{"id":351288,"date":"2024-12-17T11:31:23","date_gmt":"2024-12-17T11:31:23","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=351288"},"modified":"2026-03-30T09:02:23","modified_gmt":"2026-03-30T09:02:23","slug":"how-jj-navigated-regulatory-approval-for-a-drug-to-watch","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/blog\/how-jj-navigated-regulatory-approval-for-a-drug-to-watch\/","title":{"rendered":"J&#038;J\uac00 \uc8fc\ubaa9\ud574\uc57c \ud560 \uc758\uc57d\ud488\uc5d0 \ub300\ud55c \uaddc\uc81c \uc2b9\uc778\uc744 \ud68d\ub4dd\ud55c \ubc29\ubc95"},"content":{"rendered":"<p>\uc0c8\ub86d\uac8c \ub5a0\uc624\ub974\uace0 \uc788\ub294 \uc774\uc911\ud2b9\uc774\ud56d\uccb4 \ubd84\uc57c\ub294 \uc554 \ud658\uc790\uc5d0\uac8c \uc5c4\uccad\ub09c \uac00\ub2a5\uc131\uc744 \uc81c\uc2dc\ud569\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc774\ub7ec\ud55c \uce58\ub8cc\ubc95\uc740 \ub9e4\uc6b0 \ubcf5\uc7a1\ud55c \ubd80\uc791\uc6a9 \ud504\ub85c\ud544 \ub54c\ubb38\uc5d0 \uc758\uc57d\ud488 \uac1c\ubc1c\uc790\uc640 \uaddc\uc81c \ub2f9\uad6d\uc5d0 \uc5b4\ub824\uc6b4 \uacfc\uc81c\ub97c \uc548\uaca8\uc8fc\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 \ubd84\uc11d\uac00\ub4e4\uc740 \uc0c8\ub85c \ubc1c\uac04\ub41c \uc2dc\ub9ac\uc988 \ubcf4\uace0\uc11c\ub97c \ud1b5\ud574 <a href=\"https:\/\/clarivate.com\/drugs-to-watch\/\">2024 \ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d<\/a> \ub4e4\uc758 \uaddc\uc81c \uacbd\ub85c\ub97c \uc0b4\ud3b4\ubd24\uc2b5\ub2c8\ub2e4. \ub2e4\ubc1c\uc131 \uace8\uc218\uc885 \uce58\ub8cc\ub97c \uc704\ud55c CD3 \ubc0f GPRC5D\ub97c \ud45c\uc801\uc73c\ub85c \ud558\ub294 \ucd5c\ucd08\uc758 \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4\uc778 Johnson &amp; Johnson\uc758 TALVEY\u00ae (talquetamab)\uc758 \uacbd\uc6b0, \uaddc\uc81c \ub2f9\uad6d\uc740 \uc2ec\uac01\ud55c \ubd80\uc791\uc6a9\uacfc \uc2ec\uac01\ud55c \ubbf8\ucda9\uc871 \uc218\uc694\uc758 \uade0\ud615\uc744 \ub9de\ucdb0\uc57c \ud558\ub294 \uacfc\uc81c\ub97c \uc548\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>J&amp;J\ub294 \uc774\uc804\uc5d0 \ub2e4\ub978 \uc774\uc911\ud2b9\uc774\ud56d\uccb4\uc778 TECVAYLI (teclistimab, 2024\ub144 \ube14\ub85d\ubc84\uc2a4\ud130 \uc2e0\uc57d \ubcf4\uace0\uc11c\uc5d0 \uc774\ub984\uc744 \uc62c\ub9b0 \uc57d\ubb3c \uc911 \ud558\ub098)\uc758 \ud310\ub9e4\uc2b9\uc778\uc744 \ubc1b\uae30 \uc704\ud574 \ubbf8\uad6d FDA\uc5d0 \uac00\uc18d\uc2b9\uc778 \ud504\ub85c\uadf8\ub7a8\uc744 \uc2e0\uccad\ud588\uace0, EU\uc5d0 \uc870\uac74\ubd80 \ud310\ub9e4\uc2b9\uc778\uc744 \uc2e0\uccad\ud574 \ubaa8\ub450 \uc2b9\uc778\uc744 \ubc1b\uc558\uc2b5\ub2c8\ub2e4. J&amp;J\uac00 \ud0dd\ud55c \uc774 2\uac00\uc9c0 \uacbd\ub85c(\uac00\uc18d\uc2b9\uc778, \uc870\uac74\ubd80 \ud310\ub9e4\uc2b9\uc778)\ub294 \uce58\ub8cc\uc81c\uac00 \ubd80\uc871\ud55c \uc2ec\uac01\ud55c \uc9c8\ubcd1\uc5d0 \ub300\ud574 \ud658\uc790\ub4e4\uc774 \ube60\ub974\uac8c \uc811\uadfc\ud560 \uc218 \uc788\ub3c4\ub85d \uc2e0\uc57d\uc5d0 \ub300\ud574 \uace0\uc548\ub41c \uacbd\ub85c\ub85c \ub300\ub9ac \ud3c9\uac00\ubcc0\uc218\ub97c \uc0ac\uc6a9\ud574 \uc77c\ubc18\uc801\uc73c\ub85c \uc694\uad6c\ub418\ub294 \uac83\ubcf4\ub2e4 \uc801\uc740 \uc784\uc0c1 \ub370\uc774\ud130\ub97c \uae30\ubc18\uc73c\ub85c \uc2b9\uc778\uc744 \ubc1b\uc2b5\ub2c8\ub2e4.<\/p>\n<p>TECVAYLI\uc640 TALVEY\ub294 \uc11c\ub85c \ub2e4\ub978 \uc218\uc6a9\uccb4\ub97c \ud45c\uc801\ud558\uc9c0\ub9cc, T\uc138\ud3ec \ubc0f \uc554\uc138\ud3ec \ubaa8\ub450\uc5d0 \uacb0\ud569\ud574 \uba74\uc5ed \uc2dc\uc2a4\ud15c\uc744 \ud65c\uc131\ud654\uc2dc\ud0a4\ub294 \ub3d9\uc2dc\uc5d0 \ubcd1\ub4e0 \uc138\ud3ec\ub97c \uc5b5\uc81c\ud558\ub294 \uc720\uc0ac\ud55c \uc774\uc911 \uacf5\uaca9(one-two punch)\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub450 \uc57d\ubb3c \ubaa8\ub450 \uc77c\ubc18\uc801\uc73c\ub85c \uc608\ud6c4\uac00 \ub098\uc05c \ud608\uc561\uc554\uc758 \uacf5\uaca9\uc801\uc774\uace0 \uc57d\ubb3c\uc5d0 \uc800\ud56d\ub825\uc774 \uc788\ub294 \ud615\ud0dc\uc778 \ub2e4\ubc1c\uc131 \uace8\uc218\uc885(relapsed\/refractory multiple myeloma)\uc758 \uce58\ub8cc\ub97c \uc704\ud574 \ucd08\uae30 \uc2b9\uc778\uc744 \ubc1b\uc73c\ub824\uace0 \ud588\uc2b5\ub2c8\ub2e4. \uc774 \ud615\ud0dc\uc758 \ub2e4\ubc1c\uc131 \uace8\uc218\uc885\uc740 \uc774\ubbf8 \uce58\ub8cc\ub97c \ubc1b\uc740 \uacbd\ud5d8\uc774 \uc788\ub294 \ud658\uc790\ub4e4\uc5d0\uac8c \ub9ce\uc774 \ubc1c\uc0dd\ud558\ub294 \uc9c8\ud658\uc785\ub2c8\ub2e4.<\/p>\n<p>J&amp;J\uc758 TECAYLI\ub294 2022\ub144 8\uc6d4\uc5d0 <a href=\"https:\/\/www.jnj.com\/media-center\/press-releases\/janssen-marks-first-approval-worldwide-for-tecvayli-teclistamab-with-ec-authorisation-of-first-in-class-bispecific-antibody-for-the-treatment-of-patients-with-multiple-myeloma\" target=\"_blank\" rel=\"noopener\">EU\ub85c \ubd80\ud130 \uc870\uac74\ubd80 \ud310\ub9e4\uc2b9\uc778\uc744<\/a> \ubc1b\uc558\uc73c\uba70 <a href=\"https:\/\/www.jnj.com\/media-center\/press-releases\/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-u-s-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma#:~:text=TECVAYLI%C2%AE%20(teclistamab%2Dcqyv)%20received%20approval%20from%20the%20U.S.,lines%20of%20therapy%2C%20including%20a\" target=\"_blank\" rel=\"noopener\">2024\ub144 2\uc6d4\uc5d0 FDA\ub85c\ubd80\ud130 \uac00\uc18d\uc2b9\uc778\uc744<\/a> \ubc1b\uc558\uc2b5\ub2c8\ub2e4. \ud55c\ud3b8, <a href=\"https:\/\/www.jnj.com\/media-center\/press-releases\/u-s-fda-approves-talvey-talquetamab-tgvs-a-first-in-class-bispecific-therapy-for-the-treatment-of-patients-with-heavily-pretreated-multiple-myeloma\" target=\"_blank\" rel=\"noopener\">TALVEY\ub294 2023\ub144 8\uc6d4\uc5d0 FDA\uac00\uc18d\uc2b9\uc778\uc744<\/a> \ubc1b\uc740\ub370 \uc774\uc5b4 \ub3d9\uc77c\ud55c \ub2ec\uc5d0 <a href=\"https:\/\/www.jnj.com\/media-center\/press-releases\/european-commission-approves-talvey-talquetamab-janssens-novel-bispecific-therapy-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma\" target=\"_blank\" rel=\"noopener\">EU \ub85c\ubd80\ud130 \uc870\uac74\ubd80 \ud310\ub9e4\uc2b9\uc778\uc744<\/a> \ubc1b\uc558\uc2b5\ub2c8\ub2e4. \ub450 \uc758\uc57d\ud488\uc740 \uc2e0\uacbd\ub3c5\uc131, \uac04\ub3c5\uc131 \ubc0f \uc0ac\uc774\ud1a0\uce74\uc778 \ud3ed\ud48d \ub4f1\u2026 \uc2ec\uac01\ud55c \ubd80\uc791\uc6a9\uc774 \ubc1c\uc0dd\ud560 \uc218 \uc788\ub2e4\ub294 \uc6b0\ub824 \ub54c\ubb38\uc5d0 \ubbf8\uad6d\uc5d0\uc11c\ub294 \uacf5\ub3d9 \uc704\ud5d8 \ud3c9\uac00 \ubc0f \uc644\ud654 \uc804\ub7b5(Risk Evaluation and Mitigation Strategy )\uc5d0 \ub530\ub77c \uc0ac\uc6a9\uc774 \uc5c4\uaca9\ud788 \uc81c\ud55c\ub418\uace0 \uc788\uc73c\uba70, \ub9e4\ub144 CMA\ub97c \uac31\uc2e0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p>J&amp;J\uc758 RedirecTT-1 \uc5f0\uad6c\ub294 \uace8\uc218 \uc678 \uc9c8\ud658(\uace8\uc218 \ubc16\uc73c\ub85c \ud37c\uc9c0\ub294 \uc9c8\ud658)\uc774 \ubc1c\uc0dd\ud55c \ud658\uc790\ub4e4\uc744 \ud3ec\ud568\ud574 \uc0bc\uc911 \ud56d\uc554\uc81c\uc5d0 \ub178\ucd9c\ub41c \uc7ac\ubc1c\uc131 \ub610\ub294 \ub09c\uce58\uc131 \ub2e4\ubc1c\uc131 \uace8\uc218\uc885 \ud658\uc790\ub4e4\uc744 \ub300\uc0c1\uc73c\ub85c \ub450 \uc57d\ubb3c\uc758 \ubcd1\uc6a9 \uce58\ub8cc \uac00\ub2a5\uc131\uc744 \ud0d0\uad6c\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>TALVEY\uc640 \uad00\ub828\ub41c \uaddc\uc81c\uc5d0 \ub300\ud574 \ud0d0\uad6c\ud55c \ubcf4\uace0\uc11c\ub97c \uc77d\uae30\ub97c \uc6d0\ud558\uc2dc\uba74<a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/lp\/drugs-to-watch-regulatory-focus-talvey\/\"> \uc774\uacf3<\/a>\uc744 \ub20c\ub7ec \ud655\uc778\ud574\uc8fc\uc2ed\uc2dc\uc624. \ub610\ud55c, <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/lp\/drugs-to-watch-regulatory-focus-abrysvo-and-arexvy\/\">ABRYSVO\u2122 \ubc0f AREXVY\u2122<\/a>, <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/lp\/drugs-to-watch-regulatory-in-focus-casgevy-and-lyfgenia\/\">Casgevy\u2122 \ubc0f Lyfgenia\u2122<\/a>, <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/lp\/drugs-to-watch-regulatory-focus-tarpeyo-kinpeygo\/\">TARPEYO\u00ae\/Kinpeygo\u00ae<\/a> \uc640 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/lp\/drugs-to-watch-regulatory-focus-zolbetuximab\/\">Zolbetuximab<\/a>\uc5d0 \ub300\ud55c \uaddc\uc81c\uc804\ub7b5\uc5d0 \ub300\ud574\uc11c\ub3c4 \uac01\uac01\uc758 \ub9c1\ud06c\ub97c \ud1b5\ud574 \ud655\uc778\ud558\uc2e4 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p><em>\ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uac00 \ud601\uc2e0\uc801\uc778 \uae30\uc5c5\ub4e4\uc774 \ube60\ub974\uac8c \ubcc0\ud558\ub294 \uaddc\uc81c \ud658\uacbd\uc5d0 \ub300\uc751\ud558\uae30 \uc704\ud574 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud558\uace0 \uc788\ub294\uc9c0 \uc54c\uc544\ubcf4\uace0 \uc2f6\uc73c\uc2dc\ub2e4\uba74 <a href=\"https:\/\/clarivate.com\/life-sciences-healthcare\/ko\/research-development\/regulatory-compliance-intelligence\/regulatory-intelligence-solutions\/\">\uc774\uacf3<\/a>\uc744 \ub20c\ub7ec \ud655\uc778\ud574 \ubcf4\uc2dc\uae30 \ubc14\ub78d\ub2c8\ub2e4.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\uc0c8\ub86d\uac8c \ub5a0\uc624\ub974\uace0 \uc788\ub294 \uc774\uc911\ud2b9\uc774\ud56d\uccb4 \ubd84\uc57c\ub294 \uc554 \ud658\uc790\uc5d0\uac8c \uc5c4\uccad\ub09c \uac00\ub2a5\uc131\uc744 \uc81c\uc2dc\ud569\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc774\ub7ec\ud55c \uce58\ub8cc\ubc95\uc740 \ub9e4\uc6b0 \ubcf5\uc7a1\ud55c \ubd80\uc791\uc6a9 \ud504\ub85c\ud544 \ub54c\ubb38\uc5d0 \uc758\uc57d\ud488 \uac1c\ubc1c\uc790\uc640 \uaddc\uc81c \ub2f9\uad6d\uc5d0 \uc5b4\ub824\uc6b4 \uacfc\uc81c\ub97c \uc548\uaca8\uc8fc\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud074\ub798\ub9ac\ubca0\uc774\ud2b8\uc758 \ubd84\uc11d\uac00\ub4e4\uc740 \uc0c8\ub85c \ubc1c\uac04\ub41c&#8230;<\/p>\n","protected":false},"author":45,"featured_media":349365,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1315],"tags":[],"class_list":["post-351288","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-healthcare"],"acf":[],"lang":"ko","translations":{"ko":351288},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/351288","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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=351288"}],"version-history":[{"count":2,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/351288\/revisions"}],"predecessor-version":[{"id":408433,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/351288\/revisions\/408433"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/349365"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=351288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=351288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=351288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}