{"id":82274,"date":"2019-04-04T00:00:50","date_gmt":"2019-04-11T06:59:23","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/82274\/"},"modified":"2019-04-11T14:59:24","modified_gmt":"2019-04-11T06:59:24","slug":"e58d05eaf7","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/82274\/","title":{"rendered":"2018 \u5e74\u4e0a\u5e02\u7684\u5168\u65b0\u9776\u70b9\u836f\u7269\u6709\u54ea\u4e9b\uff1f"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u8f6c\u81ea\u607a\u601d\u4ff1\u4e50\u90e8<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 FDA \u6279\u51c6\u4e0a\u5e02\u7684\u65b0\u836f\u6570\u91cf\u521b\u4e86\u65b0\u9ad8\u3002\u6211\u4eec\u8be6\u5c3d\u68b3\u7406\u4e86 2018 \u5e74\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u65e5\u672c\u6279\u51c6\u4e0a\u5e02\u7684\u65b0\u836f\uff0c\u5176\u4e2d\u6709 39 \u4e2a\u836f\u7269\u5177\u6709 mode-of-action (MoA) \u9776\u70b9\u3002\u5728\u8fd9\u4e9b\u9776\u70b9\u4e2d\uff0c\u6709 13 \u4e2a\u9776\u70b9\u4e3a\u5168\u65b0\u9776\u70b9\uff0c\u8fd9\u91cc\u6211\u4eec\u5bf9\u8fd9\u4e9b\u5168\u65b0\u9776\u70b9\u8fdb\u884c\u7b80\u8981\u4ecb\u7ecd\u3002<\/span><\/p>\n<p style=\"text-align: left;text-indent: 0em;margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\"><span style=\"font-size: 15px;font-weight: bold;\">\u56de\u80a0Na<\/span><sup style=\"font-weight: bold;\">+<\/sup><span style=\"font-size: 15px;font-weight: bold;\">\/\u80c6\u6c41\u9178\u8f6c\u8fd0\u4f53 (Ileal sodium\/bile acid cotransporter)<\/span><br  \/><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u8be5\u8f6c\u8fd0\u4f53\u662f\u4f4d\u4e8e\u56de\u80a0\u672b\u7aef\u3001\u7279\u5f02\u6027\u5438\u6536\u80c6\u6c41\u9178\u7684\u4e00\u79cd Na<sup>+<\/sup>\u4f9d\u8d56\u6027\u80c6\u6c41\u9178\u8054\u5408\u8f6c\u8fd0\u86cb\u767d\u3002\u8be5\u8f6c\u8fd0\u86cb\u767d\u7ed3\u6784\u548c\u529f\u80fd\u7684\u6539\u53d8\u4f1a\u5f15\u8d77\u80c6\u6c41\u9178\u5438\u6536\u5f02\u5e38\uff0c\u8fdb\u800c\u5f71\u54cd\u5230\u80c6\u56fa\u9187\u548c\u8102\u7c7b\u7684\u5438\u6536\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 4 \u6708 19 \u65e5\uff0c\u65e5\u672c\u5236\u836f\u4f01\u4e1a\u536b\u6750\u516c\u53f8\u65d7\u4e0b\u80c3\u80a0\u75be\u75c5\u5b50\u516c\u53f8 EA \u836f\u4e1a\u548c Mochida \u5236\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5ba3\u5e03\uff0c\u5168\u7403\u9996\u6b3e\u80c6\u6c41\u9178\u8f6c\u8fd0\u6291\u5236\u5242\u6b63\u5f0f\u5728\u65e5\u672c\u4e0a\u5e02\u3002\u8be5\u836f\u7269\u5546\u54c1\u540d\u4e3a GOOFICE \uff08\u901a\u7528\u540d elobixibat hydrate\uff09\uff0c\u5242\u578b\u4e3a\u7247\u5242\u3002\u8be5\u836f\u7269\u53ef\u4ee5\u901a\u8fc7\u6291\u5236\u8c03\u8282\u80c6\u6c41\u9178\u91cd\u5438\u6536\u7684\u80c6\u6c41\u9178\u8f6c\u8fd0\uff0c\u4ece\u800c\u589e\u52a0\u60a3\u8005\u4f53\u5185\u80c6\u6c41\u9178\u6d41\u5411\u7ed3\u80a0\uff0c\u8fdb\u800c\u4fc3\u8fdb\u80a0\u9053\u5206\u6ccc\u66f4\u591a\u7684\u6c34\u5206\u3001\u4fc3\u8fdb\u6392\u4fbf\uff0c\u53cc\u7ba1\u9f50\u4e0b\uff0c\u8fbe\u5230\u81ea\u7136\u800c\u7136\u5730\u6539\u5584\u60a3\u8005\u81ea\u7136\u6392\u4fbf\u901a\u7545\u7684\u6548\u679c\u3002<sup class=\"md-footnote\">1<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-weight: bold;font-size: 15px;\">\u6210\u7ea4\u7ef4\u7ec6\u80de\u751f\u957f\u56e0\u5b50 23 (Fibroblast growth factor 23)<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">FGF23 \u5c5e\u4e8e FGFs \u5bb6\u65cf\u4e2d\u4e00\u5458\uff0c\u76f8\u5bf9\u5206\u5b50\u8d28\u91cf\u4e3a 32000\u3002FGF23 \u4e3b\u8981\u7531\u9aa8\u7ec6\u80de\u548c\u6210\u9aa8\u7ec6\u80de\u5206\u6ccc\uff0c\u4e3b\u8981\u9776\u5668\u5b98\u4e3a\u80be\u810f\uff0c\u5b83\u4e00\u65b9\u9762\u901a\u8fc7\u4e0b\u8c03\u8fd1\u66f2\u5c0f\u7ba1\u4e0a\u76ae\u7ec6\u80de\u94a0\u78f7\u534f\u540c\u8f6c\u8fd0\u86cb\u767d NPT2a \u548c NPT2c \u7684\u8868\u8fbe\uff0c\u800c\u4fc3\u8fdb\u5c3f\u78f7\u6392\u6cc4\uff0c\u53e6\u4e00\u65b9\u9762\u901a\u8fc7\u6291\u5236\u8fd1\u7aef\u80be\u5c0f\u7ba1\u4e0a\u76ae\u7ec6\u80de 25-\u7f9f\u57fa\u7ef4\u751f\u7d20 D-1-alpha \u7f9f\u5316\u9176 (Cyp27b1) \u6d3b\u6027\u800c\u6291\u5236 1, 25 (OH)<sub>2<\/sub>D \u7684\u5408\u6210\uff0c\u540c\u65f6\u589e\u5f3a 1,25 \u4e8c\u7f9f\u7ef4\u751f\u7d20 D-24-\u7f9f\u5316\u9176 (Cyp24a1) \u6d3b\u6027\uff0c\u4fc3\u8fdb 1,25(OH)<sub>2<\/sub>D \u964d\u89e3\u4e3a\u7ef4\u751f\u7d20 D3-23 \u7fa7\u9178\u3002 FGF23 \u5fc5\u987b\u4e0e\u5176\u53d7\u4f53\u76f8\u7ed3\u5408\u624d\u80fd\u53d1\u6325\u5176\u751f\u7269\u5b66\u6548\u5e94\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 4 \u6708 17 \u65e5\uff0cFDA \u5ba3\u5e03\u6cbb\u7597 X \u8fde\u9501\u4f4e\u78f7\u9178\u76d0\u8840\u75c7 (x-linkedhypophosphatemia, XLH) \u7684\u7279\u6548\u836f Crysvita(burosumab) \u83b7\u6279\u4e0a\u5e02\uff0c\u8fd9\u4e5f\u662f\u9996\u4e2a\u83b7\u6279\u6cbb\u7597\u8be5\u75be\u75c5\u7684\u836f\u7269\u3002<sup class=\"md-footnote\">2<\/sup>\u5728 2018 \u5e74 2 \u6708\u4efd\uff0c\u8be5\u836f\u83b7\u5f97\u6b27\u76df\u7684\u6709\u6761\u4ef6\u4e0a\u5e02\u8bb8\u53ef\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">Cap \u4f9d\u8d56\u578b\u6838\u9178\u5185\u5207\u9176<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u6d41\u611f\u75c5\u6bd2\u57fa\u56e0\u7ec4\u5f88\u5c0f\uff0c\u5176\u6240\u9700\u86cb\u767d\u8d28\u7684\u5408\u6210\u4f9d\u8d56\u5bbf\u4e3b\u7ec6\u80de\u7684\u8f6c\u8bd1\u7cfb\u7edf\u3002\u56e0\u6b64\uff0c\u6d41\u611f\u75c5\u6bd2\u7684\u4fe1\u4f7f RNA(mRNA) \u9700\u8981\u540c\u65f6\u5177\u5907\u53ef\u4f9b\u5bbf\u4e3b\u7ec6\u80de\u8f6c\u8bd1\u4f53\u7cfb\u8bc6\u522b\u7684 5\u2032 \u5e3d\u72b6 (CAP) \u7ed3\u6784\u548c 3\u2032-poly(A) \u5c3e\u7ed3\u6784\u3002\u5176\u4e2d\uff0c5\u2032 \u5e3d\u72b6\u7ed3\u6784\u662f\u901a\u8fc7\u6d41\u611f\u75c5\u6bd2 RNA \u805a\u5408\u9176\u590d\u5408\u4f53\u4e2dPA\u4e9a\u57fa\u7684\u5185\u5207\u9176\u6d3b\u6027\u4ece\u5bbf\u4e3b\u7ec6\u80de\u524d\u4f53 mRNA \u7684 5\u2032 \u7aef\u526a\u5207\u201c\u62a2\u6765\u7684\u201d\u3002\u8fd9\u79cd\u88ab\u79f0\u4e3a \u201cCAP-snatching\u201d \u7684\u65b9\u5f0f\u2014\u2014\u593a\u53d6\u5bbf\u4e3b mRNA \u7684 CAP \u5e3d\u72b6\u7ed3\u6784\u7528\u4e8e\u75c5\u6bd2\u81ea\u8eab mRNA \u8f6c\u5f55\u2014\u2014\u662f\u6d41\u611f\u75c5\u6bd2\u8f6c\u5f55\u8d77\u59cb\u6240\u5fc5\u987b\u7684\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u57fa\u4e8e \u201cCAP-snatching\u201d \u662f\u6d41\u611f\u75c5\u6bd2\u590d\u5236\u5468\u671f\u4e2d\u7684\u5173\u952e\u73af\u8282\uff0c\u53c8\u7531\u4e8e\u5bbf\u4e3b\u7ec6\u80de\u4e2d\u4e0d\u5b58\u5728\u7c7b\u4f3c\u7684\u673a\u5236\u548c\u76f8\u5e94\u7684\u86cb\u767d\u9176\uff0c\u56e0\u6b64\u9488\u5bf9 \u201cCAP-snatching\u201d \u5185\u5207\u9176\u7684\u6291\u5236\u5242\u53ef\u4ee5\u9009\u62e9\u6027\u963b\u65ad\u6d41\u611f\u75c5\u6bd2\u7684\u8f6c\u5f55\u8fc7\u7a0b\uff0c\u540c\u65f6\u5bf9\u5bbf\u4e3b\u7ec6\u80de\u4e0d\u9020\u6210\u5f71\u54cd\u3002\u4e8e\u662f\uff0c\u8fd9\u4e00\u673a\u7406\u6210\u4e3a\u6f5c\u5728\u7684\u6297\u6d41\u611f\u836f\u7269\u9776\u70b9\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\">2018 \u5e74 2 \u6708\u4efd\uff0c\u7531\u76d0\u91ce\u4e49\u5236\u836f\uff08Shionogi\uff09\u5e26\u6765\u7684\u521b\u65b0\u6297\u6d41\u611f\u836f\u7269 Xofluza\uff08baloxavir marboxil\uff0c\u66fe\u7528\u540dS-033188\uff09\u5f97\u5230\u4e86\u52a0\u901f\u6279\u51c6\uff0c\u5728\u65e5\u672c\u4e0a\u5e02\u3002Xofluza \u662f\u4e00\u6b3e\u521b\u65b0\u7684 Cap \u4f9d\u8d56\u578b\u6838\u9178\u5185\u5207\u9176\u6291\u5236\u5242\uff0c\u4e5f\u662f\u4e16\u4e0a\u5c11\u6570\u53ef\u4ee5\u6291\u5236\u6d41\u611f\u75c5\u6bd2\u589e\u6b96\u7684\u65b0\u836f\u3002\u5b83\u80fd\u9488\u5bf9\u6d41\u611f\u75c5\u6bd2\u590d\u5236\u7684\u5173\u952e\u73af\u8282\uff0c\u6291\u5236\u5b83\u4ece\u5bbf\u4e3b\u7ec6\u80de\u4e2d\u83b7\u5f97\u5bbf\u4e3b mRNA 5\u2018 \u7aef\u7684 CAP \u7ed3\u6784\uff0c\u4ece\u800c\u6291\u5236\u6d41\u611f\u75c5\u6bd2\u81ea\u8eab mRNA \u7684\u8f6c\u5f55\u3002\u7531\u4e8e\u5bbf\u4e3b\u7ec6\u80de\u5185\u4e0d\u5b58\u5728\u6709\u7c7b\u4f3c\u673a\u5236\u7684\u86cb\u767d\u9176\uff0c\u8fd9\u4e00\u836f\u7269\u7406\u8bba\u4e0a\u4e0d\u4f1a\u5bf9\u5bbf\u4e3b\u7ec6\u80de\u4ea7\u751f\u5f71\u54cd\u3002\u53e6\u5916\uff0c\u8be5\u836f\u53ea\u9700\u8981\u5355\u5242\u91cf\u7ed9\u836f\uff0c\u800c\u4e0d\u662f\u63a5\u53d7\u4e00\u7cfb\u5217\u7684\u7597\u7a0b\uff0c\u8fd9\u4e00\u7279\u70b9\u53ef\u907f\u514d\u56e0\u4e3a\u6ca1\u6709\u5b8c\u6210\u6574\u4e2a\u7597\u7a0b\u800c\u4ea7\u751f\u7684\u6f5c\u5728\u8010\u836f\u6027\u3002<sup class=\"md-footnote\">3<\/sup><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\">T \u7ec6\u80de\u8868\u9762\u7cd6\u86cb\u767d CD4<\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">CD4 \u662f\u6307\u5206\u5b50\u91cf\u4e3a 55kDa\u3001\u5b58\u5728\u4e8e\u7ec6\u80de\u819c\u8868\u9762\u7684\u5355\u94fe\u7cd6\u86cb\u767d\uff0c\u8868\u8fbe\u4e8e\u90e8\u5206 T \u6dcb\u5df4\u7ec6\u80de\u3001\u80f8\u817a\u7ec6\u80de\u53ca\u67d0\u4e9b B \u6dcb\u5df4\u7ec6\u80de\u3001EB \u75c5\u6bd2\u8f6c\u5316\u7684 B \u7ec6\u80de\u3001\u5355\u6838-\u5de8\u566c\u7ec6\u80de\u53ca\u8111\u7ec6\u80de\u819c\u4e0a\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 3 \u6708 7 \u65e5\uff0cFDA \u6279\u51c6\u521b\u65b0\u836f\u7269 ibalizumab-uiyk\/TMB-355\uff08\u5546\u54c1\u540d Trogarzo\uff09\u4e0a\u5e02\uff0c\u4f5c\u4e3a\u4e00\u79cd\u5168\u65b0\u7684\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\uff0cTrogarzo \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\u8be5\u836f\u4e0e CD4+ 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\u548c PRO140\u7c7b\u4f3c\u90fd\u662f\u4e00\u79cd\u201c\u75c5\u6bd2\u4fb5\u5165\u6291\u5236\u5242\u201d\u3002\u8be5\u836f\u662f10\u591a\u5e74\u6765\u9996\u6b3e\u5177\u6709\u5168\u65b0\u4f5c\u7528\u673a\u5236\u7684\u6297\u9006\u8f6c\u5f55\u75c5\u6bd2\u7597\u6cd5\uff0cibalizumab \u66fe\u83b7\u5f97\u7f8e\u56fd FDA \u9881\u53d1\u7684\u5feb\u901f\u901a\u9053\u8d44\u683c\uff08Fast Track\uff09\u3001\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\uff08Priority Review\uff09\u3001\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff08Breakthrough Therapy designations\uff09\u3001\u4ee5\u53ca\u5b64\u513f\u836f\u8d44\u683c\uff08 Orphan Drug \uff09\u3002<sup class=\"md-footnote\">4<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u813e\u916a\u6c28\u9178\u6fc0\u9176 SYK\uff08Tyrosine protein kinase SYK\uff09<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">SYK \u5168\u79f0\u4e3a\u813e\u916a\u6c28\u9178\u6fc0\u9176\uff08Spleen tyrosine kinase\uff09\uff0c\u662f\u4e00\u79cd\u975e\u53d7\u4f53\u916a\u6c28\u9178\u6fc0\u9176\u3002SYK \u662f BCR \u4fe1\u53f7\u901a\u8def\u4e2d\u7684\u4e00\u4e2a\u5173\u952e\u6fc0\u9176\uff0c\u4e5f\u662f\u5176\u4ed6\u514d\u75ab\u53d7\u4f53\u5982 Fc \u53d7\u4f53\u548c\u7c98\u9644\u53d7\u4f53\u4fe1\u53f7\u8f6c\u5bfc\u7684\u5173\u952e\u7ec4\u6210\u90e8\u5206\u3002 \u6b64\u5916\uff0cSYK \u8fd8\u4e0e\u5176\u4ed6 BCR \u4fe1\u53f7\u5206\u5b50\uff0c\u5982\u5e03\u9c81\u987f\u916a\u6c28\u9178\u6fc0\u9176\uff08BTK\uff09\uff0cPI3K\u03b4 \u548c\u80bf\u7624\u574f\u6b7b\u56e0\u5b50\uff08TNF\uff09\u8d85\u5bb6\u65cf\u53d7\u4f53\u4e00\u8d77\u53c2\u4e0e\u72ec\u7acb\u4e8e BCR \u7684\u4fe1\u53f7\u8f6c\u5bfc\u3002SYK \u4e3b\u8981\u8868\u8fbe\u5728 B \u7ec6\u80de\u3001\u5355\u6838\u7ec6\u80de\u3001\u5de8\u566c\u7ec6\u80de\u3001\u80a5\u5927\u7ec6\u80de\u548c\u55dc\u4e2d\u6027\u7c92\u7ec6\u80de\u7b49\u9020\u8840\u7ec6\u80de\u4e2d\uff0c\u88ab\u8ba4\u4e3a\u662f\u6cbb\u7597\u5404\u79cd\u8840\u6db2\u7cfb\u7edf\u764c\u75c7\u3001\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u548c\u5176\u4ed6\u708e\u75c7\u75be\u75c5\u7684\u6f5c\u5728\u9776\u70b9\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 4 \u6708 17 \u65e5\uff0cRigel \u5236\u836f\u5ba3\u5e03\uff0c\u7f8e\u56fd FDA \u5df2\u6279\u51c6 TAVALISSE\u2122 (fostamatinib disodium hexahydrate) \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\u3002TAVALISSE \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><sup class=\"md-footnote\">5<\/sup><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd\u53d7\u4f53 (CGRP receptor)<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd\uff08CGRP\uff09\u662f\u4e00\u79cd37\u4e2a\u6c28\u57fa\u9178\u7684\u795e\u7ecf\u80bd\uff0c\u5e7f\u6cdb\u5206\u5e03\u4e8e\u4e2d\u67a2\u548c\u5916\u5468\u795e\u7ecf\u7cfb\u7edf\u3002CGRP\u5728\u504f\u5934\u75db\u7684\u75c5\u7406\u751f\u7406\u5b66\u4e2d\u8d77\u91cd\u8981\u4f5c\u7528\uff0c\u65e9\u671f\u7814\u7a76\u8868\u660e\u9888\u9759\u8109\u8840\u6db2\u4e2d\u7684CGRP\u6c34\u5e73\u5728\u504f\u5934\u75db\u53d1\u4f5c\u671f\u95f4\u589e\u52a0\u3002\u4e0e\u504f\u5934\u75db\u76f8\u5173\u7684\u4f5c\u7528\u90e8\u4f4d\u53ef\u80fd\u6709\u5982\u4e0b\u51e0\u65b9\u9762\uff1a<\/span><\/p>\n<ul style=\"margin-left: 0px;margin-right: 0px;\" class=\"list-paddingleft-2\">\n<li>\n<p><span style=\"font-size: 15px;\">\u786c\u8111\u819c\u80a5\u5927\u7ec6\u80de\uff1a\u80a5\u5927\u7ec6\u80de\u53c2\u4e0e\u591a\u79cd\u8fc7\u654f\u53cd\u5e94\uff0c\u800c\u504f\u5934\u75db\u7684\u53d1\u75c5\u7387\u5728\u8fc7\u654f\u4f53\u8d28\u53ca\u60a3\u6709\u54ee\u5598\u7684\u75c5\u4eba\u4e2d\u66f4\u9ad8\uff0c\u8fd9\u63d0\u793a\u80a5\u5927\u7ec6\u80de\u4e0e\u504f\u5934\u75db\u7684\u53d1\u751f\u76f8\u5173\u3002\u7814\u7a76\u8868\u660e\uff0c\u795e\u7ecf\u6e90\u6027\u708e\u75c7\u6d3b\u5316\u7684 CGRP \u53d7\u4f53\u80fd\u6fc0\u6d3b\u786c\u8111\u819c\u7684\u80a5\u5927\u7ec6\u80de\u91ca\u653e\u708e\u75c7\u56e0\u5b50\u548c\u708e\u75c7\u6027\u4ecb\u8d28\uff0c\u4ece\u800c\u4fc3\u8fdb\u504f\u5934\u75db\u7684\u53d1\u751f\u3002<\/span><\/p>\n<\/li>\n<p><br  \/><\/p>\n<li>\n<p><span style=\"font-size: 15px;\">\u4e09\u53c9\u795e\u7ecf\u810a\u675f\u6838\uff08STN\uff09\uff1aSTN \u5185\u5305\u62ec\u96c6\u6210\u4f24\u5bb3\u611f\u53d7\u6027\u5e76\u81f4\u654f\u4f24\u5bb3\u611f\u53d7\u5668\u7684\u4e8c\u7ea7\u795e\u7ecf\u5143\uff0c\u5176\u6d3b\u52a8\u53cd\u6620\u4e86\u4e2d\u67a2\u4e09\u53c9\u4f24\u5bb3\u611f\u53d7\u4f20\u5bfc\u8def\u7684\u6d3b\u6027\uff0c\u6b64\u8def\u5f84\u53ef\u5f15\u8d77\u4eba\u7c7b\u9762\u90e8\u75bc\u75db\u548c\u5934\u75db\u3002CGRP \u53ef\u80fd\u53c2\u4e0e\u4e86\u8be5\u795e\u7ecf\u5143\u6d3b\u52a8\u7684\u8c03\u8282\u3002<\/span><\/p>\n<\/li>\n<p><br  \/><\/p>\n<li>\n<p><span style=\"font-size: 15px;\">\u4e09\u53c9\u795e\u7ecf\u8282\uff1aCGRP \u5bf9\u8c03\u8282\u4e09\u53c9\u795e\u7ecf\u5185\u795e\u7ecf\u5143\u53ca\u536b\u661f\u80f6\u8d28\u7ec6\u80de\u7684\u6d3b\u6027\u6709\u91cd\u8981\u4f5c\u7528\u3002\uff081\uff09\u589e\u52a0\u4e09\u53c9\u795e\u7ecf\u5143\u5185 CGRP \u7684\u5408\u6210\uff0c\u5373\u6b63\u53cd\u9988\uff1b\uff082\uff09\u523a\u6fc0\u536b\u661f\u80f6\u8d28\u7ec6\u80de\u91ca\u653e\u4e00\u6c27\u5316\u6c2e\u548c\u4e00\u4e9b\u4fc3\u708e\u7ec6\u80de\u56e0\u5b50\uff1b\uff083\uff09\u8fdb\u4e00\u6b65\u4fc3\u8fdb\u7ec6\u80de\u91ca\u653e CGRP \u53ca\u5174\u594b\u4e34\u8fd1\u7684\u795e\u7ecf\u5143\u548c\u795e\u7ecf\u80f6\u8d28\u7ec6\u80de\uff0c\u5373\u81ea\u5206\u6ccc\u548c\u65c1\u5206\u6ccc\u529f\u80fd\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\"><\/span><\/p>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 15px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;\">2018 \u5e74 5 \u6708\uff0c\u7531 Amgen \u548c Novartis \u5408\u4f5c\u5f00\u53d1\u7684\u504f\u5934\u75db\u5355\u6297 Erenumab \u83b7\u5f97\u4e86 FDA \u7684\u6279\u51c6\uff0c\u6210\u4e3a\u9996\u4e2a\u83b7\u6279\u7684\u7528\u4e8e\u6cbb\u7597\u504f\u5934\u75db\u7684\u5355\u6297\u3002Erenumab-aooe \u662f\u4e00\u79cd\u5168\u4eba\u6e90 IgG2 \u5355\u6297\uff0c\u80fd\u591f\u4e0e\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd &nbsp;(Calcitonin Gene-Related Peptide\uff0cCGRP) \u53d7\u4f53\u7ed3\u5408\uff0c\u901a\u8fc7\u62ee\u6297\u4e0e\u504f\u5934\u75db\u6fc0\u6d3b\u76f8\u5173 CGRP \u53d7\u4f53\u7684\u529f\u80fd\u6765\u9884\u9632\u504f\u5934\u75db\u3002<sup class=\"md-footnote\">6<\/sup><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\">\u5305\u819c\u86cb\u767dF13 (Envelope protein F13)<\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">F13 \u4e3a\u5929\u82b1\u75c5\u6bd2\u8868\u9762\u7684\u4e00\u79cd\u5305\u819c\u86cb\u767d\uff0c\u6291\u5236 F13 \u7684\u529f\u80fd\u53ef\u6709\u6548\u963b\u6b62\u75c5\u6bd2\u5728\u4f53\u5185\u7684\u6269\u6563\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u7f8e\u56fdFDA\u4e8e 2018 \u5e74 7 \u6708 13 \u65e5\u6279\u51c6\u4e86 TPOXX\uff08tecovirimat\uff09\uff0c\u8fd9\u662f\u7b2c\u4e00\u79cd\u6cbb\u7597\u5929\u82b1\u7684\u836f\u7269\u3002\u867d\u7136\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u5ba3\u5e03\u5929\u82b1\u8fd9\u79cd\u4f20\u67d3\u6027\u3001\u6709\u65f6\u751a\u81f3\u662f\u81f4\u547d\u7684\u4f20\u67d3\u75c5\uff0c\u5728 1980 \u5e74\u5df2\u7ecf\u6839\u9664\uff0c\u4f46\u957f\u671f\u4ee5\u6765\u4e00\u76f4\u62c5\u5fc3\u5929\u82b1\u53ef\u4ee5\u7528\u4f5c\u751f\u7269\u6b66\u5668\u3002\u4e3a\u4e86\u5e94\u5bf9\u751f\u7269\u6050\u6016\u4e3b\u4e49\u98ce\u9669\uff0c\u7f8e\u56fd\u56fd\u4f1a\u91c7\u53d6\u4e00\u7cfb\u5217\u63aa\u65bd\uff0c\u5f00\u53d1\u548c\u6279\u51c6\u53cd\u5236\u624b\u6bb5\uff0c\u4ee5\u963b\u6b62\u53ef\u7528\u4f5c\u6b66\u5668\u7684\u75c5\u539f\u4f53\u3002TPOXX \u7684\u6279\u51c6\u662f\u4e00\u4e2a\u91cd\u8981\u7684\u91cc\u7a0b\u7891\u3002\u5982\u679c\u5c06\u5929\u82b1\u7528\u4f5c\u751f\u7269\u6b66\u5668\uff0c\u8be5\u65b0\u7684\u6cbb\u7597\u65b9\u6cd5\u63d0\u4f9b\u4e86\u6709\u6548\u9009\u62e9\u3002\u5b83\u662f\u9996\u4e2a\u83b7\u5f97\u7269\u8d28\u5a01\u80c1\u533b\u7597\u5bf9\u7b56\uff08Material Threat Medical Countermeasure\uff09\u4f18\u5148\u5ba1\u67e5\u8ba4\u5b9a\u7684\u4ea7\u54c1\u3002<sup class=\"md-footnote\">7<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1\uff08IDH1\uff09<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">IDH1 \u57fa\u56e0\u6240\u7f16\u7801\u7684\u86cb\u767d\u540d\u4e3a\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u91761\u3002\u4eba\u7c7b IDH \u6709\u4e09\u79cd\u7c7b\u578b\uff0c\u5206\u522b\u4e3a IDH1\u3001IDH2 \u548c IDH3\u3002IDH1 \u5b9a\u4f4d\u4e0e\u7ec6\u80de\u8d28\u548c\u8fc7\u6c27\u5316\u7269\u9176\u4f53\u4e2d\uff0cIDH2 \u548c IDH3 \u5b9a\u4f4d\u4e8e\u7ebf\u7c92\u4f53\u4e2d\u3002\u8be5\u7c7b\u86cb\u767d\u9176\u53ef\u4ee5\u5c06\u5f02\u67e0\u6aac\u9178\u6c27\u5316\u4e3a\u8349\u9170\u7425\u73c0\u9178\uff0c\u7136\u540e\u5728\u8f6c\u5316\u4e3a \u03b1-\u916e\u620a\u4e8c\u9178\u3002\u6700\u5148\u7814\u7a76\u53d1\u73b0 IDH1 \u7684\u7a81\u53d8\u4e0e\u8111\u80f6\u8d28\u7624\u5bc6\u5207\u76f8\u5173\uff0c\u4e4b\u540e\u53c8\u53d1\u73b0\u5176\u7a81\u53d8\u4e0e\u524d\u5217\u817a\u3001\u526f\u795e\u7ecf\u8282\u7624\u4ee5\u53ca IDH1\/2 \u7a81\u53d8\u4e0e\u6025\u6027\u9ad3\u7ec6\u80de\u767d\u8840\u75c5\u76f8\u5173\u3002\u5176\u81f4\u7624\u673a\u5236\u4e3a\u7a81\u53d8\u7684 IDH \u80fd\u5c06 \u03b1-\u916e\u620a\u4e8c\u9178\u8f6c\u5316\u4e3a 2-\u7f9f\u620a\u4e8c\u9178\uff0c\u4e14\u540e\u8005\u53ef\u4ee5\u6291\u5236\u524d\u8005\u7684\u9776\u70b9\uff0c\u5bfc\u81f4\u8fd9\u4e9b\u9776\u70b9\u8868\u8fbe\u5f02\u5e38\u5f15\u53d1\u764c\u75c7\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 7 \u6708 20 \u65e5 \uff0c\u764c\u75c7\u751f\u7269\u5236\u836f\u516c\u53f8 Agios Pharmaceuticals \u5ba3\u5e03\uff0c\u5176\u6297\u764c\u836f\u7269 ivosidenib\uff08\u5546\u54c1\u540d Tibsovo\uff09 \u83b7\u5f97\u7f8e\u56fd FDA \u7684\u6279\u51c6\uff0c\u7528\u4e8e\u7ecf\u4e00\u6b3e\u68c0\u6d4b\u65b9\u6cd5\uff08\u96c5\u57f9 RealTime IDH1 \u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u76d2\uff09\u8bc1\u5b9e\u5b58\u5728\u6613\u611f\u5f02\u67e0\u6aac\u9178\u8131\u6c22\u9176-1\uff08IDH1\uff09\u7a81\u53d8\u7684\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u6025\u6027\u9ad3\u7cfb\u767d\u8840\u75c5\uff08R\/R AML\uff09\u6210\u4eba\u60a3\u8005\u3002Tibsovo \u662f\u4e00\u79cd\u9488\u5bf9 IDH1 \u9176\u7684\u53e3\u670d\u9776\u5411\u6291\u5236\u5242\uff0c\u6b64\u6b21\u6279\u51c6\uff0c\u4f7f Tibsovo \u6210\u4e3a\u9996\u4e2a\u4e5f\u662f\u552f\u4e00\u4e00\u4e2a\u83b7\u5f97 FDA \u6279\u51c6\u6cbb\u7597 IDH1 \u7a81\u53d8 R\/R AML \u7684\u836f\u7269\u3002<br  \/><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 6 \u6708\u5e95\uff0c\u57fa\u77f3\u836f\u4e1a\u4e0e Agios \u7b7e\u7f72\u72ec\u5bb6\u5408\u4f5c\u4e0e\u6388\u6743\u534f\u8bae\uff0c\u83b7\u5f97 Tibsovo \u5728\u5927\u4e2d\u534e\u533a\u7684\u72ec\u5bb6\u6743\u5229\u3002\u57fa\u77f3\u836f\u4e1a\u5c06\u8d1f\u8d23 Tibsovo \u5728\u5927\u4e2d\u534e\u533a\u9488\u5bf9\u8840\u6db2\u80bf\u7624\u548c\u5b9e\u4f53\u7624\u9002\u5e94\u75c7\u7684\u4e34\u5e8a\u5f00\u53d1\u548c\u5546\u4e1a\u5316\uff0c\u5e76\u5c06\u9996\u5148\u4e13\u6ce8\u4e8eAML\u53ca\u80c6\u7ba1\u764c\u3002\u6839\u636e\u534f\u8bae\uff0c\u57fa\u77f3\u836f\u4e1a\u5c06\u652f\u4ed8\u4e00\u7b14 1200 \u4e07\u7f8e\u5143\u7684\u9884\u4ed8\u6b3e\uff0c\u4ee5\u53ca\u4e0d\u8d85\u8fc7 4.12 \u4ebf\u7f8e\u5143\u7684\u91cc\u7a0b\u7891\u4ed8\u6b3e\u3002\u6b64\u5916\uff0c\u57fa\u77f3\u836f\u4e1a\u8fd8\u5c06\u57fa\u4e8e Tibsovo \u5728\u5927\u4e2d\u534e\u533a\u5e74\u5ea6\u51c0\u9500\u552e\u989d\u5411 Agios \u652f\u4ed8 15%-19% \u7684\u9636\u68af\u5206\u6210\u3002\u57fa\u77f3\u836f\u4e1a\u5c06\u627f\u62c5 Tibsovo \u5728\u5927\u4e2d\u534e\u533a\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u7684\u5168\u90e8\u8d39\u7528\u3002<sup class=\"md-footnote\">8<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u8840\u7ba1\u6027\u8840\u53cb\u75c5\u56e0\u5b50 (von Willebrand factor)<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u8840\u7ba1\u6027\u8840\u53cb\u75c5\u56e0\u5b50 (von Willebrand Factor, vWF)\uff0c\u662f\u7531\u7b2c 12 \u53f7\u67d3\u8272\u4f53\u7684\u77ed\u81c2\u6240\u7f16\u7801\u7684\u7cd6\u86cb\u767d\u3002vWF \u53ef\u540c\u65f6\u4e0e\u80f6\u539f\u7ea4\u7ef4\u548c\u8840\u5c0f\u677f\u7ed3\u5408\uff0c\u5f53\u8840\u7ba1\u7834\u88c2\u65f6\u5927\u91cf\u8840\u5c0f\u677f\u4ee5 vWF \u4e3a\u4e2d\u4ecb\uff0c\u7c98\u9644\u5728\u80f6\u539f\u7ea4\u7ef4\u4e0a\uff0c\u5f62\u6210\u8840\u6813\uff0c\u5f97\u4ee5\u6b62\u8840\u3002vWF\u5728\u6b62\u8840\u8fc7\u7a0b\u4e2d\u4e3b\u8981\u7531\u4e24\u79cd\u4f5c\u7528\uff1a<\/span><\/p>\n<ul style=\"margin-left: 0px;margin-right: 0px;\" class=\"list-paddingleft-2\">\n<li>\n<p><span style=\"font-size: 15px;\">\u4e0e\u8840\u5c0f\u677f\u819c GPIb-\u2168 \u590d\u5408\u7269\u53ca\u5185\u76ae\u4e0b\u80f6\u539f\u7ed3\u5408\uff0c\u4ecb\u5bfc\u8840\u5c0f\u677f\u5728\u8840\u7ba1\u635f\u4f24\u90e8\u4f4d\u7684\u9ecf\u9644\uff1b<\/span><\/p>\n<\/li>\n<p><br  \/><\/p>\n<li>\n<p><span style=\"font-size: 15px;\">\u4e0e\u56e0\u5b50 \u2167 \u7ed3\u5408\uff0c\u4f5c\u4e3a\u8f7d\u4f53\u5177\u6709\u7a33\u5b9a\u56e0\u5b50 \u2167 \u7684\u4f5c\u7528\u3002\u6b64\u5916\uff0cvWF \u4e5f\u80fd\u7ed3\u5408 GP\u2161b-\u2162a\uff0c\u53c2\u4e0e\u8840\u5c0f\u677f\u7684\u805a\u96c6\u8fc7\u7a0b\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p><br  \/><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 9 \u6708 3 \u65e5\uff0cEMA \u5ba3\u5e03\u6279\u51c6 Cablivi (caplacizumab) \u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u5e74\u83b7\u5f97\u6027\u8840\u6813\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u6027\u7d2b\u765c\uff08aTTP\uff09\u60a3\u8005\u3002Cablivi\u662f\u83b7\u5f97\u6279\u51c6\u7684\u7b2c\u4e00\u6b3e\u4e13\u95e8\u9488\u5bf9 aTTP \u7684\u7597\u6cd5\uff0c\u4e5f\u662f\u7b2c\u4e00\u6b3e\u83b7\u5f97\u6279\u51c6\u7684\u7eb3\u7c73\u6297\u4f53\u7597\u6cd5\u3002\u7f8e\u56fdFDA\u5df2\u7ecf\u63a5\u53d7\u4e86 caplacizumab \u7684\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\uff0c\u5e76\u4e14\u6388\u4e88\u5176\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002<\/span><\/p>\n<p><span style=\"font-size: 15px;\">Caplacizumab \u7531\u8d5b\u8bfa\u83f2\uff08Sanofi\uff09\u516c\u53f8\u65d7\u4e0b\u7684 Ablynx \u516c\u53f8\u7814\u53d1\uff0c\u8fd9\u662f\u4e00\u79cd 2 \u4ef7 vWF \u6297\u4f53\u3002\u901a\u8fc7\u4e0e vWF \u86cb\u767d\u7ed3\u5408\uff0c\u5b83\u80fd\u591f\u9632\u6b62\u8d85\u5927\u578b vMF \u86cb\u767d\u4e0e\u8840\u5c0f\u677f\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u9632\u6b62\u51dd\u8840\u7684\u53d1\u751f\u3002\u5b83\u65e9\u5728 2009 \u5e74\u5c31\u83b7\u5f97\u7f8e\u56fd\u548c\u6b27\u76df\u6388\u4e88\u7684\u5b64\u513f\u836f\u8d44\u683c\u3002<sup class=\"md-footnote\">9<\/sup><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\">\u964d\u9499\u7d20\u57fa\u56e0\u76f8\u5173\u80bd (CGRP)<\/span><\/p>\n<p><span style=\"font-size: 15px;font-weight: bold;\"><br  \/><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u9776\u70b9\u76f8\u5173\u5185\u5bb9\u8bf7\u89c1\u524d\u9762 CGRP \u53d7\u4f53\u4ecb\u7ecd\u90e8\u5206\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 9 \u6708 14 \u65e5\uff0c\u906d\u9047\u6ce2\u6298\u4e4b\u540e\uff0cTeva \u91cd\u8981\u8d44\u4ea7\u504f\u5934\u75db\u836f\u7269 CGRP \u6297\u4f53 AJOVYTM (fremanezumab-vfrm) \u7ec8\u4e8e\u4e0a\u5e02\uff0c\u6210\u4e3a\u5168\u7403\u7b2c2\u6b3e\u83b7\u6279\u4e0a\u5e02\u7684 CGRP \u5355\u6297\uff0c\u7528\u836f\u65b9\u5f0f\u66f4\u4e3a\u7075\u6d3b\uff0c\u5b9a\u4ef7\u4e0e\u5b89\u8fdb\/\u8bfa\u534e\u76f8\u5f53\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 9 \u6708 27 \u65e5\uff0c\u793c\u6765\u7684 Emgality\uff08galcanezumab-gnlm\uff09\u83b7\u5f97 FDA \u7684\u6279\u51c6\u7528\u4e8e\u6210\u4eba\u504f\u5934\u75db\u7684\u9884\u9632\u6027\u6cbb\u7597\uff0c\u662f\u7ee7Amgen\/Novaris \u7684 Aimovig \u53ca Teva \u7684 Ajovy \u4e4b\u540e\u7b2c\u4e09\u6b3e\u8fdb\u5165 CGRP \u5e02\u573a\u7684\u504f\u5934\u75db\u65b0\u836f\u3002Emgality \u7684\u83b7\u6279\uff0c\u4e3a\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u591a\u7684\u6cbb\u7597\u9009\u62e9\uff0c\u4f46\u4e5f\u8fdb\u4e00\u6b65\u52a0\u5267\u4e86 CGRP \u9776\u70b9\u836f\u7269\u4e4b\u95f4\u7684\u7ade\u4e89\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u4e0e Aimovig \u9776\u5411 CGRP \u53d7\u4f53\u4e0d\u540c\uff0cAjovy \u4e0e Emgality \u662f\u76f4\u63a5\u9776\u5411 CGRP\u3002<sup class=\"md-footnote\">10<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u03b3-\u5e72\u6270\u7d20 (IFNG)<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u03b3-\u5e72\u6270\u7d20\uff08Interferon-\u03b3\uff0cIFN-\u03b3)\u662f\u6c34\u6eb6\u6027\u4e8c\u805a\u4f53\u7ec6\u80de\u56e0\u5b50 \uff0c\u662f II \u578b\u5e72\u6270\u7d20\u7684\u552f\u4e00\u6210\u5458\u3002\u6700\u521d\u53eb\u5de8\u566c\u7ec6\u80de\u6d3b\u5316\u56e0\u5b50\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 11 \u6708 21 \u65e5\uff0cSobi \u548c Novimmune SA \u516c\u53f8\u8054\u5408\u5ba3\u5e03\uff0c\u7f8e\u56fd FDA \u6279\u51c6\u53cc\u65b9\u5171\u540c\u5f00\u53d1\u7684\u5e72\u6270\u7d20\u03b3\uff08IFN\u03b3\uff09\u6297\u4f53 Gamifant\uff08emapalumab-lzsg\uff09 \u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u513f\u7ae5\u6216\u6210\u5e74\u539f\u53d1\u6027\u566c\u8840\u7ec6\u80de\u6dcb\u5df4\u7ec4\u7ec7\u7ec6\u80de\u589e\u591a\u75c7\uff08HLH\uff09\u60a3\u8005\u3002\u8fd9\u4e9b\u60a3\u8005\u60a3\u6709\u590d\u53d1\/\u96be\u6cbb\u6027\u75be\u75c5\uff0c\u5728\u63a5\u53d7\u5e38\u89c4HLH\u7597\u6cd5\u540e\u75be\u75c5\u7ee7\u7eed\u6076\u5316\uff0c\u6216\u5bf9\u5e38\u89c4\u7597\u6cd5\u4e0d\u8010\u53d7\u3002Gamifant \u662f FDA \u6279\u51c6\u7684\u9996\u4f8b\u9488\u5bf9 HLH \u7684\u7597\u6cd5\uff0c\u8fd9\u4ee3\u8868\u7740\u6cbb\u7597\u539f\u53d1\u6027 HLH \u9886\u57df 24 \u5e74\u6765\u7684\u9996\u4e2a\u91cd\u5927\u7a81\u7834\u3002Gamifant \u662f\u4e00\u79cd IFN\u03b3 \u7684\u5355\u514b\u9686\u6297\u4f53\u3002\u5b83\u80fd\u591f\u4e0e IFN\u03b3 \u7ed3\u5408\u5e76\u4e14\u4e2d\u548c\u5b83\u7684\u4f5c\u7528\u3002\u8be5\u836f\u7269\u5df2\u7ecf\u83b7\u5f97 FDA \u6388\u4e88\u7684\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\u548c\u5b64\u513f\u836f\u8d44\u683c\uff0c\u800c\u4e14\u65b0\u836f\u7533\u8bf7\u4e5f\u83b7\u5f97\u4e86\u4f18\u5148\u5ba1\u8bc4\u8d44\u683c\u3002<sup class=\"md-footnote\">11<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u539f\u808c\u7403\u86cb\u767d\u53d7\u4f53\u6fc0\u9176 (Tropomyosin receptor kinases, TRK)<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">TRK \u5bb6\u65cf\u5305\u62ec TRKA\uff0cTRKB \u548c TRKC\u3002TRK \u4fe1\u53f7\u901a\u8def\u4e0e\u80bf\u7624\u5bc6\u5207\u76f8\u5173\uff0c\u5728\u8bb8\u591a\u80bf\u7624\u4e2d\u5747\u53ef\u9ad8\u8868\u8fbe\uff0c\u5305\u62ec\u795e\u7ecf\u4e0a\u76ae\u7ec6\u80de\u548c\u6210\u795e\u7ecf\u7ec6\u80de\u7624\u7b49\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 11 \u6708 26 \u65e5\uff0c\u62dc\u8033\u548c LOXO Oncology \u516c\u53f8\u8054\u5408\u53d1\u5e03\uff0cFDA \u6279\u51c6 larotrectinib (Vitrakvi) &nbsp;\u7528\u4e8e\u6cbb\u7597\u643a\u5e26 NTRK \u57fa\u56e0\u878d\u5408\u3001\u4e0d\u53ef\u624b\u672f\u5207\u9664\u6216\u8f6c\u79fb\u6027\u5b9e\u4f53\u80bf\u7624\u3002\u6b64\u6b21\u6279\u51c6\u4e0d\u540c\u4e8e\u57fa\u4e8e\u5668\u5b98\u6216\u764c\u75c7\u5f00\u59cb\u589e\u957f\u7ec4\u7ec7\u7684\u5e38\u89c4\u8bc4\u5ba1\u9014\u5f84\uff0c\u8fd9\u662f\u7b2c\u4e00\u4e2a\u57fa\u4e8e\u80bf\u7624\u7684\u9057\u4f20\u7279\u5f81\uff0c\u800c\u4e0d\u662f\u80bf\u7624\u5728\u4eba\u4f53\u5185\u8d77\u6e90\u7684\u6297\u764c\u836f\u3002<sup class=\"md-footnote\">12<\/sup><\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;font-weight: bold;\">\u767d\u7ec6\u80de\u4ecb\u7d20-3 \u53d7\u4f53\uff08IL3RA\uff09<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">\u767d\u7ec6\u80de\u4ecb\u7d20-3 \u53d7\u4f53\uff08IL-3R\uff09\u662f\u9020\u8840\u751f\u957f\u56e0\u5b50\u53d7\u4f53\u5bb6\u65cf\u6210\u5458\u4e4b\u4e00\uff0c\u5176\u7f16\u7801\u86cb\u767d CD123 \u662f\u672a\u5206\u5316\u767d\u8840\u75c5\u7684\u7279\u5f02\u6807\u5fd7\u3002\u5b83\u5728\u7ec6\u80de\u4fe1\u53f7\u8f6c\u5bfc\u3001\u7ec6\u80de\u51cb\u4ea1\u53ca\u8840\u6db2\u80bf\u7624\u53d1\u751f\u4e2d\u8d77\u91cd\u8981\u4f5c\u7528\u3002\u4ee5 CD123 \u4e3a\u9776\u70b9\uff0c\u5b83\u6709\u53ef\u80fd\u6210\u4e3a\u9009\u62e9\u6027\u6e05\u9664\u767d\u8840\u75c5\u7ec6\u80de\u7684\u6709\u524d\u9014\u7684\u65b0\u9776\u70b9\u3002<\/span><\/p>\n<p style=\"margin: 0px 0px 1.2em !important;\"><span style=\"font-size: 15px;\">2018 \u5e74 12 \u6708 21 \u65e5\uff0cStemline Therapeutics \u5ba3\u5e03\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5df2\u6279\u51c6 Elzonris\uff08tagraxofusp-erzs\uff0cSL-401\uff09\uff0c\u7528\u4e8e 2 \u5c81\u53ca\u4ee5\u4e0a\u6bcd\u7ec6\u80de\u6027\u6d46\u7ec6\u80de\u6837\u6811\u7a81\u72b6\u7ec6\u80de\u80bf\u7624\uff08BPDCN\uff09\u513f\u79d1\u60a3\u8005\u548c\u6210\u4eba\u60a3\u8005\u7684\u6cbb\u7597\uff0c\u5305\u62ec\u65e2\u5f80\u672a\u63a5\u53d7\u6cbb\u7597\uff08\u521d\u6cbb\uff09\u548c\u65e2\u5f80\u5df2\u63a5\u53d7\u6cbb\u7597\uff08\u7ecf\u6cbb\uff09\u7684 BPDNC \u60a3\u8005\u3002\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0c\u6b64\u6b21\u6279\u51c6\uff0c\u4f7f Elzonris \u6210\u4e3a\u9996\u4e2a\u83b7\u6279\u6cbb\u7597 BPDCN \u7684\u836f\u7269\uff0c\u540c\u65f6\u4e5f\u662f\u9996\u4e2a\u83b7\u5f97\u6279\u51c6\u7684 CD123 \u9776\u5411\u836f\u7269\u3002Elzonris &nbsp;\u4e13\u95e8\u9488\u5bf9 CD123 &nbsp;\u9776\u70b9\u8bbe\u8ba1\uff0c\u8be5\u836f\u7531\u4eba IL-3 \u4e0e\u622a\u77ed\u7684\u767d\u5589\u6bd2\u7d20\uff08DT\uff09\u8fdb\u884c\u91cd\u7ec4\u878d\u5408\u800c\u6210\uff0cIL-3 \u7ed3\u6784\u57df\u80fd\u591f\u5c06\u7ec6\u80de\u6bd2\u6027 DT \u7247\u6bb5\u5f15\u5bfc\u81f3\u8868\u8fbe CD123 \u7684\u80bf\u7624\u7ec6\u80de\u3002\u5728\u88ab\u80bf\u7624\u7ec6\u80de\u5185\u5316\u540e\uff0cElzonris \u80fd\u591f\u4e0d\u53ef\u9006\u5730\u6291\u5236\u86cb\u767d\u8d28\u5408\u6210\u5e76\u8bf1\u5bfc\u9776\u7ec6\u80de\u51cb\u4ea1\u3002<sup class=\"md-footnote\">13<\/sup><\/span><\/p>\n<h4 style=\"margin: 1.3em 0px 1em;padding: 0px;font-weight: bold;font-size: 1.2em;\"><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">\u53c2\u8003\u8d44\u6599<\/span><\/h4>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">1 https:\/\/www.albireopharma.com\/programs\/elobixibat<br  \/><\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">2 https:\/\/www.ultragenyx.com\/medicines\/crysvita\/<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">3 https:\/\/en.wikipedia.org\/wiki\/Baloxavir_marboxil<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">4 https:\/\/en.wikipedia.org\/wiki\/Ibalizumab<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">5 https:\/\/en.wikipedia.org\/wiki\/Fostamatinib<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">6 https:\/\/en.wikipedia.org\/wiki\/Erenumab<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">7 https:\/\/en.wikipedia.org\/wiki\/Tecovirimat<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">8 http:\/\/www.bioon.com\/article\/6725032.html<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">9 https:\/\/www.sohu.com\/a\/251981935_282570<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">10 http:\/\/www.jintiankansha.me\/t\/mytczSY24v<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">11 https:\/\/en.wikipedia.org\/wiki\/Emapalumab<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">12 https:\/\/en.wikipedia.org\/wiki\/Larotrectinib<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">13 https:\/\/doi.org\/10.1007\/s40265-019-01087-z<\/span><\/p>\n<p><span style=\"font-size: 12px;color: rgb(136, 136, 136);\">14&nbsp;https:\/\/www.nature.com\/articles\/d41573-019-00052-5<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u8f6c\u81ea\u607a\u601d\u4ff1\u4e50\u90e8 2018 \u5e74 FDA \u6279\u51c6\u4e0a\u5e02\u7684\u65b0\u836f\u6570\u91cf\u521b\u4e86\u65b0\u9ad8\u3002\u6211\u4eec\u8be6\u5c3d\u68b3\u7406\u4e86 2018 \u5e74\u5728\u7f8e\u56fd\u3001\u6b27\u6d32\u548c\u65e5 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":82275,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82274"}],"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=82274"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82274\/revisions"}],"predecessor-version":[{"id":82276,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/82274\/revisions\/82276"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/82275"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=82274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=82274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=82274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}