{"id":270791,"date":"2020-03-24T11:09:28","date_gmt":"2020-03-24T18:09:28","guid":{"rendered":"https:\/\/icitynews.com.cn\/?p=270791"},"modified":"2020-03-25T09:28:14","modified_gmt":"2020-03-25T16:28:14","slug":"270791","status":"publish","type":"post","link":"https:\/\/icitynews.com\/?p=270791","title":{"rendered":"\u745e\u5fb7\u897f\u97e6\u83b7FDA \u201c\u5b64\u513f\u836f\u8d44\u683c\u201d\u5168\u7f8e\u9996\u6279\u4e34\u5e8a\u5b9e\u9a8c\u5df2\u4e8e\u5c14\u6e7e\u52a0\u5927\u533b\u5b66\u9662\u6295\u5165\u4f7f\u7528"},"content":{"rendered":"<p style=\"text-align: left;\">\u636e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5b98\u7f51\u663e\u793a\uff0c\u5409\u5229\u5fb7\u79d1\u5b66\u516c\u53f8\uff08Gilead Sciences, Inc.\uff09\u7814\u5236\u7684\u5b9e\u9a8c\u836f\u7269\u745e\u59c6\u6614\u97e6\uff08Remdesivir\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u513f\u836f\u8d44\u683c\uff08Orphan Drug Designation\uff09\u3002<strong>\u4f46\u5b64\u513f\u836f\u8d44\u683c\uff0c\u5e76\u4e0d\u610f\u5473\u7740\u6b64\u836f\u5df2\u88abFDA\u6279\u51c6\u4e0a\u5e02\u3002<\/strong><\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-270796\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/smHLXQs.png\" alt=\"\" width=\"630\" height=\"320\" srcset=\"https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/smHLXQs.png 630w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/smHLXQs-600x305.png 600w\" sizes=\"auto, (max-width: 630px) 100vw, 630px\" \/><em><span style=\"font-size: 8pt;\">techdirt.com<\/span><\/em><\/p>\n<p>\u65e9\u524d\uff0c\u7279\u6717\u666e\u603b\u7edf\u66fe\u7763\u4fc3FDA\u7b80\u5316\u5176\u5bf9\u745e\u59c6\u6614\u97e6\u7b49\u836f\u7269\u7684\u6279\u51c6\u7a0b\u5e8f\uff0c\u4f46\u8be5\u836f\u7269\u76ee\u524d\u6b63\u5728\u8fdb\u884c\u4e34\u5e8a\u6d4b\u8bd5\u4e2d\uff0c\u9884\u8ba1\u5c06\u4e8e\u4e0b\u4e2a\u6708\u6709\u7ed3\u679c\u3002<strong>\u745e\u59c6\u6614\u97e6\u867d\u7136\u5c1a\u672a\u88abFDA\u6279\u51c6\u7528\u4e8e\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u60a3\u8005\uff0c\u4f46\u5bf9\u4e8e\u975e\u5e38\u4e25\u91cd\u7684\u60a3\u8005\u53ef\u4ee5\u201c\u540c\u60c5\u4f7f\u7528\u201d\uff08Compassionate Use\uff09\u3002<\/strong><\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-270691\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/640-800x533.jpeg\" alt=\"\" width=\"800\" height=\"533\" srcset=\"https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/640-800x533.jpeg 800w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/640-768x512.jpeg 768w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/640-600x400.jpeg 600w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/640.jpeg 810w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><em><span style=\"font-size: 8pt;\">CNN<\/span><\/em><\/p>\n<p><span style=\"color: #993300;\"><strong>\u745e\u59c6\u6614\u97e6\uff08Remdesivir\uff09<\/strong><\/span><br \/>\n\u745e\u59c6\u6614\u97e6\u662f\u5409\u5229\u5fb7\u79d1\u5b66\u516c\u53f8\u5f00\u53d1\u7684\u4e00\u79cd\u65b0\u578b\u5b9e\u9a8c\u6027\u5e7f\u8c31\u6297\u75c5\u6bd2\u836f\u7269\uff0c\u53ef\u4ee5\u6709\u6548\u6291\u5236\u547c\u5438\u9053\u4e0a\u76ae\u7ec6\u80de\u4e2dSARS\u75c5\u6bd2\u548cMERS\u75c5\u6bd2\u7684\u590d\u5236\uff0c\u88ab\u89c6\u4e3a\u6cbb\u6108\u65b0\u51a0\u80ba\u708e\u6700\u6709\u5e0c\u671b\u7684\u836f\u7269\u4e4b\u4e00\u3002\u56e0\u88ab\u7528\u4e8e\u7f8e\u56fd\u9996\u4f8b\u65b0\u51a0\u80ba\u708e\u786e\u8bca\u60a3\u8005\uff0c\u5373\u4e00\u540d\u534e\u76db\u987f\u5dde\u768435\u5c81\u7537\u5b50\u540e\u53d6\u5f97\u826f\u597d\u6548\u679c\u800c\u5907\u53d7\u5173\u6ce8\u3002<\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-270792\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/105733600-1549973302033rts1phdi.jpg\" alt=\"\" width=\"630\" height=\"354\" srcset=\"https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/105733600-1549973302033rts1phdi.jpg 630w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/105733600-1549973302033rts1phdi-600x337.jpg 600w\" sizes=\"auto, (max-width: 630px) 100vw, 630px\" \/><em><span style=\"font-size: 8pt;\">NBC<\/span><\/em><\/p>\n<p style=\"text-align: left;\"><span style=\"color: #993300;\"><strong>\u5b64\u513f\u836f\uff08Orphan Drug\uff09<\/strong><\/span><br \/>\n\u5b64\u513f\u836f\uff0c\u53c8\u540d\u7f55\u89c1\u75c5\u836f\u3002\u7279\u6307\u6cbb\u7597\u3001\u6cbb\u7597\u6216\u63a7\u5236\u7f55\u89c1\u75c5\u7684\u836f\u7269\u3002\u800c\u7f55\u89c1\u75c5\u662f\u6307\u53d1\u75c5\u7387\u5f88\u4f4e\u3001\u5f88\u5c11\u89c1\u7684\u75be\u75c5\u3002\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u5c06\u7f55\u89c1\u75c5\u5b9a\u4e49\u4e3a\u60a3\u75c5\u4eba\u6570\u5360\u603b\u4eba\u53e3\u65700.65\u2030\u81f31\u2030\u4e4b\u95f4\u7684\u75be\u75c5\u3002\u7531\u4e8e\u7f55\u89c1\u75c5\u60a3\u75c5\u4eba\u6570\u5c11\u3001\u7f3a\u533b\u5c11\u836f\u4e14\u5f80\u5f80\u75c5\u60c5\u4e25\u91cd\uff0c\u56e0\u800c\u53c8\u88ab\u79f0\u4e3a\u201c\u5b64\u513f\u75c5\u201d\u3002<\/p>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-270793\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/american-gene-technologies-granted-fda-orphan-drug-designation-for-phenylketonuria-800x444.jpg\" alt=\"\" width=\"800\" height=\"444\" srcset=\"https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/american-gene-technologies-granted-fda-orphan-drug-designation-for-phenylketonuria-800x444.jpg 800w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/american-gene-technologies-granted-fda-orphan-drug-designation-for-phenylketonuria-768x427.jpg 768w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/american-gene-technologies-granted-fda-orphan-drug-designation-for-phenylketonuria-600x333.jpg 600w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/american-gene-technologies-granted-fda-orphan-drug-designation-for-phenylketonuria.jpg 900w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><em><span style=\"font-size: 8pt;\">americangene.com<\/span><\/em><\/p>\n<p>\u7f8e\u56fd\u57281983\u5e74\u9881\u5e03\u5b64\u513f\u836f\u6cd5\u6848\uff08Orphan Drug Act\uff0cODA\uff09\u4e4b\u524d\uff0c\u53ea\u670938\u4e2a\u5b64\u513f\u836f\u3002\u56e0\u4e3a\u7814\u53d1\u6210\u672c\u9ad8\uff0c\u5e02\u573a\u5c0f\uff0c\u6240\u4ee5\u65e0\u4eba\u7814\u7a76\u751f\u4ea7\u5b64\u513f\u836f\u3002\u4e3a\u4e86\u6539\u53d8\u8fd9\u79cd\u60c5\u51b5\uff0c\u9881\u5e03\u5b64\u513f\u836f\u6cd5\u6848\u3002\u6cd5\u6848\u4e3b\u8981\u5185\u5bb9\uff1a<\/p>\n<ul style=\"list-style-type: circle;\">\n<li>\u5b64\u513f\u836f\u662f\u6307\u6cbb\u7597\u5f71\u54cd\u5c11\u4e8e200,000\u7f8e\u56fd\u516c\u6c11\u7684\u75be\u75c5\u7684\u836f\u7269\uff0c\u8bca\u65ad\u8bd5\u5242\u53ca\u75ab\u82d7\u3002<\/li>\n<li>\u5b64\u513f\u836f\u7814\u53d1\u751f\u4ea7\u6fc0\u52b1\u653f\u7b56\uff1a<\/li>\n<\/ul>\n<ol style=\"list-style-type: lower-alpha;\">\n<li style=\"list-style-type: none;\">\n<ol style=\"list-style-type: lower-alpha;\">\n<li>\u5305\u62ec7\u5e74\u7814\u53d1\u5e02\u573a\u72ec\u5360\uff0c\u4e0d\u540c\u4e8e\u4f20\u7edf\u4e13\u5229\u5e02\u573a\u72ec\u5360\uff0c\u8fd9\u4e2a\u5e02\u573a\u72ec\u5360\u7684\u610f\u601d\u662f\u4ea7\u54c1\u4e0a\u5e02\u540e7\u5e74\u4e4b\u5185\u5176\u4ed6\u516c\u53f8\u4e0d\u53ef\u4ee5\u7814\u53d1\uff0c\u4e5f\u5c31\u662f\u65e0\u6cd5\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff1b<\/li>\n<li>\u8bfe\u7a0e\u6263\u9664\u6807\u51c6\u51cf\u534a\uff1b<\/li>\n<li>15\u5e74\u4e8f\u635f\u9884\u8b66\u6761\u6b3e\u548c3\u5e74\u7684\u76c8\u5229\u5e74\u4e8f\u635f\u8865\u62a5\uff08\u8fd9\u4e24\u4e2a\u90fd\u662f\u51cf\u7a0e\u653f\u7b56\uff09\uff0c<\/li>\n<li>\u8865\u52a9\u91d1\uff1b<\/li>\n<li>\u4e0a\u5e02\u7533\u8bf7\u5feb\u901f\u901a\u9053\uff1b<\/li>\n<li>\u53d6\u6d88PDUFA\u7533\u8bf7\u8d39\uff08\u540e\u6765\u7684\u6cd5\u6848\uff09\u3002<\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<p style=\"text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-270794\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/img015.jpeg\" alt=\"\" width=\"512\" height=\"384\" \/><em><span style=\"font-size: 8pt;\">uninet.edu<\/span><\/em><\/p>\n<p><span style=\"color: #993300;\"><strong>\u540c\u60c5\u7528\u836f\uff08Compassionate Use\uff09<\/strong><\/span><br \/>\n\u6b63\u5e38\u60c5\u51b5\u4e0b\uff0c\u836f\u7269\u53ea\u6709\u88ab\u6279\u51c6\u540e\u624d\u80fd\u7528\u4e8e\u6cbb\u7597\u60a3\u8005\uff0c\u6240\u4ee5\u540c\u60c5\u7528\u836f\u53c8\u79f0\u201c\u6279\u51c6\u524d\u4f7f\u7528\u201d\uff0c\u5176\u4e3b\u65e8\u662f\u4e3a\u4e86\u89e3\u51b3\u60a3\u8005\u6025\u96be\u75c5\u60c5\uff0c\u62ef\u6551\u751f\u547d\u3002\u7279\u6b8a\u65f6\u671f\uff0c\u7279\u6b8a\u5904\u7406\u3002<\/p>\n<p>\u7531\u4e8e\u65b0\u51a0\u80ba\u708e\u75ab\u60c5\u8fc5\u901f\u53d1\u5c55\uff0c\u60a3\u8005\u5bf9\u4e8e\u6709\u6548\u836f\u7269\u7684\u9700\u6c42\u5341\u5206\u8feb\u5207\u3002\u5982\u60a3\u8005\u9047\u5230\u5a01\u80c1\u751f\u547d\u7684\u72b6\u51b5\uff0c\u4e14\u6ca1\u6709\u53ef\u6bd4\u6216\u66f4\u597d\u7684\u66ff\u4ee3\u7597\u6cd5\uff0c\u533b\u7597\u673a\u6784\u5c31\u6709\u53ef\u80fd\u4f1a\u91c7\u7528\u540c\u60c5\u7528\u836f\u3002<\/p>\n<p><span style=\"color: #993300;\"><strong>\u5357\u52a0\u9996\u5bb6\u6d4b\u8bd5\u533b\u7597\u673a\u6784<\/strong><\/span><br \/>\n\u52a0\u5dde\u5927\u5b66\u5c14\u6e7e\u5206\u6821\uff08UC Irvine\uff09\u6210\u4e3a\u5357\u52a0\u9996\u5bb6\u4f7f\u7528\u745e\u5fb7\u897f\u97e6\u4e34\u5e8a\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u7684\u533b\u7597\u673a\u6784\u3002\u52a0\u5dde\u5927\u5b66\u5c14\u6e7e\u5206\u6821\u533b\u5b66\u7cfb\u4e3b\u4efbAlpesh Amin\u535a\u58eb\u8868\u793a\u5bf9\u745e\u5fb7\u897f\u97e6\u6cbb\u7597\u65b0\u51a0\u80ba\u708e\u7684\u6548\u679c\u6301\u4e50\u89c2\u6001\u5ea6\u3002<\/p>\n<p>Amin\u535a\u58eb\u79f0\uff0c\u5f53\u6211\u4eec\u5bf9\u60a3\u8005\u8fdb\u884c\u65b0\u51a0\u80ba\u708e\u6d4b\u8bd5\u65f6\uff0c\u5982\u679c\u7ed3\u679c\u5448\u9633\u6027\uff0c\u4e14\u5728\u60a3\u8005\u77e5\u60c5\u548c\u540c\u610f\u7684\u60c5\u51b5\u4e0b\uff0c\u6211\u4eec\u624d\u4f1a\u5bf9\u5176\u8fdb\u884c\u745e\u5fb7\u897f\u97e6\u7528\u836f\u3002\u745e\u5fb7\u897f\u97e6\u5c06\u901a\u8fc7\u9759\u8109\u6ce8\u5c04\u7ed9\u836f\uff0c1\u59291\u6b21\uff0c\u5171\u6ce8\u5c0410\u5929\u3002\u6211\u4eec\u5c06\u5173\u6ce8\u75c5\u60a3\u5728\u7528\u836f\u540e\u75c7\u72b6\u662f\u5426\u6709\u6240\u6539\u5584\u3002\u9664\u4e86\u5173\u6ce8\u836f\u7269\u7597\u6548\u5916\uff0c\u533b\u9662\u8fd8\u5c06\u5bc6\u5207\u7559\u610f\u5176\u526f\u4f5c\u7528\u3002<\/p>\n<p>\u76ee\u524d\uff0c\u52a0\u5dde\u5927\u5b66\u5c14\u6e7e\u5206\u6821\u533b\u5b66\u9662\u5df2\u5f00\u59cb\u63a5\u6536\u613f\u610f\u53c2\u4e0e\u5b9e\u9a8c\u7684\u75c5\u60a3\u3002\u5f81\u96c6\u8be6\u60c5\uff1ahttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT04280705<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-270813\" src=\"http:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41-800x446.png\" alt=\"\" width=\"800\" height=\"446\" srcset=\"https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41-800x446.png 800w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41-1024x571.png 1024w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41-768x428.png 768w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41-600x334.png 600w, https:\/\/icitynews.com.cn\/wp-content\/uploads\/2020\/03\/\u5c4f\u5e55\u5feb\u7167-2020-03-24-\u4e0a\u534811.49.41.png 1093w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p class=\"post-copyright\">\u672a\u7ecf\u5141\u8bb8\u4e0d\u5f97\u8f6c\u8f7d\uff1a<a href=\"https:\/\/icitynews.com\">\u57ce\u5e02\u65b0\u95fb\u7f51icitynews<\/a> &raquo; <a href=\"https:\/\/icitynews.com\/?p=270791\">\u745e\u5fb7\u897f\u97e6\u83b7FDA \u201c\u5b64\u513f\u836f\u8d44\u683c\u201d\u5168\u7f8e\u9996\u6279\u4e34\u5e8a\u5b9e\u9a8c\u5df2\u4e8e\u5c14\u6e7e\u52a0\u5927\u533b\u5b66\u9662\u6295\u5165\u4f7f\u7528<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>\u636e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5b98\u7f51\u663e\u793a\uff0c\u5409\u5229\u5fb7\u79d1\u5b66\u516c\u53f8\uff08Gilead Sciences, Inc.\uff09\u7814\u5236\u7684\u5b9e\u9a8c\u836f\u7269\u745e\u59c6\u6614\u97e6\uff08Remdesivir\uff09\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6388\u4e88\u7684\u5b64\u513f\u836f [&hellip;]<\/p>\n","protected":false},"author":58,"featured_media":270795,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[23,9],"tags":[],"class_list":["post-270791","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-wechat_submit","category-la_local_news"],"_links":{"self":[{"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/posts\/270791","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/users\/58"}],"replies":[{"embeddable":true,"href":"https:\/\/icitynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=270791"}],"version-history":[{"count":0,"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/posts\/270791\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/icitynews.com\/index.php?rest_route=\/wp\/v2\/media\/270795"}],"wp:attachment":[{"href":"https:\/\/icitynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=270791"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/icitynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=270791"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/icitynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=270791"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}