{"id":579585,"date":"2026-02-24T08:53:17","date_gmt":"2026-02-24T08:53:17","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=574161"},"modified":"2026-04-24T11:29:22","modified_gmt":"2026-04-24T11:29:22","slug":"tolebrutinib-crl-safety-overrides-efficacy","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/tolebrutinib-crl-safety-overrides-efficacy\/","title":{"rendered":"Tolebrutinib: \uc720\ud6a8\uc131\ubcf4\ub2e4 \uc548\uc804\uc131 \uc6b0\ub824\uac00 \uc6b0\uc120\ub41c \uc0ac\ub840"},"content":{"rendered":"<p><em>\uc774 \uae00\uc740 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 2025\ub144 12\uc6d4 23\uc77c <strong data-start=\"117\" data-end=\"127\">Sanofi<\/strong>\uc758 \ube44\uc7ac\ubc1c\uc131 \uc774\ucc28\uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(nrSP-MS) \uce58\ub8cc\uc81c <strong data-start=\"160\" data-end=\"176\">tolebrutinib<\/strong>\uacfc, 2025\ub144 12\uc6d4 30\uc77c <strong data-start=\"193\" data-end=\"217\">Corcept Therapeutics<\/strong>\uc758 \ucfe0\uc2f1\uc99d\ud6c4\uad70 \uce58\ub8cc\uc81c <strong data-start=\"229\" data-end=\"245\">relacorilant<\/strong>\uc5d0 \ub300\ud574 \ubc1c\ud589\ud55c \uc644\uc804\uc751\ub2f5\uc11c\ud55c(CRL, Complete Response Letter)\uc744 \ub2e4\ub8e8\ub294 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/navigating-fda-complete-response-letters-clarivate\/\">\uc2dc\ub9ac\uc988<\/a>\uc758 \ub450 \ubc88\uc9f8 \uae00\uc785\ub2c8\ub2e4. \ub450 \uc57d\ubb3c\uc740 \ubaa8\ub450 \ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758<a href=\"https:\/\/clarivate.com\/ko\/drugs-to-watch\/\"><strong data-start=\"330\" data-end=\"355\"> \u20182026\ub144 \ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d\ubcf4\uace0\uc11c\u2019<\/strong> <\/a>\ubcf4\uace0\uc11c\uc5d0 \ud3ec\ud568\ub418\uc5b4 \uc788\uc73c\uba70, \uc774\ubc88 \uacb0\uc815\uc740 \ud574\ub2f9 \ubcf4\uace0\uc11c\uac00 \ucd5c\uc885 \ud655\uc815\ub41c \uc774\ud6c4 \ub0b4\ub824\uc84c\uc2b5\ub2c8\ub2e4. <\/em><\/p>\n<p>\ube0c\ub8e8\ud1a4 \ud2f0\ub85c\uc2e0 \ud0a4\ub098\uc81c(BTK) \uc5b5\uc81c\uc81c\uc778 <a href=\"https:\/\/download.open.fda.gov\/crl\/CRL_NDA219624_20251223.pdf\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"427\" data-end=\"443\">tolebrutinib<\/strong>\uc5d0 \ub300\ud55c CRL<\/a>\uc740 \ub124 \uac00\uc9c0 \ud575\uc2ec \uc774\uc288\ub97c \uc911\uc2ec\uc73c\ub85c \uc81c\uae30\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n<p>(1) \uc911\uc99d(\uce58\uba85\uc801 \uc0ac\ub840 \ud3ec\ud568) \uc57d\ubb3c \uc720\ubc1c \uac04\uc190\uc0c1(DILI)\uc758 \uc2ec\uac01\ud55c \uc704\ud5d8,<br data-start=\"523\" data-end=\"526\" \/>(2) \ud2b9\uc815 \ud658\uc790 \ud558\uc704\uad70\uc5d0\uc11c\uc758 \uce58\ub8cc \ud6a8\uacfc\uc5d0 \ub300\ud55c \ubd88\ud655\uc2e4\uc131,<br data-start=\"558\" data-end=\"561\" \/>(3) \uc7ac\ubc1c \ud65c\ub3d9\uacfc \ubb34\uad00\ud558\uac8c \uc7a5\uc560 \uc9c4\ud589\uc744 \ub2a6\ucd94\ub294 \ud6a8\uacfc\uc5d0 \ub300\ud55c \uadfc\uac70 \ubd80\uc871,<br data-start=\"601\" data-end=\"604\" data-is-only-node=\"\" \/>(4) \ud3b8\uc775-\uc704\ud5d8 \uade0\ud615\uc774 \uae0d\uc815\uc801\uc778 \uac83\uc73c\ub85c \ud655\uc778\ub41c \ud658\uc790\uad70\uc758 \ubd80\uc7ac\uc785\ub2c8\ub2e4.<\/p>\n<p>FDA\ub294 \uac04\ub3c5\uc131 \uc704\ud5d8\uc744 \u201c\uc77c\ubc18\uc801\uc778 \uc2e0\uc57d \uac1c\ubc1c \ud504\ub85c\uadf8\ub7a8 \uc804\ubc18\uc740 \ubb3c\ub860, \ud2b9\ud788 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(MS) \uce58\ub8cc\uc81c \ubd84\uc57c\uc5d0\uc11c\ub3c4 \uc774\ub840\uc801\uc73c\ub85c \ub192\uace0 \uc911\ub300\ud55c \uc218\uc900\u201d\uc774\ub77c\uace0 \ud3c9\uac00\ud588\uc2b5\ub2c8\ub2e4. \uc57d 2,700\uba85\uc758 \uc784\uc0c1\uc2dc\ud5d8 \ucc38\uc5ec\uc790 \uac00\uc6b4\ub370 6\uac74\uc774 Hy\u2019s Law \uae30\uc900\uc744 \ucda9\uc871\ud588\uc73c\uba70, \uc774 \uc911 1\uba85\uc740 \uac04\uc774\uc2dd \ud6c4 \uc0ac\ub9dd\uc5d0 \uc774\ub974\ub800\uc2b5\ub2c8\ub2e4. \ub610\ud55c FDA\ub294 <strong data-start=\"815\" data-end=\"825\">Sanofi<\/strong>\uac00 \uc81c\uc548\ud55c REMS(\uc704\ud5d8\ud3c9\uac00 \ubc0f \uc644\ud654 \uc804\ub7b5)\uc758 \ubaa8\ub2c8\ud130\ub9c1 \ud504\ub85c\uadf8\ub7a8\uc774 \ucda9\ubd84\ud55c\uc9c0\uc5d0 \ub300\ud574 \uc6b0\ub824\ub97c \uc81c\uae30\ud558\uba70, \u201ctolebrutinib\uacfc \uad00\ub828\ub41c \uce58\uba85\uc801 DILI \uc704\ud5d8\uc740 BTK \uc5b5\uc81c\uc81c \uacc4\uc5f4 \ub0b4\uc5d0\uc11c\ub3c4 \uac00\uc7a5 \ub192\uc740 \uc218\uc900\uc5d0 \uc18d\ud558\ub294 \uac83\uc73c\ub85c \ubcf4\uc778\ub2e4\u201d\uace0 \uc9c0\uc801\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\uc784\uc0c1\uc801 \ub9e5\ub77d<\/strong><\/h3>\n<p data-start=\"38\" data-end=\"266\">\uc774\ubc88 CRL\uc758 \uc601\ud5a5\uc740 <strong data-start=\"50\" data-end=\"66\">tolebrutinib<\/strong>\uc758 \uc784\uc0c1 \uc131\uacfc\ub97c \uace0\ub824\ud560 \ub54c \ub354\uc6b1 \ub450\ub4dc\ub7ec\uc9d1\ub2c8\ub2e4. 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8\uc778 <strong data-start=\"101\" data-end=\"113\">HERCULES<\/strong>\uc5d0\uc11c <a href=\"https:\/\/clarivate.com\/drugs-to-watch\/drugs-to-watch-listing\/tolebrutinib\/?utm_content=dtw-blog-series&amp;utm_term=blog-2&amp;campaignname=Drugs_to_Watch_Annual_Report_LeadGen_LS_Global_2026&amp;campaignid=701VO00000nqEKYYA2\">tolebrutinib<\/a>\uc740 \uc704\uc57d \ub300\ube44 6\uac1c\uc6d4 \ud655\uc815 \uc7a5\uc560 \uc9c4\ud589 \ubc1c\uc0dd \uc2dc\uc810\uc744 31% \uc9c0\uc5f0\uc2dc\ud0a4\uba70 1\ucc28 \ud3c9\uac00\ubcc0\uc218\ub97c \ucda9\uc871\ud588\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ube44\uc7ac\ubc1c\uc131 \uc774\ucc28\uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(nrSP-MS)\uc5d0\uc11c \uc7a5\uc560 \uc9c4\ud589\uc744 \uc720\uc758\ud558\uac8c \ub2a6\ucd94\ub294 \ud6a8\uacfc\ub97c \uc785\uc99d\ud55c \ucd5c\ucd08\uc758 \uc57d\ubb3c\ub85c, \uc911\uc694\ud55c \uc784\uc0c1\uc801 \uc131\uacfc\ub85c \ud3c9\uac00\ub429\ub2c8\ub2e4.<\/p>\n<p data-start=\"268\" data-end=\"549\">\uadf8\ub7ec\ub098 \ud574\ub2f9 \uc57d\ubb3c\uc758 \uc804\uccb4 \uac1c\ubc1c \ud504\ub85c\uadf8\ub7a8\uc740 \ubcf4\ub2e4 \ubcf5\uc7a1\ud55c \uc591\uc0c1\uc744 \ubcf4\uc600\uc2b5\ub2c8\ub2e4. 2024\ub144 9\uc6d4 \ubc1c\ud45c\ub41c \uc7ac\ubc1c\ud615 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d \ub300\uc0c1 3\uac74\uc758 3\uc0c1 \uc784\uc0c1\uc2dc\ud5d8 \uc911 2\uac74\uc740 1\ucc28 \ud3c9\uac00\ubcc0\uc218\ub97c \ucda9\uc871\ud558\uc9c0 \ubabb\ud588\uc2b5\ub2c8\ub2e4. \ub610\ud55c \ucd5c\uadfc \uc6d0\ubc1c\uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d\uc744 \ub300\uc0c1\uc73c\ub85c \ud55c <strong data-start=\"402\" data-end=\"413\">PERSEUS<\/strong> \uc2dc\ud5d8 \uc5ed\uc2dc 1\ucc28 \ud3c9\uac00\ubcc0\uc218\ub97c \ub2ec\uc131\ud558\uc9c0 \ubabb\ud558\uba74\uc11c, <strong data-start=\"440\" data-end=\"451\">Sanofi<\/strong>\ub294 \ud574\ub2f9 \uc801\uc751\uc99d\uc5d0\uc11c\uc758 \uac1c\ubc1c\uc744 \uc911\ub2e8\ud588\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc0c1\ubc18\ub41c \uacb0\uacfc\uc5d0 \ub354\ud574, 2022\ub144 \ubd80\ubd84\uc801\uc778 \uc784\uc0c1 \ubcf4\ub958\ub97c \ucd08\ub798\ud588\ub358 \uac04 \uc548\uc804\uc131 \uc774\uc288\uae4c\uc9c0 \uacb9\uce58\uba74\uc11c \uaddc\uc81c \ud658\uacbd\uc740 \ub354\uc6b1 \uae4c\ub2e4\ub85c\uc6cc\uc84c\uc2b5\ub2c8\ub2e4.<\/p>\n<h3><\/h3>\n<h3><strong>\uc2dc\uc7a5 \uc601\ud5a5<\/strong><\/h3>\n<p data-start=\"37\" data-end=\"288\">\ud074\ub798\ub9ac\ubca0\uc774\ud2b8 \ubd84\uc11d\uac00\ub4e4\uc740 \uc2b9\uc778\ub420 \uacbd\uc6b0 <strong data-start=\"57\" data-end=\"73\">tolebrutinib<\/strong>\uc774 2031\ub144\uae4c\uc9c0 G7 \uc2dc\uc7a5\uc5d0\uc11c \uc57d 14\uc5b5 \ub2ec\ub7ec\uc758 \ucd5c\ub300 \ub9e4\ucd9c\uc744 \uae30\ub85d\ud560 \uac83\uc73c\ub85c \uc804\ub9dd\ud588\uc73c\uba70, \uc77c\ubd80\uc5d0\uc11c\ub294 \ubbf8\uad6d \uc2dc\uc7a5\ub9cc\uc73c\ub85c\ub3c4 30\uc5b5~35\uc5b5 \ub2ec\ub7ec \uaddc\ubaa8\uc758 \uae30\ud68c\uac00 \uc788\uc744 \uac83\uc73c\ub85c \ucd94\uc815\ud588\uc2b5\ub2c8\ub2e4. \uc774 \uc57d\ubb3c\uc740 \uc2b9\uc778\ub41c \uce58\ub8cc \uc635\uc158\uc774 \uac70\uc758 \uc5c6\ub294 nrSP-MS \uc601\uc5ed\uc5d0\uc11c \u2018\ub808\ud37c\ub7f0\uc2a4 \uc57d\ubb3c(reference drug)\u2019 \ub610\ub294 \uc7a0\uc7ac\uc801\uc73c\ub85c \u2018\ud45c\uc900 \uce58\ub8cc(standard of care)\u2019\ub85c \uc790\ub9ac\uc7a1\uc744 \uac83\uc73c\ub85c \uae30\ub300\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n<p data-start=\"290\" data-end=\"461\">FDA \uc2b9\uc778 \uc9c0\uc5f0\uacfc PERSEUS \uc784\uc0c1\uc2dc\ud5d8 \uc2e4\ud328\uac00 \ub3d9\uc2dc\uc5d0 \ubc1c\ud45c\ub41c \uc774\ud6c4 <strong data-start=\"329\" data-end=\"339\">Sanofi<\/strong>\uc758 \uc8fc\uac00\ub294 \uc57d 6% \ud558\ub77d\ud588\uc2b5\ub2c8\ub2e4. \ud68c\uc0ac\ub294 \ud604\uc7ac 2021\ub144 <strong data-start=\"371\" data-end=\"387\">tolebrutinib<\/strong> \ud655\ubcf4\ub97c \uc704\ud574 \uc9c4\ud589\ud588\ub358 Principia Biopharma \uc778\uc218(\uc57d 37\uc5b5 \ub2ec\ub7ec)\uc640 \uad00\ub828\ud574 \uc190\uc0c1\ucc28\uc190 \ubc18\uc601 \uac00\ub2a5\uc131\uc744 \uac80\ud1a0\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\ud658\uc790 \ubc0f \uc784\uc0c1\uc801 \uc2dc\uc0ac\uc810<\/strong><\/h3>\n<p data-start=\"44\" data-end=\"183\">\uc7ac\ubc1c\ud615 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d\uacfc \ub2ec\ub9ac, nrSP-MS\ub294 \ud6a8\uacfc\uc801\uc778 \uce58\ub8cc \uc635\uc158\uc774 \ub9e4\uc6b0 \uc81c\ud55c\uc801\uc785\ub2c8\ub2e4. \uc774 \uc9c8\ud658\uc740 \ub2e4\ub978 \ud615\ud0dc\uc758 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d\uc5d0\uc11c \ub098\ud0c0\ub098\ub294 \uac04\ud5d0\uc801\uc778 \uc7ac\ubc1c \uc5c6\uc774 \uc7a5\uc560\uac00 \uc810\uc9c4\uc801\uc73c\ub85c \uc545\ud654\ub418\ub294 \ud2b9\uc9d5\uc744 \uac00\uc9c0\uba70, \uadf8\ub9cc\ud07c \uce58\ub8cc\uac00 \ub9e4\uc6b0 \uc5b4\ub824\uc6b4 \uc9c8\ud658\uc73c\ub85c \uc54c\ub824\uc838 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p data-start=\"185\" data-end=\"459\">FDA\uac00 \ud655\ub300 \uc811\uadfc \ud504\ub85c\uadf8\ub7a8(expanded access protocol)\uc744 \uc694\uccad\ud55c \uc810\uc740 \uc774\ub7ec\ud55c \ubbf8\ucda9\uc871 \uc758\ub8cc \uc218\uc694\ub97c \uc778\uc9c0\ud558\uace0 \uc788\uc74c\uc744 \uc2dc\uc0ac\ud569\ub2c8\ub2e4. Jefferies \ubd84\uc11d\uac00\ub4e4\uc774 \uc5b8\uae09\ud588\ub4ef\uc774, \u201cFDA\uac00 \ud655\ub300 \uc811\uadfc \ud504\ub85c\uadf8\ub7a8\uc744 \uc694\uccad\ud588\ub2e4\ub294 \uac83\uc740 \ud604\uc7ac\ub85c\uc11c\ub294 \uc704\ud5d8-\ud3b8\uc775 \uade0\ud615\uc744 \uc218\uc6a9 \uac00\ub2a5\ud55c \uc218\uc900\uc73c\ub85c \ubcf4\uace0 \uc788\uc74c\uc744 \uc758\ubbf8\ud55c\ub2e4\u201d\ub294 \ud574\uc11d\uc774 \uac00\ub2a5\ud558\uba70, \uc774\ub294 \ud5a5\ud6c4 \uc2b9\uc778\uc73c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\ub294 \uacbd\ub85c\uac00 \uc5f4\ub824 \uc788\uc74c\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \ub9cc\uc57d \uc2b9\uc778\ub420 \uacbd\uc6b0, \ud574\ub2f9 \uc57d\ubb3c\uc740 nrSP-MS\ub97c \uc801\uc751\uc99d\uc73c\ub85c \uba85\uc2dc\ud55c \ucd5c\ucd08\uc758 \uce58\ub8cc\uc81c\uac00 \ub420 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uac00 \uaddc\uc81c \ub09c\uad00 \ub300\uc751\uc744 \uc9c0\uc6d0\ud558\ub294 \ubc29\uc2dd<\/strong><\/h3>\n<p>\ud074\ub798\ub9ac\ubca0\uc774\ud2b8 \uc194\ub8e8\uc158\uc5d0 \uc801\uc6a9\ub41c AI \uae30\ubc18 \uc778\ud154\ub9ac\uc804\uc2a4\ub97c \ud65c\uc6a9\ud558\uba74 \uc81c\uc57d\uc0ac\ub294 CRL\uc744 \ud3ec\ud568\ud55c \uaddc\uc81c \ub09c\uad00\uc5d0 \ubcf4\ub2e4 \uc2e0\uc18d\ud558\uace0 \uc815\uad50\ud558\uba70 \uaddc\uc81c \uc694\uac74\uc5d0 \ubd80\ud569\ud558\ub294 \ubc29\uc2dd\uc73c\ub85c \ub300\uc751\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h4>Cortellis Regulatory Intelligence + AI\uae30\ubc18 Regulatory Assistant<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/regulatory-compliance-intelligence\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \ub294 \ud3ed\ub113\uace0 \uc2ec\uce35\uc801\uc778 \uc778\uc0ac\uc774\ud2b8\uc640 \uc804\ubb38\uac00 \uc9c0\uc2dd\uc744 \uacb0\ud569\ud55c \ud575\uc2ec \uaddc\uc81c \uc778\ud154\ub9ac\uc804\uc2a4\ub97c \uc81c\uacf5\ud558\uba70, \uc5ec\uae30\uc5d0 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/lp\/decades-of-trusted-regulatory-guidance-meet-ai-powered-insights-ko\/\">AI \uae30\ubc18 <strong data-start=\"318\" data-end=\"342\">Regulatory Assistant<\/strong> <\/a>\uae30\ub2a5\uc774 \ub354\ud574\uc838 \ud65c\uc6a9\uc131\uc774 \ud55c\uce35 \uac15\ud654\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n<ul>\n<li><strong>\uaddc\uc81c \uc120\ub840 \ubd84\uc11d:<\/strong> \uc774 \ud50c\ub7ab\ud3fc\uc740 2000\ub144 \uc774\ud6c4 FDA \uc790\ubb38\uc704\uc6d0\ud68c(AdComm) \ud68c\uc758\ub85d\uacfc 28\ub9cc 5\ucc9c \uac74 \uc774\uc0c1\uc758 \ubb38\uc11c, 7\ucc9c \uac74 \uc774\uc0c1\uc758 \ubcf4\uace0\uc11c\uc5d0 \ub300\ud55c \uc804\ubb38\uac00 \ubd84\uc11d\uc744 \ud3ec\ud568\ud558\uace0 \uc788\uc5b4, \uc720\uc0ac\ud55c \uc548\uc804\uc131 \uc774\uc288\ub97c \ub2e4\ub978 \uae30\uc5c5\ub4e4\uc774 \uc5b4\ub5bb\uac8c \ud574\uacb0\ud574\uc654\ub294\uc9c0\ub97c \uc815\ud655\ud788 \ud30c\uc545\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4 AI Assistant\uc5d0\ub294 \u201c\uac04\ub3c5\uc131 \ubb38\uc81c\ub85c CRL\uc744 \ubc1b\uc740 \ud6c4 \uc2b9\uc778\ub41c \uc57d\ubb3c \uc0ac\ub840\ub97c \ubcf4\uc5ec\uc918\u201d \ub610\ub294 \u201c\uc911\uc99d DILI \uc704\ud5d8\uc744 \ud6a8\uacfc\uc801\uc73c\ub85c \uad00\ub9ac\ud55c REMS \uc804\ub7b5\uc744 \ube44\uad50\ud574\uc918\u201d\uc640 \uac19\uc740 \uc9c8\uc758\ub97c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\uaddc\uc81c \uc804\ub7b5 \ud1b5\ud569 \ubc0f \ub3c4\ucd9c<\/strong>:AI Assistant\ub294 \uad00\ub828 \ubb38\uc11c\ub97c \uc2e0\uc18d\ud558\uac8c \uac80\uc0c9\ud558\uace0, \uad6d\uac00\ubcc4 \uaddc\uc81c \uc694\uac74\uc744 \uc885\ud569\uc801\uc73c\ub85c \ubd84\uc11d\ud558\uc5ec \uc2e4\ud589 \uac00\ub2a5\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \ub3c4\ucd9c\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 FDA, EMA, PMDA \ub4f1 \uc8fc\uc694 \uaddc\uc81c \uae30\uad00 \uc804\ubc18\uc5d0\uc11c \uc694\uad6c\ub418\ub294 \uac04\ub3c5\uc131 \uad00\ub9ac \uae30\uc900\uc744 \ube60\ub974\uac8c \uc815\ub9ac\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\ud22c\uba85\uc131\uacfc \ucd94\uc801 \uac00\ub2a5\uc131 \ud655\ubcf4:<\/strong>\ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 AI \uc811\uadfc \ubc29\uc2dd\uc740 \ud56d\uc0c1 \uc6d0\ubcf8 \uc790\ub8cc\uc5d0 \ub300\ud55c \ub9c1\ud06c\ub97c \uc81c\uacf5\ud568\uc73c\ub85c\uc368 \ud22c\uba85\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uc774\ub294 AI \uacb0\uacfc\uc758 \uc2e0\ub8b0\uc131\uc5d0 \ub300\ud55c \uc6b0\ub824\ub97c \ud574\uc18c\ud558\ub294 \ub3d9\uc2dc\uc5d0, \ubaa8\ub4e0 \ubd84\uc11d \uacfc\uc815\uc758 \ucd94\uc801 \uac00\ub2a5\uc131\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4.<\/li>\n<li><strong>\uad6d\uac00 \uac04 \uaddc\uc81c \ube44\uad50 \ubd84\uc11d :<\/strong>tolebrutinib\uc758 \uac1c\ubc1c\uc740 \ub2e4\ub978 \uc2dc\uc7a5\uc5d0\uc11c\ub3c4 \uacc4\uc18d \uc9c4\ud589\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \ub3d9\ud5a5\uc5d0 \ub300\ud55c \uc2e4\uc2dc\uac04 \ubaa8\ub2c8\ud130\ub9c1, \uc2b9\uc778 \uacbd\ub85c\uc5d0 \ub300\ud55c \uc120\ub840 \ubd84\uc11d, \uad6d\uac00 \uac04 \uaddc\uc81c \uc804\ub7b5 \ube44\uad50\ub97c \ud1b5\ud574 \uac01 \uaddc\uc81c \uae30\uad00(FDA, EMA, PMDA \ub4f1)\uc758 \ud3b8\uc775-\uc704\ud5d8 \ud3c9\uac00 \uad00\uc810 \ucc28\uc774\ub97c \ud30c\uc545\ud560 \uc218 \uc788\uc73c\uba70, \uc774\ub294 FDA \uc7ac\uc81c\ucd9c \uc804\ub7b5 \uc218\ub9bd\uc5d0 \uc911\uc694\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h4>DRG Fusion<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/drg-fusion\/\"><strong data-start=\"42\" data-end=\"56\">DRG Fusion<\/strong><\/a>\uc740 \uc0c1\ud638 \uc5f0\uacb0\ub41c \uace0\uc720\ud55c \ub9ac\uc5bc\uc6d4\ub4dc \ub370\uc774\ud130\uc640 AI \uae30\ubc18 \ubd84\uc11d \ud658\uacbd\uc744 \ud1b5\ud574, \ub2e4\uc591\ud55c \uad00\uc810\uc5d0\uc11c \uc9c8\ud658\uc744 \ubd84\uc11d\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud558\ub294 \ud50c\ub7ab\ud3fc\uc785\ub2c8\ub2e4.<\/p>\n<p><strong>\ucd94\uac00\uc801\uc778 \ub9ac\uc5bc\uc6d4\ub4dc \uc548\uc804\uc131 \uadfc\uac70 \uc0dd\uc131 \ubc0f \uc800\uc704\ud5d8 \ud658\uc790\uad70 \uc2dd\ubcc4<\/strong><\/p>\n<ul>\n<li data-section-id=\"lrib01\" data-start=\"171\" data-end=\"354\"><strong data-start=\"173\" data-end=\"196\">\uacc4\uc5f4(Class) \uae30\ubc18 \uc548\uc804\uc131 \ubd84\uc11d<\/strong><br data-start=\"196\" data-end=\"199\" \/>\uc758\ub8cc \ubc0f \uc57d\uad6d \uccad\uad6c \ub370\uc774\ud130\uc640 \ub2e4\uc591\ud55c \ub9ac\uc5bc\uc6d4\ub4dc \ub370\uc774\ud130 \uc18c\uc2a4\ub97c \ud65c\uc6a9\ud574 BTK \uc5b5\uc81c\uc81c \uacc4\uc5f4(ibrutinib, acalabrutinib, zanubrutinib)\uc758 \uac04\ub3c5\uc131 \ud328\ud134\uc744 \ubd84\uc11d\ud568\uc73c\ub85c\uc368, <strong data-start=\"306\" data-end=\"322\">tolebrutinib<\/strong>\uc758 \uc548\uc804\uc131 \ud504\ub85c\ud30c\uc77c\uc744 \ubcf4\ub2e4 \ub9e5\ub77d\uc801\uc73c\ub85c \uc774\ud574\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li data-section-id=\"oad2f2\" data-start=\"356\" data-end=\"491\"><strong data-start=\"358\" data-end=\"371\">\ud658\uc790 \ud558\uc704\uad70 \uc2dd\ubcc4<\/strong><br data-start=\"371\" data-end=\"374\" \/>\ud658\uc790 \uc138\ubd84\ud654 \uae30\ub2a5\uc744 \ud1b5\ud574 \uac04\uc9c8\ud658 \uc704\ud5d8\uc774 \ub0ae\uc740 nrSP-MS \ud658\uc790\uad70\uc744 \uc2dd\ubcc4\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, \ub300\uc0ac\uc9c8\ud658 \ub3d9\ubc18 \uc5ec\ubd80, \uc74c\uc8fc \uc774\ub825, \uac04\ub3c5\uc131 \uc720\ubc1c \uc57d\ubb3c \ubcd1\uc6a9 \uc5ec\ubd80 \ub4f1\uc774 \uc5c6\ub294 \ud658\uc790\uad70\uc744 \uad6c\ubd84\ud574\ub0bc \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li data-section-id=\"jyvckb\" data-start=\"493\" data-end=\"638\"><strong data-start=\"495\" data-end=\"514\">\ub9e5\ub77d \uae30\ubc18 \ube44\uad50 \uc720\ud6a8\uc131 \ubd84\uc11d<\/strong><br data-start=\"514\" data-end=\"517\" \/>\ub2e4\ubc1c\uc131\uacbd\ud654\uc99d \ud658\uc790\uad70\uc5d0\uc11c\uc758 \ub9ac\uc5bc\uc6d4\ub4dc \uc720\ud6a8\uc131 \ub370\uc774\ud130\ub97c \ubd84\uc11d\ud568\uc73c\ub85c\uc368, \uc801\uc808\ud788 \uc120\ubcc4\ub41c \ud658\uc790\uad70\uc5d0\uc11c\ub294 tolebrutinib\uc758 \uc720\ud6a8\uc131 \uc774\uc810\uc774 \uc704\ud5d8 \uad00\ub9ac \uc804\ub7b5\uacfc \ud568\uaed8 \ucda9\ubd84\ud788 \uc815\ub2f9\ud654\ub420 \uc218 \uc788\uc74c\uc744 \uc785\uc99d\ud558\ub294 \ub370 \uae30\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li data-section-id=\"4hhba8\" data-start=\"640\" data-end=\"799\"><strong data-start=\"642\" data-end=\"656\">\ubaa8\ub2c8\ud130\ub9c1 \uc804\ub7b5 \uac80\uc99d<\/strong><br data-start=\"656\" data-end=\"659\" \/>\uc2e4\uc81c \uc784\uc0c1 \ud658\uacbd\uc5d0\uc11c\uc758 \uac04 \ubaa8\ub2c8\ud130\ub9c1 \uc218\ud589 \ubc29\uc2dd\uc5d0 \ub300\ud55c \ubd84\uc11d\uc744 \ud1b5\ud574, \ubcf4\ub2e4 \uac15\ud654\ub41c REMS(\uc704\ud5d8\ud3c9\uac00 \ubc0f \uc644\ud654 \uc804\ub7b5) \uc218\ub9bd\uc744 \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \ub9ac\uc5bc\uc6d4\ub4dc \ub370\uc774\ud130\ub294 <strong data-start=\"745\" data-end=\"755\">Sanofi<\/strong>\uac00 \ub3c4\uc785\ud55c \uc9d1\uc911 \ubaa8\ub2c8\ud130\ub9c1 \ud504\ub85c\ud1a0\ucf5c\uc758 \ud6a8\uacfc\ub97c \uac80\uc99d\ud558\ub294 \ub370\uc5d0\ub3c4 \ud65c\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<h4>Cortellis Clinical Development Intelligence \uc194\ub8e8\uc158: \ud504\ub85c\ud1a0\ucf5c \ucd5c\uc801\ud654<\/h4>\n<p><a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/discovery-development\/cortellis-clinical-trials-intelligence\/\">Cortellis Clinical Trials Intelligence<\/a> \uc640\u00a0\u00a0<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/pharmacovigilance-drug-safety\/off-x\/\">OFF-X<\/a>\ub294 \uc784\uc0c1\uc2dc\ud5d8 \uc9c4\ud589 \uc0c1\ud669, \uacbd\uc7c1\uc0ac \uc804\ub7b5, \uadf8\ub9ac\uace0 \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4 \ucd5c\uc801\ud654\uc5d0 \ub300\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>\uac15\ud654\ub41c \uc548\uc804\uc131 \ubaa8\ub2c8\ud130\ub9c1 \ud504\ub85c\ud1a0\ucf5c \ubc0f \ud658\uc790 \ud558\uc704\uad70 \uc784\uc0c1 \uc124\uacc4 \uc9c0\uc6d0<\/strong><\/p>\n<ul>\n<li><strong>\uc548\uc804\uc131 \ubaa8\ub2c8\ud130\ub9c1 \ubca4\uce58\ub9c8\ud0b9:<\/strong>60\ub9cc \uac74 \uc774\uc0c1\uc758 \uc784\uc0c1\uc2dc\ud5d8 \ub370\uc774\ud130\ub97c \uae30\ubc18\uc73c\ub85c \uac04 \ubaa8\ub2c8\ud130\ub9c1 \ud504\ub85c\ud1a0\ucf5c\uc744 \ubd84\uc11d\ud558\uc5ec, \ucd5c\uc801\uc758 \ubc14\uc774\uc624\ub9c8\ucee4, \ubaa8\ub2c8\ud130\ub9c1 \ube48\ub3c4, \uc870\uae30 \uc911\ub2e8 \uae30\uc900\uc744 \ub3c4\ucd9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc784\uc0c1\uc2dc\ud5d8\uc758 \uc2e4\ud589 \uac00\ub2a5\uc131\uc744 \uc720\uc9c0\ud558\uba74\uc11c\ub3c4 \uc548\uc804\uc131\uc744 \uadf9\ub300\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<li><strong>\ud658\uc790 \ud558\uc704\uad70 \ub300\uc0c1 \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4:<\/strong>\ub9cc\uc57d Sanofi\uac00 \uc704\ud5d8\uc774 \ub0ae\uc740 \ud658\uc790 \ud558\uc704\uad70\uc744 \ub300\uc0c1\uc73c\ub85c \uc81c\ud55c\uc801 \uc2b9\uc778 \uc804\ub7b5\uc744 \ucd94\uc9c4\ud560 \uacbd\uc6b0, \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(MS) \ud658\uc790\uad70\ubcc4 \uc784\uc0c1\uc2dc\ud5d8 \uc9c4\ud589 \ubc29\uc2dd, \uacbd\uc7c1 \ud658\uacbd, \ucd5c\uc801\uc758 \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4\uc5d0 \ub300\ud55c \uc778\uc0ac\uc774\ud2b8\ub97c \ud655\ubcf4\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<p data-start=\"547\" data-end=\"771\">\uc774 \uc2dc\ub9ac\uc988\uc758 \ub2e4\uc74c \uae00\uc778 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/relacorilant-crl-fda-evidence-bar\">\u201cRelacorilant: \uaddc\uc81c \ub2f9\uad6d\uc758 \uadfc\uac70 \uae30\uc900\uc5d0 \ub3c4\ub2ec\ud55c \uc0ac\ub840<\/a>\u201d\uc5d0\uc11c\ub294 2026\ub144 \ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d\ubcf4\uace0\uc11c\uc5d0 \ud3ec\ud568\ub41c \ub610 \ub2e4\ub978 \uce58\ub8cc\uc81c\uc778 <strong data-start=\"670\" data-end=\"694\">Corcept Therapeutics<\/strong>\uc758 <strong data-start=\"696\" data-end=\"712\">relacorilant<\/strong>\uc5d0 \ub300\ud55c \uc5f0\ub9d0 CRL\uc758 \uc601\ud5a5\uacfc, \uc774\ub97c \uadf9\ubcf5\ud558\uae30 \uc704\ud55c \ud074\ub798\ub9ac\ubca0\uc774\ud2b8 \uc778\ud154\ub9ac\uc804\uc2a4 \ud65c\uc6a9 \ubc29\uc548\uc744 \uc0b4\ud3b4\ubcfc \uc608\uc815\uc785\ub2c8\ub2e4.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc774 \uae00\uc740 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 2025\ub144 12\uc6d4 23\uc77c Sanofi\uc758 \ube44\uc7ac\ubc1c\uc131 \uc774\ucc28\uc9c4\ud589\uc131 \ub2e4\ubc1c\uc131\uacbd\ud654\uc99d(nrSP-MS) \uce58\ub8cc\uc81c tolebrutinib\uacfc, 2025\ub144 12\uc6d4 30\uc77c Corcept Therapeutics\uc758 \ucfe0\uc2f1\uc99d\ud6c4\uad70 \uce58\ub8cc\uc81c relacorilant\uc5d0 \ub300\ud574 \ubc1c\ud589\ud55c \uc644\uc804\uc751\ub2f5\uc11c\ud55c(CRL, Complete Response Letter)\uc744 \ub2e4\ub8e8\ub294 \uc2dc\ub9ac\uc988\uc758 \ub450&#8230;<\/p>\n","protected":false},"author":141,"featured_media":574172,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[2452],"tags":[2559,2562,2864,2653,2776,2627,2464,1414,2867,2870,2686],"class_list":["post-579585","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","tag-biopharma","tag-biotech","tag-clinical-trials","tag-commercialization","tag-fda","tag-market-access-2","tag-pharma","tag-real-world-data","tag-regulatory","tag-safety","tag-u-s","clarivate-product-biopharma"],"acf":[],"lang":"ko","translations":{"ko":579585,"en":574161,"ja":574416},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579585","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/141"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=579585"}],"version-history":[{"count":1,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579585\/revisions"}],"predecessor-version":[{"id":579586,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/579585\/revisions\/579586"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/574172"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=579585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=579585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=579585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}