
<\/p>\n


<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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

Akynzeo\u662f5-HT3\u53d7\u4f53\u62ee\u6297\u5242\u5e15\u6d1b\u8bfa\u53f8\u743c\uff08palonosetron\uff09\u548cNK-1\u53d7\u4f53\u62ee\u6297\u5242fosnetupitant<\/span>\u7684\u590d\u65b9\u9759\u8109\u6ce8\u5c04\u5242\uff0c\u7528\u4ee5\u9884\u9632\u764c\u75c7\u60a3\u8005\u5316\u7597\u51fa\u73b0\u7684\u6076\u5fc3\u548c\u5455\u5410\u3002<\/span><\/p>\n


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

\u5e15\u6d1b\u8bfa\u53f8\u743c\u4e8e2008\u5e74\u83b7\u5f97\u6279\u51c6\uff0c\u8fd9\u6b3e\u836f\u7269\u7528\u4e8e\u9884\u9632\u764c\u75c7\u5316\u7597\u5f00\u59cb\u4e4b\u540e\u6025\u6027\u671f\uff0824 \u5c0f\u65f6\u5185\uff09\u4ea7\u751f\u7684\u6076\u5fc3\u548c\u5455\u5410\u3002fosnetupitant\u662f\u4e00\u79cd\u65b0\u836f\uff0c\u7528\u4e8e\u9884\u9632\u764c\u75c7\u5316\u7597\u5f00\u59cb\u540e\u6025\u6027\u671f\u4e0e\u5ef6\u8fdf\u671f\uff08\u4ece\u5316\u7597\u540e 25 \u5c0f\u65f6\u5230 120 \u5c0f\u65f6\uff09\u4ea7\u751f\u7684\u6076\u5fc3\u548c\u5455\u5410\u3002<\/span><\/p>\n


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

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

fosnetupitant\u7ed3\u6784\u5f0f<\/span>
<\/p>\n


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

2014\u5e7410\u670810\u65e5\uff0cFDA\u66fe\u6279\u51c6\u540c\u4e3aHelsinn\u5f00\u53d1\u5e76\u4e14\u5546\u54c1\u540d\u540c\u6837\u4e3aAkynzeo\u7684\u53e3\u670d\u80f6\u56ca\u5236\u5242\uff0c\u7531\u5e15\u6d1b\u8bfa\u53f8\u743c\u548c<\/span>netupitant\u7ec4\u6210\u7684<\/span>\u56fa\u5b9a\u5242\u91cf\u590d\u65b9\u836f\u7269\u3002\u8be5\u4ea7\u54c1\u4e5f\u662f\u7528\u4e8e\u764c\u75c7\u5316\u7597\u60a3\u8005\u6076\u5fc3\u548c\u5455\u5410\u75c7\u72b6\u7684\u7f13\u89e3\u6cbb\u7597\u3002<\/span><\/span><\/span><\/p>\n


<\/p>\n

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

netupitant\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

Akynzeo\u7684\u6709\u6548\u6027\u57fa\u4e8e\u4e24\u9879\u75311720\u540d\u63a5\u53d7\u764c\u75c7\u5316\u7597\u53d7\u8bd5\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u53d7\u8bd5\u8005\u88ab\u968f\u673a\u6ce8\u5c04Akynzeo\u6216\u53e3\u670d\u5e15\u6d1b\u8bfa\u53f8\u743c\u3002\u8be5\u4e24\u9879\u8bd5\u9a8c\u65e8\u5728\u68c0\u6d4b\u7814\u7a76\u836f\u7269\u662f\u5426\u53ef\u9884\u9632\u764c\u75c7\u5316\u7597\u5f00\u59cb\u540e\u6025\u6027\u671f\u3001\u5ef6\u8fdf\u671f\u53ca\u5316\u7597\u6574\u4f53\u9636\u6bb5\u7684\u5455\u5410\u53d1\u4f5c\u3002\u7b2c\u4e00\u9879\u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\uff0c\u6025\u6027\u671f\u3001\u5ef6\u8fdf\u671f\u53ca\u5316\u7597\u6574\u4f53\u9636\u6bb5\u5206\u522b\u670998.5%\u300190.4%\u548c 89.6%\u7684Akynzeo\u6cbb\u7597\u53d7\u8bd5\u8005\u672a\u53d1\u751f\u5455\u5410\u6216\u9700\u6025\u6551\u836f\u7269\u7684\u6076\u5fc3\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u53e3\u670d\u5e15\u6d1b\u8bfa\u53f8\u743c\u6cbb\u7597\u53d7\u8bd5\u8005\u5728\u6025\u6027\u671f\u3001\u5ef6\u8fdf\u671f\u53ca\u5316\u7597\u6574\u4f53\u9636\u6bb5\u5206\u522b\u6709 89.7%\u300180.1% \u548c 76.5%\u7684\u53d7\u8bd5\u8005\u672a\u53d1\u751f\u5455\u5410\u6216\u9700\u6025\u6551\u836f\u7269\u7684\u6076\u5fc3\u3002\u7b2c\u4e8c\u9879\u8bd5\u9a8c\u663e\u793a\u6709\u7c7b\u4f3c\u7684\u7ed3\u679c\u3002<\/span><\/p>\n

\n
\n
\n

10. Lucemyra\uff08lofexidine hydrochloride\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

<\/span>Lucemyra\u662f\u4e00\u6b3e\u53e3\u670d\u9009\u62e9\u6027\u03b12-\u80be\u4e0a\u817a\u7d20\u53d7\u4f53\u6fc0\u52a8\u5242\uff0c\u53ef\u51cf\u5c11\u53bb\u7532\u80be\u4e0a\u817a\u7d20\uff08norepinephrine\uff09\u7684\u91ca\u653e\u3002\u53bb\u7532\u80be\u4e0a\u817a\u7d20\u5728\u81ea\u4e3b\u795e\u7ecf\u7cfb\u7edf\u4e2d\u7684\u4f5c\u7528\u88ab\u8ba4\u4e3a\u5728\u963f\u7247\u6212\u65ad\u7684\u8bb8\u591a\u75c7\u72b6\u4e2d\u8d77\u4f5c\u7528\u3002 FDA\u6279\u51c6Lucemyra\u7528\u4e8e\u7f13\u89e3\u6210\u5e74\u4eba\u963f\u7247\u7c7b\u836f\u7269\u7a81\u7136\u505c\u836f\u540e\u51fa\u73b0\u7684\u6212\u65ad\u75c7\u72b6\u3002<\/span><\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

lofexidine\u7ed3\u6784\u5f0f<\/span><\/p>\n


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

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

Lucemyra\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5f97\u5230\u4e86\u4e24\u9879\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\u7684\u652f\u6301\uff0c866\u540d\u7b26\u5408\u963f\u7247\u7c7b\u836f\u7269\u4f9d\u8d56\u7684\u8bca\u65ad\u548c\u7edf\u8ba1\u624b\u518cIV\u6807\u51c6\u7684\u6210\u5e74\u4eba\u53c2\u4e0e\u4e86\u8fd9\u4e9b\u4e34\u5e8a\u8bd5\u9a8c\u3002\u7814\u7a76\u8bc4\u4f30\u4e86\u4f7f\u7528SOWS-Gossop\uff08\u77ed\u9e26\u7247\u5242\u91cf\u6212\u8868\uff09\u7684\u76ca\u5904\uff0c\u8be5\u91cf\u8868\u7528\u4e8e\u8bc4\u4f30\u963f\u7247\u7c7b\u6212\u65ad\u75c7\u72b6\u3002\u75c7\u72b6\u5305\u62ec\u611f\u89c9\u4e0d\u9002\u3001\u80c3\u75c9\u631b\u3001\u808c\u8089\u75c9\u631b\/\u62bd\u6410\u3001\u611f\u89c9\u51b7\u6de1\u3001\u5fc3\u8df3\u52a0\u901f\u3001\u808c\u8089\u7d27\u5f20\u3001\u75bc\u75db\u3001\u6253\u54c8\u6b20\u3001\u6d41\u773c\u6cea\u548c\u5931\u7720\/\u5931\u7720\u3002<\/span><\/p>\n

\n
\n
\n

11. Aimovig\uff08erenumab-aooe\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

<\/span>Aimovig\u662fFDA\u6279\u51c6\u7684\u9996\u4e2a\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd\uff08Calcitonin gene related peptide\uff0cCGRP\uff09\u6297\u4f53\u836f\u7269<\/strong>\uff0c\u7528\u4e8e\u9884\u9632\u6210\u4eba\u504f\u5934\u75db\uff0c\u60a3\u8005\u6bcf\u67081\u6b21\u81ea\u884c\u76ae\u4e0b\u6ce8\u5c04\u7ed9\u836f\u3002<\/span><\/p>\n


<\/p>\n

Aimovig\u7684\u7597\u6548\u57283\u9879\u4e34\u5e8a\u7814\u7a76\u4e2d\u5f97\u5230\u8bc1\u5b9e\u3002\u7b2c1\u9879\u7814\u7a76\u5165\u7ec4955\u4f8b\u6709\u504f\u5934\u75db\u95f4\u6b47\u53d1\u4f5c\u75c5\u53f2\u7684\u60a3\u8005\uff0c\u6bd4\u8f83Aimovig\u4e0e\u5b89\u6170\u5242\u7684\u7597\u6548\u5dee\u5f02\uff0c\u7ecf\u8fc76\u4e2a\u6708\u6cbb\u7597\uff0c\u7ed9\u836f\u7ec4\u6bcf\u6708\u5934\u75db\u53d1\u4f5c\u5929\u6570\u6bd4\u5b89\u6170\u5242\u7ec4\u5e73\u5747\u5c111~2\u5929\uff1b\u7b2c2\u9879\u7814\u7a76\u5165\u7ec4577\u4f8b\u504f\u5934\u75db\u95f4\u6b47\u53d1\u4f5c\u60a3\u8005\uff0c\u7ecf\u8fc73\u4e2a\u6708\u6cbb\u7597\uff0c\u7ed9\u836f\u7ec4\u6bcf\u6708\u5934\u75db\u53d1\u4f5c\u5929\u6570\u6bd4\u5b89\u6170\u5242\u7ec4\u5e73\u5747\u5c111\u5929\uff1b\u7b2c3\u9879\u7814\u7a76\u5165\u7ec4667\u4f8b\u6709\u6162\u6027\u504f\u5934\u75db\u53d1\u4f5c\u53f2\u7684\u60a3\u8005\uff0c\u7ecf\u8fc73\u4e2a\u6708\u6cbb\u7597\uff0c\u7ed9\u836f\u7ec4\u6bcf\u6708\u5934\u75db\u53d1\u4f5c\u5929\u6570\u6bd4\u5b89\u6170\u5242\u7ec4\u5e73\u5747\u5c112.5\u5929\u3002<\/span> <\/span><\/p>\n


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

\u89c1\uff1a<\/span>FDA\u6279\u51c6\u9996\u4e2aGPCR\u6297\u4f53\u836f\u7269\uff0120\u5e74\u6765\u9996\u4e2a\u9884\u9632\u504f\u5934\u75db\u65b0\u836f\uff0c\u9500\u552e\u5cf0\u503c\u9884\u6d4b125\u4ebf\u7f8e\u5143<\/a><\/span><\/span><\/p>\n

\n
\n
\n

12. Lokelma\uff08sodium zirconium cyclosilicate\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

Lokelma\uff08\u524d\u79f0ZS-9\uff0c\u73af\u7845\u9178\u94a0\u9506\uff09\u5728\u4e24\u5ea6\u906d\u5230FDA\u62d2\u7edd\uff08\u9996\u6b21\u662f\u57282015\u5e745\u6708\uff0c\u7b2c\u4e8c\u6b21\u662f\u57282017\u5e743\u6708\uff09\u540e\uff0c\u4e8e5\u670818\u65e5\u7ec8\u4e8e\u83b7\u5f97FDA\u6279\u51c6\uff0c\u7528\u4e8e\u6cbb\u7597\u7f79\u60a3\u9ad8\u94be\u8840\u75c7\uff08hyperkalaemia\uff09\u7684\u6210\u4eba\u60a3\u8005\u3002\u8fd9\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u75be\u75c5\uff0c\u8868\u73b0\u4e3a\u4e0e\u5fc3\u8840\u7ba1\u3001\u80be\u810f\u548c\u4ee3\u8c22\u76f8\u5173\u7684\u8840\u94be\u6c34\u5e73\u5347\u9ad8\u3002<\/span>
<\/span><\/p>\n


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

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

ZS-9\u6676\u4f53\u7ed3\u6784<\/span><\/p>\n


<\/p>\n

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

Lokelma\u7531ZS\u5236\u836f\u516c\u53f8\u7814\u5236\uff0c\u963f\u65af\u5229\u5eb7\u4e8e2015\u5e7411\u6708\u4ee527\u4ebf\u7f8e\u5143\u6536\u8d2dZS\u5236\u836f\u516c\u53f8\u540e\u83b7\u5f97\u4e86\u8fd9\u6b3e\u6f5c\u5728\u91cd\u78c5\u836f\u7269\u3002 Lokelma\u88ab\u89c6\u4e3abest-in-class\u7684\u9ad8\u94be\u8840\u75c7\u6cbb\u7597\u836f\u7269\u3002<\/strong><\/span><\/p>\n


<\/p>\n

Lokelma\u662f\u4e00\u79cd\u4e0d\u6eb6\u6027\u7684\u3001\u975e\u5438\u6536\u7684\u65b0\u578b\u9009\u62e9\u6027\u9633\u79bb\u5b50\u4ea4\u6362\u5242\uff0c\u5176\u7ed3\u6784\u8bbe\u8ba1\u4e3a\u4f18\u5148\u6355\u83b7\u94be\u79bb\u5b50\u3002\u83b7\u6279\u662f\u57fa\u4e8e3\u9879\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7814\u7a76\u548c\u4e00\u9879\u5f00\u653e\u6807\u7b7e\u7814\u7a76\u7684\u6570\u636e\u3002\u5728\u8fd9\u4e9b\u7814\u7a76\u4e2d\uff0c\u63a5\u53d7Lokelma\u6cbb\u7597\u7684\u9ad8\u94be\u8840\u75c7\u60a3\u8005\uff0c\u5176\u8840\u6db2\u94be\u6d53\u5ea6\u8fbe\u5230\u6b63\u5e38\u6c34\u5e73\u7684\u4e2d\u4f4d\u65f6\u95f4\u4e3a2.2\u5c0f\u65f6\uff0c\u9ad8\u8fbe98%\u7684\u60a3\u8005\u5728\u6cbb\u759748\u5c0f\u65f6\u5185\u8fbe\u5230\u6b63\u5e38\u6c34\u5e73\u3002\u6b64\u5916\uff0cLokelma\u4e5f\u8868\u73b0\u51fa\u6301\u7eed\u957f\u8fbe\u4e00\u5e74\u7684\u8840\u94be\u6c34\u5e73\u63a7\u5236\u3002<\/span><\/p>\n

\n
\n
\n

13. Doptelet\uff08avatrombopag\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u8840\u5c0f\u677f\u662f\u9aa8\u9ad3\u4e2d\u4ea7\u751f\u7684\u65e0\u8272\u7ec6\u80de\uff0c\u5e2e\u52a9\u5728\u8840\u7ba1\u4e2d\u5f62\u6210\u8840\u51dd\u5757\uff0c\u9632\u6b62\u51fa\u8840\u3002\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u662f\u8840\u6db2\u4e2d\u7684\u5faa\u73af\u8840\u5c0f\u677f\u6570\u4f4e\u4e8e\u6b63\u5e38\u6570\u91cf\u7684\u4e00\u79cd\u75c5\u75c7\u3002\u5f53\u60a3\u8005\u7684\u8840\u5c0f\u677f\u6570\u6709\u4e2d\u5ea6\u6216\u91cd\u5ea6\u51cf\u5c11\u65f6\uff0c\u53ef\u80fd\u4f1a\u53d1\u751f\u4e25\u91cd\u751a\u81f3\u5371\u53ca\u751f\u547d\u7684\u51fa\u8840\uff0c\u7279\u522b\u662f\u5728\u5b9e\u65bd\u4fb5\u5165\u6027\u624b\u672f\u8fc7\u7a0b\u4e2d\u3002\u4e25\u91cd\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u60a3\u8005\u901a\u5e38\u9700\u8981\u5728\u624b\u672f\u524d\u63a5\u53d7\u8840\u5c0f\u677f\u8f93\u6ce8\uff0c\u4ee5\u589e\u52a0\u8840\u5c0f\u677f\u8ba1\u6570\u3002<\/span>
<\/span><\/p>\n


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

Doptelet\uff08avatrombopag\uff09\u662f\u7b2c\u4e8c\u4ee3\u3001\u6bcf\u65e5\u4e00\u6b21\u7684\u53e3\u670d\u9996\u4e2a\u8840\u5c0f\u677f\u751f\u6210\u7d20\uff08TPO\uff09\u53d7\u4f53\u6fc0\u52a8\u5242\u3002Doptelet\u80fd\u6a21\u62dfTPO\u7684\u4f5c\u7528\uff0c\u5b83\u662f\u6b63\u5e38\u8840\u5c0f\u677f\u751f\u4ea7\u7684\u4e3b\u8981\u8c03\u8282\u8005\u3002\u8be5\u836f\u7269\u66fe\u83b7\u5f97\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff0c\u6cbb\u7597\u5c06\u63a5\u53d7\u624b\u672f\u7684CLD\u6210\u4eba\u60a3\u8005\u7684\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u3002<\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

avatrombopag\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

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

Doptelet\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u5728\u4e24\u9879\u8bd5\u9a8c\uff08ADAPT-1\u548cADAPT-2\uff09\u4e2d\u5f97\u5230\u4e86\u9a8c\u8bc1\u3002\u8fd9\u4e9b\u7814\u7a76\u5171\u5305\u542b435\u540d\u6162\u6027\u809d\u75c5\u548c\u4e25\u91cd\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\u60a3\u8005\uff0c\u4ed6\u4eec\u5c06\u63a5\u53d7\u901a\u5e38\u9700\u8981\u8f93\u6ce8\u8840\u5c0f\u677f\u7684\u624b\u672f\u3002\u8fd9\u4e9b\u8bd5\u9a8c\u8bc4\u4f30\u4e86\u4e24\u4e2a\u5242\u91cf\u6c34\u5e73\u7684\u53e3\u670dDoptelet\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u6cbb\u75975\u5929\u7684\u6548\u679c<\/span>\u3002<\/span><\/p>\n

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

\n
\n
\n

14. Palynziq\uff08pegvaliase-pqpz\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

PKU\u662f\u4e00\u79cd\u7f55\u89c1\u7684\u9057\u4f20\u75c5\uff0c\u5728\u60a3\u8005\u51fa\u751f\u65f6\u5c31\u8868\u73b0\u51fa\u6765\uff0c\u4f1a\u5bfc\u81f4\u5bf9\u5927\u8111\u7684\u5404\u79cd\u7d2f\u79ef\u6bd2\u6027\u3002\u5728\u7f8e\u56fd\uff0c\u6bcf12,500\u4e2a\u65b0\u751f\u513f\u4e2d\u5c31\u67091\u4eba\u53d7PKU\u5f71\u54cd\u3002PKU\u8868\u73b0\u4e3a\u60a3\u8005\u65e0\u6cd5\u5206\u89e3Phe\uff0c\u8fd9\u662f\u4e00\u79cd\u5728\u6240\u6709\u5f62\u5f0f\u7684\u86cb\u767d\u8d28\u4e2d\u53d1\u73b0\u7684\u6c28\u57fa\u9178\u3002\u5982\u679c\u4e0d\u8fdb\u884c\u6cbb\u7597\uff0c\u9ad8\u6c34\u5e73\u7684Phe\u4f1a\u5bf9\u5927\u8111\u4ea7\u751f\u6bd2\u6027\uff0c\u5e76\u53ef\u80fd\u5bfc\u81f4\u4e25\u91cd\u7684\u795e\u7ecf\u548c\u795e\u7ecf\u7cbe\u795e\u95ee\u9898\uff0c\u5f71\u54cd\u4eba\u4eec\u601d\u8003\u3001\u611f\u53d7\u53ca\u884c\u4e3a\u65b9\u5f0f\u3002<\/span><\/span><\/span><\/p>\n


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

Palynziq\u662f\u4e00\u79cd\u805a\u4e59\u4e8c\u9187\u5316\u7684\u91cd\u7ec4\u82ef\u4e19\u6c28\u9178\u89e3\u6c28\u9176\uff0c\u7528\u6765\u66ff\u4ee3PKU\u60a3\u8005\u7f3a\u4e4f\u7684\u82ef\u4e19\u6c28\u9178\u7f9f\u5316\u9176\uff08PAH\uff09\u4ee5\u5206\u89e3Phe\u3002<\/span><\/p>\n


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

Palynziq\u6548\u679c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5f97\u5230\u8bc1\u5b9e\u3002\u5728\u5173\u952e\u2162\u671f\u7814\u7a76PRISM-2\u4e2d\uff0cPalynziq\u4e0e\u5b89\u6170\u5242\u76f8\u6bd4\u663e\u8457\u964d\u4f4e\u4e86\u8840\u6db2Phe\u6c34\u5e73\uff08p<0.0001\uff09\uff0c\u62b5\u8fbe\u4e86\u8840\u6db2Phe\u53d8\u5316\u7684\u4e3b\u8981\u7ec8\u70b9\u3002\u5728PRISM-2\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u3001\u968f\u673a\u505c\u836f\u671f\u8bd5\u9a8c\uff08RWP\uff09\u4e2d\uff0c\u60a3\u8005\u4ee52\uff1a1\u7684\u6bd4\u4f8b\u88ab\u968f\u673a\u5206\u914d\u7ee7\u7eed\u63a5\u53d7Palynziq\u6cbb\u7597\uff08\u6bcf\u65e520 mg\u6216\u6bcf\u65e540 mg\uff09\u6216\u63a5\u53d7\u5b89\u6170\u5242\uff0c\u6301\u7eed8\u5468\u3002\u7ed3\u679c\u663e\u793a\uff0cPalynziq\u7ec4\u60a3\u8005\u53ef\u4ee5\u7ef4\u6301\u8840\u6db2Phe\u6d53\u5ea6\uff0c\u800c\u5b89\u6170\u5242\u7ec4\u60a3\u8005\u7684\u8840\u6db2Phe\u6d53\u5ea6\u6062\u590d\u5230\u6cbb\u7597\u524d\u57fa\u7ebf\u3002<\/span><\/p>\n

\n
\n
\n

15. Olumiant\uff08baricitinib\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u662f\u4e00\u79cd\u6162\u6027\u4e14\u5bb9\u6613\u53d1\u751f\u8fdb\u5c55\u7684\u5173\u8282\u708e\uff0c\u975e\u5e38\u75bc\u75db\u3002\u76ee\u524d\uff0cTNF\u6291\u5236\u5242\u662f\u5e38\u89c1\u7684\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u7597\u6cd5\uff0c\u4f46\u7ea6\u67092\/3\u7684\u60a3\u8005\u65e0\u6cd5\u4ece\u9996\u6b21\u6cbb\u7597\u4e2d\u5f97\u5230\u4e34\u5e8a\u7f13\u89e3\u3002\u800c\u4e14\u968f\u7740\u65f6\u95f4\u63a8\u79fb\uff0c\u5927\u91cf\u60a3\u8005\u65e0\u6cd5\u7ef4\u6301\u836f\u7269\u7684\u7597\u6548\u3002\u56e0\u6b64\uff0c\u8fd9\u4e9b\u60a3\u8005\u6025\u9700\u4e00\u6b3e\u521b\u65b0\u836f\u7269\u6765\u7f13\u89e3\u75c5\u60c5\u3002<\/span><\/p>\n


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

\u793c\u6765\u516c\u53f8\u4e0eIncyte\u8054\u5408\u5f00\u53d1\u7684\u65b0\u836fOlumiant\uff08baricitinib\uff09\u6cbb\u7597\u7f79\u60a3\u4e2d\u5ea6\u81f3\u91cd\u5ea6\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u3001\u5374\u65e0\u6cd5\u4eceTNF\u6291\u5236\u5242\u6cbb\u7597\u4e2d\u53d7\u76ca\u7684\u6210\u4eba\u60a3\u8005\u3002<\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

<\/span>baricitinib\u7ed3\u6784\u5f0f<\/span><\/p>\n


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

Olumiant\u662f\u4e00\u6b3e\u6bcf\u65e5\u4e00\u6b21\u7684\u53e3\u670dJAK\u6291\u5236\u5242\uff0c\u80fd\u9ad8\u6548\u6291\u5236JAK1\u3001JAK2\u3001\u4ee5\u53caTYK2\u3002\u5728\u4eba\u4f53\u5185\uff0c\u4e0d\u5c11\u7ec6\u80de\u56e0\u5b50\u4f9d\u8d56\u4e8eJAK\u7684\u6d3b\u6027\uff0c\u5176\u5728\u4e0d\u5c11\u708e\u6027\u75be\u75c5\u548c\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u7684\u53d1\u75c5\u8fc7\u7a0b\u4e2d\u6709\u6f5c\u5728\u4f5c\u7528\u3002\u901a\u8fc7\u6291\u5236\u591a\u79cdJAK\u7684\u6d3b\u6027\uff0cOlumiant\u6709\u671b\u7ed9\u7c7b\u98ce\u6e7f\u5173\u8282\u708e\u60a3\u8005\u5e26\u6765\u798f\u97f3\u3002<\/span><\/p>\n

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

\n
\n
\n

16. Moxidectin\uff08moxidectin\uff09<\/span><\/p>\n


<\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u76d8\u5c3e\u4e1d\u866b\u75c5\u662f\u7ee7\u6c99\u773c\u540e\u5728\u4e16\u754c\u4e0a\u81f4\u76f2\u7684\u7b2c\u4e8c\u5927\u539f\u56e0\uff0c\u8fd9\u662f\u4e00\u79cd\u65cb\u76d8\u5c3e\u7ebf\u866b\u5bc4\u751f\u4e8e\u4eba\u4f53\u76ae\u80a4\u3001\u76ae\u4e0b\u7ec4\u7ec7\u548c\u773c\u90e8\u6240\u81f4\u82d4\u85d3\u6837\u76ae\u708e\u3001\u76ae\u4e0b\u7ed3\u8282\u548c\u89c6\u529b\u969c\u788d\u4e3a\u7279\u5f81\u7684\u5bc4\u751f\u866b\u75c5\uff0c\u53c8\u79f0\u6cb3\u76f2\u75c7\u6216\u778e\u773c\u4e1d\u866b\u75c5\u3002<\/span><\/p>\n


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

6\u670813\u65e5\uff0cFDA\u6279\u51c6\u83ab\u897f\u514b\u6c40\uff08moxidectin\uff09\u7528\u4e8e12\u5c81\u53ca\u4ee5\u4e0a\u60a3\u8005\u7684\u76d8\u5c3e\u4e1d\u866b\u75c5\uff08\u6cb3\u76f2\u75c7\uff09\u6cbb\u7597\uff0c\u4f7f\u7528\u65b9\u5f0f\u4e3a\u6bcf\u5929\u53e3\u670d8mg\uff084\u72472mg\u7247\u5242\uff09\u3002<\/span><\/p>\n


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

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

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

moxidectin\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

\u83ab\u897f\u514b\u6c40\u662f\u4e00\u79cd\u65b0\u578b\u6297\u5bc4\u751f\u866b\u836f\uff0c\u7531\u94fe\u9709\u83cc\u53d1\u9175\u6240\u5f97\u7684\u5355\u4e00\u6210\u5206\u7684\u5927\u73af\u5185\u916f\u7c7b\u6297\u751f\u7d20\u3002\u5176\u83b7\u6279\u4e3b\u8981\u662f\u57fa\u4e8e\u4e24\u9879\u4e34\u5e8a\u7814\u7a76\u6570\u636e\u3002<\/span><\/p>\n


<\/p>\n

\u8bd5\u9a8c1\u4e2d\uff0c978\u540d\u60a3\u8005\u63a5\u53d7Moxidectin\u7247\u5242\uff0c\u5355\u6b21\u53e3\u670d\u5242\u91cf\u4e3a8mg\uff1b494\u540d\u60a3\u8005\u63a5\u53d7\u4f0a\u7ef4\u83cc\u7d20\u5355\u6b21\u53e3\u670d\u5242\u91cf\u7ea6\u4e3a150mcg\/kg\u3002 \u8bd5\u9a8c2\u4e2d\uff0c127\u540d\u60a3\u8005\u63a5\u53d7Moxidectin\u7247\u5242\uff0c\u5355\u6b21\u53e3\u670d\u5242\u91cf\u8303\u56f4\u4ece2mg\uff08\u8fd9\u4e0d\u662f\u83b7\u5f97\u6279\u51c6\u7684\u5242\u91cf\uff09\u52308mg\uff0838\u540d\u63a5\u53d7\u63a8\u8350\u76848mg\u5242\u91cf\uff09\uff0c45\u540d\u60a3\u8005\u63a5\u53d7\u4f0a\u7ef4\u83cc\u7d20\u7684\u5355\u6b21\u53e3\u670d\u5242\u91cf\u7ea6\u4e3a150mcg\/ kg\u3002\u6570\u636e\u663e\u793a\uff0c\u5728\u6291\u5236\u76ae\u80a4\u4e2d\u5fae\u4e1d\u866b\u65b9\u9762\uff0c\u83ab\u897f\u514b\u6c40\u6bd4\u76ee\u524d\u6807\u51c6\u6cbb\u7597\u6cd5\uff08ivermectin\uff09\u6709\u663e\u8457\u6027\u4f18\u52bf\u3002<\/span><\/p>\n

\n
\n
\n

17. Epidiolex\uff08cannabidiol\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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

Lennox-Gastaut\u7efc\u5408\u5f81\uff08LGS\uff09\uff0c\u662f\u4e00\u79cd\u4e0e\u5e74\u9f84\u6709\u5173\u7684\u9690\u6e90\u6027\u6216\u75c7\u72b6\u6027\u5168\u8eab\u6027\u766b\u75eb\u7efc\u5408\u5f81\uff0c\u5373\u5e74\u9f84\u4f9d\u8d56\u6027\u766b\u75eb\u6027\u8111\u75c5\u7684\u4e00\u79cd\u7c7b\u578b\u3002\u5176\u7279\u70b9\u4e3a\u53d1\u75c5\u5e74\u9f84\u65e9\uff0c\u5e7c\u513f\u65f6\u671f\u8d77\u75c5\uff0c\u53d1\u4f5c\u5f62\u5f0f\u591a\u6837\uff0c\u667a\u529b\u53d1\u80b2\u53d7\u5f71\u54cd\uff0c\u6cbb\u7597\u8f83\u56f0\u96be\u3002\u662f\u4e00\u79cd\u4e25\u91cd\u7684\u766b\u75eb\u7c7b\u578b\u3002<\/span><\/p>\n


<\/p>\n

Dravet\u7efc\u5408\u5f81\uff08Dravet syndrome\uff0cDS\uff09\u53c8\u79f0\u5a74\u513f\u4e25\u91cd\u808c\u9635\u631b\u6027\u766b\u75eb\uff0c\u662f\u4e00\u79cd\u5c11\u89c1\u7684\u4e3b\u8981\u7531\u9057\u4f20\u56e0\u7d20\u5f15\u8d77\u7684\u8fdb\u884c\u6027\u766b\u75eb\u6027\u8111\u75c5\uff0c\u5177\u6709\u53d1\u75c5\u5e74\u9f84\u65e9\uff0c\u53d1\u4f5c\u7c7b\u578b\u591a\u6837\uff0c\u53d1\u4f5c\u9891\u7387\u9ad8\uff0c\u667a\u80fd\u635f\u5bb3\u4e25\u91cd\uff0c\u836f\u7269\u6cbb\u7597\u6548\u679c\u5dee\u7b49\u7279\u70b9\u3002\u8be5\u75c5\u9884\u540e\u8f83\u5dee\uff0c\u51e0\u4e4e\u6240\u6709\u60a3\u513f\u90fd\u6709\u8ba4\u77e5\u635f\u4f24\u3002<\/span><\/p>\n


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

<\/span>6\u670825\u65e5\u88abFDA\u6279\u51c6\u7684Epidiolex\uff08cannabidiol\uff09[CBD]\u53e3\u670d\u6eb6\u6db2\u5c31\u662f\u7528\u4e8e\u6cbb\u75972\u5c81\u53ca\u4ee5\u4e0a\u60a3\u8005\u7684\u8fd9\u4e24\u79cd\u7f55\u89c1\u7efc\u5408\u5f81\u7684\u4e25\u91cd\u766b\u75eb\u53d1\u4f5c\u3002<\/span><\/p>\n


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

Epidiolex\u662fFDA\u6279\u51c6\u7684\u7b2c\u4e00\u79cd\u542b\u6709\u4ece\u5927\u9ebb\u4e2d\u63d0\u53d6\u7684\u7eaf\u5316\u836f\u7269\u7684\u836f\u7269<\/strong>\uff0c\u540c\u65f6\u662f\u662fFDA\u9996\u6b21\u6279\u51c6\u7528\u4e8e\u6cbb\u7597Dravet\u7efc\u5408\u5f81\u60a3\u8005\u7684\u836f\u7269<\/strong>\u3002<\/span><\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

cannabidiol\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

Epidiolex\u8f85\u52a9\u6cbb\u7597LGS\u548cDS\u76f8\u5173\u766b\u75eb\u7684\u83b7\u6279\uff0c\u662f\u57fa\u4e8e3\u4e2aIII\u671f\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7814\u7a76\u7684\u6570\u636e\uff0c\u6bcf\u4e00\u4e2a\u7814\u7a76\u90fd\u8fbe\u5230\u4e86\u4e3b\u8981\u7ec8\u70b9\u3002\u8fd9\u4e9b\u7814\u7a76\u4e2d\uff0cEpidiolex\u7684\u4e00\u822c\u8010\u53d7\u6027\u826f\u597d\u3002Epidiolex NDA\u4e2d\u5305\u62ec\u5927\u7ea61500\u4f8b\u60a3\u8005\u7684\u5b89\u5168\u6570\u636e\uff0c\u4ee5\u53ca\u5927\u7ea6400\u4f8b\u60a3\u8005\u8fde\u7eed\u6cbb\u75971\u5e74\u4ee5\u4e0a\u7684\u6570\u636e\u3002\u9664\u4e86\u5173\u952e\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6570\u636e\u5916\uff0cNDA\u4e2d\u8fd8\u5305\u62ec\u4e00\u4e2a\u5168\u9762\u7684\u4e34\u5e8a\u836f\u7406\u5b66\u3001\u4e34\u5e8a\u524d\u548c\u6bd2\u7406\u5b66\u6570\u636e\u96c6\u3002<\/span><\/p>\n

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

\n
\n
\n

18. Zemdri\uff08plazomicin\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

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

Zemdri\uff08plazomicin\uff09\u7528\u4e8e\u7531\u67d0\u4e9b\u80a0\u6746\u83cc\u79d1\u7ec6\u83cc\u611f\u67d3\u5f15\u8d77\u7684\u3001\u6cbb\u7597\u9009\u62e9\u975e\u5e38\u6709\u9650\u6216\u65e0\u6cbb\u7597\u9009\u62e9\u7684\u590d\u6742\u6027\u5c3f\u8def\u611f\u67d3\uff08cUTI\uff0c\u5305\u62ec\u80be\u76c2\u80be\u708e\uff09\u6210\u4eba\u60a3\u8005\uff0c\u8be5\u836f\u662f\u4e00\u79cd\u9759\u8109\u8f93\u6ce8\u836f\u7269\uff0c\u6bcf\u5929\u7ed9\u836f\u4e00\u6b21\u3002<\/span><\/p>\n


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

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

plazomicin\u7ed3\u6784\u5f0f<\/span><\/p>\n


<\/p>\n

Zemdri\u7684\u83b7\u6279\uff0c\u662f\u57fa\u4e8e<\/span>\u4e00\u9879\u8de8\u56fd\uff0c\u53cc\u76f2\uff0c\u975e\u52a3\u6548\u6027\u8bd5\u9a8c\uff0c\u5171\u6709609\u540d\u60a3\u6709cUTI\uff08\u5305\u62ec\u80be\u76c2\u80be\u708e\uff09\u7684\u6210\u5e74\u60a3\u8005\uff0c\u88ab\u968f\u673a\u5206\u914d\u5230\u63a5\u53d7Zemdri<\/span>\uff0815mg\/kg IV\u6bcf\u65e5\u4e00\u6b21\uff0c30\u5206\u949f\u8f93\u6db2\uff09\u548c\u7f8e\u7f57\u57f9\u5357\uff08\u6bcf8\u5c0f\u65f6\u9759\u8109\u6ce8\u5c041g\uff0c30\u5206\u949f\u8f93\u6db2\uff09\u6cbb\u7597\uff0c\u6bd4\u8f83<\/span>\u4e24\u8005\u7684\u7efc\u5408\u6cbb\u6108\u7387\u4ee5\u53ca\u6d88\u9664\u611f\u67d3\u5fae\u751f\u7269\u6bd4\u4f8b\u6548\u679c\u3002\u7ed3\u679c\u663e\u793a\u8f83\u7f8e\u7f57\u57f9\u5357\u7ec4\u76f8\u6bd4<\/span>\uff0c\u63a5\u53d7<\/span><\/span>Zemdri\u6cbb\u7597\u7684\u60a3\u8005\u5177\u6709\u663e\u8457\u7684\u7efc\u5408\u6cbb\u6108\u7387\uff0881.7%  VS 70.1%\uff09\u53ca\u6d88\u9664\u611f\u67d3\u5fae\u751f\u7269\u6bd4\u4f8b\uff0889.5% VS 74.6%\uff09<\/span><\/span>\u3002<\/span><\/p>\n


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

\u4e0d\u8fc7Zemdri<\/span>\u7684\u8840\u6db2\u611f\u67d3\uff08BSI\uff09\u9002\u5e94\u75c7\u5374\u906dFDA\u62d2\u7edd\u6279\u51c6\uff0c\u539f\u56e0\u662f\u5728\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7f3a\u4e4f\u6709\u6548\u6027\u7ed3\u8bba\u3002<\/span><\/p>\n

\n
\n
\n

19~20. Braftiovi+Mektovi<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

Braftiovi\uff08encorafenib\uff09\u662f\u4e00\u79cd\u53e3\u670d\u5c0f\u5206\u5b50BRAF\u6fc0\u9176\u6291\u5236\u5242\uff0c\u800cMektovi\uff08binimetinib\uff09\u662f\u4e00\u79cd\u53e3\u670d\u5c0f\u5206\u5b50MEK\u6291\u5236\u5242\uff0c\u53ef\u4ee5\u9776\u5411MAPK\u4fe1\u53f7\u901a\u8def\uff08RAS-RAF-MEK-ERK\uff09\u4e2d\u7684\u5173\u952e\u9176\u3002\u8fd9\u4e24\u4e2a\u836f\u7269\u5747\u4e3aArray BioPharma\u5f00\u53d1\u3002<\/span><\/span><\/p>\n


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

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


<\/p>\n

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

\"2018\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\"<\/p>\n

encorafenib\u7ed3\u6784\u5f0f<\/span>
<\/span><\/p>\n


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

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

\n

binimetinib\u7ed3\u6784\u5f0f<\/span>
<\/span><\/p>\n

 <\/p>\n

FDA\u6279\u51c6Braftiovi\u4e0eMektovi\u7ec4\u5408\u7597\u6cd5\u662f\u57fa\u4e8e\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8cCOLUMBUS\u7684\u7ed3\u679c\u3002\u4e0e\u5355\u72ec\u4f7f\u7528vemurafenib\u76f8\u6bd4\uff0cBraftiovi+Mektovi<\/span><\/span>\u4f7f\u4e2d\u4f4d\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08mPFS\uff09\u7ffb\u500d\uff087.3\u4e2a\u6708 VS 14.9\u4e2a\u6708\uff09\u3002 <\/span><\/p>\n


<\/p>\n

\u76f8\u5173\u94fe\u63a5:<\/span><\/p>\n

2017\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f\uff1a3\u5927\u91cc\u7a0b\u7891\uff0c6\u5f20\u4f18\u5148\u5ba1\u8bc4\u5238\uff0c15\u4e2a\u80bf\u7624\u65b0\u836f<\/a><\/p>\n

2017\u4e0a\u534a\u5e74FDA\u6279\u51c6\u7684\u65b0\u836f<\/a><\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u57f9\u4f18\u521b\u65b0\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

2018\u4e0a\u534a\u5e74\uff0cFDA\u5171\u6279\u51c620\u4e2a\u65b0\u5206\u5b50\u5b9e\u4f53\u548c\u65b0\u751f\u7269\u5236\u54c1\uff0c\u5305\u62ec15\u4e2a\u65b0\u5206\u5b50\u5b9e\u4f53\u548c5\u4e2a\u65b0\u751f\u7269\u5236\u54c1\u3002 1.&nbs […]<\/p>\n","protected":false},"author":1,"featured_media":2333,"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\/2332"}],"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=2332"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/2332\/revisions"}],"predecessor-version":[{"id":2351,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/2332\/revisions\/2351"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/2333"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=2332"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=2332"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=2332"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}