{"id":435886,"date":"2026-02-24T07:42:39","date_gmt":"2026-02-24T07:42:39","guid":{"rendered":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/?p=435886"},"modified":"2026-04-30T10:21:09","modified_gmt":"2026-04-30T10:21:09","slug":"relacorilant-crl-fda-evidence-bar","status":"publish","type":"post","link":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/blog\/relacorilant-crl-fda-evidence-bar\/","title":{"rendered":"Relacorilant\uff1a\u5f53\u8bc1\u636e\u6ee1\u8db3\u65e2\u5b9a\u8bc1\u636e\u6807\u51c6\u65f6"},"content":{"rendered":"<p><i>\u672c\u535a\u5ba2\u6587\u7ae0\u662f\u6211\u4eec<a href=\"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/blog\/navigating-fda-complete-response-letters-clarivate\/\">\u7cfb\u5217<\/a>\u6587\u7ae0\u4e2d\u7684\u7b2c\u4e09\u7bc7\uff0c\u8be5\u7cfb\u5217\u63a2\u8ba8\u4e86\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u4e8e 2025 \u5e74 12 \u6708 23 \u65e5\u5c31\u8d5b\u8bfa\u83f2\uff08Sanofi\uff09\u7528\u4e8e\u6cbb\u7597\u975e\u590d\u53d1\u6027\u7ee7\u53d1\u8fdb\u5c55\u578b\u591a\u53d1\u6027\u786c\u5316\uff08non-relapsing secondary progressive multiple sclerosis\uff0cnrSP-MS\uff09\u7684<a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/blog\/tolebrutinib-when-safety-concerns-override-efficacy-signals\">Tolebrutinib<\/a>\uff0c\u4ee5\u53ca\u4e8e 2025 \u5e74 12 \u6708 30 \u65e5\u5c31 Corcept Therapeutics \u7528\u4e8e\u6cbb\u7597\u5e93\u6b23\u7efc\u5408\u5f81\u7684 Relacorilant \u6240\u53d1\u51fa\u7684\u5b8c\u6574\u56de\u590d\u51fd\uff08CRL\uff09\u3002\u8fd9\u4e24\u79cd\u836f\u7269\u5747\u88ab\u6536\u5f55\u5728<a href=\"https:\/\/clarivate.com.cn\/drugs-to-watch\/\">\u79d1\u777f\u552f\u5b89\u300a2026 \u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u9884\u6d4b\u300b\u62a5\u544a<\/a>\u4e2d\uff0c\u800c\u4e0a\u8ff0\u51b3\u5b9a\u662f\u5728\u8be5\u62a5\u544a\u5b9a\u7a3f\u540e\u505a\u51fa\u7684\u3002<\/i><\/p>\n<p>\u5728\u9488\u5bf9 <a href=\"https:\/\/corcept.gcs-web.com\/news-releases\/news-release-details\/corcept-receives-complete-response-letter-relacorilant-treatment\" target=\"_blank\" rel=\"noopener\">Relacorilant<\/a> \u7684 CRL \u4e2d\uff0cFDA \u7684\u7ed3\u8bba\u662f\uff0c\u201c\u5982\u679c Corcept \u4e0d\u63d0\u4f9b\u989d\u5916\u7684\u6709\u6548\u6027\u8bc1\u636e\uff0c\u5219\u65e0\u6cd5\u5bf9 Relacorilant \u505a\u51fa\u6709\u5229\u7684\u83b7\u76ca-\u98ce\u9669\u8bc4\u4f30\u201d\u3002\u8be5\u51fd\u5e76\u672a\u63d0\u53ca\u5bf9\u836f\u7269\u672c\u8eab\u7597\u6548\u6216\u5b89\u5168\u6027\u6570\u636e\u7684\u62c5\u5fe7\uff0c\u800c\u662f\u6307\u51fa\u8be5\u673a\u6784\u9700\u8981\u66f4\u591a\u8bc1\u636e\u6765\u660e\u786e\u8bc1\u5b9e\u83b7\u76ca\u5927\u4e8e\u98ce\u9669\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u4e34\u5e8a\u80cc\u666f<\/strong><\/h3>\n<p><a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/relacorilant\/\" target=\"_blank\" rel=\"noopener\">Relacorilant<\/a> \u662f\u4e00\u79cd\u9009\u62e9\u6027\u7cd6\u76ae\u8d28\u6fc0\u7d20\u53d7\u4f53\u62ee\u6297\u5242\uff08SGRA\uff09\uff0c\u53ef\u963b\u65ad\u76ae\u8d28\u9187\u4fe1\u53f7\u4f20\u5bfc\uff0c\u4e14\u4e0d\u4e0e\u5b55\u6fc0\u7d20\u53d7\u4f53\u7ed3\u5408\u2014\u2014\u8fd9\u662f\u5176\u4e0e\u73b0\u6709\u7597\u6cd5\u7684\u5173\u952e\u4f18\u52bf\u3002\u5728\u5f02\u8d28\u6027\u5e93\u6b23\u7efc\u5408\u5f81\u4eba\u7fa4\u4e2d\uff0c3 \u671f GRACE \u8bd5\u9a8c\u8fbe\u5230\u4e86\u5176\u4e3b\u8981\u7ec8\u70b9\uff0c\u8bc1\u660e\u5728\u60a3\u6709\u9ad8\u8840\u538b\u7684\u60a3\u8005\u4e2d\uff0c22 \u5468\u65f6\u6536\u7f29\u538b\u548c\u8212\u5f20\u538b\u5747\u6709\u663e\u8457\u6539\u5584\uff08\u5e73\u5747\u53d8\u5316\u5206\u522b\u4e3a -7.9 \u548c -5.1 mm Hg\uff0c\u4e24\u8005\u7684 <em>P <\/em>\u503c\u5747 &lt;.0001\uff09\u3002<\/p>\n<p>GRADIENT \u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u4e3a\u56e0\u80be\u4e0a\u817a\u817a\u7624\u6216\u80be\u4e0a\u817a\u589e\u751f\u5bfc\u81f4\u76ae\u8d28\u9187\u589e\u591a\u75c7\u7684\u60a3\u8005\uff0c\u8be5\u60a3\u8005\u4e9a\u7ec4\u8303\u56f4\u66f4\u7a84\uff0c\u8bd5\u9a8c\u663e\u793a\u4e86\u76f8\u4f3c\u7684\u8840\u538b\u63a7\u5236\u83b7\u76ca\uff08\u5728\u7b2c 22 \u5468\u65f6\uff0cRelacorilant \u6cbb\u7597\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec4\u7684\u6cbb\u7597\u5dee\u5f02\u4e3a -6.6 mm Hg vs -2.1 mm Hg\uff09\u3002\u5c3d\u7ba1 Relacorilant \u5e26\u6765\u7684\u8840\u538b\u964d\u4f4e\u5728\u7edf\u8ba1\u5b66\u548c\u4e34\u5e8a\u4e0a\u5747\u5177\u6709\u663e\u8457\u610f\u4e49\uff0c\u4f46 Relacorilant \u4e0e\u5b89\u6170\u5242\u4e4b\u95f4\u7684\u5dee\u5f02\u5e76\u4e0d\u663e\u8457\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u5e02\u573a\u5f71\u54cd<\/strong><\/h3>\n<p>\u5c3d\u7ba1\u5e93\u6b23\u7efc\u5408\u5f81\u6cbb\u7597\u836f\u7269\u5e02\u573a\u76f8\u5bf9\u8f83\u5c0f\uff0c\u4f46\u5b83\u4ee3\u8868\u7740\u4e00\u4e2a\u5de8\u5927\u7684\u673a\u9047\u3002\u8be5\u5e02\u573a\u5728 2025 \u5e74\u7684\u4f30\u503c\u4e3a 3.83 \u4ebf\u81f3 3.86 \u4ebf\u7f8e\u5143\uff0c\u9884\u8ba1\u5230 2030 \u5e74\u5c06\u4ee5 5.64% \u7684\u590d\u5408\u5e74\u589e\u957f\u7387\uff08CAGR\uff09\u589e\u957f\u3002Corcept \u66fe\u9884\u6d4b\uff0cRelacorilant \u5728\u83b7\u6279\u540e\u7684 3-5 \u5e74\u5185\uff0c\u5176\u6240\u6709\u9002\u5e94\u75c7\u7684\u5e74\u9500\u552e\u989d\u53ef\u8fbe 30 \u4ebf\u81f3 50 \u4ebf\u7f8e\u5143\uff0c\u8fd9\u610f\u5473\u7740\u5176\u5728\u76ae\u8d28\u9187\u589e\u591a\u75c7\u5e02\u573a\u53ef\u80fd\u5360\u636e 50-85% \u7684\u4efd\u989d\u3002<\/p>\n<p>Relacorilant \u7684\u7ade\u4e89\u5b9a\u4f4d\u96c6\u4e2d\u4e8e\u5176\u5dee\u5f02\u5316\u7684\u5b89\u5168\u6027\u7279\u5f81\u3002\u4e0e\u7c73\u975e\u53f8\u916e\uff08Korlym<sup>\u00ae<\/sup>\uff0c\u4e5f\u7531 Corcept \u751f\u4ea7\uff09\u4e0d\u540c\uff0cRelacorilant \u53ef\u907f\u514d\u4e0e\u5b55\u6fc0\u7d20\u53d7\u4f53\u7ed3\u5408\uff0c\u6709\u671b\u4f7f\u5987\u79d1\u4e0d\u826f\u4e8b\u4ef6\u53d1\u751f\u7387\u964d\u4f4e 70%\u3002\u8be5\u836f\u7269\u4e5f\u4e0d\u4f1a\u5f15\u8d77\u5176\u4ed6\u6cbb\u7597\u4e2d\u51fa\u73b0\u7684\u80be\u4e0a\u817a\u529f\u80fd\u4e0d\u5168\u6216\u4f4e\u94be\u8840\u75c7\u3002<\/p>\n<p>\u5728 CRL \u516c\u5e03\u540e\uff0cCorcept \u7684\u80a1\u4ef7\u4e0b\u8dcc\u4e86 50.4%\uff0c\u53cd\u6620\u4e86\u6295\u8d44\u8005\u7684\u53cd\u5e94\u4ee5\u53ca\u5bf9\u5f00\u53d1\u98ce\u9669\u7684\u91cd\u65b0\u8bc4\u4f30\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3>\u4e00\u7ebf\u5e0c\u671b\uff1a\u62d3\u5c55\u5375\u5de2\u764c\u9886\u57df<\/h3>\n<p>Relacorilant \u7684\u76d1\u7ba1\u4e4b\u8def\u4e0d\u6b62\u4e8e\u5e93\u6b23\u7efc\u5408\u5f81\u3002\u5176\u7528\u4e8e\u94c2\u8010\u836f\u6027\u5375\u5de2\u764c\u7684\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\u7684\u300a\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\u300b\uff08PDUFA\uff09\u51b3\u5b9a\u65e5\u671f\u4e3a 2026 \u5e74 7 \u6708 11 \u65e5\u30023 \u671f ROSELLA \u8bd5\u9a8c\u7684\u9633\u6027\u7ed3\u679c\u652f\u6301\u4e86\u8be5\u7533\u8bf7\uff1aRelacorilant \u8054\u5408\u767d\u86cb\u767d\u7ed3\u5408\u578b\u7d2b\u6749\u9187\u663e\u793a\u51fa\u66f4\u4f18\u7684\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff086.5 \u4e2a\u6708 vs 5.5 \u4e2a\u6708\uff09\u548c\u603b\u751f\u5b58\u671f\uff0816.0 \u4e2a\u6708 vs 11.5 \u4e2a\u6708\uff09\uff0c\u4e14\u6bd2\u6027\u4e0d\u5927\u4e8e\u5355\u7528\u767d\u86cb\u767d\u7ed3\u5408\u578b\u7d2b\u6749\u9187\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u8be5 CRL \u4ec5\u6d89\u53ca\u5e93\u6b23\u7efc\u5408\u5f81\uff0c\u5e76\u672a\u8868\u660e\u5b58\u5728\u7cfb\u7edf\u6027\u7684\u5b89\u5168\u6027\u6216\u7597\u6548\u9690\u5fe7\u201d\uff0c\u5e76\u4e14\u4e0e\u5375\u5de2\u764c\u7684\u63d0\u4ea4\u7533\u8bf7\u65e0\u5173\u3002<\/p>\n<p>\u672a\u6ee1\u8db3\u7684\u9700\u6c42\u5de8\u5927\uff0c\u76ee\u524d\u7528\u4e8e\u94c2\u8010\u836f\u6027\u5375\u5de2\u764c\u7684\u7597\u6548\u6301\u4e45\u6027\u6709\u9650\uff0c\u9884\u8ba1\u5230 2034 \u5e74\uff0c\u4e8c\u7ebf\u548c\u4e09\u7ebf\u94c2\u8010\u836f\u6027\u5375\u5de2\u764c\u836f\u7269\u5e02\u573a\u5c06\u8fbe\u5230 23 \u4ebf\u7f8e\u5143\uff0c\u5360\u4e3b\u8981\u5e02\u573a\u9500\u552e\u989d\u7684 39%\u3002<\/p>\n<h3><\/h3>\n<h3>\u79d1\u777f\u552f\u5b89\u5982\u4f55\u5e2e\u52a9\u5e94\u5bf9\u76d1\u7ba1\u6311\u6218<\/h3>\n<h4>Cortellis \u5168\u7403\u836f\u653f\u6cd5\u89c4\u60c5\u62a5\u6570\u636e\u5e93 + AI \u8d4b\u80fd\u7684\u6cd5\u89c4\u52a9\u624b<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/research-development\/regulatory-compliance-intelligence\/regulatory-intelligence-solutions\/\" target=\"_blank\" rel=\"noopener\">Cortellis \u5168\u7403\u836f\u653f\u6cd5\u89c4\u60c5\u62a5\u6570\u636e\u5e93<\/a>\u63d0\u4f9b\u5173\u952e\u7684\u76d1\u7ba1\u60c5\u62a5\uff0c\u5c06\u5e7f\u6cdb\u800c\u6df1\u5165\u7684\u89c1\u89e3\u4e0e\u4e3b\u9898\u4e13\u4e1a\u77e5\u8bc6\u76f8\u7ed3\u5408\uff0c<a href=\"https:\/\/clarivate.com.cn\/news\/clarivate-presents-cortellis-regulatory-ai-assistant\/\">\u73b0\u5728\u901a\u8fc7\u6cd5\u89c4\u52a9\u624b\uff0c\u5229\u7528 AI \u8d4b\u80fd\u7684\u529f\u80fd\u589e\u5f3a<\/a>\u4e86\u76d1\u7ba1\u60c5\u62a5\u3002Corcept \u9762\u4e34\u7740\u4e00\u4e2a\u9519\u7efc\u590d\u6742\u7684\u76d1\u7ba1\u6311\u6218\uff1aFDA \u627f\u8ba4\u4e86\u4ed6\u4eec\u7684\u6570\u636e\uff0c\u4f46\u8981\u6c42\u63d0\u4f9b\u66f4\u591a\u6570\u636e\u3002\u6cd5\u89c4\u52a9\u624b\u53ef\u4ee5\u5e2e\u52a9 Corcept \u51c6\u786e\u7406\u89e3\u201c\u989d\u5916\u8bc1\u636e\u201d\u5728\u5ba1\u8bc4\u8bed\u5883\u4e0b\u7684\u5177\u4f53\u5b9a\u4e49\u3002<\/p>\n<p><strong>\u4e86\u89e3 FDA \u7684\u8bc1\u636e\u6807\u51c6\u548c\u6210\u529f\u5148\u4f8b<\/strong><\/p>\n<ul>\n<li><strong>\u67e5\u8be2\u83b7\u6279\u9014\u5f84\u7684\u5148\u4f8b\uff1a<\/strong>\u4e3a\u4e86\u89e3\u7c7b\u4f3c\u60c5\u51b5\u548c\u6210\u529f\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u6cd5\u89c4\u52a9\u624b\u7684\u67e5\u8be2\u53ef\u4ee5\u5305\u62ec\u201c\u663e\u793a\u5728\u7f55\u89c1\u5185\u5206\u6ccc\u75be\u75c5\u4e2d\u56e0\u2018\u8bc1\u636e\u4e0d\u8db3\u2019\u6536\u5230 CRL \u540e\u6210\u529f\u91cd\u65b0\u63d0\u4ea4\u7684\u6848\u4f8b\u201d\u6216\u201c\u5206\u6790 FDA \u5728\u5c0f\u60a3\u8005\u7fa4\u4f53\u4e2d\u8fdb\u884c\u83b7\u76ca-\u98ce\u9669\u8bc4\u4f30\u7684\u8bc1\u636e\u6807\u51c6\u201d\u3002<\/li>\n<li><strong>\u8bc1\u636e\u6807\u51c6\u6bd4\u8f83\uff1a<\/strong>Corcept \u53ef\u4ee5\u5206\u6790\u8de8\u533a\u57df\u7684\u76d1\u7ba1\u7b56\u7565\u6bd4\u8f83\u8bc4\u4f30\uff0c\u4ee5\u4e86\u89e3\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08European Medicines Agency\uff0cEMA\uff09\u5bf9\u76ae\u8d28\u9187\u589e\u591a\u75c7\u7684\u8bc1\u636e\u6807\u51c6\u662f\u5426\u4e0e FDA \u4e0d\u540c\uff0c\u4ece\u800c\u4e3a\u5176\u6b27\u76df\u63d0\u4ea4\u7b56\u7565\u548c\u5411 FDA \u91cd\u65b0\u63d0\u4ea4\u7533\u8bf7\u7684\u6f5c\u5728\u8bba\u70b9\u63d0\u4f9b\u4fe1\u606f\u3002<\/li>\n<li><strong>\u52a0\u901f\u9014\u5f84\u5206\u6790\uff1a<\/strong>\u8be5\u5e73\u53f0\u53ef\u4ee5\u5e2e\u52a9\u63a2\u7d22\u6765\u81ea\u5f85\u6279\u51c6\u7684\u5375\u5de2\u764c\u9002\u5e94\u75c7\uff08PDUFA \u65e5\u671f\uff1a2026 \u5e74 7 \u6708 11 \u65e5\uff09\u7684\u989d\u5916\u6570\u636e\u662f\u5426\u53ef\u4ee5\u652f\u6301\u5e93\u6b23\u7efc\u5408\u5f81\u7684\u91cd\u65b0\u63d0\u4ea4\uff0c\u5e76\u7814\u7a76\u591a\u9002\u5e94\u75c7\u6570\u636e\u52a0\u5f3a\u83b7\u76ca-\u98ce\u9669\u8bba\u8bc1\u7684\u5148\u4f8b\u3002<\/li>\n<\/ul>\n<h4>DRG Fusion<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/real-world-data\/drg-fusion\/\" target=\"_blank\" rel=\"noopener\">DRG Fusion<\/a> \u7531\u72ec\u7279\u8fde\u63a5\u7684\u771f\u5b9e\u4e16\u754c\u6570\u636e\u548c AI \u9a71\u52a8\u7684\u4f53\u9a8c\u63d0\u4f9b\u652f\u6301\uff0c\u80fd\u591f\u4ece\u4efb\u4f55\u89d2\u5ea6\u8fdb\u884c\u75be\u75c5\u5206\u6790\u3002<\/p>\n<p><strong>\u4ece\u771f\u5b9e\u4e16\u754c\u6765\u6e90\u751f\u6210\u652f\u6301\u6027\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u8bc1\u636e<\/strong><\/p>\n<ul>\n<li><strong>\u81ea\u7136\u75c5\u7a0b\u6bd4\u8f83\uff1a<\/strong>DRG Fusion \u7684\u7efc\u5408\u4fdd\u9669\u7406\u8d54\u6570\u636e\u53ef\u4ee5\u63cf\u8ff0\u672a\u7ecf\u6cbb\u7597\u6216\u6cbb\u7597\u4e0d\u5145\u5206\u7684\u5e93\u6b23\u7efc\u5408\u5f81\u5728\u771f\u5b9e\u4e16\u754c\u4e2d\u7684\u8fdb\u5c55\uff0c\u63d0\u4f9b\u81ea\u7136\u75c5\u7a0b\u6bd4\u8f83\uff0c\u4ece\u800c\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u63d0\u4f9b\u80cc\u666f\u53c2\u8003\uff0c\u5e76\u8bc1\u660e\u5176\u4e34\u5e8a\u610f\u4e49\u3002<\/li>\n<li><strong>\u7c73\u975e\u53f8\u916e\u7684\u771f\u5b9e\u4e16\u754c\u6709\u6548\u6027\uff1a<\/strong>Corcept \u7684\u9996\u6b3e\u836f\u7269\u7c73\u975e\u53f8\u916e\uff08Korlym\uff09\u4e3a\u5e93\u6b23\u7efc\u5408\u5f81\u60a3\u8005\u5728\u771f\u5b9e\u4e16\u754c\u4e2d\u7684\u6709\u6548\u6027\u6a21\u5f0f\u3001\u53cd\u5e94\u6301\u4e45\u6027\u548c\u957f\u671f\u5b89\u5168\u6027\u63d0\u4f9b\u4e86\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff0c\u8fd9\u53ef\u80fd\u652f\u6301 SGRAs \u7684\u7c7b\u6548\u5e94\u8bba\u8bc1\uff0c\u6216\u8bc1\u660e Relacorilant \u7684\u5dee\u5f02\u5316\u7279\u5f81\u3002<\/li>\n<li><strong>\u60a3\u8005\u65c5\u7a0b\u5206\u6790\uff1a<\/strong>\u8be5\u5e73\u53f0\u7684\u60a3\u8005\u8bca\u7597\u8def\u5f84\u5206\u6790\u6a21\u5757\u53ef\u4ee5\u63cf\u7ed8\u5e93\u6b23\u7efc\u5408\u5f81\u60a3\u8005\u7684\u4f53\u9a8c\uff0c\u5c55\u793a\u6cbb\u7597\u5dee\u8ddd\u3001\u672a\u6ee1\u8db3\u7684\u9700\u6c42\u4ee5\u53ca Relacorilant \u53ef\u5728\u54ea\u4e9b\u4e34\u5e8a\u60c5\u5883\u4e0b\u63d0\u4f9b\u6709\u610f\u4e49\u7684\u83b7\u76ca\uff0c\u4ece\u800c\u52a0\u5f3a\u4e34\u5e8a\u610f\u4e49\u7684\u8bba\u8bc1\u3002<\/li>\n<li><strong>\u957f\u671f\u5b89\u5168\u6027\u9a8c\u8bc1\uff1a<\/strong>\u771f\u5b9e\u4e16\u754c\u7684\u5b89\u5168\u6027\u6570\u636e\u53ef\u4ee5\u8865\u5145\u8bd5\u9a8c\u8bc1\u636e\uff0c\u8bc1\u660e\u53ef\u63a5\u53d7\u7684\u957f\u671f\u8010\u53d7\u6027\u7279\u5f81\uff0c\u4ece\u800c\u52a0\u5f3a\u83b7\u76ca-\u98ce\u9669\u8bc4\u4f30\u3002<\/li>\n<\/ul>\n<h4>Cortellis \u4e34\u5e8a\u8bd5\u9a8c\u60c5\u62a5\u6570\u636e\u5e93<\/h4>\n<p><a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/research-development\/discovery-development\/cortellis-clinical-trials-intelligence\/\">Cortellis \u4e34\u5e8a\u8bd5\u9a8c\u60c5\u62a5\u6570\u636e\u5e93<\/a>\u63d0\u4f9b\u5173\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u5c55\u3001\u7ade\u4e89\u5bf9\u624b\u7b56\u7565\u548c\u65b9\u6848\u8bbe\u8ba1\u4f18\u5316\u7684\u89c1\u89e3\uff0c\u5982\u679c\u9700\u8981\uff0c\u8fd9\u6709\u52a9\u4e8e\u4f18\u5316\u989d\u5916\u7684\u524d\u77bb\u6027\u7814\u7a76\u3002<\/p>\n<p><strong>\u8bbe\u8ba1\u5177\u6709\u6700\u9ad8\u6210\u529f\u6982\u7387\u7684\u9776\u5411\u6027\u989d\u5916\u7814\u7a76\uff08\u5982\u679c\u9700\u8981\uff09<\/strong><\/p>\n<ul>\n<li><strong>\u7ec8\u70b9\u9009\u62e9\uff1a<\/strong>\u5bf9\u4e8e\u76ae\u8d28\u9187\u589e\u591a\u75c7\uff0cCorcept \u53ef\u4ee5\u5bf9\u7f55\u89c1\u5185\u5206\u6ccc\u75be\u75c5\u4e2d\u54ea\u4e9b\u7ec8\u70b9\uff08\u8840\u538b\u63a7\u5236\u3001\u8461\u8404\u7cd6\u4ee3\u8c22\u3001\u751f\u6d3b\u8d28\u91cf\u3001\u4f53\u91cd\u51cf\u8f7b\uff09\u5bf9\u76d1\u7ba1\u673a\u6784\u6700\u5177\u8bf4\u670d\u529b\u8fdb\u884c\u5bf9\u6807\u5206\u6790\u3002<\/li>\n<li><strong>\u7814\u7a76\u4e2d\u5fc3\u9009\u62e9\u4f18\u5316\uff1a<\/strong>\u5728 200 \u4e2a\u56fd\u5bb6\u7684\u8d85\u8fc7 27.7 \u4e07\u4e2a\u7814\u7a76\u4e2d\u5fc3\u4e2d\uff0cCorcept \u53ef\u4ee5\u8bc6\u522b\u51fa\u5177\u6709\u7ecf\u8bc1\u5b9e\u7684\u5e93\u6b23\u75c5\u4e13\u4e1a\u77e5\u8bc6\u548c\u60a3\u8005\u8d44\u6e90\u7684\u5185\u5206\u6ccc\u4e2d\u5fc3\uff0c\u8fd9\u5bf9\u7f55\u89c1\u75c5\u800c\u8a00\u662f\u4e00\u4e2a\u5173\u952e\u8003\u91cf\u56e0\u7d20\u3002<\/li>\n<li><strong>\u65b9\u6848\u53ef\u884c\u6027\uff1a<\/strong>\u8be5\u5e73\u53f0\u53ef\u4ee5\u901a\u8fc7\u4e86\u89e3\u6210\u529f\u7684\u65b9\u6848\u3001\u7814\u7a76\u4e2d\u5fc3\u548c\u60a3\u8005\u7ec6\u5206\uff0c\u5e76\u8bc4\u4ef7\u6574\u5408\u4e86\u6d41\u884c\u75c5\u5b66\u6570\u636e\u3001\u7814\u7a76\u4e2d\u5fc3\u53ef\u7528\u6027\u548c\u62db\u52df\u60c5\u51b5\u7684\u5e7f\u6cdb\u7814\u7a76\u4e2d\u5fc3\u60c5\u62a5\uff0c\u4ee5\u8fdb\u884c\u5f7b\u5e95\u7684\u8bd5\u9a8c\u53ef\u884c\u6027\u5206\u6790\u3002<\/li>\n<li><strong>\u5206\u5c42\u7b56\u7565\uff1a<\/strong>\u5206\u6790\u7f55\u89c1\u5185\u5206\u6ccc\u75be\u75c5\u8bd5\u9a8c\u4e2d\u6210\u529f\u7684\u60a3\u8005\u5206\u5c42\u65b9\u6cd5\uff0c\u53ef\u4ee5\u4f18\u5316\u65b9\u6848\u8bbe\u8ba1\uff0c\u4ee5\u8bc1\u660e\u5728\u5f02\u8d28\u6027\u60a3\u8005\u7fa4\u4f53\u4e2d\u7684\u83b7\u76ca\u3002<\/li>\n<\/ul>\n<h4>\u6d41\u884c\u75c5\u5b66\u60c5\u62a5<\/h4>\n<p><a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/portfolio-strategy\/market-assessment\/epidemiology-intelligence\/\">\u6d41\u884c\u75c5\u5b66\u60c5\u62a5<\/a>\u901a\u8fc7\u5bf9 1,000 \u591a\u79cd\u75be\u75c5\u548c\u64cd\u4f5c\u7684\u53d1\u75c5\u7387\u548c\u60a3\u75c5\u7387\u6587\u732e\u8fdb\u884c\u7efc\u5408\u56de\u987e\uff0c\u5e2e\u52a9\u8bc4\u4f30\u5e02\u573a\u89c4\u6a21\u548c\u4e86\u89e3\u60a3\u8005\u7fa4\u4f53\u3002<\/p>\n<p><strong>\u5b9a\u4e49\u5177\u6709\u6700\u660e\u786e\u83b7\u76ca\u7684\u5e93\u6b23\u75c5\u4e9a\u7fa4<\/strong><\/p>\n<ul>\n<li><strong>\u63cf\u8ff0\u5e93\u6b23\u7efc\u5408\u5f81\u4e9a\u7fa4\u7279\u5f81\uff1a<\/strong>\u8be5\u5e73\u53f0\u80fd\u591f\u6839\u636e\u75c5\u56e0\uff08\u5782\u4f53\u6027\u3001\u80be\u4e0a\u817a\u6027\u3001\u5f02\u4f4d\u6027\uff09\u3001\u75be\u75c5\u4e25\u91cd\u7a0b\u5ea6\u548c\u5408\u5e76\u75c7\u7279\u5f81\u8fdb\u884c\u5b9a\u4e49\u3002<\/li>\n<li><strong>\u91cf\u5316\u76ee\u6807\u60a3\u8005\u7fa4\u4f53\uff1a<\/strong> \u53ef\u4ee5\u5bf9\u9776\u5411\u6027\u76d1\u7ba1\u548c\u5546\u4e1a\u7b56\u7565\u8fdb\u884c\u538b\u529b\u6d4b\u8bd5\u3002<\/li>\n<li><strong>\u652f\u6301\u7cbe\u51c6\u9776\u5411\u8bba\u70b9\uff1a<\/strong> \u53ef\u4ee5\u786e\u5b9a\u54ea\u4e9b\u7b56\u7565\u5728\u660e\u786e\u5b9a\u4e49\u7684\u7ec6\u5206\u5e02\u573a\u4e2d\u663e\u793a\u51fa\u6709\u610f\u4e49\u7684\u4e34\u5e8a\u83b7\u76ca\u3002<\/li>\n<\/ul>\n<p>\u6211\u4eec\u4e4b\u524d\u7684\u535a\u5ba2\u6587\u7ae0 <a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/blog\/tolebrutinib-crl-safety-overrides-efficacy\">Tolebrutinib\uff1a\u5f53\u5b89\u5168\u6027\u62c5\u5fe7\u8d85\u8fc7\u7597\u6548\u4fe1\u53f7\u65f6<\/a>\uff0c\u8ba8\u8bba\u4e86 Tolebrutinib \u7684 CRL \u6240\u5e26\u6765\u7684\u5f71\u54cd\uff0c\u4ee5\u53ca\u53ef\u4fe1\u7684\u60c5\u62a5\u5982\u4f55\u5e2e\u52a9\u89e3\u51b3 FDA \u7684\u62c5\u5fe7\u3002\u672c\u7cfb\u5217\u7684\u4e0b\u4e00\u7bc7\u4e5f\u662f\u6700\u540e\u4e00\u7bc7\u6587\u7ae0\u5c06\u63a2\u8ba8<a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/blog\/what-comes-after-fda-complete-response-letter\">\u8d5b\u8bfa\u83f2\u548c Corcept \u7684\u4e00\u4e9b\u542f\u793a\uff0c\u4ee5\u53ca\u516c\u53f8\u5982\u4f55\u4ece CRL \u4e2d<\/a>\u5bfb\u6c42\u7834\u5c40\u4e4b\u9053\u3002<\/p>\n<p><i>\u4e86\u89e3\u66f4\u591a\u5173\u4e8e<a href=\"https:\/\/clarivate.com.cn\/drugs-to-watch\/\">\u300a2026 \u5e74\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u9884\u6d4b\u300b<\/a>\u7684\u4fe1\u606f\uff0c\u60a8\u8fd8\u53ef\u4ee5\u9605\u8bfb<a href=\"https:\/\/clarivate.com\/ai\/\" target=\"_blank\" rel=\"noopener\">\u79d1\u777f\u552f\u5b89\u5982\u4f55\u4f7f\u7528 AI \u5de5\u5177<\/a>\u6765\u8d4b\u80fd\u5176\u5ba2\u6237\u66f4\u5feb\u5730\u505a\u51fa\u66f4\u597d\u7684\u51b3\u7b56\u3002<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u672c\u535a\u5ba2\u6587\u7ae0\u662f\u6211\u4eec\u7cfb\u5217\u6587\u7ae0\u4e2d\u7684\u7b2c\u4e09\u7bc7\uff0c\u8be5\u7cfb\u5217\u63a2\u8ba8\u4e86\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u4e8e 2025 \u5e74 12 \u6708 23 \u65e5\u5c31\u8d5b\u8bfa\u83f2\uff08Sanofi\uff09\u7528\u4e8e\u6cbb\u7597\u975e\u590d\u53d1\u6027\u7ee7\u53d1\u8fdb\u5c55\u578b\u591a\u53d1\u6027\u786c\u5316\uff08non-relapsing secondary progressive multiple sclerosis\uff0cnrSP-MS\uff09\u7684Tolebrutinib\uff0c\u4ee5\u53ca\u4e8e 2025 \u5e74 12 \u6708 30 \u65e5\u5c31 Corcept Therapeutics \u7528\u4e8e\u6cbb\u7597\u5e93\u6b23\u7efc\u5408\u5f81\u7684 Relacorilant \u6240\u53d1\u51fa\u7684\u5b8c\u6574\u56de\u590d\u51fd\uff08CRL\uff09\u3002<\/p>\n","protected":false},"author":7,"featured_media":435889,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[3,43],"tags":[66,73,69,74,50,55,56],"class_list":["post-435886","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-healthcare","category-biopharma","tag-fda","tag-clinical-trials","tag-market-access","tag-top-drugs","tag-real-world-data","tag-us-market","tag-pharmaceutical-regulations"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-22 03:58:54","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/435886","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=435886"}],"version-history":[{"count":7,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/435886\/revisions"}],"predecessor-version":[{"id":435922,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/435886\/revisions\/435922"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/435889"}],"wp:attachment":[{"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=435886"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=435886"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=435886"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}