{"id":28326,"date":"2025-09-02T12:10:01","date_gmt":"2025-09-02T10:10:01","guid":{"rendered":"https:\/\/kymos.com\/news\/%ec%a4%91%ed%99%94-%ed%95%ad%ec%b2%b4-%ec%83%9d%eb%ac%bc%ed%95%99-%ec%a0%9c%ec%a0%9c%ec%97%90-%eb%8c%80%ed%95%9c-%ed%85%8c%ec%8a%a4%ed%8a%b8-%ec%a7%80%ec%b9%a8-%eb%b0%8f-%ec%98%81%ed%96%a5\/"},"modified":"2025-12-03T19:05:15","modified_gmt":"2025-12-03T18:05:15","slug":"%ec%a4%91%ed%99%94-%ed%95%ad%ec%b2%b4-%ec%83%9d%eb%ac%bc%ed%95%99-%ec%a0%9c%ec%a0%9c%ec%97%90-%eb%8c%80%ed%95%9c-%ed%85%8c%ec%8a%a4%ed%8a%b8-%ec%a7%80%ec%b9%a8-%eb%b0%8f-%ec%98%81%ed%96%a5","status":"publish","type":"post","link":"https:\/\/kymos.com\/ko\/news\/%ec%a4%91%ed%99%94-%ed%95%ad%ec%b2%b4-%ec%83%9d%eb%ac%bc%ed%95%99-%ec%a0%9c%ec%a0%9c%ec%97%90-%eb%8c%80%ed%95%9c-%ed%85%8c%ec%8a%a4%ed%8a%b8-%ec%a7%80%ec%b9%a8-%eb%b0%8f-%ec%98%81%ed%96%a5\/","title":{"rendered":"\uc911\ud654 \ud56d\uccb4: \uc0dd\ubb3c\ud559 \uc81c\uc81c\uc5d0 \ub300\ud55c \ud14c\uc2a4\ud2b8, \uc9c0\uce68 \ubc0f \uc601\ud5a5"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:10px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:10px;--awb-width-medium:100%;--awb-spacing-right-medium:10px;--awb-spacing-left-medium:10px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\"><strong>\uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ubc0f \ucca8\ub2e8 \uce58\ub8cc \uc758\uc57d\ud488(ATMP)\uc740<\/strong> \uc758\ud559\uc758 \ubbf8\ub798\ub97c \ud601\uc2e0\ud558\uace0 \uc788\uc73c\uba70, \uadf8 \uc548\uc804\uc131\uacfc \ud6a8\ub2a5\uc740 \ucd5c\uc6b0\uc120 \uacfc\uc81c\uc785\ub2c8\ub2e4. \uc774 \uacfc\uc815\uc5d0\uc11c \uc911\uc694\ud55c \uce21\uba74\uc740 <strong>ATMP\uac00 \uc720\ubc1c\ud560 \uc218 \uc788\ub294 \uba74\uc5ed \ubc18\uc751<\/strong> , \ud2b9\ud788 <strong>\uc911\ud654 \ud56d\uccb4(NAb) \uc0dd\uc131\uc785\ub2c8\ub2e4<\/strong> . \uc774\ub7ec\ud55c \ud56d\uccb4\ub294 \uc57d\ubb3c \uc131\ub2a5\uc5d0 \uc911\uc694\ud55c \uc601\ud5a5\uc744 \ubbf8\uce58\uba70, \uc7a0\uc7ac\uc801\uc73c\ub85c \uce58\ub8cc \uc791\uc6a9\uc744 \ubcc0\ud654\uc2dc\ud0a4\uac70\ub098 \uc2ec\uc9c0\uc5b4 \uc5b5\uc81c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uba74\uc5ed\uc6d0\uc131 \uac80\uc0ac\ub294 \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \ubc0f ATMP \uac1c\ubc1c\uc5d0 \uc788\uc5b4 \ub9e4\uc6b0 \uc911\uc694\ud55c \uc694\uc18c\uc785\ub2c8\ub2e4.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774 \uae30\uc0ac\uc5d0\uc11c\ub294 <strong>\uc911\ud654 \ud56d\uccb4\uac00 \ubb34\uc5c7\uc778\uc9c0<\/strong> , \uc65c \uac80\uc0ac\ub97c \ubc1b\ub294 \uac83\uc774 \uc911\uc694\ud55c\uc9c0, <strong>\uc5b4\ub5bb\uac8c \uac80\ucd9c\ub418\ub294\uc9c0<\/strong> , \uac80\uc0ac\ub97c \uc704\ud574 \ub530\ub77c\uc57c \ud560 \ud604\uc7ac <strong>\uc9c0\uce68\uc740<\/strong> \ubb34\uc5c7\uc778\uc9c0, \uadf8\ub9ac\uace0 <strong>Kymos\uac00 NAb \uac80\uc0ac \uc694\uad6c \uc0ac\ud56d\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294\uc9c0\uc5d0 \ub300\ud574<\/strong> \uac04\ub7b5\ud558\uac8c \uc124\uba85\ud569\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc911\ud654 \ud56d\uccb4\ub780 \ubb34\uc5c7\uc778\uac00?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>\uc911\ud654 \ud56d\uccb4\ub294 \ud2b9\uc815 \uc720\ud615\uc758 \ud56d\uc57d\ubb3c \ud56d\uccb4(ADA)\uc785\ub2c8\ub2e4<\/strong> . \uacb0\ud569 ADA\ub294 \uce58\ub8cc \ubd84\uc790\uc5d0 \uacb0\ud569\ud558\uc9c0\ub9cc \ubc18\ub4dc\uc2dc \uae30\ub2a5\uc744 \uc190\uc0c1\uc2dc\ud0a4\uc9c0\ub294 \uc54a\ub294 \ubc18\uba74, <strong>\uc911\ud654 \ud56d\uccb4\ub294 \uc57d\ubb3c\uc758 \uc0dd\ubb3c\ud559\uc801 \ud65c\uc131\uc744 \ucc28\ub2e8\ud558\uc5ec \ud6a8\ub2a5\uc744 \uc7a0\uc7ac\uc801\uc73c\ub85c \ubcc0\ud654\uc2dc\ud0b5\ub2c8\ub2e4<\/strong> . <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c NAb\uc758 \uc874\uc7ac\ub294 \ud2b9\ud788 \uc7a5\uae30 \ub610\ub294 \ubc18\ubcf5 \ud22c\uc5ec \uc694\ubc95\uc5d0\uc11c \uce58\ub8cc \ubc18\uc751 \uac10\uc18c, \uce58\ub8cc \uc2e4\ud328, \uc2ec\uc9c0\uc5b4 \ubd80\uc791\uc6a9\uc73c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc774\uc720\ub85c <strong>NAb\ub97c \uc2dd\ubcc4\ud558\uace0 \ud2b9\uc131\ud654\ud558\ub294 \uac83\uc740 \uc57d\ubb3c \uac1c\ubc1c \uacfc\uc815\uc5d0\uc11c \ud544\uc218\uc801\uc785\ub2c8\ub2e4<\/strong> . <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>NAb \uac80\uc0ac\ub294 \uc5b8\uc81c \ud544\uc694\ud55c\uac00\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">NAb \ud14c\uc2a4\ud2b8\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ub2e4\uc74c\uc744 \ud3ec\ud568\ud558\uc5ec <strong>\uba74\uc5ed \ubc18\uc751\uc744 \uc720\ubc1c\ud560 \uac00\ub2a5\uc131\uc774 \uc788\ub294 \ubaa8\ub4e0 \uc81c\ud488\uc5d0 \ub300\ud574 \uc694\uad6c\ub429\ub2c8\ub2e4<\/strong> .<\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\ub2e8\uc77c\ud074\ub860 \ud56d\uccb4(mAb)<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\">\ud6a8\uc18c, \ud638\ub974\ubaac, \uc0ac\uc774\ud1a0\uce74\uc778 \ub4f1\uc758 <strong>\uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc720\uc804\uc790 \uce58\ub8cc<\/strong> \ubc0f <strong>\uc62c\ub9ac\uace0\ub274\ud074\ub808\uc624\ud0c0\uc774\ub4dc \uae30\ubc18 \uce58\ub8cc<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc885\uc591 \uc6a9\ud574 \ubc14\uc774\ub7ec\uc2a4<\/strong> \ubc0f <strong>\ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130 \uae30\ubc18 \uce58\ub8cc\ubc95<\/strong><\/span><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ubc31\uc2e0<\/strong> (\uba74\uc5ed \ubcf4\ud638 \ubc18\uc751\uc5d0 \ucd08\uc810)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uce58\ub8cc \ubc29\uc2dd\uc774 \uc810\uc810 \ub354 \ubcf5\uc7a1\ud574\uc9d0\uc5d0 \ub530\ub77c NAb \ud14c\uc2a4\ud2b8\uc758 \uad00\ub828\uc131\uc774 \ub354\uc6b1 \ub192\uc544\uc84c\uc73c\uba70 \uc55e\uc73c\ub85c\ub3c4 \uacc4\uc18d \uc131\uc7a5\ud560 \uac83\uc785\ub2c8\ub2e4.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc911\ud654 \ud56d\uccb4\ub294 \uc5b4\ub5bb\uac8c \uac80\ucd9c\ub418\ub098\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>NAb \uac80\ucd9c\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ub354 \uad11\ubc94\uc704\ud55c \uba74\uc5ed\uc6d0\uc131 \uac80\uc0ac \ud504\ub808\uc784\uc6cc\ud06c \ub0b4\uc5d0\uc11c \ub2e4\ub2e8\uacc4 \uc804\ub7b5\uc744 \ub530\ub985\ub2c8\ub2e4<\/strong> . \uc774 \uacfc\uc815\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ol>\n<li><span style=\"font-size: 14pt;\"> <strong>\uac00\uad50 \ub9ac\uac04\ub4dc \uacb0\ud569 \ubd84\uc11d\ubc95(\uc608: ELISA \ub610\ub294 ECLA)\uc744 \uc774\uc6a9\ud55c ADA \uc2a4\ud06c\ub9ac\ub2dd<\/strong> . \uacb0\ud569 \ud56d\uccb4\uc640 \uc911\ud654 \ud56d\uccb4\uac00 \ubaa8\ub450 \uac80\ucd9c\ub418\uc9c0\ub9cc, \uc774 \ub2e8\uacc4\uc5d0\uc11c\ub294 \uac10\ubcc4 \uc9c4\ub2e8\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uacbd\uc7c1\uc801 \ub9ac\uac04\ub4dc \uacb0\ud569 \uac80\uc0ac\ub97c \uc0ac\uc6a9\ud558\uc5ec \uce58\ub8cc \ubd84\uc790\uc5d0 \ub300\ud55c \ud2b9\uc774\uc131\uc744 \ud655\uc778\ud558\uae30 \uc704\ud574 <strong>\uc591\uc131 \uc0d8\ud50c\uc5d0 \ub300\ud55c \ud655\uc778 \ud14c\uc2a4\ud2b8\uc785\ub2c8\ub2e4<\/strong> .<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\ub9ac\uac04\ub4dc \uacb0\ud569 \uac80\uc0ac\ub97c \ud1b5\ud574 <strong>ADA \ub18d\ub3c4\ub97c \ubc18\uc815\ub7c9\uc801\uc73c\ub85c \ud3c9\uac00\ud558\uae30 \uc704\ud55c \uc801\uc815<\/strong> .<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc57d\ubb3c\uc5d0 \ub300\ud55c \uae30\ub2a5\uc801 \uc601\ud5a5\uc744 \ud655\uc778\ud558\uae30 \uc704\ud574 ADA \uc591\uc131\uc73c\ub85c \ud655\uc778\ub41c \uc0d8\ud50c\uc5d0 \ub300\ud574\uc11c\ub9cc NAb \uac80\uc0ac\ub97c \uc2e4\uc2dc\ud569\ub2c8\ub2e4<\/strong> . \uc774 \uacbd\uc6b0, <strong>NAb \uac80\uc0ac\uc5d0\ub294 \ub450 \uac00\uc9c0 \uc77c\ubc18\uc801\uc778 \ubd84\uc11d \ubc29\uc2dd\uc774 \uc0ac\uc6a9\ub429\ub2c8\ub2e4<\/strong> . <\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>\uc138\ud3ec \uae30\ubc18 \ubd84\uc11d(CBA):  <\/strong><\/span><span style=\"font-size: 14pt;\">\uc774\ub7ec\ud55c \uc720\ud615\uc758 \ubd84\uc11d\ubc95\uc740 \uc138\ud3ec \uc2dc\uc2a4\ud15c\uc5d0\uc11c <strong>\uc57d\ubb3c\uc758 \uc0dd\ubb3c\ud559\uc801 \ud65c\uc131\uc5d0 \ub300\ud55c \uae30\ub2a5\uc801 \uc5b5\uc81c(\uc608: \uc138\ud3ec \uc131\uc7a5, \uc138\ud3ec \uc0ac\uba78 \ub610\ub294 \ub9ac\ud3ec\ud130 \uc720\uc804\uc790 \ubd84\uc11d)\ub97c \uc815\ub7c9\uc801\uc73c\ub85c \ud3c9\uac00\ud558\uae30 \ub54c\ubb38\uc5d0 \ud669\uae08 \ud45c\uc900\uc73c\ub85c<\/strong> \uac04\uc8fc\ub429\ub2c8\ub2e4. \uc0dd\ub9ac\ud559\uc801 \uad00\ub828\uc131 \ub54c\ubb38\uc5d0 \ub300\ubd80\ubd84\uc758 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uc120\ud638\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ub9ac\uac04\ub4dc \uacb0\ud569 \ubd84\uc11d(LBA):<\/strong> \uc774\ub294 \uc138\ud3ec \uae30\ubc18\uc774 \uc544\ub2c8\uba70, <strong>\uc77c\ubc18\uc801\uc73c\ub85c CBA\uac00 \uc2e4\ud589 \uac00\ub2a5\ud558\uc9c0 \uc54a\uc744 \ub54c \uc0ac\uc6a9<\/strong> \ub429\ub2c8\ub2e4. LBA\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uacbd\uc7c1\uc801 \uacb0\ud569 \ubd84\uc11d\uc774\uba70, \uc218\ud589 \uc18d\ub3c4\ub294 \ube60\ub974\uc9c0\ub9cc <strong>\uc0dd\uccb4 \ub0b4 \uc911\ud654 \ud65c\uc131\uc744 \uc608\uce21\ud558\ub294 \ub370 \uc5b4\ub824\uc6c0\uc774 \uc788\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4<\/strong> . <\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>NAb \uacb0\uc815\uc5d0\ub294 \uc5b4\ub5a4 \uc9c0\uce68\uc774 \uc801\uc6a9\ub429\ub2c8\uae4c?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">\uc911\ud654 \ud56d\uccb4 \uac80\uc0ac\ub294 \ud655\ub9bd\ub41c \uaddc\uc81c \uccb4\uacc4\uc640 \uc9c0\uce68\uc5d0 \ub530\ub77c \uad00\ub9ac\ub429\ub2c8\ub2e4. \uac00\uc7a5 \uad00\ub828\uc131\uc774 \ub192\uc740 \ub0b4\uc6a9\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\"><strong>FDA (2019)<\/strong> \u2013 <em>\uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8 \uc81c\ud488\uc758 \uba74\uc5ed\uc6d0\uc131 \uc2dc\ud5d8<\/em> : <strong>\uc704\ud5d8 \uae30\ubc18 \uc811\uadfc\ubc95\uc744 \uad8c\uc7a5\ud558\uace0 CBA\ub97c \uc120\ud638\ud558\ub294 \ubc29\ubc95\uc73c\ub85c \uc9c0\uc9c0\ud569\ub2c8\ub2e4<\/strong> . \uc774 \uc9c0\uce68\uc740 \ubbfc\uac10\ub3c4, \ud2b9\uc774\ub3c4 \ubc0f \uc57d\ubb3c \ub0b4\uc131\uc744 \ud3ec\ud568\ud55c <strong>CBA \uac80\uc99d\uc744<\/strong> \uc81c\uc548\ud569\ub2c8\ub2e4. <\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>EMA(2017)<\/strong> \u2013 <em>\uc0dd\uba85\uacf5\ud559 \uc720\ub798 \uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8\uc758 \uba74\uc5ed\uc6d0\uc131 \ud3c9\uac00 \uc9c0\uce68<\/em> : \uc57d\ubb3c \uc791\uc6a9 \uae30\uc804\uc5d0\uc11c NAb \uce21\uc815\uc758 \uc911\uc694\uc131\uc744 \uac15\uc870\ud569\ub2c8\ub2e4. <strong>\uc774 \uc9c0\uce68\uc740 ADA\uac00 \uac80\ucd9c\ub418\uace0 \uc784\uc0c1\uc801\uc73c\ub85c \uad00\ub828\uc131\uc774 \uc788\ub2e4\uace0 \ud310\ub2e8\ub418\ub294 \uacbd\uc6b0 NAb \uac80\uc0ac\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4.<\/strong><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>ICH S6(R1) (2011)<\/strong> \u2013 <strong>\uc784\uc0c1 \uc804 \uba74\uc5ed\uc6d0\uc131 \uace0\ub824 \uc0ac\ud56d<\/strong> \uc5d0 \ucd08\uc810\uc744 \ub9de\ucd94\uace0 <strong>\ucd08\uae30 \uac1c\ubc1c \ub2e8\uacc4\uc5d0\uc11c \uc704\ud5d8 \uae30\ubc18 \ud3c9\uac00\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/strong><\/span><\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><strong>\uacb0\ub860: \uc0dd\ubb3c\ud559\uc801 \uc81c\uc81c \uac1c\ubc1c\uc758 \uc911\uc694\ud55c \ub3c4\uad6c<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\"><strong>NAb \uce21\uc815\uc740<\/strong> \uc0dd\ubb3c\ud559\uc801 \uce58\ub8cc\uc81c \uac1c\ubc1c \ubc0f \ubaa8\ub2c8\ud130\ub9c1\uc5d0 \uc788\uc5b4 \uc911\uc694\ud55c \ub2e8\uacc4\uc774\uba70, <strong>\uc548\uc804\uc131, \ud6a8\ub2a5 \ubc0f \uce58\ub8cc\uc801 \uc77c\uad00\uc131\uc744 \ubcf4\uc7a5\ud558\ub294<\/strong> \ub3c4\uad6c\uc785\ub2c8\ub2e4. \uc720\uc804\uc790 \ubc0f \uc138\ud3ec \uce58\ub8cc\uc640 \uac19\uc740 \uc0c8\ub85c\uc6b4 \uce58\ub8cc\ubc95\uc758 \ub4f1\uc7a5\uc73c\ub85c \uba74\uc5ed\uc6d0\uc131\uc744 \uc774\ud574\ud558\uace0 \uc644\ud654\ud558\ub294 \uac83\uc740 <strong>\uc57d\ubb3c \ud6a8\ub2a5 \ubc0f \ud658\uc790 \uc548\uc804\uc744 \uc704\ud574 \ud544\uc218\uc801<\/strong> \uc774\uba70 \uc55e\uc73c\ub85c\ub3c4 \ud544\uc218\uc801\uc77c \uac83\uc785\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>\uac1c\ubc1c \ucd08\uae30\ubd80\ud130 \uac15\ub825\ud55c \uba74\uc5ed\uc6d0\uc131 \uc804\ub7b5\uc744 \ud1b5\ud569\ud558\uace0<\/strong> \uc774\ub97c \ud6c4\uae30 \ub2e8\uacc4\uc5d0 \uac78\uccd0 \uac1c\uc120\ud558\uba74 <strong>\ud6c4\uae30 \ub2e8\uacc4 \uc2e4\ud328 \uc704\ud5d8\uc744 \ud06c\uac8c \uc904\uc774\uace0, \ucd9c\uc2dc \uae30\uac04\uc744 \ub2e8\ucd95\ud558\uba70, \uaddc\uc81c \uc2b9\uc778\uc744 \uc9c0\uc6d0\ud560<\/strong> \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc774\uc720\ub85c \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ud30c\ud2b8\ub108\ub97c \ud655\ubcf4\ud558\ub294 \uac83\uc774 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>Kymos\ub294 \uba74\uc5ed\uc6d0\uc131 \uc5f0\uad6c\uc5d0 \uc5b4\ub5bb\uac8c \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\ub098\uc694?<\/strong><\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Kymos Group\uc740 \ucd08\uae30 R&amp;D\ubd80\ud130 \ud575\uc2ec \uc784\uc0c1 \ub2e8\uacc4\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 <strong>\ubaa8\ub4e0 \uac1c\ubc1c \ub2e8\uacc4\uc5d0 \uac78\uccd0 \uba74\uc5ed\uc6d0\uc131 \uac80\uc0ac\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4<\/strong> . <strong>\ub3c5\uc77c\uc5d0 \uc0c8\ub85c\uc6b4 GLP \uc138\ud3ec \uae30\ubc18 \ubd84\uc11d \uc2e4\ud5d8\uc2e4\uc744<\/strong> \uac1c\uc18c\ud568\uc73c\ub85c\uc368 \ub2e4\uc74c\uc744 \ud3ec\ud568\ud55c \uc0dd\ubb3c\ud559 \ubd84\uc57c \uc5ed\ub7c9\uc744 \ud06c\uac8c \ud655\uc7a5\ud588\uc2b5\ub2c8\ub2e4. <\/span><\/p>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\uc644\uc804\ud55c \uba74\uc5ed\uc6d0\uc131 \ud504\ub85c\ud30c\uc77c\ub9c1:<\/span><\/strong>\n<ul>\n<li><span style=\"font-size: 14pt;\">\uacb0\ud569 \ud56d\uc57d\ubb3c \ud56d\uccb4( <strong>ADA<\/strong> )<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc911\ud654 \ud56d\uccb4( <strong>NAb<\/strong> )<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\uc804\ubb38\uc131<\/strong> :<\/span>\n<ul>\n<li><strong><span style=\"font-size: 14pt;\">\ud601\uc2e0\uc801\uc778 \ub2e8\uc77c\ud074\ub860 \ud56d\uccb4<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\uce58\ub8cc\uc6a9 \ud3a9\ud0c0\uc774\ub4dc<\/span><\/strong><\/li>\n<li><strong><span style=\"font-size: 14pt;\">\uc62c\ub9ac\uace0\ub274\ud074\ub808\uc624\ud0c0\uc774\ub4dc<\/span><\/strong><\/li>\n<li><span style=\"font-size: 14pt;\"><strong>\ubc14\uc774\ub7ec\uc2a4 \ubca1\ud130<\/strong> \ubc0f <strong>\uc885\uc591 \uc6a9\ud574 \ubc14\uc774\ub7ec\uc2a4<\/strong><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\"><strong>\ub3c5\uc77c\uacfc \uc2a4\ud398\uc778\uc5d0 \uc788\ub294 \uc800\ud76c \ud300\uc740<\/strong> <strong>EMA \ubc0f FDA \uc0dd\ubb3c\ubd84\uc11d \uc9c0\uce68\uc5d0 \ub530\ub77c<\/strong> \ubd84\uc11d\ubc95 <strong>\uad6c\ud604<\/strong> , <strong>\uac80\uc99d<\/strong> \ub610\ub294 \uc804\uccb4 \ubd84\uc11d\ubc95 <strong>\uac1c\ubc1c\uc744 \ucc98\uc74c\ubd80\ud130<\/strong> \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc5f0\uad6c\uc5d0 \ubaa9\uc801\uc5d0 \ub9de\ub294 \ud0d0\uc0c9\uc774 \ud544\uc694\ud558\ub4e0 <strong>GLP \uc870\uac74 \ud558\uc5d0\uc11c<\/strong> \uc644\uc804\ud55c \uaddc\uc815 \uc900\uc218\uac00 \ud544\uc694\ud558\ub4e0, Kymos\ub294 \uc720\ub7fd \uc804\uc5ed\uc5d0 \ub9de\ucda4\ud615 \uacfc\ud559 \uae30\ubc18 \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\uba74\uc5ed\uc6d0\uc131 \ubc0f \uc911\ud654 \ud56d\uccb4 \uc11c\ube44\uc2a4\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uc138\uc694:<\/span> <a href=\"https:\/\/kymos.com\/ko\/%ec%84%9c%eb%b9%84%ec%8a%a4\/%ec%a0%84%ec%9e%84%ec%83%81-%eb%b0%8f-%ec%9e%84%ec%83%81-%ec%84%9c%eb%b9%84%ec%8a%a4\/%ec%83%9d%eb%ac%bc%ed%95%99-%eb%b0%8f-%eb%b0%94%ec%9d%b4%ec%98%a4%ec%8b%9c%eb%b0%80%eb%9f%ac%ec%9d%98-%ec%83%9d%eb%ac%bc%ed%95%99%ec%a0%81-%eb%b6%84%ec%84%9d-%eb%b0%8f-%eb%a9%b4%ec%97%ad%ec%9b%90\/\" data-wpel-link=\"internal\"><span style=\"font-size: 14pt;\">https:\/\/kymos.com\/services\/pre-clinical-clinical-services\/bioanalysis-immunogenicity-of-biologics-biosimilars\/<\/span><\/a><\/p>\n<h2><span style=\"font-size: 18pt;\"><strong>\uc11c\uc9c0<\/strong><\/span><\/h2>\n<ol>\n<li><span style=\"font-size: 14pt;\">\ubbf8\uad6d \ubcf4\uac74\ubcf5\uc9c0\ubd80 \uc2dd\ud488\uc758\uc57d\uad6d \uc57d\ubb3c\ud3c9\uac00\uc5f0\uad6c\uc13c\ud130(CDER) \uc0dd\ubb3c\ud559\uc81c\uc81c\ud3c9\uac00\uc5f0\uad6c\uc13c\ud130(CBER) <strong>.<\/strong> <strong>\uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8 \uc81c\ud488\uc758 \uba74\uc5ed\uc6d0\uc131 \uc2dc\ud5d8 &#8211; \ud56d\uc57d\ubb3c \ud56d\uccb4 \uac80\ucd9c\uc744 \uc704\ud55c \ubd84\uc11d\ubc95 \uac1c\ubc1c \ubc0f \uac80\uc99d. \uc0b0\uc5c5\uacc4 \uc9c0\uce68(2019) <\/strong>. <a href=\"https:\/\/www.fda.gov\/media\/119788\/download\" data-wpel-link=\"external\">https:\/\/www.fda.gov\/media\/119788\/\ub2e4\uc6b4\ub85c\ub4dc<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\uc778\uccb4\uc6a9\uc758\uc57d\ud488\uc704\uc6d0\ud68c(CHMP). <strong>\uce58\ub8cc\uc6a9 \ub2e8\ubc31\uc9c8\uc758 \uba74\uc5ed\uc6d0\uc131 \ud3c9\uac00 \uc9c0\uce68(2017)<\/strong> . <em><u>EMEA\/CHMP\/BMWP\/14327\/2006 Rev 1.<\/u><\/em> <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf\" data-wpel-link=\"external\">https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf<\/a><\/span><\/li>\n<li><span style=\"font-size: 14pt;\"> <strong>ICH \uac00\uc774\ub4dc\ub77c\uc778 S6(R1) \u2013 \uc0dd\uba85\uacf5\ud559 \uc720\ub798 \uc758\uc57d\ud488\uc758 \uc804\uc784\uc0c1 \uc548\uc804\uc131 \ud3c9\uac00(2011)<\/strong> <em><u>EMA\/CHMP\/ICH\/731268\/1998.<\/u><\/em><\/span><\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":28329,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[259],"tags":[67],"class_list":["post-28326","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-259","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\uc911\ud654 \ud56d\uccb4: \uc0dd\ubb3c\ud559 \uc81c\uc81c\uc5d0 \ub300\ud55c \ud14c\uc2a4\ud2b8 \ubc0f \uc9c0\uce68<\/title>\n<meta name=\"description\" content=\"\uc911\ud654 \ud56d\uccb4(NAb)\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uace0, \ud14c\uc2a4\ud2b8 \ubc29\ubc95, \uad00\ub828 \uc9c0\uce68, \uc0dd\ubb3c\ud559 \uc2dc\uc7a5\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\uc5d0 \ub300\ud574 \uc54c\uc544\ubcf4\uc138\uc694.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/ko\/news\/%ec%a4%91%ed%99%94-%ed%95%ad%ec%b2%b4-%ec%83%9d%eb%ac%bc%ed%95%99-%ec%a0%9c%ec%a0%9c%ec%97%90-%eb%8c%80%ed%95%9c-%ed%85%8c%ec%8a%a4%ed%8a%b8-%ec%a7%80%ec%b9%a8-%eb%b0%8f-%ec%98%81%ed%96%a5\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\uc911\ud654 \ud56d\uccb4: \uc0dd\ubb3c\ud559 \uc81c\uc81c\uc5d0 \ub300\ud55c \ud14c\uc2a4\ud2b8 \ubc0f \uc9c0\uce68\" \/>\n<meta property=\"og:description\" content=\"\uc911\ud654 \ud56d\uccb4(NAb)\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uace0, \ud14c\uc2a4\ud2b8 \ubc29\ubc95, \uad00\ub828 \uc9c0\uce68, \uc0dd\ubb3c\ud559 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