{"id":1991,"date":"2025-03-24T14:11:44","date_gmt":"2025-03-24T06:11:44","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=1991"},"modified":"2025-04-01T11:27:38","modified_gmt":"2025-04-01T03:27:38","slug":"%e7%be%8e%e5%9c%8bfda%e5%b0%8d%e6%96%bc%e5%9a%b4%e9%87%8d%e7%96%be%e7%97%85%e5%8a%a0%e9%80%9f%e8%a8%88%e7%95%ab-%e8%97%a5%e5%93%81%e6%9f%a5%e9%a9%97%e7%99%bb%e8%a8%98%e5%8a%a0%e9%80%9f%e6%a0%b8","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1991","title":{"rendered":"\u7f8e\u570bFDA\u5c0d\u65bc\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u767c\u5e03\u6307\u5f15\u8349\u6848 (Part 1.)"},"content":{"rendered":"\n<p>\u7f8e\u570bFDA\u65bc2024\u5e7412\u6708\u91dd\u5c0d\u300c\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6 (Accelerated 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class=\"wp-block-list\">\n<li>\u662f\u5426\u70ba\u56b4\u91cd\u75be\u75c5(Serious Condition)<\/li>\n\n\n\n<li>\u73fe\u6709\u6cbb\u7642\u9078\u64c7(Available Therapy)<\/li>\n\n\n\n<li>\u662f\u5426\u6709\u91ab\u7642\u8feb\u5207\u9700\u6c42(Unmet Medical Needs)\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u7533\u8acb\u904e\u7a0b\u4e2d\u76f8\u95dc\u8981\u6c42\uff1a<\/p>\n\n\n\n<ol start=\"1\" style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>\u98a8\u96aa\u8207\u8003\u91cf\uff1a<br>\u5118\u7ba1\u52a0\u901f\u6838\u51c6\u53ef\u7e2e\u77ed\u85e5\u54c1\u4e0a\u5e02\u6642\u9593\uff0c\u4f46\u7531\u65bc\u8a66\u9a57\u6578\u64da\u8f03\u5c11\u6216\u898f\u6a21\u8f03\u5c0f\uff0c\u53ef\u80fd\u5e36\u4f86\u6f5b\u5728\u98a8\u96aa\uff0c\u4f8b\u5982\u5c1a\u672a\u5b8c\u5168\u4e86\u89e3\u7684\u526f\u4f5c\u7528\u6216\u7121\u6cd5\u8b49\u5be6\u9810\u671f\u7684\u81e8\u5e8a\u6548\u76ca\uff0c\u9032\u800c\u53ef\u80fd\u5c0d\u60a3\u8005\u5b89\u5168\u6027\u69cb\u6210\u5a01\u8105\u3002\u57fa\u65bc\u524d\u8ff0\u8003\u91cf\uff0c\u52a0\u901f\u6838\u51c6\u5f8c\uff0cFDA\u8981\u6c42\u5ee0\u5546\u9032\u884c\u78ba\u8a8d\u6027\u8a66\u9a57\u4ee5\u9a57\u8b49\u81e8\u5e8a\u6548\u76ca\uff0c\u5426\u5247\u53ef\u80fd\u9762\u81e8\u64a4\u92b7\u6838\u51c6\u7684\u98a8\u96aa\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"2\" style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>\u52a0\u901f\u6838\u51c6\u4e4b\u8a66\u9a57\u6307\u6a19(Accelerated Approval Endpoints)\uff1a<br>1.\u66ff\u4ee3\u6307\u6a19(Surrogate Endpoint)\uff1a<br>\u9019\u662f\u4e00\u7a2e\u80fd\u9810\u6e2c\u81e8\u5e8a\u6548\u76ca\u4f46\u975e\u76f4\u63a5\u6e2c\u91cf\u81e8\u5e8a\u6548\u76ca\u7684\u6307\u6a19\uff0c\u901a\u5e38\u8207\u751f\u7269\u6a19\u8a18(biomarker)\u76f8\u95dc\u3002\u4f8b\u5982\uff1a(1)\u80ba\u7d50\u6838\u6cbb\u7642\u4e2d\uff0c\u75f0\u6db2\u57f9\u990a\u7531\u967d\u6027\u8f49\u70ba\u9670\u6027\u7684\u8f49\u5316\u6642\u9593\uff1b(2)\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e(noncirrhotic nonalcoholic steatohepatitis, NASH)\u4e2d\uff0c\u809d\u81df\u767c\u708e\u6216\u7e96\u7dad\u5316\u7a0b\u5ea6\u7684\u6e1b\u5c11\uff0c\u88ab\u8a8d\u70ba\u80fd\u5408\u7406\u9810\u6e2c\u60a3\u8005\u7684\u9577\u671f\u81e8\u5e8a\u6548\u76ca\uff1b(3)\u5730\u4e2d\u6d77\u8ca7\u8840\u75c7\u60a3\u8005\u4e2d\uff0c\u9435\u5132\u91cf\u7684\u6e1b\u5c11\u88ab\u8a8d\u70ba\u53ef\u9810\u671f\u6e1b\u5c11\u7531\u9ad4\u5167\u9435\u904e\u8f09\u5f15\u8d77\u7684\u8f38\u8840\u76f8\u95dc\u4e0d\u826f\u4e8b\u4ef6\u3002<br><br>2.\u4e2d\u9593\u81e8\u5e8a\u6307\u6a19(Intermediate Clinical Endpoints)\uff1a<br>\u9019\u662f\u4e00\u7a2e\u80fd\u66f4\u65e9\u6e2c\u91cf\u6cbb\u7642\u6548\u679c\u7684\u6307\u6a19\uff0c\u76f8\u8f03\u65bc\u4e0d\u53ef\u9006\u7684\u767c\u75c5\u7387\u6216\u6b7b\u4ea1\u7387\u6307\u6a19\uff0c\u66f4\u5177\u63d0\u524d\u6027\u3002\u4f8b\u5982\uff0c\u5728\u6162\u6027\u75be\u75c5\u4e2d\uff0c\u77ed\u671f\u7684\u7642\u6548(\u5982\u6539\u5584\u529f\u80fd\u969c\u7919\u7684\u521d\u6b65\u6307\u6a19)\u53ef\u80fd\u8996\u70ba\u9810\u6e2c\u9577\u671f\u6548\u76ca\u7684\u5408\u7406\u4f9d\u64da\u3002\u6307\u5f15\u4e2d\u63d0\u5230\u4e86\u4e00\u500b\u6848\u4f8b\uff1a\u4e00\u7a2e\u91dd\u5c0d4\u81f317\u6b72\u7537\u5b69\u7684\u6d3b\u8e8d\u6027\u8166\u814e\u4e0a\u817a\u767d\u8cea\u5931\u990a(active cerebral adrenoleukodystrophy)\u7684\u7642\u6cd5\uff0c\u9996\u6b21\u795e\u7d93\u529f\u80fd\u8a55\u5206\u22671\u5206\u5f8c\u768424\u500b\u6708\u5167\u7121\u91cd\u5927\u529f\u80fd\u969c\u7919(MFD-Free)\u7684\u5b58\u6d3b\u7387\u3002\u6b64\u6cbb\u7642\u7372\u5f97FDA\u52a0\u901f\u6838\u51c6\uff0c\u4e26\u88ab\u8981\u6c42\u9032\u884c\u4e0a\u5e02\u5f8c\u7814\u7a76\u4ee5\u9a57\u8b49\u5176\u9577\u671fMFD-Free\u5b58\u6d3b\u7387\u3002<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"675\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/03\/\u7f8e\u570bFDA\u5c0d\u65bc\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u767c\u5e03\u6307\u5f15\u8349\u6848-Part-1-1024x675.png\" alt=\"VCRO \u7dad\u5dde\u751f\u7269\u79d1\u6280 \u7522\u696d\u65b0\u8a0a 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https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/03\/\u7f8e\u570bFDA\u5c0d\u65bc\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u767c\u5e03\u6307\u5f15\u8349\u6848-Part-1-768x506.png 768w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2025\/03\/\u7f8e\u570bFDA\u5c0d\u65bc\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u767c\u5e03\u6307\u5f15\u8349\u6848-Part-1.png 1346w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570bFDA\u65bc2024\u5e7412\u6708\u91dd\u5c0d\u300c\u56b4\u91cd\u75be\u75c5\u52a0\u901f\u8a08\u756b-\u85e5\u54c1\u67e5\u9a57\u767b\u8a18\u52a0\u901f\u6838\u51c6 (Accelerated Appro 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