{"id":435890,"date":"2026-02-24T07:44:41","date_gmt":"2026-02-24T07:44:41","guid":{"rendered":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/?p=435890"},"modified":"2026-03-30T09:40:14","modified_gmt":"2026-03-30T09:40:14","slug":"what-comes-after-fda-complete-response-letter","status":"publish","type":"post","link":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/blog\/what-comes-after-fda-complete-response-letter\/","title":{"rendered":"\u524d\u8fdb\u4e4b\u8def\uff1a\u6536\u5230 CRL \u540e\u8be5\u4f55\u53bb\u4f55\u4ece\uff1f"},"content":{"rendered":"<p><i>\u672c\u7bc7\u535a\u6587\u662f\u6211\u4eec <a href=\"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/blog\/navigating-fda-complete-response-letters-clarivate\/\">\u7cfb\u5217\u6587\u7ae0<\/a> \u7684\u6700\u540e\u4e00\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\/drugs-to-watch\/drugs-to-watch-listing\/tolebrutinib\/\" target=\"_blank\" rel=\"noopener\">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 <a href=\"https:\/\/clarivate.com\/drugs\/to-watch\/drugs-to-watch-listing\/relacorilant\/\" target=\"_blank\" rel=\"noopener\">Relacorilant<\/a> \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>\u9762\u5bf9 CRL \u5e26\u6765\u7684\u6311\u6218\uff0c\u8d5b\u8bfa\u83f2\u548c Corcept Therapeutics \u7b49\u516c\u53f8\u9762\u4e34\u7740\u5173\u4e8e\u540e\u7eed\u6b65\u9aa4\u7684\u5173\u952e\u51b3\u7b56\u3002\u5173\u4e8e CRL \u7684\u5386\u53f2\u5148\u4f8b\u8868\u660e\uff0c\u5b83\u4eec\u7684\u836f\u7269 Tolebrutinib \u548c Relacorilant \u90fd\u6709\u53ef\u80fd\u901a\u8fc7\u751f\u6210\u989d\u5916\u8bc1\u636e\u3001\u5b8c\u5584\u98ce\u9669\u7ba1\u7406\u7b56\u7565\u6216\u91cd\u65b0\u5b9a\u4f4d\u81f3\u4e0d\u540c\u60a3\u8005\u4eba\u7fa4\u7b49\u9014\u5f84\uff0c\u6700\u7ec8\u83b7\u5f97\u6279\u51c6\u3002\u5927\u591a\u6570\u6536\u5230 CRL \u7684\u836f\u7269\u6700\u7ec8\u90fd\u80fd\u83b7\u5f97\u6279\u51c6\uff0c\u4f46\u6839\u636e\u6240\u9700\u7684\u8865\u6551\u63aa\u65bd\uff0c\u65f6\u95f4\u8868\u5dee\u5f02\u5f88\u5927\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Tolebrutinib \u7684\u524d\u8fdb\u4e4b\u8def<\/strong><\/h3>\n<p>\u8d5b\u8bfa\u83f2\u7684\u524d\u8fdb\u4e4b\u8def\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u53d6\u51b3\u4e8e\u89e3\u51b3\u836f\u7269\u8bf1\u5bfc\u7684\u809d\u635f\u4f24\uff08drug-induced liver injury\uff0cDILI\uff09\u98ce\u9669\uff0c\u8fd9\u53ef\u80fd\u9700\u8981\u5229\u7528\u6b64\u524d\u672a\u8fbe\u7ec8\u70b9\u7684\u539f\u53d1\u8fdb\u5c55\u578b\u591a\u53d1\u6027\u786c\u5316\uff08primary progressive multiple sclerosis\uff0cPP-MS\uff09\u7814\u7a76\u7684\u6570\u636e\u3002FDA \u6307\u51fa\uff0c\u5728\u8d5b\u8bfa\u83f2\u6539\u4e3a\u6bcf\u5468\u8fdb\u884c\u809d\u810f\u76d1\u6d4b\u540e\uff0c\u672a\u518d\u53d1\u751f\u5bfc\u81f4\u6b7b\u4ea1\u6216\u79fb\u690d\u7684 DILI \u75c5\u4f8b\uff0c\u8fd9\u8868\u660e\u76d1\u6d4b\u5f3a\u5ea6\u81f3\u5173\u91cd\u8981\u3002\u8d5b\u8bfa\u83f2\u8868\u793a\uff0c\u5176\u201c\u575a\u4fe1 <a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/tolebrutinib\/\" target=\"_blank\" rel=\"noopener\">Tolebrutinib<\/a> \u7684\u98ce\u9669\u6548\u76ca\u7279\u5f81\u201d\uff0c\u8868\u660e\u8be5\u516c\u53f8\u6253\u7b97\u5bfb\u6c42\u91cd\u65b0\u63d0\u4ea4\u7533\u8bf7\u3002FDA \u8981\u6c42\u7684\u6269\u5927\u4f7f\u7528\u8ba1\u5212\u8868\u660e\u53cc\u65b9\u4ecd\u5728\u6301\u7eed\u5bf9\u8bdd\uff0c\u800c\u8fd9\u901a\u5e38\u662f\u6210\u529f\u91cd\u65b0\u63d0\u4ea4\u7533\u8bf7\u7684\u524d\u5146\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u53ef\u80fd\u9700\u8981\u66f4\u4e25\u683c\u7684\u9002\u5e94\u75c7\u8303\u56f4\uff0c\u5c06\u7b26\u5408\u6761\u4ef6\u7684\u60a3\u8005\u4eba\u7fa4\u7f29\u5c0f\u5230\u4ec5\u9650\u4e8e\u65e0\u6d3b\u52a8\u6027 MRI \u7684 nrSP-MS \u60a3\u8005\u3002FDA \u6307\u51fa\uff0c\u6709 MRI \u75c5\u7076\u6d3b\u52a8\u8bc1\u636e\u7684 nrSP-MS \u60a3\u8005\u5e94\u88ab\u89c6\u4e3a\u201c\u6d3b\u52a8\u6027 SP-MS\u201d\uff08\u590d\u53d1\u578b\uff09\uff0c\u56e0\u6b64\u6709\u8d44\u683c\u4f7f\u7528\u8bb8\u591a\u5df2\u83b7\u6279\u7528\u4e8e\u590d\u53d1\u578b\u60a3\u8005\u7684\u75be\u75c5\u4fee\u6b63\u7597\u6cd5\u3002\u7136\u800c\uff0c\u5bf9\u4e8e\u8fd9\u4e2a\u66f4\u7a84\u7684\u60a3\u8005\u4eba\u7fa4\uff0c\u4ec5\u51ed HERCULES \u7814\u7a76\u7684\u6570\u636e\u53ef\u80fd\u65e0\u6cd5\u5b9e\u9645\u663e\u793a\u51fa\u8db3\u591f\u7684\u83b7\u76ca\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Relacorilant \u7684\u524d\u8fdb\u4e4b\u8def<\/strong><\/h3>\n<p>Corcept \u7684\u524d\u8fdb\u4e4b\u8def\u4f3c\u4e4e\u76f8\u5bf9\u660e\u6717\uff0c\u56e0\u4e3a CRL \u5e76\u672a\u63d0\u53ca\u5b9e\u8d28\u6027\u7684\u5b89\u5168\u6027\u6216\u7597\u6548\u7f3a\u9677\u3002\u9996\u5e2d\u6267\u884c\u5b98 Joseph Belanoff \u8868\u793a\uff0cCorcept\u201c\u6709\u4fe1\u5fc3\u627e\u5230\u4e00\u79cd\u65b9\u6cd5\uff0c\u5c06 <a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/relacorilant\/\" target=\"_blank\" rel=\"noopener\">Relacorilant<\/a> \u5e26\u7ed9\u5b83\u80fd\u5e2e\u52a9\u7684\u60a3\u8005\u201d\u3002\u8be5\u516c\u53f8\u8ba1\u5212\u4e0e FDA \u4f1a\u9762\uff0c\u4ee5\u786e\u5b9a\u6240\u9700\u7684\u540e\u7eed\u6b65\u9aa4\uff0c\u5176\u4e2d\u53ef\u80fd\u5305\u62ec\u91cd\u65b0\u5206\u6790\u73b0\u6709\u7684 3 \u671f\u6570\u636e\u4ee5\u5173\u6ce8\u7279\u5b9a\u4e9a\u7ec4\uff0c\u6216\u5f00\u5c55\u4e00\u9879\u65b0\u7684 3 \u671f\u8bd5\u9a8c\uff08\u8fd9\u53ef\u80fd\u5bfc\u81f4\u4e25\u91cd\u5ef6\u8bef\uff09\u3002<\/p>\n<p>\u540c\u65f6\u5bfb\u6c42\u5375\u5de2\u764c\u9002\u5e94\u75c7\u7684\u6279\u51c6\u65e2\u63d0\u4f9b\u4e86\u6536\u5165\u6f5c\u529b\uff0c\u4e5f\u751f\u6210\u4e86\u989d\u5916\u7684\u8bc1\u636e\u3002\u5982\u679c\u8be5\u9002\u5e94\u75c7\u83b7\u6279\uff0cRelacorilant \u5c06\u6210\u4e3a\u9996\u4e2a\u4ee5\u5176\u4f5c\u7528\u673a\u5236\u4e0a\u5e02\u7684\u836f\u7269\uff0c\u4e5f\u662f\u9996\u4e2a\u8bc1\u660e\u53ef\u6539\u5584\u603b\u751f\u5b58\u671f\u7684\u836f\u7269\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u4f5c\u4e3a\u836f\u7269\u5f00\u53d1\u751f\u547d\u5468\u671f\u4e00\u90e8\u5206\u7684\u76d1\u7ba1\u632b\u6298<\/strong><\/h3>\n<p>Tolebrutinib \u548c Relacorilant \u7684 CRL \u51f8\u663e\u4e86\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u4e00\u4e2a\u6838\u5fc3\u535a\u5f08\uff1a\u65e2\u8981\u5c3d\u5feb\u4e3a\u60a3\u8005\u5e26\u6765\u6240\u9700\u7684\u7597\u6cd5\uff0c\u53c8\u5fc5\u987b\u786e\u4fdd\u8fd9\u4e9b\u7597\u6cd5\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u4e24\u8005\u4e4b\u95f4\u5fc5\u987b\u53d6\u5f97\u5e73\u8861\u3002\u867d\u7136\u8fd9\u4e9b\u8fdb\u5c55\u5f71\u54cd\u4e86\u516c\u53f8\u3001\u6295\u8d44\u8005\u548c\u7b49\u5f85\u65b0\u6cbb\u7597\u65b9\u6848\u7684\u60a3\u8005\uff0c\u4f46\u5b83\u4eec\u53cd\u6620\u4e86\u76d1\u7ba1\u4f53\u7cfb\u6b63\u5728\u6309\u5176\u8bbe\u8ba1\u7684\u65b9\u5f0f\u8fd0\u4f5c\u3002<\/p>\n<p>\u5bf9\u4e8e\u66f4\u5e7f\u6cdb\u7684\u5236\u836f\u884c\u4e1a\u800c\u8a00\uff0c\u8fd9\u4e9b\u6848\u4f8b\u518d\u6b21\u5370\u8bc1\uff0c\u5c3d\u7ba1\u53cd\u6620\u4e86\u771f\u6b63\u7684\u5546\u4e1a\u548c\u6cbb\u7597\u524d\u666f\uff0c\u4f46\u6210\u4e3a\u201c\u6700\u503c\u5f97\u5173\u6ce8\u7684\u836f\u7269\u201d\u5e76\u4e0d\u80fd\u4fdd\u8bc1\u76d1\u7ba1\u8fc7\u7a0b\u4e00\u5e06\u98ce\u987a\u3002\u5c06\u79d1\u5b66\u521b\u65b0\u8f6c\u5316\u4e3a\u83b7\u6279\u836f\u7269\uff0c\u4e0d\u4ec5\u9700\u8981\u4e34\u5e8a\u8bc1\u636e\uff0c\u8fd8\u9700\u8981\u524d\u77bb\u6027\u7684\u76d1\u7ba1\u7b56\u7565\u5e03\u5c40\u3001\u7cfb\u7edf\u6027\u7684\u5b89\u5168\u6027\u8bc4\u4f30\u4e0e\u754c\u5b9a\uff0c\u4ee5\u53ca\u5728\u9762\u5bf9\u632b\u6298\u65f6\u901a\u5e38\u6240\u9700\u8981\u7684\u97e7\u6027\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u5feb\u901f\u51b3\u7b56\u4f18\u52bf<\/strong><\/h3>\n<p>\u901a\u8fc7\u4f7f\u7528\u7531\u4eba\u5de5\u667a\u80fd\uff08AI\uff09\u9a71\u52a8\u7684\u53ef\u4fe1\u3001\u96c6\u6210\u884c\u4e1a\u60c5\u62a5\uff08\u4f8b\u5982\u79d1\u777f\u552f\u5b89\u89e3\u51b3\u65b9\u6848\u63d0\u4f9b\u7684\u60c5\u62a5\uff09\uff0c\u516c\u53f8\u53ef\u4ee5\u5728\u4e0d\u53ef\u9884\u6d4b\u7684\u751f\u547d\u79d1\u5b66\u9886\u57df\u4fdd\u6301\u66f4\u9ad8\u7684\u654f\u6377\u6027\uff1a<\/p>\n<ul>\n<li><strong>\u5b9e\u73b0\u8de8\u804c\u80fd\u56e2\u961f\u7684\u666e\u53ca\u5316\u8bbf\u95ee\uff1a<\/strong>\u81ea\u7136\u8bed\u8a00\u754c\u9762\u4f7f\u76d1\u7ba1\u3001\u4e34\u5e8a\u548c\u5546\u4e1a\u56e2\u961f\u80fd\u591f\u5728\u6ca1\u6709\u6280\u672f\u969c\u788d\u7684\u60c5\u51b5\u4e0b\u63a2\u7d22\u590d\u6742\u95ee\u9898\uff0c\u4e3a\u6240\u6709\u804c\u80fd\u90e8\u95e8\u63d0\u4f9b\u81f3\u5173\u91cd\u8981\u7684\u590d\u6742\u60c5\u62a5\u3002<\/li>\n<li><strong>\u52a0\u5feb\u51b3\u7b56\u65f6\u95f4\uff1a<\/strong>\u5728\u56de\u5e94 CRL \u65f6\uff0c\u65f6\u95f4\u5c31\u662f\u4e00\u79cd\u7ade\u4e89\u4f18\u52bf\u2014\u2014\u6bcf\u5ef6\u8fdf\u4e00\u4e2a\u6708\u90fd\u4f1a\u8ba9\u7ade\u4e89\u5bf9\u624b\u53d6\u5f97\u8fdb\u5c55\u3002\u79d1\u777f\u552f\u5b89 AI \u9a71\u52a8\u7684\u89e3\u51b3\u65b9\u6848\uff08\u4ece\u76d1\u7ba1\u4ee3\u7406\u5230\u7ade\u4e89\u60c5\u62a5\u5206\u6790\uff09\uff0c\u5c06\u8017\u65f6\u7684\u624b\u52a8\u5206\u6790\u8f6c\u53d8\u4e3a\u5feb\u901f\u3001\u7ecf\u8fc7\u6765\u6e90\u9a8c\u8bc1\u7684\u6d1e\u5bdf\uff0c\u4ee5\u652f\u6301\u81ea\u4fe1\u7684\u51b3\u7b56\u3002<\/li>\n<li><strong>\u786e\u4fdd\u6218\u7565\u534f\u540c\u6027\uff1a<\/strong>\u4e00\u81f4\u7684\u91cd\u65b0\u63d0\u4ea4\u7b56\u7565\u4f9d\u8d56\u4e8e\u5bf9\u76d1\u7ba1\u5148\u4f8b\uff08<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>\uff09\u3001\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u4f18\u5316\uff08<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>\uff09\u3001\u7528\u4e8e\u5dee\u5f02\u5316\u5b9a\u4f4d\u7684\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff08<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/real-world-data\/drg-fusion\/\" target=\"_blank\" rel=\"noopener\">DRG Fusion<\/a>\uff09\u3001\u7ade\u4e89\u52a8\u6001\uff08<a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/portfolio-strategy\/competitive-intelligence\/cortellis-competitive-intelligence-analytics\/\">Cortellis \u7ade\u4e89\u60c5\u62a5\u6570\u636e\u5e93<\/a>\uff09\u548c\u5e02\u573a\u9884\u6d4b\uff08<a href=\"https:\/\/clarivate.com.cn\/life-sciences-healthcare\/portfolio-strategy\/market-assessment\/disease-landscape-and-forecast\/\">\u75be\u75c5\u6982\u89c8\u4e0e\u9884\u6d4b\u62a5\u544a<\/a>\uff09\u7684\u7efc\u5408\u5206\u6790\u3002<\/li>\n<li><strong>\u5e94\u5bf9\u76d1\u7ba1\u590d\u6742\u6027\uff1a<\/strong>\u5728\u5168\u7403\u5236\u836f\u9886\u57df\uff0c\u516c\u53f8\u4e0d\u4ec5\u9700\u8981\u5e94\u5bf9 FDA \u7684\u8981\u6c42\uff0c\u8fd8\u9700\u8981\u5904\u7406\u5728\u5176\u4ed6\u5730\u533a\u7684\u5e76\u884c\u63d0\u4ea4\u3002\u79d1\u777f\u552f\u5b89\u89e3\u51b3\u65b9\u6848\u4e2d\u7684\u6bd4\u8f83\u6027\u7ba1\u8f96\u533a\u5206\u6790\u6709\u52a9\u4e8e\u7ba1\u7406\u5168\u7403\u5e02\u573a\u4e2d\u5dee\u5f02\u5316\u7684\u76d1\u7ba1\u8def\u5f84\u3001\u8bc1\u636e\u8981\u6c42\u548c\u653f\u6cbb\u52a8\u6001\uff0c\u540c\u65f6\u786e\u4fdd\u5408\u89c4\u6027\u548c\u53ef\u5ba1\u8ba1\u6027\u3002<\/li>\n<li><strong>\u4fdd\u6301\u53ef\u5ba1\u8ba1\u6027\uff1a<\/strong>\u79d1\u777f\u552f\u5b89\u7684\u900f\u660e AI \u65b9\u6cd5\u5c06\u8f93\u51fa\u76f4\u63a5\u94fe\u63a5\u5230\u6e90\u6587\u6863\uff0c\u56e0\u6b64\u6bcf\u4e00\u4e2a\u6d1e\u5bdf\u3001\u5efa\u8bae\u548c\u6218\u7565\u51b3\u7b56\u90fd\u53ef\u4ee5\u8ffd\u6eaf\u5230\u6743\u5a01\u6765\u6e90\u3002\u8fd9\u79cd\u53ef\u89c1\u6027\u5bf9\u4e8e\u76d1\u7ba1\u63d0\u4ea4\u81f3\u5173\u91cd\u8981\uff0c\u56e0\u4e3a\u5728\u8fd9\u4e9b\u63d0\u4ea4\u4e2d\uff0c\u8bc1\u636e\u7684\u6eaf\u6e90\u53ef\u9760\u6027\u662f\u5173\u952e\u56e0\u7d20\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>\u4ece\u632b\u6298\u5230\u6218\u7565\u4f18\u52bf<\/strong><\/h3>\n<p>CRL \u4ee3\u8868\u7740\u91cd\u5927\u7684\u632b\u6298\uff0c\u4f46\u5b83\u4eec\u5e76\u4e0d\u80fd\u51b3\u5b9a\u6700\u7ec8\u7684\u6210\u529f\u3002\u51ed\u501f\u6b63\u786e\u7684\u60c5\u62a5\u3001\u6218\u7565\u6d1e\u5bdf\u548c\u8bc1\u636e\u751f\u6210\u80fd\u529b\uff0c\u8d5b\u8bfa\u83f2\u548c Corcept Therapeutics \u90fd\u53ef\u4ee5\u89e3\u51b3 FDA \u7684\u5177\u4f53\u5173\u5207\uff0c\u5e76\u5c06\u76d1\u7ba1\u53cd\u9988\u8f6c\u5316\u4e3a\u91cd\u70b9\u660e\u786e\u7684\u5f00\u53d1\u7b56\u7565\u3002\u79d1\u777f\u552f\u5b89\u96c6\u6210\u7684 AI \u9a71\u52a8\u89e3\u51b3\u65b9\u6848\u5957\u4ef6\u63d0\u4f9b\u5148\u4f8b\u5206\u6790\uff0c\u53ef\u5c06\u76d1\u7ba1\u6311\u6218\u8f6c\u5316\u4e3a\u673a\u9047\uff0c\u6784\u5efa\u66f4\u575a\u5b9e\u7684\u83b7\u6279\u4f9d\u636e\u2014\u2014\u6700\u7ec8\u670d\u52a1\u4e8e\u7b49\u5f85\u8fd9\u4e9b\u6f5c\u5728\u53d8\u9769\u6027\u7597\u6cd5\u7684 nrSP-MS \u548c\u5e93\u6b23\u7efc\u5408\u5f81\u60a3\u8005\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\u7bc7\u535a\u6587\u662f\u6211\u4eec \u7cfb\u5217\u6587\u7ae0 \u7684\u6700\u540e\u4e00\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 Tolebrutinib\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":435894,"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":[66,73,69,74,55,56],"class_list":["post-435890","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-us-market","tag-pharmaceutical-regulations"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-22 05:13:05","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\/435890","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=435890"}],"version-history":[{"count":7,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/435890\/revisions"}],"predecessor-version":[{"id":435923,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/435890\/revisions\/435923"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/435894"}],"wp:attachment":[{"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=435890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=435890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=435890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}