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䆜⽰䈣㓼㜔ഖᆆ䠀᭴㔲ਾᖷδ&56ε᧛਍Ṳ㨨࿛ঋᣍ⋱⯍Ⲻᛙ㘻ਥ㜳Րਇ⭕㓼㜔ഖᆆ䠀᭴㔲ਾᖷ δ&56εθऻ ᤢ ћ䠅䙈໔ᯯṾδ⴪㠩&56⎾䘶ε ᡌ≮ѻ㓾↘Ṳ㨨࿛ঋᣍ⋱⯍ δ৸㿷 ɋ⭞⌋⭞䠅ɌȽɋу㢥ਃᓊɌ ԛ਀ ɋ⌞ᝅӁ亯ɌεȾ

Ǐ㦟૱਽〠ǐ䙊⭘਽〠˖Ṭ㨢࿕অᣇ⌘ሴ⏢୶૱਽〠˖ѝ᮷˖儈㖇ॾ®˗㤡᮷˖Columvi®㤡᮷਽〠˖Glofitamab Injection≹䈝᤬丣˖Gefeituo Dankang ZhusheyeǏᡀԭǐ⍫ᙗᡀԭ˖Ṭ㨢࿕অᣇṬ㨢࿕অᣇᱟа⿽൘ѝഭԃ啐থᐒ㓶㜎˄ CHO⢙ѝ㺘䗮Ⲵ䟽㓴ӪⓀॆৼ⢩ᔲᙗ˄CD20/CD3˅ᣇփDŽ䖵ᯉ˖L-㓴≘䞨ǃL-㓴≘䞨ⴀ䞨ⴀа≤ਸ⢙ǃL-⭢⺛≘䞨ǃD-㭇㌆ǃ㚊ኡỘ䞟 20DŽǏᙗ⣦ǐǃᰐ㢢ǃ▴␵ⓦ⏢DŽ

ǏǏ䘲ᓄ⯷ǐᵜ૱অ㦟䘲⭘Ҿ⋫⯇ᰒᖰ᧕ਇ䗷㠣ቁє㓯㌫㔏ᙗ⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗᕕ╛བྷ B 㓶㜎⏻ᐤⱔ˄DLBCL˅ᡀӪᛓ㘵DŽк䘠Ҿਾᵏ⺞䇱ᙗ䲿ᵪሩ➗Ѥᒺ䈅傼Ⲵ㔃᷌DŽǏ㿴Ṭǐ10mg (10ml)/⬦Ǐ⭘⌅⭘䟿ǐа㡜⌘᜿һ亩૱ᴯԓᵜ૱ˈ䴰ᖱᗇ༴ᯩ५⭏Ⲵ਼᜿DŽ䘲ᖃ५⯇᭟ᤱ᧚ᯭԕ㇑⨶㓶㜎ഐᆀ䟺᭮㔬ਸᖱ˄CRS⭘DŽ൘ㅜ 1 ઘᵏ઼ㅜ 2䇱㠣ቁᴹ 1ᢈ⨐অᢈ⨐অᣇ㔉㦟ਾ 8Ⲵᢈ⨐অᣇˈԕ༷ CRS ⋫⯇䴰㾱˄৲㿱Ǐ⌘᜿һ亩ǐ˅DŽྕ࿕⨐অᣇ亴༴⨶ᡰᴹᛓ㘵ᗵ享൘ㅜ 1 ઘᵏㅜ 1ࡽ7 ཙ˅᧕ਇ1000mg㔉㦟˄৲㿱㺘 2 ઼Āᔦ䘏ᡆ䚇┿㔉㦟ā˅DŽ䘉ᱟѪҶ⎸㙇ཆઘ㹰઼⏻ᐤ㓴㓷ѝⲴ B 㓶㜎ˈԕ䱽վ CRS Ⲵ仾䲙DŽྕ࿕⨐অᣇᓄԕ 50mg/h Ⲵ䙏⦷䶉㜹䗃⌘㔉㦟DŽ䗃⌘䙏⦷ਟ⇿ 30࣐50mg/hᴰ儈䙏⦷ 400mg/hDŽ傡⭘㦟˅ ઼н㢟৽ᓄ㇑⨶Ⲵᆼ᚟DŽ傡⭘㦟㓶㜎ഐᆀ䟺᭮㔬ਸᖱ亴䱢⋫⯇≤ॆਾ㔉ҸṬ㨢࿕অᣇDŽ㺘 1 ᾲᤜҶ⭘Ҿ䱽վ CRS 仾䲙˄৲傡⭘㦟DŽ㺘㺘 1 傡⭘㦟㔉㦟ઘᵏ˄ཙ˅ 傡 ⭘㦟㦟Ⲵᛓ㘵傡⭘㦟 㔉㦟ㅜ 1 ઘઘᵏ˄ㅜ 8 ཙཙǃㅜ15 ཙ˅˗ㅜ 2 ઘᵏ˄ㅜ 1 ཙ˅˗ㅜㅜ 3 ઘઘᵏ˄ㅜ 1 ཙཙ˅䜘ᛓ㘵䶉㜹⌘ሴⳞ䍘㊫പ䞷 a ࡽ㠣ቁ 1 ሿᰦᆼᡀDŽਓᴽ䭷Ⰻ/䀓✝㦟 b ࡽ㠣ቁ 30䫏DŽ ᣇ㓴㜪㦟 cᡰᴹਾ㔝䗃⌘䜘ᛓ㘵 ਓᴽ䭷Ⰻ/䀓✝㦟 b ࡽ㠣ቁ 30䫏DŽ ᣇ㓴㜪㦟 c㔉㦟ਾਁ⭏ CRS Ⲵᛓ㘵 䶉㜹⌘ሴⳞ䍘㊫പ䞷 a ࡽ㠣ቁ 1 ሿᰦᆼᡀDŽa 20mg ൠຎ㊣ᶮᡆ 100mg ⌬ቬᶮ/⌬ቬᶮ嗉ᡆ 80mg ⭢⌬ቬ嗉DŽb ྲˈ1000mg ሩ҉䞠≘ส䞊/ᢁ✝᚟ⰋDŽc ྲˈ50mg 㤟⎧᣹᰾DŽ䟿Ṭ㨢࿕অᣇ㔉㦟Ѫㅜ 1䟿䙂໎㔉㦟ᯩṸ˄ᰘ൘䱽վ CRS 仾䲙˅ˈ䟿 30mgDŽ⇿њઘᵏѪ 21 ཙDŽㅜ 1 ઘᵏ˖ ൘ㅜ1 ઘᵏㅜ 1䟿䙂໎㔉㦟ᯩṸ䶉㜹䗃⌘Ṭ㨢࿕অᣇˈㅜ 8 ཙ㔉Ҹᵜ૱ 2.5mgˈㅜ 15 ཙ㔉Ҹᵜ૱10mgDŽㅜ 2~12 ઘᵏ˖⇿њઘᵏㅜ 1 ཙ㔉Ҹᵜ૱ 30mgDŽ䟿઼䗃⌘ᤱ㔝ᰦ䰤˅ˈ䈖㿱㺘 2DŽ㺘 2 Ṭ㨢࿕অᣇঅ㦟⋫⯇㔉㦟ᯩṸ㔉㦟ઘᵏ˄ཙ˅a 䟿 䗃⌘ᤱ㔝ᰦ䰤ㅜ 1 ઘઘᵏ˄亴༴⨶઼䱦ở䟿䙂໎㔉㦟˅ㅜ 1 ཙ ྕ࿕⨐অᣇ b 亴༴⨶ㅜ 8 ཙ 2.5mg4 ሿᰦ c ㅜ 15 ཙ 10mgㅜ 2 ઘઘᵏ ㅜ 1 ཙ 30mgㅜ 3~12 ઘઘᵏ ㅜ 1 ཙ 30mg 2 ሿᰦ da ⇿њ㔉㦟ઘᵏѪ 21 ཙDŽb ৲㿱к䘠Āྕ࿕⨐অᣇ亴༴⨶āDŽc Ṭ㨢࿕অᣇ㔉㦟ᰦਁ⭏ CRS Ⲵᛓ㘵ˈ䗃⌘ᤱ㔝ᰦ䰤ਟᔦ䮯㠣 8 ሿᰦ˄৲㿱㺘 3 ઼Ǐ⌘᜿һ亩ǐ˅DŽd ᯝˈ 䟷⭘2 ሿᰦ䗃⌘DŽ ྲ᷌ᛓ㘵൘к㔉㦟ਾਁ⭏ CRS䗃⌘ᤱ㔝ᰦ䰤ᓄ㔤ᤱ൘ 4 ሿᰦDŽ䗃⌘ਾⴁ⍻Ṭ㨢࿕অᣇ˄ㅜ 1 ઘᵏㅜ 8 ཙ2.5mg˅䗃⌘ਾ㠣ቁ 10Ⲵ▌൘ CRS փᖱ઼⯷⣦DŽᓄሩᰒᖰ㔉㦟ਾਁ⭏≥2 㓗 CRS Ⲵᛓ㘵൘䗃⌘ᆼᡀਾ䘋㹼ⴁ⍻˄৲㿱㺘 3˅DŽҾ CRS Ⲵ仾䲙ǃփᖱ઼⯷⣦ˈᒦᔪ䇞൘ਁ⭏CRS փᖱӪઈDŽ⋫⋫⯇ᤱ㔝ᰦ䰤ޡ12⧠нਟ㇑⨶Ⲵ∂ᙗDŽᔦ䘏ᡆ䚇┿㔉㦟䟿䙂໎㔉㦟ᵏ䰤˄⇿ઘ㔉㦟˅˖䟷⭘ྕ࿕⨐অᣇ䘋㹼亴༴⨶ਾˈ ྲ᷌Ṭ㨢࿕অᣇ2.5mg䟿㔉㦟ᔦ䘏䎵䗷 1䴰䟽ᯠ䘋㹼ྕ࿕⨐অᣇ亴༴⨶DŽ൘Ṭ㨢࿕অᣇ 2.5mg ᡆ 10mg㦟䰤䳄Ѫ2 ઘ㠣 6䟿䙂໎㔉㦟DŽ൘Ṭ㨢࿕অᣇ 2.5mg ᡆ 10mg㦟䰤䳄䎵䗷 6䟿䙂໎㔉㦟 ˄৲㿱㺘 2 ѝⲴㅜ 1 ઘᵏ˅DŽㅜ 2 ઘᵏ৺ԕਾ˄30mg䟿˅˖㦟䰤䳄䎵䗷 6䟽ᯠԕྕ࿕⨐অᣇ䘋䟿䙂໎㔉㦟˄৲㿱㺘 2 ѝⲴㅜ 1 ઘᵏ˅ˈ❦ਾ䟿˄30mg䟿˅DŽ઼༷㔉㦟༷䘋㹼〰䟺DŽ䈤᰾āDŽ㔉㦟Ṭ㨢࿕অᣇӵਟ䟷⭘䶉㜹䗃⌘㔉㦟DŽᗵ享䟷⭘у⭘䗃⏢㇑䶉㜹䗃⌘Ṭ㨢࿕অᣇDŽṬ㨢࿕অᣇнᗇԕ䶉㜹᧘⌘ᯩᔿ㔉㦟DŽԆ㦟⢙␧ਸDŽࡲ䟿䈳ᮤ䟿DŽ㓶㜎ഐᆀ䟺᭮㔬ਸᖱⲴ㇑⨶㓶㜎ഐᆀ䟺᭮㔬ਸᖱ ˄৲㿱 Ǐ⌘᜿һ亩ǐ˅DŽ ᓄ䇴ՠᛓԆ৏ഐˈྲᝏḃᡆ㝃∂⯷DŽྲ᷌ᘰ⯁ਁ⭏ CRSˈᓄṩᦞ㺘 3 ѝสҾ㖾ഭ〫Ἵ઼㓶㜎⋫⯇ᆖՊ˄ASTCT㓗Ⲵ CRS ㇑⨶ᔪ䇞䘋㹼㇑⨶DŽ㺘 3 CRS ASTCT㓗઼㇑⨶ᤷই࡛a CRS ㇑㇑⨶ ⲴṬ㨢࿕অᣇ䗃⌘1 㓗㓗ਁ✝≥38°Cྲ᷌䗃⌘ᵏ䰤ਁ⭏ CRS˖x ѝᯝ䗃⌘ᒦ⋫⯇⯷⣦x ൘⯷⣦⎸䘰ਾԕ䖳ធⲴ䙏⦷䟽ᯠᔰ࿻䗃⌘x ྲ᷌⯷⣦༽ਁˈ㓸→↔⅑䗃⌘ྲ᷌䗃⌘ਾਁ⭏ CRS˖x ሩ⯷⋫⯇ྲ᷌ሩ⯷⋫⯇ਾ CRS ᤱ㔝䎵䗷48 ሿᰦ˖x ⭘Ⳟ䍘㊫പ䞷 cx ⭘ᢈ⨐অᣇ dx ⯷⣦ᐢ⎸䘰㠣ቁ 72 ሿᰦx ធ䗃⌘䙏⦷ b2 㓗㓗ਁ✝≥38°C઼/঻㦟Ⲵվ㹰঻઼/ᡆ䴰㾱啫ሬ㇑ᡆ੩≄㔉Ҹվ⍱䟿≗≄㇑⨶Ⲵ㕪≗ྲ᷌䗃⌘ᵏ䰤ਁ⭏ CRS˖x 䗃⌘ᒦሩ⯷⋫⯇x 㔉ҸⳞ䍘㊫പ䞷 cx ⭘ᢈ⨐অᣇ dྲ᷌䗃⌘ਾਁ⭏ CRS˖x ሩ⯷⋫⯇x 㔉ҸⳞ䍘㊫പ䞷 cx ⭘ᢈ⨐অᣇ dx ⯷⣦ᐢ⎸䘰㠣ቁ 72 ሿᰦx ធ䗃⌘䙏⦷ bx 䗃⌘ਾⴁ⍻ᛓ㘵⣦ᘱ e, f2 㓗⭘˖ᢈ⨐অᣇ d⭘൘ 6нᗇ䎵䗷 3DŽ⭘ᢈ⨐অᣇᡆ൘䗷৫ 6⭘Ҷ 1ᢈ⨐অᣇ˖x ᢈ⨐অᣇ dx ྲ᷌ 8㔉Ҹㅜ 2ᢈ⨐অᣇ dx ൘㔉Ҹ 2⭘ᴯԓᣇ㓶㜎ഐᆀ઼/⋫⯇DŽྲ᷌൘䗷৫ 6⭘Ҷ 2ᢈ⨐অᣇ˖x ӵ㔉Ҹ 1ᢈ⨐অᣇDŽx ྲ᷌ 8⭘ᴯԓᣇ㓶㜎ഐᆀ⋫⯇઼/⋫⯇DŽ3 㓗㓗ਁ✝≥38°C઼/঻঻㍐˅㇑⨶Ⲵվ㹰঻઼/ᡆ䴰㾱䙊䗷啫ሬ㇑ǃ 䶒㖙ǃྲ᷌䗃⌘ᵏ䰤ਁ⭏ CRS˖x 㓸→↔⅑䗃⌘ᒦሩ⯷⋫⯇x 㔉ҸⳞ䍘㊫പ䞷 cx 㔉Ҹᢈ⨐অᣇ dྲ᷌䗃⌘ਾਁ⭏ CRS˖x ሩ⯷⋫⯇x ⯷⣦ᐢ⎸䘰㠣ቁ 72 ሿᰦx ធ䗃⌘䙏⦷ bx 䗃⌘ਾ㔗㔝ⴁ⍻ᛓ㘵⣦ᘱe, fx ਁ㓗࡛a CRS ㇑㇑⨶ лⲴṬ㨢࿕অᣇ䗃⌘䶎䟽༽બ੨䶒㖙ᡆ᮷ш䟼䶒㖙䘋㹼儈⍱䟿㔉≗㇑⨶Ⲵ㕪≗x 㔉ҸⳞ䍘㊫പ䞷 cx 㔉Ҹᢈ⨐অᣇ d⭏≥3 㓗 CRS・ণ㓸⭘Ṭ㨢࿕অᣇ4 㓗㓗ਁ✝≥38°C઼/঻঻㍐˅㇑⨶Ⲵվ㹰঻઼/ᡆ䴰㾱ྲ CPAP gǃBiPAP h ǃᨂ㇑઼ᵪỠ䙊≄˅㇑⨶Ⲵ㕪≗ྲ᷌൘䗃⌘ᵏ䰤ᡆ䗃⌘ਾਁ⭏ CRS˖x ≨ѵ㓸→Ṭ㨢࿕অᣇᒦሩ⯷⋫⯇x 㔉ҸⳞ䍘㊫പ䞷 cx 㔉Ҹᢈ⨐অᣇ d3 㓗㓗઼ 4 㓗⭘ᢈ⨐অᣇ d⭘൘ 6нᗇ䎵䗷 3DŽ⭘ᢈ⨐অᣇᡆ൘䗷৫ 6⭘Ҷ 1ᢈ⨐অᣇ˖x ᢈ⨐অᣇ dx ྲ᷌ CRS ൘ 8㔉Ҹㅜ 2ᢈ⨐অᣇ dx ൘㔉Ҹ 2⭘ᴯԓᣇ㓶㜎ഐᆀ⋫⯇઼/⋫⯇DŽྲ᷌൘䗷৫ 6⭘Ҷ 2ᢈ⨐অᣇ˖x ӵ㔉Ҹ 1ᢈ⨐অᣇDŽx ྲ᷌ CRS ൘ 8⭘ᴯԓᣇ㓶㜎ഐᆀ⋫⯇઼/⯛⋫⯇DŽa 㖾ഭ〫Ἵо㓶㜎⋫⯇ᆖՊ˄ASTCTDŽb ྲ䴰㾱ˈ䗃⌘ᤱ㔝ᰦ䰤ᴰ䮯ਟᔦ䮯㠣 8 ሿᰦ˄৲㿱㺘 2˅DŽc ྲ 10mg IV ൠຎ㊣ᶮǃ100mg IV ⌬ቬᶮ嗉ǃ⇿ᰕ 1~2mg/kg IV ⭢⌬ቬ嗉ᡆㅹᖃ䟿㦟⢙˅DŽd ᢈ⨐অᣇ 8mg/kg IV˄н䎵䗷 800mg˅DŽe ㅜ 1 ઘᵏㅜ 15 ཙṬ㨢࿕অᣇ 10mg 㔉㦟ਾˈ5.2%Ⲵᛓ㘵ਁ⭏≥2 㓗 CRSˈ 㠣һԦਁ⭏Ⲵѝսᰦ䰤˄Ӿ䗃⌘ᔰ࿻˅Ѫ 26.2 ሿᰦ˄㤳ത˖6.7~144.2 ሿᰦ˅DŽf 1ᛓ㘵˄0.8%˅൘ㅜ 2 ઘᵏㅜ 1 ཙ᧕ਇṬ㨢࿕অᣇ 30mg 㔉㦟ਾਁ⭏≥2 㓗 CRSˈ㠣һԦਁ⭏ᰦ䰤˄Ӿ䗃⌘ᔰ࿻˅Ѫ 15.0 ሿᰦDŽg CPAP ˖ᤱ㔝≄䚃↓঻䙊≄h BiPAP ˖ৼ⴨≄䚃↓঻䙊≄⢩䟿䈤᰾˄ᙫ㛶㓒㍐>к䲀[ULN]ф≤1.5ؽULNˈ≘䞨≘ส䖜〫䞦[AST] >ULN䟿DŽቊᵚ൘ѝᓖᡆ䟽ᓖᛓ㘵ѝሩṬ㨢࿕অᣇ䘋㹼у䰘⹄ウ˄৲㿱ǏѤᒺ㦟⨶ǐ˅DŽ˄㚼䞀␵䲔⦷[CrCL] 30 㠣<90ml/min˅ᛓᛓ㘵ѝ䘋㹼Ṭ㨢࿕অᣇ⹄ウ˄৲㿱ǏѤᒺ㦟⨶ǐ˅DŽ㘱ᒤӪ˖≥65䟿˄৲㿱ǏѤᒺ㦟⨶ǐ˅DŽㄕ˖ቊᰐᵜ૱⭘Ҿ 18 ኱ԕлᛓ㘵ⲴѤᒺ⹄ウ䍴ᯉDŽ֯䈤᰾〰䟺䈤᰾⭘DŽ䘋㹼〰䟺DŽⴞ㿶ỰḕṬ㨢࿕অᣇ㦟⬦ѝᱟ੖ᆈ൘ᗞ㋂ᡆਈ㢢DŽṬ㨢࿕অᣇᱟа⿽ᓄђᔳ䈕⬦㦟⢙DŽ⭘ᰐ㧼䪸ཤ઼⌘ሴಘӾ䗃⏢㺻ѝᣭਆᡰ䴰փ〟Ⲵ 0.9%ᡆ 0.45%≟ॆ䫐ⓦ⏢˄৲㿱㺘 4˅ᒦђᔳDŽ䟿ᡰ䴰փ〟ⲴṬ㨢࿕অᣇ⎃㕙⏢ˈᒦ㖞Ҿ䗃⏢㺻ѝ〰䟺˄৲㿱㺘 4⭘Ⲵ㦟⢙DŽ〰䟺ਾⲴᴰ㓸㦟⢙⎃ᓖᓄѪ 0.1~0.6mg/mlDŽयᥟ᩷DŽҸԕђᔳDŽᆈDŽ㺘 4 䗃⌘⭘Ṭ㨢࿕অᣇⲴ〰䟺ᯩ⌅Ṭ㨢࿕অᣇ㔉㦟䟿0.9%ᡆᡆ 0.45%≟≟ॆ䫐ⓦ⏢䗃⏢㺻㿴㿴ṬᣭਆᒦђᔳⲴ 0.9%ᡆᡆ 0.45%≟≟ॆ䫐ⓦ⏢փ〟ⲴṬ㨢࿕অᣇ⎃㕙⏢փ〟2.5mg 50ml 27.5ml 2.5ml100ml 77.5ml 2.5ml10mg 50ml 10ml 10ml100ml 10ml 10ml30mg 50ml 30ml 30ml100ml 30ml 30ml䝽Խ⾱ᗼ⭘ 0.9%ᡆ 0.45%≟ॆ䫐ⓦ⏢〰䟺Ṭ㨢࿕অᣇDŽᖃԕ 0.9%≟ॆ䫐ⓦ⏢〰䟺ᰦˈṬ㨢࿕অᣇоਜ਼ᴹ㚊≟҉✟˄PVC˅ǃ㚊҉✟˄PE˅ǃ 㚊щ✟ ˄PP˅ᡆ 䶎PVC 㚊✟⛳Ⲵ䶉㜹䗃⏢㺻㜭ཏ⴨ᇩDŽ ᖃԕ0.45%≟ॆ䫐ⓦ⏢〰䟺ᰦˈṬ㨢࿕অᣇоਜ਼ PVC Ⲵ䶉㜹䗃⏢㺻㜭ཏ⴨ᇩDŽ⭘㚊≘䞟˄PUR˅ǃPVC ᡆ PE ӗ૱᧕䀖㺘䶒Ⲵ䗃⏢ಘԕ৺ਜ਼㚊䟊⹌˄PES˅└㟌DŽ⭘/䗷ᵏ㦟⢙Ⲵ༴㖞᤹⭏⍫ඳ൮༴㖞㦟⢙DŽ⛩˖x ⭘DŽx а⅑ᙗᇩಘ˅ѝDŽ⭘Ⲵ㦟⢙ᡆᓏᔳᶀᯉᓄ᤹➗ᖃൠ㾱≲䘋㹼༴㖞DŽǏǏн㢟৽ᓄǐѤᒺ䈅傼ᙗ⢩ᖱᙫ㔃Ṭ㨢࿕অᣇঅ㦟⋫⯇㓖ᴹ 469༽ਁᡆ䳮⋫ᙗ䶎䴽ཷ䠁⏻ᐤⱔᛓ㘵൘Ṭ㨢࿕অᣇѤᒺᔰਁ亩ⴞѝ᧕ਇҶṬ㨢࿕অᣇঅ㦟⋫⯇DŽл䘠㦟⢙н㢟৽ᓄᱟสҾ 154ᰒᖰ᧕ਇ䗷㠣ቁє㓯㌫㔏ᙗ⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗ DLBCL˄वᤜ└⌑⏻ᐤⱔ䖜ॆⲴ DLBCL࡛B 㓶㜎⏻ᐤⱔ઼৏ਁᙗ㓥䳄བྷ BᙗᮠᦞDŽ䘉Ӌᛓ㘵൘ NP30179 ⹄ウ˄а亩ᔰ᭮ᙗǃཊѝᗳѤᒺ䈅傼˅ѝ᧕ਇҶѝս 5 њઘᵏ˄㤳ത˖ㅜ 1~13 ઘᵏ˅ⲴṬ㨢࿕অᣇঅ㦟⋫⯇DŽᴰᑨ㿱Ⲵн㢟৽ᓄ˄≥20%ቁ⯷ǃቁ⯷DŽ≥2%Ⲵᛓ㘵ᣕ੺Ⲵᴰᑨ㿱ѕ䟽н㢟৽ᓄѪ㓶㜎ഐᆀ䟺᭮㔬ਸᖱ˄ 20.8%˅ǃ㝃∂⯷˄3.9%˅ǃCOVID-19˄3.2%˅ǃCOVID-19㛪⚾˄3.2%˅઼⟳ⱔ৽ᓄ˄3.2%˅DŽ6.5%⭘Ṭ㨢࿕অᣇⲴᴰᑨ㿱н㢟৽ᓄѪ COVID-19˄1.3%ቁ⯷˄1.3%˅DŽѤᒺ䈅傼ѝⲴ㦟⢙н㢟৽ᓄ≷ᙫ㺘᤹ MedDRAҶѤᒺ䈅傼ѝⲴ㦟⢙н㢟৽ᓄ˄㺘 5˅DŽṩᦞᑨ㿱˄ ≥1/10˅˗ᑨ㿱˄≥1/100 㠣<1/10㿱˄≥1/1000 㠣<1/100˅˗㖅㿱˄≥1/10000 㠣<1/1000˅˗ॱ㖅㿱˄<1/10000˅DŽ㺘㺘 5 ᧕ਇṬ㨢࿕অᣇঅ㦟⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗ DLBCL ᛓ㘵ѝਁ⭏Ⲵ㦟⢙н㢟৽ᓄ㊫н㢟৽ᓄṬ㨢࿕অᣇN=154࡛˅࡛)%(3~4 㓗˄%˅⯛㌫㔏⯮⯵㓶㜎ഐᆀ䟺᭮㔬ਸᖱ a ᑨ㿱 64.3 3.9㹰⏢৺⏻ᐤ㌫㔏⯮⯵ቁ⯷ b ᑨ㿱 37.7 27.3䍛㹰 c ᑨ㿱 30.5 7.8ቁ⯷ d ᑨ㿱 24.7 7.8ቁ⯷ e ᑨ㿱 4.5 4.5ቁ⯷ f ᑨ㿱 3.2 3.2䓛ᙗ⯮⯵৺㔉㦟䜘ս਴⿽৽ᓄਁ✝ ᑨ㿱 16.2 0㊫⯮⯵վ⼧㹰⯷ ᑨ㿱 17.5 5.8վ䭱㹰⯷ ᑨ㿱 14.3 0վ䫉㹰⯷ ᑨ㿱 12.3 0վ䫮㹰⯷ ᑨ㿱 11.0 1.3վ䫐㹰⯷ ᑨ㿱 7.8 1.3㛯ⱔⓦ䀓㔬ਸᖱ ᑨ㿱 1.3 1.3Ⳟ㛔৺Ⳟл㓴㓷㊫⯮⯵Ⳟ⯩ g ᑨ㿱 18.8 1.3㛳㛐㌫㔏⯮⯵〈 ᑨ㿱 13.6 0㞩⌫ ᑨ㿱 13.0 0ᚦᗳ ᑨ㿱 10.4 0㹰 h ᑨ㿱 2.6 2.6અੀ ᑨ㿱 4.5 0㢟ᙗǃᚦᙗ৺ᙗ䍘н᰾Ⲵ㛯ⱔ˄वᤜ೺⣦઼᚟㚹⣦˅⟳ⱔ৽ᓄ ᑨ㿱 11.0 2.6਴㊫⾎㓿㌫㔏⯮⯵ཤⰋ ᑨ㿱 9.7 0ఌⶑ ᑨ㿱 1.3 0.6䴷仔 ᑨ㿱 1.3 0㜺儃⚾ i 㿱 0.6 0.6ḃ㊫⯮⯵⯵∂ᝏḃ j ᑨ㿱 11.0 3.2*㓶㧼ᙗᝏḃ k ᑨ㿱 6.5 1.9кબ੨䚃ᝏḃ l ᑨ㿱 5.2 0㌫㊫н㢟৽ᓄṬ㨢࿕অᣇN=154࡛˅࡛)%(3~4 㓗˄%˅㝃∂⯷ m ᑨ㿱 3.9 2.6*лબ੨䚃ᝏḃ n ᑨ㿱 1.9 0ᝏḃᙗ㛪⚾ ᑨ㿱 4.5 1.3ቯ䐟ᝏḃ o ᑨ㿱 2.6 0.6ⵏ㧼ᝏḃ p ᑨ㿱 1.3 0਴㊫Ựḕщ≘䞨≘ส䖜〫䞦ॷ儈 ᑨ㿱 8.4 2.6≘䞨≘ส䖜〫䞦ॷ儈 ᑨ㿱 7.8 2.6㹰⻡ᙗ⼧䞨䞦ॷ儈 ᑨ㿱 8.4 1.3γ-䉧≘䞠䖜〫䞦ॷ儈 ᑨ㿱 6.5 2.6㹰㛶㓒㍐ॷ儈 ᑨ㿱 3.9 0.6㛍䞦ॷ儈 ᑨ㿱 1.3 1.3㋮⾎⯵㊫᜿䇶⁑㋺⣦ᘱ ᑨ㿱 1.9 0* ᣕ੺Ⲵ 5 㓗н㢟৽ᓄवᤜ㝃∂⯷˄1.3%˅ǃCOVID-19 㛪⚾˄1.9%˅઼ COVID-19˄1.9%˅DŽa สҾ ASTCT㓗DŽb ቁ⯷઼ѝᙗ㋂㓶㜎䇑ᮠ䱽վDŽc वᤜ䍛㹰઼㹰㓒㳻ⲭ䱽վDŽd ቁ⯷઼㹰ሿᶯ䇑ᮠ䱽վDŽe ቁ⯷઼⏻ᐤ㓶㜎䇑ᮠ䱽վDŽf ቁᙗᝏḃDŽg 㝡ᙗⳞ⚾ǃ㓒ᯁǃ᡻ᦼ㓒ᯁǃⱉⰂ઼㓒ᯁᙗⳞ⯩DŽh 㹰DŽi 㜺儃⚾о CRS ਼ᰦਁ⭏DŽj वᤜ COVID-19ǃCOVID-19઼⵬ᑖ⣦⯡⯩DŽk वᤜ㹰㇑㻵㖞ᝏḃǃ 㓶㧼ᙗᝏḃǃᕟᴢᵶ㧼ᝏḃǃ 㛶䚃㓶㧼ᝏḃǃ ቯ䐟㓶㧼ᝏḃǃ 䳮䗘ờ⣦㣭㜎ᵶ㧼ᝏḃǃෳᐼ㧼ᝏḃ઼㞩㟌⚾DŽl वᤜкબ੨䚃ᝏḃǃ啫ブ⚾ǃ啫૭⚾ǃធᙗ啫ブ⚾઼啫⚾DŽm DŽn वᤜлબ੨䚃ᝏḃ઼᭟≄㇑⚾DŽo वᤜቯ䐟ᝏḃ઼ෳᐼ∿㧼ᙗቯ䐟ᝏḃDŽp वᤜ伏㇑ᘥ⨐㧼⯵઼ਓ㞄ᘥ⨐㧼⯵DŽѤᒺ䈅傼ѝ⢩ᇊ㦟⢙н㢟৽ᓄ᧿䘠㓶㜎ഐᆀ䟺᭮㔬ਸᖱ64.3%࡛CRS˄ṩᦞ ASTCT˅ˈ48.1%Ⲵᛓ㘵ᣕ੺Ҷ1 㓗 CRSˈ12.3%Ⲵᛓ㘵ᣕ੺Ҷ 2 㓗 CRSˈ2.6%Ⲵᛓ㘵ᣕ੺Ҷ 3 㓗 CRSˈ1.3%Ⲵᛓ㘵ᣕ੺Ҷ 4 㓗 CRSDŽᰐ↫ӑ CRSDŽ䲔 1։ᡰᴹᛓ㘵Ⲵ CRS൷⎸䘰DŽ1ᛓ㘵ഐѪ CRS⭘Ṭ㨢࿕অᣇDŽ൘ਁ⭏ CRS ᛓ㘵ѝˈ CRS Ⲵᴰᑨ㿱㺘⧠वᤜਁ✝˄ 99.0%䗷䙏˄26.3%˅ǃվ㹰঻˄23.2%˅ǃሂᡈ˄14.1%˅઼㕪≗˄12.1%˅DŽо CRSⲴ 3㓗ᡆԕкһԦवᤜվ㹰঻˄3.0%˅ǃ㕪≗˄3.0%˅ǃਁ✝˄2.0%䗷䙏˄2.0%˅DŽ54.5%˄79/145˅Ⲵᛓ㘵൘ㅜ 1 ઘᵏㅜ 8 ཙ᧕ਇ 2.5mg Ṭ㨢࿕অᣇ㔉㦟ਾਁⲴ CRSˈ㠣һԦਁ⭏Ⲵѝսᰦ䰤˄Ӿ䗃⌘ᔰ࿻˅Ѫ12.6 ሿᰦ˄㤳ത˖5.2~50.8 ሿᰦ˅˗33.3%˄45/135˅ Ⲵᛓ㘵൘ㅜ1 ઘᵏㅜ 15 ཙ᧕ਇ 10mg 㔉㦟ਾਁⲴ CRSˈ㠣һԦਁ⭏Ⲵѝսᰦ䰤Ѫ 26.8 ሿᰦ˄㤳ത˖6.7~125.0 ሿᰦ˅˗26.8%˄34/127˅Ⲵᛓ㘵൘ㅜ 2 ઘᵏㅜ 1 ཙ᧕ਇ 30mgⲴ CRSˈ㠣һԦਁ⭏Ⲵѝսᰦ䰤Ѫ 28.2 ሿᰦ˄㤳ത˖15.0~44.2 ሿᰦ˅DŽㅜ 3 ઘᵏᰦᴹ 0.9%ᛓ㘵㘼ㅜ 3 ઘᵏਾᴹ 2%ᛓ㘵ᣕ੺Ҷ CRSDŽ12.4%Ⲵᛓ㘵൘俆⅑Ṭ㨢࿕অᣇ㔉㦟˄2.5mg˅ਾਁ⭏≥2 㓗 CRSˈ㠣һԦਁ⭏Ⲵѝսᰦ䰤Ѫ 9.7 ሿᰦ ˄㤳ത˖5.2~19.1 ሿᰦ˅ˈ ѝսᤱ㔝ᰦ䰤Ѫ50.4 ሿᰦ ˄㤳ത˖6.5~316.7 ሿᰦ˅DŽㅜ 1 ઘᵏㅜ 15 ཙṬ㨢࿕অᣇ 10mg 㔉㦟ਾˈ≥2 㓗 CRS Ⲵਁ⭏⦷䱽㠣 5.2%ˈ㠣һԦਁ⭏Ⲵѝսᰦ䰤Ѫ 26.2 ሿᰦ˄㤳ത˖6.7~144.2 ሿᰦ˅ˈѝսᤱ㔝ᰦ䰤Ѫ 30.9 ሿᰦ˄㤳ത˖3.7~227.2 ሿᰦ˅DŽ1ᛓ㘵˄0.8%˅൘ㅜ 2 ઘᵏㅜ 1 ཙ᧕ਇṬ㨢࿕অᣇ 30mg 㔉㦟ਾਁ⭏≥2 㓗 CRSˈ㠣һԦਁ⭏ᰦ䰤Ѫ 15.0ሿᰦˈᤱ㔝ᰦ䰤Ѫ 44.8 ሿᰦDŽㅜ 2 ઘᵏਾᵚᣕ੺≥2 㓗 CRSDŽ൘Ṭ㨢࿕অᣇ㔉㦟ਾਁ⭏ 2 㓗ᡆԕк CRS Ⲵ 25ᛓ㘵ѝˈ22˄88%˅᧕ਇҶᢈ⨐অᣇˈ15˄60%˅᧕ਇҶⳞ䍘㊫പ䞷ˈ14˄56%˅਼ᰦ᧕ਇҶᢈ⨐অᣇ઼Ⳟ䍘㊫പ䞷DŽ10ᛓ㘵 ˄40%˅ ᧕ਇҶ੨≗⋫⯇DŽ ᡰᴹਁ⭏3~4 㓗 CRSⲴ 6˄24.0%঻㦟DŽㅜ 1 ઘᵏㅜ 8 ཙṬ㨢࿕অᣇ 2.5mg傡⭘㦟Ⲵᛓ㘵˄N=39傡⭘㦟Ⲵᛓ㘵˄ N=106࡛CRS Ⲵਁ⭏⦷Ѫ 48.7% vs. 56.6% ˗1 㓗 CRS Ⲵਁ⭏⦷Ѫ 38.5% vs. 43.4% ˗2 㓗CRS Ⲵਁ⭏⦷Ѫ 7.7% vs. 9.4% ˗3 㓗 CRS Ⲵਁ⭏⦷Ѫ 2.6% vs. 1.9% ˗4 㓗 CRSⲴਁ⭏⦷Ѫ 0% vs. 1.9%DŽㅜ 1 ઘᵏㅜ 15 ཙṬ㨢࿕অᣇ 10mg 㔉㦟ਾ˄ൠຎ㊣ᶮ傡⭘㦟 N=36傡⭘㦟N=99࡛CRS Ⲵਁ⭏⦷Ѫ22.2% vs. 37.4% ˗1 㓗 CRS Ⲵਁ⭏⦷Ѫ 22.2% vs. 30.3% ˗2 㓗 CRS Ⲵਁ⭏⦷Ѫ0% vs. 6.1%˗3 㓗 CRS Ⲵਁ⭏⦷Ѫ 0% vs. 1%DŽㅜ 2 ઘᵏㅜ 1 ཙṬ㨢࿕অᣇ 30mg傡⭘㦟 N=32傡⭘㦟 N=95˅ˈԫօ㓗࡛CRS Ⲵਁ⭏⦷Ѫ 6.3% vs. 33.7%˗1 㓗 CRS Ⲵਁ⭏⦷Ѫ 6.3% vs. 32.6% ˗2 㓗CRS Ⲵਁ⭏⦷Ѫ 0% vs. 1.1%DŽѕѕ䟽ᝏḃ18.2%Ⲵᛓ㘵ᣕ੺Ҷѕ䟽ᝏḃDŽᴰᑨ㿱ѕ䟽ᝏḃ˄≥2%ᛓ㘵ᣕ੺˅Ѫ㝃∂⯷˄3.9%˅ǃCOVID-19 㛪⚾˄3.2%˅઼ COVID-19˄3.2%˅DŽ5.2%Ⲵᛓ㘵ᣕ੺Ҷᝏӑ˄㝃∂⯷ǃCOVID-19 㛪⚾઼ COVID-19 ᡰ㠤˅DŽ4ᛓ㘵˄2.6%˅ਁ⭏ѕ䟽ᝏḃˈ਼ᰦਁ⭏ 3~4ቁ⯷DŽቁ⯷37.7%ቁ⯷˄वᤜѝᙗ㋂㓶㜎䇑ᮠ䱽վ˅ˈ27.3%ቁ⯷˄3~4ቁ⯷һԦਁ֌Ⲵѝսᰦ䰤Ѫ 29 ཙ˄㤳ത˖1~203 ཙ˅DŽ11.0%Ⲵᛓ㘵ਁ⭏Ҷ䮯ᵏѝᙗ㋂㓶ቁ⯷˄ᤱ㔝ᰦ䰤䎵䗷 30ቁ⯷ᛓ㘵˄79.3%˅᧕ਇҶ G-CSF ⋫⯇DŽ2.6%ቁ⯷DŽ⟳ⱔ৽ᓄ11.0%ѝवᤜ 4.5%ᛓ㘵ѝⲴ 2 㓗⟳ⱔ৽ᓄ઼ 2.6%ᛓ㘵ѝⲴ 3 㓗⟳ⱔ৽ᓄDŽ ᣕ੺Ⲵ㍟৺ཤ亸䜘⏻ᐤ㔃Ⲵ⟳ⱔ৽ᓄ㺘⧠Ѫ⯬Ⰻˈ ㍟৺㜨䜘⏻ᐤ㔃Ⲵ⟳ⱔ৽ᓄդᴹ㜨㞄〟⏢ᕅ䎧Ⲵબ੨ഠ䳮DŽཊᮠ⟳ⱔ৽ᓄһԦ˄16/17˅ਁ⭏൘ㅜ 1 ઘᵏˈ൘ㅜ 2⟳ⱔ৽ᓄਁ֌Ⲵѝսᰦ䰤Ѫ 2 ཙ ˄㤳ത˖1~16 ཙ˅ˈ ѝսᤱ㔝ᰦ䰤Ѫ3.5 ཙ ˄㤳ത˖1~35⭘Ṭ㨢࿕অᣇDŽ㛯ⱔⓦ䀓㔬ਸᖱ2ᛓ㘵˄1.3%˅ᣕ੺Ҷ㛯ⱔⓦ䀓㔬ਸᖱ˄TLSⲴѕ䟽〻ᓖ൷Ѫ 3 㓗DŽTLS ਁ֌Ⲵѝսᰦ䰤Ѫ 2 ཙˈѝսᤱ㔝ᰦ䰤Ѫ 4 ཙ˄㤳ത˖3~5 ཙ˅DŽ⯛৏ᙗ⯛৏ᙗDŽ൘ NP30179 ⹄ウѝ᧕ਇṬ㨢࿕অᣇঅ㦟⋫⯇Ⲵབྷཊᮠᛓ㘵˄94.6%ˈN=418˅൘ส㓯ᰦѪᣇ㦟⢙ᣇփ˄ADAᤱ䱤ᙗDŽ2ᛓ㘵 ˄0.5%˅ ൘ส㓯ᰦ੸ADA 䱤ᙗˈ ᒦ൘ањᡆཊњ㔉㦟ਾᰦ䰤⛩੸ADA䱣ᙗDŽ3ᛓ㘵˄0.7%˅൘ส㓯઼ањᡆཊњ㔉㦟ਾᰦ䰤⛩൷Ѫ ADA 䱣ᙗDŽ⭡ޘᙗᴹ▌൘ᖡ૽Ⲵ㔃䇪DŽ䎆Ҿᡰ⭘Ự⍻ᯩ⌅Ⲵ⚥᭿ᓖ઼⢩ᔲᓖǃ ṧᵜ༴⨶ǃ ṧᵜ䟷䳶ᰦ䰤⛩ǃ դ䲿⭘㦟઼ส⹰⯮⯵DŽ ഐ↔ˈ ∄䖳Ṭ㨢࿕অᣇᣇ㦟ᣇփਁ⭏⦷оԆӗ૱ᣇ㦟ᣇփⲴਁ⭏⦷ਟ㜭Պӗ⭏䈟ሬDŽᇎᇎ傼ᇔỰḕᔲᑨ㺘 6 ᙫ㔃Ҷ NP30179 ⹄ウѝᇎ傼ᇔỰḕᔲᑨ൘⋫⯇ѝ⴨ሩҾส㓯ⲴਈॆDŽ㺘 6 Ṭ㨢࿕অᣇঅ㦟⋫⯇༽ਁᡆ䳮⋫ᙗ DLBCL ਁ⭏⦷≥10%Ⲵ 3~4 㓗ᇎ傼ᇔỰḕᔲᑨ˄䖳ส㓯˅ᇎ傼ᇔỰḕᔲᑨ aṬ㨢࿕অᣇNCI CTCAE࠶㓗˄%˅˅b 3 㓗㓗ᡆ 4 㓗㓗˄%˅˅b, c㹰ᑨ㿴ቁ 88.5 81.1ቁ 54.4 25.5ቁ 69.3 13.3㹰⭏ॆỰḕվ⼧㹰⯷ 67.8 26.8儈㹰㌆⯷ 13.7 13.7儈ቯ䞨㹰⯷ 22.5 22.5a Ⲵᛓ㘵DŽb ቁ N=148ቁ N=149ቁ N=150˗վ⼧㹰⯷ N=149˗儈㹰㌆⯷ N=146˗儈ቯ䞨㹰⯷ N=142DŽc वᤜӾส㓯ᰦ 0~2 㓗ਈѪส㓯ਾ≥3 㓗ԕ৺Ӿส㓯ᰦ 3 㓗ਈѪส㓯ਾ 4 㓗DŽᙗ㔃᷌⨳Ӫ㗔а㠤DŽкᐲਾ㓿傼н䘲⭘DŽǏ⾱ᗼǐԫօ䖵ᯉ䗷᭿Ⲵᛓ㘵⾱⭘ᵜ૱DŽ᚟ѝⲴྕ࿕⨐অᣇ⢩ᇊ⾱ᗼDŽǏǏ⌘᜿һ亩ǐа㡜һ亩᚟ѝⲴྕ࿕⨐অᣇ⢩ᇊ⌘᜿һ亩DŽ⭘ӗ૱Ⲵ୶૱਽઼ᢩਧDŽ㓶㜎ഐᆀ䟺᭮㔬ਸᖱ൘᧕ਇṬ㨢࿕অᣇ⋫⯇Ⲵᛓ㘵ѝᐢᣕ੺ CRSˈवᤜᴹਟ㜭ড৺⭏ભⲴ৽ᓄDŽCRS৽ᓄਟ㜭о CRSDŽNP30179 ⹄ウѝᴹ 64.3%Ⲵ CRS˄ASTCT˅DŽ3.9%Ⲵᛓ㘵ਁ⭏ 3 㓗ᡆ 4 㓗 CRSDŽ ᰐ㠤↫ᙗCRS࠶CRS һԦਁ⭏൘Ṭ㨢࿕অᣇ俆⅑㔉㦟ਾ˄৲㿱Ǐн㢟৽ᓄǐ˅DŽቁ CRSࡽ7 ཙ᧕ਇྕ࿕⨐অᣇ亴༴⨶ˈ ᒦ᧕ਇ䭷Ⰻ/傡⭘㦟 ˄৲㿱 Ǐ⭘⌅⭘䟿ǐ˅DŽ൘ㅜ 1 ઘᵏ઼ㅜ 2䇱㠣ቁᴹ 1ᢈᢈ⨐অᣇ㔉㦟ਾ 8Ⲵᢈ⨐অᣇˈԕ༷ CRS ⋫⯇䴰㾱DŽ享൘Ṭ㨢࿕অᣇ䗃⌘ᵏ䰤઼俆⅑䗃⌘ᆼᡀਾ㠣ቁ 10ޣ⧠ CRSփᖱᡆ⯷⣦ᰦᓄ・ণቡ५DŽԆ৏ഐˈ ྲᝏḃᡆ㝃∂⯷DŽ ᓄṩᦞᛓ㘵ⲴѤᒺ㺘⧠઼㺘 3Ⲵ CRS ㇑⨶ᤷইሩ CRS 䘋㹼㇑⨶˄৲㿱Ǐ⭘⌅⭘䟿ǐ˅DŽ⾎㓿∂ᙗ⯛᭸ᓄ㓶ᙗ⾎㓿∂ᙗ㔬ਸᖱ˄ICANS˅DŽNP30179˅ѪཤⰋ˄9.7%˅ǃ᜿䇶⁑㋺⣦ᘱ˄1.9%˅ǃఌⶑ˄1.3%˅ǃ䴷仔˄1.3%˅઼㜺儃⚾˄0.6%˅DŽᣕ੺Ⲵ 3㓗ᡆԕк⾎㓿㌫㔏н㢟৽ᓄवᤜఌⶑ˄0.6%˅઼㜺儃⚾˄0.6%˅˄৲㿱Ǐн㢟৽ᓄǐ˅DŽ4.5%Ⲵ ICANSDŽ࣐ཤᲅᡆ㋮⾎⣦ᘱ᭩ਈDŽ 䟷ਆ䘲亴䱢᧚ᯭDŽ᭟ᤱᙗ⋫⯇˗ṩᦞѕᡆ≨ѵ㓸→Ṭ㨢࿕অᣇ⋫⯇DŽ⧠⾎㓿∂ᙗ˄ྲ䴷仔ǃཤᲅᡆਟ㜭ᦏᇣ䇔⸕ᡆ᜿䇶Ⲵн㢟৽ᓄ˅Ⲵᛓ㘵䘋㹼৺ᰦ䇴ԧˈवᤜ▌൘Ⲵ⾎㓿ᆖ䇴ԧDŽѕѕ䟽ᝏḃ᧕ਇṬ㨢࿕অᣇ⋫⯇Ⲵᛓ㘵ѝᐢᴹਁ⭏ѕ䟽ᝏḃ˄ྲ㝃∂⯷઼ᝏḃᙗ㛪⚾˅˄৲㿱Ǐн㢟৽ᓄǐ˅DŽᙗᝏḃⲴᛓ㘵DŽሩҾᴹធᙗᡆ༽ਁᙗᝏḃਢⲴ⋫⯇Ⲵᛓ⧠ਟ◰⍫Ⲵ⯵∂ᝏḃˈᒦ䘋㹼䘲ᖃ⋫⯇DŽ⭘Ṭ㨢࿕অᣇˈ ⴤ㠣ᝏḃ⎸䘰DŽ ᓄᤷ⧠ᨀ⽪ᝏḃⲴփᖱ઼⯷⣦ᰦቡ५DŽቁ⯷Ⲵᣕ੺DŽᓄ䇴ˈᒦ〟ᶱ䘋㹼⋫⯇DŽ⟳ⱔ৽ᓄѤᒺ㺘⧠वᤜተ䜘⯬Ⰻ઼㛯㛰˄৲㿱Ǐн㢟৽ᓄǐ˅DŽа㠤ˈ⟳ⱔ৽ᓄਟ㜭ᱟṬ㨢࿕অᣇ㔉㦟ਾ T 㓶㜎㛯ⱔ䜘սᡰ㠤ˈ 㺘⧠ਟ㜭㊫լҾ⯮⯵䘋ኅDŽ ⟳ⱔ৽ᓄᒦн᜿ણ⵰⋫⯇ཡ䍕ᡆԓ㺘㛯ⱔ䘋ኅDŽቊᵚ⺞ᇊ⟳ⱔ৽ᓄⲴ⢩ᇊ仾䲙ഐ㍐ˈնᱟˈ൘սҾ䶐䘁≄䚃઼ /ᡆ䟽㾱ಘᇈⲴᐘབྷ㛯ⱔⲴᛓ㘵ˈ㔗ਁҾ⟳ⱔ৽ᓄⲴᐘඇ᭸ᓄਟሬ㠤ᦏᇣ઼ਁ⯵Ⲵ仾䲙໎䜘սⲴ⟳ⱔ৽ᓄˈᒦṩᦞѤᒺᤷᖱ䘋㹼㇑⨶DŽ㛯㛯ⱔⓦ䀓㔬ਸᖱ൘᧕ਇṬ㨢࿕অᣇ⋫⯇Ⲵᛓ㘵ѝᣕ੺Ҷ㛯ⱔⓦ䀓㔬ਸᖱ˄ TLS˅˄৲㿱Ǐнᡆ㝡≤ᛓ㘵ਁ⭏ TLS Ⲵ仾䲙ᴤབྷDŽⴁ⍻儈仾䲙ᛓ㘵Ⲵ⭥䀓䍘⣦ᘱǃ≤ਸ઼࡛≤ॆDŽTLS Ⲵ㇑⨶ਟ㜭वᤜ˖ 〟ᶱ㺕⏢ǃ 㓐↓⭥䀓䍘ᔲᑨǃ ᣇ儈ቯ䞨㹰⯷⋫⯇઼᭟ᤱᙗ⋫⯇DŽCD20 䱤ᙗ⯮⯵᧕ਇṬ㨢࿕অᣇ⋫⯇Ⲵ CD20-䱤ᙗ DLBCL ᛓ㘵Ⲵਟ⭘ᮠᦞᴹ䲀ˈ оCD20-䱣ᙗ DLBCL ᛓ㘵⴨∄ˈCD20 䱤ᙗ DLBCL ᛓ㘵Ⲵ㧧⳺ਟ㜭䖳ቁDŽᓄ㘳㲁оṬ㨢࿕অᣇ⋫⯇ CD20 䱤ᙗ DLBCLⲴ▌൘仾䲙઼㧧⳺DŽ⯛᧕⿽ᙗDŽṬ㨢࿕অᣇ⋫⯇ᵏ䰤нᔪ䇞᧕⿽⍫⯛㤇DŽ∂ᙗ䙐ᡀՔⲴྣᙗ൘Ṭ㨢࿕অᣇ⋫⯇ᵏ䰤઼ᵛ⅑㔉㦟ਾ 2䟷ਆᴹ᭸Ⲵ䚯ᆅ᧚ᯭ ˄৲㿱 ǏǏᆅྷ৺ପңᵏྷྣ⭘㦟ǐǐ઼ǏǏ㦟⨶∂⨶ǐǐ˅DŽ䎆ᙗ䎆Ⲵਟ㜭ᙗDŽ傮࣋⧠CRSǃ㕪≗˅઼⾎㓿∂ᙗ˄ྲ䴷仔ǃཤн㾱傮傦䖖䖶ᡆ᫽֌ᵪಘDŽǏᆅྷ৺ପңᵏྷྣ⭘㦟ǐⲴྣᙗ઼⭧ᙗ䚯ᆅⲴྣᙗᛓ㘵ᗵ享൘⋫⯇ᵏ䰤ԕ৺Ṭ㨢࿕অᣇᵛ⅑㔉㦟ਾ㠣ቁ 2⭘儈᭸䚯ᆅᯩ⌅DŽᆅྷⲴྣᙗᛓ㘵൘᧕⯛⨳㳻ⲭ G˄IgG˅DŽᐢ⸕ IgGݯBDŽ ྲ᷌ਁ⭏ྺၐˈᓄᔪ䇞ྣᙗᛓ㘵㚄㌫ѫ䇺५⭏DŽ࣋⹄ウ˄৲㿱Ǐ㦟⨶∂⨶ǐ˅DŽၙᙗDŽପңᵏྷྣ⋼DŽቊᵚ䘋㹼⹄ウԕ䇴ՠṬ㨢࿕অᣇሩӗྦ䟿Ⲵᖡ૽ԕ৺ң≱ѝᱟ੖ᆈ൘Ṭ㨢࿕অᣇDŽ ᐢ⸕ӪIgG ᆈ൘Ҿң≱ѝDŽ ቊн␵ᱟ੖ਟ੨᭦Ṭ㨢࿕অᣇᒦਁ⭏н㢟৽ᓄDŽᓄᔪ䇞ྣᙗ൘Ṭ㨢࿕অᣇ⋫⯇ᵏ䰤઼Ṭ㨢࿕অᣇᵛ⅑㔉㦟ਾ 2ପңDŽㄕ⭘㦟ǐቊᵚ⺞ᇊᵜ૱൘ 18ᙗ઼ᴹ᭸ᙗDŽǏǏ㘱ᒤ⭘㦟ǐ൘ NP30179 ⹄ウѝᴹ 84ֻ≥65 ኱Ⲵᰒᖰ᧕ਇ䗷㠣ቁє㓯㌫㔏ᙗ⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗ DLBCL ᛓ㘵᧕ਇҶ⹄ウ⭘㦟⋫⯇ˈঐᡰᴹ᳤䵢ӪᮠⲴ 54.5%DŽᵚ㿲ሏࡠ≥65 ኱Ⲵᛓ㘵о 65ᙗᡆᴹ᭸ᙗᆈ൘ᐞᔲDŽ≥65䟿˄৲㿱Ǐ⭘⌅⭘䟿ǐ઼ǏѤᒺ㦟⨶ǐ˅DŽǏ㦟⢙⴨ӂ֌⭘ǐቊᵚ䘋㹼Ѥᒺ㦟⢙⴨ӂ֌⭘⹄ウDŽ亴䇑нՊᴹ㦟⢙䙊䗷㓶㜎㢢㍐ P450Ԇԓ䉒䞦ᡆ䖜䘀㳻ⲭоṬ㨢࿕অᣇਁ⭏⴨ӂ֌⭘DŽᆖᔪ⁑ˈԕՠ䇑⭡Ṭ㨢࿕অᣇ䈡ሬⲭӻ㍐ -6˄IL-6˅ ≤ᒣа䗷ᙗॷ儈ᕅ䎧ᒦਟ㜭ᖡ૽CYP ⍫ᙗⲴ▌൘㦟⢙⴨ӂ֌⭘Ⲵ〻ᓖDŽᔪ⁑㔃᷌㺘᰾ˈа䗷ᙗ IL-6 ≤ᒣॷ儈ሩ CYP֌⭘ᑵᓖ<50%DŽ↔ཆˈ亴䇑 CYP3A4ǃCYP1A2 ઼ CYP2C9 ᓅ⢙Ⲵ᳤䵢䟿ਈॆሿҾᡆㅹҾ 2DŽ⭘ CYP450ᱟ⋫⯇ᤷᮠ䖳ゴⲴ㦟⢙[ྲˈॾ⌅᷇ǃ⧟ᆒ㍐]є⅑㔉㦟˄ণㅜ 1 ઘᵏㅜ 8 ཙ઼ㅜ 15 ཙ˅ਾ 1⭘⋫⯇ᤷᮠ䖳ゴⲴ CYP450ᕅ䎧∂ᙗㅹн㢟һԦDŽǏ㦟⢙䗷䟿ǐ൘Ѥᒺ䈅傼ѝᰐṬ㨢࿕অᣇ⭘㦟䗷䟿Ⲵ㓿傼DŽǏѤᒺ㦟⨶ǐࡦ䲶ᣇփˈо൘ B 㓶㜎㺘䶒к㺘䗮Ⲵ CD20˅ˈо൘ T 㓶㜎㺘䶒к㺘䗮Ⲵ T 㓶㜎ਇփ༽ਸ⢙ѝⲴ CD3অԧ㔃ਸDŽṬ㨢࿕অᣇ䙊䗷о B 㓶㜎кⲴ CD20 ઼ T 㓶㜎кⲴ CD3 ਼ᰦ㔃ਸ㘼⯛ケ䀖ᖒᡀˈԕ৺䲿ਾᕪ᭸ T⋼઼㓶㜎ⓦ䀓㳻ⲭ䟺᭮ˈሬ㠤㺘䗮 CD20 Ⲵ B 㓶㜎ⓦ䀓DŽ㦟᭸ᆖ൘ NP30179 ⹄ウѝˈ84%˄84/100ࠪ⧠ B 㓶㜎㙇ㄝ˄<70 њ㓶㜎/μLˈྕ࿕⨐অᣇ亴༴⨶ਾ B㠣 100%˄94/94ᤱ䖳վ≤ᒣDŽ൘ㅜ 1䟿䙂໎˅Ṭ㨢࿕অᣇ䗃⌘ਾ 6㹰⍶ IL-6 ≤ᒣа䗷ᙗॷ儈ˈ൘䗃⌘ਾ 20ᚒ༽㠣ส㓯≤ᒣDŽ㦟ᆖᴰ儈≤ᒣ ˄Cmax˅ˈ䟿㤳ത ˄0.005~30mgˈ Ṭ㨢࿕অᣇⲴ㦟DŽ੨੨᭦ጠ⎃ᓖ˄Cmax˅DŽᐳ൘ IVᐳᇩ〟Ѫ 3.33Lᐳᇩ〟Ѫ2.18LDŽԓ䉒䀓ԓ䉒␵䲔DŽ⎸䲔䎆ᙗ␵䲔⦷Ⲵ㗔փ㦟ᆖ⁑ර᧿䘠ҶṬ㨢࿕অᣇ㹰␵⎃ᓖ-ᰦ䰤ᮠᦞDŽ䎆ᙗ␵䲔⦷Ѫ 0.602L/ཙˈ⁑ර⁑ᤏⲴṬ㨢䎆ᙗ␵䲔⦷Ѫ 0.396L/˄Kdes 㓖0.445/ཙ˅DŽ䎆ᙗ␵䲔䱽վ㠣ਟᘭ⮕н䇑ਾ˅⁑ᤏⲴṬ㨢࿕অᣇॺ㺠ᵏѪ 6.54 ཙDŽᆖ൘а亩ᔰ᭮ḷㆮⲴঅ㟲 I ᵏ⹄ウ ˄YO42610˅ ѝ䇴ՠҶ൘ѝഭ3L+DLBCL ᛓᆖ˄ PK᷀˄NCA˅⁑රᶕ䇴ԧѝഭᛓ㘵 PK ᮠᦞᱟ੖о䶎ѝഭᛓ㘵ѝⲴṬ㨢࿕অᣇ PK ᮠᦞа㠤DŽṬ㨢࿕অᣇ൘ YO42610 ઼ NP30179ѻ䰤ᱮ⽪⴨լⲴ PK ⢩ᖱDŽ㺘 7 ᙫ㔃Ҷ⹄ウ YO42610 ઼⹄ウ NP30179 ⲴṬ㨢࿕অᣇⲴ᳤䵢䟿ᤷḷሩ∄DŽ㺘㺘 7 ⹄ウ YO42610 ઼⹄ウ NP30179˄2.5/10/30 mg 㔉㦟ᯩṸ˅ѻ䰤Ⲵ᳤䵢䟿ᤷḷ∄䖳⹄ウ N AvgRO%D1 AvgRO%C1+C2 AUCD1(μg.d/mL)AUCC1+C2(μg.d/mL)CmaxD1(μg/mL)CmaxC1+C2(μg/mL)NP30179 230 0.227(0.217)1.22 (1.07) 0.522(0.468)58.0 (44.4) 0.698(0.666)9.04 (7.57)YO42610 27 0.173(0.162)1.09 (1.01) 0.449(0.397)54.8 (45.0) 0.621(0.557)8.52 (7.31)˅㺘⽪DŽAvgROD1=ᒣ൷Ṭ㨢࿕অᣇਇփঐᴹ⦷˄ㅜ 1 ཙ˅ˈAvgRO%C1+C2=ᒣ൷Ṭ㨢࿕অᣇਇփঐᴹ⦷˄ㅜ 1 ઘᵏ+ㅜ 2 ઘᵏ˅ˈAUCD1=Ṭ㨢࿕অᣇ⎃ᓖ-ᰦ䰤ᴢ㓯л䶒〟˄ㅜ 1 ཙ˅ˈAUCC1+C2=Ṭ㨢࿕অᣇ⎃ᓖ-ᰦ䰤ᴢ㓯л䶒〟˄ㅜ 1 ઘᵏ+ㅜ 2 ઘᵏ˅ˈCmaxD1=Ṭ㨢࿕অᣇጠ⎃ᓖ˄ㅜ 1 ཙ˅ˈCmaxC1+C2=Ṭ㨢࿕অᣇጠ⎃ᓖ˄ㅜ 1 ઘᵏ+ㅜ 2 ઘᵏ˅DŽ

ᆖㄕӪ㗔ᆖ⹄ウDŽ㘱ᒤӪ㗔᷀ˈ൘ 65 ኱৺ԕкᛓ㘵о 65 ኱ԕлᛓ㘵ѻ䰤ᵚ㿲ሏṬ㨢࿕অᣇ᳤䵢䟿ᐞᔲDŽޘᆖDŽ˄CrCL 30 㠣<90ml/minᆖ䟿DŽ ቊᵚᛓ㘵ѝ䘋㹼Ṭ㨢࿕অᣇ⹄ウDŽޘᆖDŽ˄ᙫ㛶㓒㍐>ULN фİ1.5ؽULNˈᡆ AST>ULN˅ᛓ㘵ⲴṬ㨢ᛓ㘵ˈ ᰐ䴰䈳ᮤᛓ㘵ѝ䘋㹼Ṭ㨢࿕অᣇ⹄ウDŽ䚇䚇Ր㦟⨶ᆖቊᵚⴤ᧕⹄ウṬ㨢࿕অᣇⲴ䚇Ր㦟⨶ᆖDŽǏѤᒺ䈅傼ǐ⨳ NP30179 Ѥᒺ䈅傼NP30179䈅傼˅൘108ᰒᖰ᧕ਇ䗷㠣ቁє㓯㌫㔏ᙗ⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗ DLBCL ᛓ㘵ѝ䇴ԧҶṬ㨢࿕অᣇঅ㦟ᛓᙗѝ᷒⾎㓿㌫㔏⏻ᐤⱔǃь䜘㛯ⱔॿ֌㓴˄ECOG˅փ㜭⣦ᘱ˄PS˅≥2ǃ㚼䞀␵䲔⦷˄CrCL˅<50ml/minǃ㛍䖜≘䞦>3ؽULN Ⲵᛓ㘵DŽ൘ㅜ 1 ઘᵏㅜ 1䟿䙂໎㔉㦟ᯩṸ൘ㅜ 1 ઘᵏㅜ 8 ཙ᧕ਇ 2.5mg Ṭ㨢࿕অᣇˈ൘ㅜ 1 ઘᵏㅜ 15 ཙ᧕ਇ 10mg Ṭ㨢࿕অᣇˈ൘ㅜ 2 ઘᵏㅜ 1 ཙ᧕ਇ 30mg Ṭ㨢࿕অᣇDŽᛓ㘵൘ㅜ 3~12 ઘᵏㅜ 1ཙ㔗㔝᧕ਇ 30mg傡⭘㦟ˈ वᤜ䀓✝/䭷Ⰻ㦟ǃ ᣇ㓴㜪㦟઼Ⳟ䍘㊫പ䞷˄৲㿱Ǐ⭘⌅⭘䟿ǐ˅DŽ⇿њઘᵏѪ 21 ཙDŽᛓ㘵᧕ਇҶѝս 5 њઘᵏ˄㤳ത˖ㅜ 1~13 ઘᵏ˅ⲴṬ㨢࿕অᣇ⋫⯇DŽส㓯Ӫਓ㔏䇑ᆖ઼⯮⯵⢩ᖱѪ˖ѝսᒤ喴 66 ኱˄㤳ത˖21~90 ኱˅˗69.4%Ⲵ⭧ᙗ˗74.1%ⲴⲭӪǃ5.6%Ⲵӊ㼄઼ 0.9%Ⲵ唁Ӫᡆ䶎㼄㖾ഭӪ˗5.6%Ⲵ㾯⨝⢉㼄ᡆ᣹б㼄˗ECOG PS Ѫ 0˄46.3%˅ᡆ 1˄52.8%˅DŽབྷཊᮠᛓ㘵˄71.3%˅ᛓᴹ䶎⢩ᤷරⲴ DLBCLˈ15.7%ᛓᴹ䖜ॆර└⌑ᙗ⏻ᐤⱔ˄trFL˅ˈ7.4%࡛B 㓶㜎⏻ᐤⱔˈ5.6%ᛓᴹ৏ਁᙗ㓥䳄བྷ B 㓶㜎⏻ᐤⱔDŽ ᰒᖰ⋫⯇㓯ᮠѝսᮠѪ3˄㤳ത˖2~7ѝ 39.8%Ⲵᛓ㘵ᰒᖰ᧕ਇ䗷є㓯⋫⯇ˈ60.2%Ⲵᛓ㘵ᰒᖰ᧕ਇ䗷 3 㓯ᡆԕк⋫⯇DŽᡰᴹᛓ㘵ᰒᖰ൷᧕ਇ䗷ॆ⯇઼ᣇ CD20䲶ᣇփ⋫⯇˗35.2%Ⲵᛓ㘵ᰒᖰ᧕ਇ䗷 CAR-T 㓶㜎⯇⌅ˈ16.7%Ⲵᛓ㘵᧕ਇ䗷㠚փ䙐㹰ᒢ㓶㜎〫ἽDŽབྷཊᮠᛓ㘵˄89.8%˅ᛓᴹ䳮⋫ᙗ⯮⯵ˈ 60.2%Ⲵᛓ㘵ᛓᴹ৏ਁ䳮⋫ᙗ⯮⯵ˈ83.3%Ⲵᛓ㘵Ѫᰒᖰᵛ⅑⋫⯇䳮⋫ˈ89.5%ᰒᖰ᧕ਇ䗷 CAR-T 㓶㜎⯇⌅Ⲵᛓ㘵Ѫ CAR-T 㓶㜎⯇⌅䳮⋫DŽṩᦞ⤜・ᇑḕငઈՊ ˄IRC˅ 䇴ՠⲴPFS ѝս䲿䇯ᤱ㔝ᰦ䰤Ѫ 15.0 њᴸ ˄㤳ത˖0~21 њᴸ˅DŽṩ ᦞIRC 䇴ՠ㔃᷌⺞ᇊⲴӾ俆⅑㕃䀓ᰕᵏ䎧Ⲵѝս䲿䇯ᤱ㔝ᰦ䰤Ѫ 12.8 њᴸ˄㤳ത˖0~20 њᴸ˅DŽѫ㾱⯇᭸㓸⛩ᱟ⭡ IRC⭘ 2014 ᒤ Lugano㕃䀓 ˄CR˅⦷ DŽ⅑㾱⯇᭸㓸⛩वᤜ⹄ウ㘵˄INV˅䇴ՠⲴ CR ⦷ǃIRC ઼ INV 䇴ՠⲴᙫ㕃䀓⦷˄ORR˅ǃ㕃䀓ᤱ㔝ᰦ䰤˄DOR㕃䀓ᤱ㔝ᰦ䰤˄DOCR˅ǃ㠣俆⅑㕃䀓Ⲵᰦ䰤˄TFOR㕃䀓Ⲵᰦ䰤˄TFCR˅ǃᰐ䘋ኅ⭏ᆈᵏ˄PFS˅઼ᙫ⭏ᆈᵏ˄OS˅DŽ⯇᭸㔃᷌ᙫ㔃৲㿱㺘 8DŽ

㺘㺘 8 ൘᧕ਇṬ㨢࿕অᣇঅ㦟⋫⯇Ⲵ༽ਁᡆ䳮⋫ᙗ DLBCL ᛓ㘵ѝⲴ⯇᭸⯇᭸㓸⛩ Ṭ㨢࿕অᣇN=108ѫ㾱㓸⛩IRC 䇴㕃䀓⦷CR ᛓ㘵ˈn˄%˅ 38 (35.2)95% CI [26.24, 44.96]⅑㾱㓸⛩INV 䇴㕃䀓⦷CR ᛓ㘵ˈn˄%˅ 36 (33.3)95% CI [24.55, 43.05]ᙫ㕃䀓⦷ IRC 䇴ՠ INV 䇴ՠࡠCR ᡆ PR Ⲵᛓ㘵ˈn˄%˅ 54 (50.0) 61 (56.5)95% CI [40.22, 59.78] [46.60, 66.00]㕃䀓˄PR˅ˈn˄%˅ 16 (14.8) 25 (23.1)95% CI [8.71, 22.94] [15.57, 32.25]㕃䀓ᤱ㔝ᰦ䰤 a IRC 䇴ՠ INV 䇴ՠѝս DOCRˈᴸ[95% CI] NE [18.4, NE] a NE [18.2, NE]㤳തˈᴸ 0b~20 b 0b~21b9 њᴸ DOCRˈ%[95% CI]c 78.1 [63.66, 92.56] 74.3 [58.83, 89.81]12 њᴸ DOCRˈ%[95% CI]c 74.6 [59.19, 89.93] 74.3 [58.83, 89.81]㕃䀓ᤱ㔝ᰦ䰤 d IRC 䇴ՠ INV 䇴ՠѝս DORˈᴸ[95% CI] 14.4 [8.6, NE] a 7.8 [3.8, NE]㤳തˈᴸ 0b~20b 0b~21b9 њᴸ DORˈ%[95% CI]c 61.4 [47.71, 75.15] 46.8 [33.66, 59.98]12 њᴸ DORˈ%[95% CI]c 56.3 [41.99, 70.60] 44.8 [31.60, 57.96]㠣俆⅑㕃䀓Ⲵᰦ䰤 IRC 䇴ՠ INV 䇴ՠѝս TFORˈཙ[95% CI] 42 [41, 42] 41 [40, 42]㤳തˈཙ 31~178 31~178㕃䀓Ⲵᰦ䰤 IRC 䇴ՠ INV 䇴ՠѝս TFCRˈཙ[95% CI] 42 [41, 47] 42 [42, 48]㤳തˈཙ 31~308 31~274ᰐ䘋ኅ⭏ᆈᵏ IRC 䇴ՠ INV 䇴ՠਁ⭏һԦⲴᛓ㘵ˈn˄%˅ 71 (65.7) 72 (66.7)ѝս PFSˈᴸ[95% CI] 3.7 [3.3, 6.8] 3.4 [2.8, 5.0]6 њᴸ PFSˈ%[95% CI]c 41.0 [31.34, 50.72] 34.9 [25.46, 44.29]9 њᴸ PFSˈ%[95% CI]c 35.5 [25.98, 45.03] 31.4 [22.12, 40.65]12 њᴸ PFSˈ%[95% CI]c 33.0 [23.50, 42.44] 27.8 [18.75, 36.86]ᙫ⭏ᆈᵏ63 (58.3) ਁ⭏һԦⲴᛓ㘵ˈn˄%˅ѝս OSˈᴸ[95% CI] 8.9 [7.1, 15.3]6 њᴸ OSˈ%[95% CI]c 67.8 [58.68, 76.84]9 њᴸ OSˈ%[95% CI]c 49.7 [39.91, 59.46]12 њᴸ OSˈ%[95% CI]c 45.6 [35.88, 55.38]CI=४䰤˗INV=⹄ウ㘵˗IRC=⤜・ᇑḕငઈՊ˗N/A=н䘲⭘˗NE=нਟՠ䇑DŽa ഐ↫ӑDŽb DŽc ᰐһԦਁ⭏⦷สҾ Kaplan-Meier ՠ䇑DŽd Ӿ俆⅑㕃䀓˄PR ᡆ CRഐ↫ӑDŽк䘠䘲ᓄҾਾᵏ⺞䇱ᙗ䲿ᵪሩ➗Ѥᒺ䈅傼Ⲵ㔃᷌DŽǏǏ㦟⨶∂⨶ǐ㦟⨶֌⭘Ṭ㨢࿕অᣇᱟа⿽ৼ⢩ᔲᙗᣇփˈਟ㔃ਸ B 㓶㜎㺘䶒㺘䗮Ⲵ CD20 ઼ T 㓶㜎㺘䶒㺘䗮Ⲵ CD3 ਇփDŽ Ṭ㨢࿕অᣇਟᕅ䎧T⋼㓶㜎ഐᆀˈ㻲䀓㺘䗮 CD20 Ⲵ B 㓶㜎DŽ Ṭ㨢࿕অᣇ൘ሿ啐DLBCLᣇ㛯ⱔ⍫ᙗDŽ∂⨶⹄ウ䚇Ր∂ᙗṬ㨢࿕অᣇቊᵚᔰኅ䚇Ր∂ᙗ⹄ウDŽ⭏⇆∂ᙗ޵⹄ウѝˈCD20 BࡠB 㓶㜎䲶ᣇփ ˄ྲṬDŽ Ṭ㨢࿕অᣇⲴ֌⭘˄B 㓶㜎㙇ㄝǃTᱟ䮯ᵏB 㓶㜎㙇ㄝՊሬⲴ㓶㜎ഐᆀ䟺᭮㔬ਸᖱҏᴹਟ㜭ሩྺၐӗ⭏ডᇣDŽ㠤ⱼᙗṬ㨢࿕অᣇቊᵚ䘋㹼㠤ⱼᙗ⹄ウDŽǏ䍞㯿ǐሿ⬦㖞Ҿ 2°C~8°CᆈDŽᆈDŽयᥟ᩷DŽ⭘Ҿ䶉㜹䗃⌘Ⲵ〰䟺ⓦ⏢⭘ˈਟሶ䗃⌘ⓦ⏢㖞Ҿ2°C~8°C㇡ѝ䍞㯿ᴰ䮯 64 ሿᰦˈ ᡆ㖞Ҿ25°C л䍞㯿ᴰ䮯 4 ሿᰦDŽ ᰐ㧼ᶑԦ༷䗃⌘ⓦ⏢ᴰ䮯䗃⌘ᰦ䰤 8 ሿᰦDŽǏǏव㻵ǐ1 ⬦/ⴂDŽǏᴹ᭸ᵏǐ30 њᴸDŽǐJS20230037᮷ਧǐXXXXXXXXXкᐲǏкᐲ䇨ਟᤱᴹӪǐ਽〠 ˖ Roche Pharma (Schweiz) AGൠ൰˖Gartenstrasse 9, 4052 Basel, SwitzerlandǏ⭏ӗԱъǐԱъ਽〠˖Genentech, Inc.⭏ӗൠ൰˖1 DNA Way, South San Francisco, California (CA) 94080, UnitedStates (USA)Ǐव㻵লǐ਽〠 ˖ F. Hoffmann-La Roche AGൠ൰ ˖ Wurmisweg 4303 Kaiseraugst SwitzerlandǏຳ㚄㌫ᵪᶴǐਨൠ൰˖ѝഭ˄к⎧˅㠚⭡䍨᱃䈅傼४嗉ьབྷ䚃 1100 ਧ䛞᭯㕆⸱˖201203㚄㌫ᯩᔿ˖021-28922888˄ᙫᵪ˅Րⵏ ˖ 021-50801800૘䈒⭥䈍˖800-820-8780˄പ䈍˅ᡆ 400-820-8780˄᡻ᵪ˅˄Ӫᐕ᧕ੜᰦ䰤˖ᐕ֌ᰕઘа㠣ઘӄ 9:00~17:00˅Ⲵѝ᮷䈤᰾Җˈ䈧䇯䰞㖇∿ѝഭ㖁ㄉ˖www.roche.com.cn

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