{"id":1849,"date":"2025-03-24T14:18:09","date_gmt":"2025-03-24T06:18:09","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1849"},"modified":"2025-04-01T11:31:13","modified_gmt":"2025-04-01T03:31:13","slug":"%e7%be%8e%e5%9b%bdfda%e5%af%b9%e4%ba%8e%e4%b8%a5%e9%87%8d%e7%96%be%e7%97%85%e5%8a%a0%e9%80%9f%e8%ae%a1%e5%88%92-%e8%8d%af%e5%93%81%e6%9f%a5%e9%aa%8c%e7%99%bb%e8%ae%b0%e5%8a%a0%e9%80%9f%e6%a0%b8","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1849","title":{"rendered":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 1.)"},"content":{"rendered":"\n<p>\u7f8e\u56fdFDA\u4e8e2024\u5e7412\u6708\u9488\u5bf9\u300c\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated 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class=\"wp-block-list\">\n<li>\u662f\u5426\u4e3a\u4e25\u91cd\u75be\u75c5(Serious Condition)<\/li>\n\n\n\n<li>\u73b0\u6709\u6cbb\u7597\u9009\u62e9(Available Therapy)<\/li>\n\n\n\n<li>\u662f\u5426\u6709\u533b\u7597\u8feb\u5207\u9700\u6c42(Unmet Medical Needs)\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u7533\u8bf7\u8fc7\u7a0b\u4e2d\u76f8\u5173\u8981\u6c42\uff1a<\/p>\n\n\n\n<ol style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>\u98ce\u9669\u4e0e\u8003\u8651\uff1a<br>\u5c3d\u7ba1\u52a0\u901f\u6838\u51c6\u53ef\u7f29\u77ed\u836f\u54c1\u4e0a\u5e02\u65f6\u95f4\uff0c\u4f46\u7531\u4e8e\u8bd5\u9a8c\u6570\u636e\u8f83\u5c11\u6216\u89c4\u6a21\u8f83\u5c0f\uff0c\u53ef\u80fd\u5e26\u6765\u6f5c\u5728\u98ce\u9669\uff0c\u4f8b\u5982\u5c1a\u672a\u5b8c\u5168\u4e86\u89e3\u7684\u526f\u4f5c\u7528\u6216\u65e0\u6cd5\u8bc1\u5b9e\u9884\u671f\u7684\u4e34\u5e8a\u6548\u76ca\uff0c\u8fdb\u800c\u53ef\u80fd\u5bf9\u60a3\u8005\u5b89\u5168\u6027\u6784\u6210\u5a01\u80c1\u3002\u57fa\u4e8e\u524d\u8ff0\u8003\u8651\uff0c\u52a0\u901f\u6838\u51c6\u540e\uff0cFDA\u8981\u6c42\u5382\u5546\u8fdb\u884c\u786e\u8ba4\u6027\u8bd5\u9a8c\u4ee5\u9a8c\u8bc1\u4e34\u5e8a\u6548\u76ca\uff0c\u5426\u5219\u53ef\u80fd\u9762\u4e34\u64a4\u9500\u6838\u51c6\u7684\u98ce\u9669\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\u8bd5\u9a8c\u6307\u6807(Accelerated Approval Endpoints)\uff1a<br>1.\u66ff\u4ee3\u6307\u6807(Surrogate Endpoint)\uff1a<br>\u8fd9\u662f\u4e00\u79cd\u80fd\u9884\u6d4b\u4e34\u5e8a\u6548\u76ca\u4f46\u975e\u76f4\u63a5\u6d4b\u91cf\u4e34\u5e8a\u6548\u76ca\u7684\u6307\u9488\uff0c\u901a\u5e38\u4e0e\u751f\u7269\u6807\u8bb0(biomarker)\u76f8\u5173\u3002\u4f8b\u5982\uff1a(1)\u80ba\u7ed3\u6838\u6cbb\u7597\u4e2d\uff0c\u75f0\u6db2\u57f9\u517b\u7531\u9633\u6027\u8f6c\u4e3a\u9634\u6027\u7684\u8f6c\u5316\u65f6\u95f4\uff1b(2)\u975e\u9152\u7cbe\u6027\u8102\u80aa\u6027\u809d\u708e(noncirrhotic nonalcoholic steatohepatitis, NASH)\u4e2d\uff0c\u809d\u810f\u53d1\u708e\u6216\u7ea4\u7ef4\u5316\u7a0b\u5ea6\u7684\u51cf\u5c11\uff0c\u88ab\u8ba4\u4e3a\u80fd\u5408\u7406\u9884\u6d4b\u60a3\u8005\u7684\u957f\u671f\u4e34\u5e8a\u6548\u76ca\uff1b(3)\u5730\u4e2d\u6d77\u8d2b\u8840\u75c7\u60a3\u8005\u4e2d\uff0c\u94c1\u50a8\u91cf\u7684\u51cf\u5c11\u88ab\u8ba4\u4e3a\u53ef\u9884\u671f\u51cf\u5c11\u7531\u4f53\u5185\u94c1\u8fc7\u8f7d\u5f15\u8d77\u7684\u8f93\u8840\u76f8\u5173\u4e0d\u826f\u4e8b\u4ef6\u3002<br><br>2.\u4e2d\u95f4\u4e34\u5e8a\u6307\u6807(Intermediate Clinical Endpoints)\uff1a<br>\u8fd9\u662f\u4e00\u79cd\u80fd\u66f4\u65e9\u6d4b\u91cf\u6cbb\u7597\u6548\u679c\u7684\u6307\u6807\uff0c\u76f8\u8f83\u4e8e\u4e0d\u53ef\u9006\u7684\u53d1\u75c5\u7387\u6216\u6b7b\u4ea1\u7387\u6307\u6807\uff0c\u66f4\u5177\u63d0\u524d\u6027\u3002\u4f8b\u5982\uff0c\u5728\u6162\u6027\u75be\u75c5\u4e2d\uff0c\u77ed\u671f\u7684\u7597\u6548(\u5982\u6539\u5584\u529f\u80fd\u969c\u788d\u7684\u521d\u6b65\u6307\u9488)\u53ef\u80fd\u89c6\u4e3a\u9884\u6d4b\u957f\u671f\u6548\u76ca\u7684\u5408\u7406\u4f9d\u636e\u3002\u6307\u5f15\u4e2d\u63d0\u5230\u4e86\u4e00\u4e2a\u6848\u4f8b\uff1a\u4e00\u79cd\u9488\u5bf94\u81f317\u5c81\u7537\u5b69\u7684\u6d3b\u8dc3\u6027\u8111\u80be\u4e0a\u817a\u767d\u8d28\u5931\u517b(active cerebral adrenoleukodystrophy)\u7684\u7597\u6cd5\uff0c\u9996\u6b21\u795e\u7ecf\u529f\u80fd\u8bc4\u5206\u22671\u5206\u540e\u768424\u4e2a\u6708\u5185\u65e0\u91cd\u5927\u529f\u80fd\u969c\u788d(MFD-Free)\u7684\u5b58\u6d3b\u7387\u3002\u6b64\u6cbb\u7597\u83b7\u5f97FDA\u52a0\u901f\u6838\u51c6\uff0c\u5e76\u88ab\u8981\u6c42\u8fdb\u884c\u4e0a\u5e02\u540e\u7814\u7a76\u4ee5\u9a8c\u8bc1\u5176\u957f\u671fMFD-Free\u5b58\u6d3b\u7387\u3002<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"675\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/03\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-1-1024x675.png\" alt=\"VCRO \u7ef4\u5dde\u751f\u6280 \u4ea7\u4e1a\u65b0\u8baf 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https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/03\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-1-768x506.png 768w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/03\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-1.png 1346w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fdFDA\u4e8e2024\u5e7412\u6708\u9488\u5bf9\u300c\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Appro [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1850,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[53,19,147,143,149,145,144,24,47,25,26,45,141,148,146,150],"class_list":["post-1849","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","tag-fda","tag-vcro","tag-147","tag-143","tag-149","tag-145","tag-144","tag-24","tag-47","tag-25","tag-26","tag-45","tag-141","tag-148","tag-146","tag-150"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 1.) - VCRO<\/title>\r\n<meta name=\"description\" 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