泽贝妥单抗注射液

澳澳ᰕᵏ˖᭩ᰕᵏ˖⌭⌭䍍࿕অᣇ⌘ሴ⏢䈤᰾Җ⭘䆖⽪䈝䗃⏢৽ᓄⴁ⍻DŽਁ⭏ѕ䟽ᵜ૱䗃⏢ᒦሩ 3̚4㦟⢙⋫⯇˄䈧৲䰵Ǐ⌘᜿һ亩ǐ઼Ǐн㢟৽ᓄǐ˅DŽ҉ර㛍⚾⯵∂˄HBV◰⍫᧕ਇᵜ૱⋫⯇Ⲵᛓ㘵ਟ㜭ਁ⭏ HBVлሬ㠤᳤ਁᙗ㛍ᓄሩᛓ㘵䘋㹼 HBV Ⲵㆋ䘹ˈ⋫⯇ᵏ䰤઼⋫⯇⧠ HBVᵜ૱৺դ䲿㦟⢙Ⲵ⋫⯇˄䈧৲䰵Ǐ⌘᜿һ亩ǐ˅DŽᵜ૱㕪ѿ䎵䗷 6 њ⋫⯇ઘᵏⲴ⭘㦟㓿傼/ᙗᮠᦞ˄䈧৲䰵ǏѤᒺ䈅傼ǐ˅DŽǏ㦟૱਽〠ǐ䙊⭘਽〠˖⌭䍍࿕অᣇ⌘ሴ⏢୶૱਽〠˖ᆹ⪎᱄®㤡᮷਽〠˖Zuberitamab Injection≹䈝᤬丣˖Zebeituo Dankang ZhusheyeǏᡀԭǐᵜ૱ѫ㾱⍫ᙗᡀԭѪ⌭䍍࿕অᣇDŽ1澳澳䖵ᯉ˖ᷨ€䞨䫐ǃ≟ॆ䫐ǃ㚊ኡỘ䞟 80 ઼ᷨ€䞨DŽǏǏᙗ⣦ǐ⏢փDŽǏ䘲ᓄ⯷ǐᵜ૱䘲⭘Ҿ CD20 䱣ᙗᕕ╛བྷ B 㓶㜎⏻ᐤⱔˈ䶎⢩ᤷᙗ˄DLBCLˈNOS˅߶CHOP ॆ⯇˄⧟⼧䞠㜪ǃ 䱯䴹㍐ǃ䮯᱕ᯠ⻡ǃ⌬ቬᶮ˅㚄ਸ⋫⯇DŽǏ㿴Ṭǐ100mg˄10ml˅/⬦Ǐ⭘⌅⭘䟿ǐ⭘䈤᰾䟿Ⲵ⌭䍍࿕অᣇˈ㖞Ҿᰐ㧼ᰐ㠤✝৏Ⲵਜ਼ 0.9%⭏⌭䍍࿕অᣇⲴ⎃ᓖѪ 1mg/ml֯ᆈ 12 ሿᰦDŽ㇡ѝ˄2~8ć˅ᆈ 24؍ᓄ㿲ሏ⌘ሴ⏢ᴹᰐᗞ㋂ᡆਈ㢢DŽԆ㦟⢙␧⭘Ⲵ䗃⏢㇑䶉㜹┤⌘ˈ䘲⭘Ҿнগᒺᛓ㘵Ⲵ⋫⯇DŽᛓ㘵ⴁᣔ䘋㹼ˈᒦ൘ᴹ㓿傼Ⲵ㛯ⱔ⧠બ੨㌫㔏⯷⣦ᡆվ㹰঻Ⲵᛓ㘵㠣ቁⴁᣔ 24 ሿᰦDŽ⧠ѕ䟽→ڌྲਟԕ䘋㹼䘲ᖃⲴᇎ傼ᇔỰ2澳澳ᡆ㛯ⱔ㛪⎨⏖Ⲵᛓ㘵ᗵ享䘋㹼㜨䜘 X 㓯ỰḕDŽᡰᴹⲴ⯷⣦⎸ཡ઼ᇎ傼ᇔỰḕᚒ༽↓ᑨਾ᡽㜭㔗㔝┤⌘ˈ↔ᰦ┤⌘䙏ᓖн㜭䎵䗷৏┤⌘㦟DŽ亴亴䱢⭘㦟ྲᢁ✝᚟Ⰻ˅ ઼ᣇ㓴㜪㦟⭘Ⲵ⋫⯇ᯩṸнवᤜⳞ䍘◰㍐DŽ䟿߶CHOP䟿Ѫ375mg/m2BSA߶CHOP ॆ⯇Ⲵ㓴⭘DŽ൘ DLBCL ѝˈᵜ૱ӵᴹ㠣ཊ⋫⯇ 6 њ⋫⯇ઘᵏᴹ᭸ᙗᮠᦞDŽ䈧਼ᰦ৲㘳 CHOP⭘䈤᰾ҖDŽ┤⌘᧘㦀䎧࿻┤⌘䙏ᓖѪ 50mg/hࡍ60䫏䗷ਾˈ ྲᰐ䗃⏢৽ᓄˈ ਟ⇿30࠶࣐50mg/hˈⴤ㠣ᴰབྷ䙏ᓖ 400mg/hDŽԕਾⲴ┤⌘⌭䍍࿕অᣇ┤⌘Ⲵᔰ࿻䙏ᓖਟѪ 100mg/hˈ⇿30࣐100mg/hˈ ⴤ㠣ᴰབྷ䙏ᓖ 400mg/hDŽ䟿䈳ᮤ߶CHOP߶CHOPቁDŽ⢩↺Ӫ㗔ޘᛓ㘵ⲴѤᒺ⹄ウ䍴ᯉDŽޘ3澳澳ᛓ㘵ⲴѤᒺ⹄ウ䍴ᯉDŽ㘱㘱ᒤӪ䟿䈳ᮤ˄৲㿱Ǐ㘱ᒤ⭘㦟ǐ˅DŽㄕቊᰐᵜ૱⭘Ҿ 18 ኱ԕлᛓ㘵ⲴѤᒺ⹄ウ䍴ᯉDŽǏн㢟৽ᓄǐᯝѪਟ㜭䐏⌭䍍࿕অᣇ⌘ሴ⏢ᴹਁ⭏⦷DŽ ⭡Ҿ਴亩Ѥᒺ䈅傼ⲴᇎᯭᶑԦнቭ⴨਼ˈ ഐ↔൘а亩Ⲵн㢟৽ᓄਁ⭏⦷н㜭ⴤ᧕оਖа亩㦟⢙Ѥᒺ䈅傼ѝⲴн㢟৽ᓄਁ⭏⦷DŽᙗ⢩ᖱᙫ㔃ᙗᮠᦞสҾа亩 I ᵏǃа亩 I/II ᵏǃа亩 II ᵏ઼а亩 III ᵏѤᒺޕ693ਇ䈅㘵ˈ689ਇ䈅㘵᧕ਇҶ䈅傼⭘㦟ˈ488ਇ䈅㘵᧕ਇ⌭䍍࿕অᣇ⋫⯇DŽ69᧕ਇঅ㦟⋫⯇ˈ419᧕ਇ㚄ਸ CHOPѝ 372䟿ǃ47䟿㚄ਸ CHOP ᯩṸॆ⯇DŽ433˄88.73%Ⲵн㢟৽ᓄˈᑨ㿱н㢟৽ᓄ˄ਁ⭏⦷≥10%˅वᤜⲭ㓶㜎䇑ᮠ䱽վ˄44.67%˅ǃѝᙗ㋂㓶㜎䇑ᮠ䱽վ˄41.39%˅ǃ⏻ᐤ㓶㜎䇑ᮠ䱽վ˄37.09%˅ǃ䍛㹰˄30.53%˅ǃਁ✝˄19.06%˅ǃ㹰ሿᶯ䇑ᮠ䱽վ˄15.98%˅ǃሂᡈ˄15.37%˅ǃщ≘䞨≘ส䖜〫䞦ॷ儈˄13.32%≘䞨≘ส䖜〫䞦ॷ儈 ˄11.68%˅ǃ㝡 ਁ˄11.27%˅ǃ 㛪䜘⚾⯷ ˄10.04%˅˗261˄53.48%˅਽ᛓ㘵ਁ⭏䗷㠣ቁа⅑≥3 㓗Ⲵн㢟৽ᓄˈᑨ㿱Ⲵ≥3 㓗н㢟৽ᓄ˄ਁ⭏⦷≥5%˅वᤜѝᙗ㋂㓶㜎䇑ᮠ䱽վ ˄30.33%˅ǃ ⲭ㓶㜎䇑ᮠ䱽վ ˄29.92%˅ǃ ⏻ᐤ㓶㜎䇑ᮠ䱽վ˄25.20%˅ǃ䍛㹰˄5.33%˅DŽ31˄6.35%˅ ਽ᛓ㘵ਁ⭏䗷㠣ቁа⅑ѕ䟽н㢟৽ᓄˈ ᑨ㿱Ⲵѕ䟽н㢟৽ᓄ ˄ਁ4澳澳⭏⦷≥1%˅वᤜᝏḃᙗ㛪⚾˄2.05%˅ǃ㛪䜘⚾⯷˄1.43%߿ቁ⯷˄1.23%˅DŽ21˄4.30%ڌ㦟Ⲵн㢟৽ᓄवᤜ㛪䜘⚾⯷˄1.02%˅઼ᝏḃᙗ㛪⚾˄1.02%˅DŽ106˄21.72%ڌ㔉㦟Ⲵн㢟৽ᓄवᤜሂᡈ˄10.66%˅ǃਁ✝˄8.81%˅ǃ㹰঻ॷ儈˄2.87%˅ǃⳞ⯩˄2.05%˅ǃ㛪䜘⚾⯷˄1.84%˅ǃሂ✝н㙀ਇ˄1.84%˅ǃᝏḃᙗ㛪⚾˄1.43%˅DŽ4˄0.82%˅਽ᛓ㘵ഐн㢟৽ᓄ↫ӑˈሬ㠤↫ӑⲴн㢟৽ᓄवᤜᝏḃᙗ㛪⚾˄0.41%˅ǃ㛪䜘⚾⯷˄0.20%˄0.20%˅DŽѤѤᒺ䈅傼ѝⲴн㢟৽ᓄ⌭䍍࿕অᣇ⋫⯇ DLBCL᚟ѫ㾱ᶕⓀҾа亩䲿ᵪǃৼⴢǃཊѝ㓴 487⋫Ⲵ CD20 䱣ᙗⲴ DLBCL ᛓ㘵ˈ᤹2ĩ1䝽㠣⌭䍍࿕অᣇ㚄ਸ CHOP˄Hi-CHOP࿕᱄অᣇ㚄ਸCHOP˄R-CHOPѝ483᧕ਇҶ䈅傼⭘㦟⢙⋫⯇ˈ4䲿ᵪਾᵚ㔉㦟DŽHi-CHOP˄n=327˅઼ R-CHOP˄n=156⋫⯇ 6 њઘᵏDŽHi-CHOP 㓴⌭䍍࿕অᣇᒣ൷᳤䵢䟿Ѫ 3714.200±841.494mg˄㤳ത 43.3̚8093.0mg˅˗R-CHOP࿕᱄অᣇᒣ൷᳤䵢䟿Ѫ 3687.939±682.355mg˄㤳ത600.0̚5501.0mg˅˗Hi-CHOP 㓴о R-CHOP 㓴Ⲵ CHOP ॆ⯇㦟⢙᳤䵢䟿⴨ᖃDŽHi-CHOP 㓴 287˄87.77%ਇ䈅㘵઼R-CHOP 㓴 128˄82.05%ਇ䈅㘵Ⲵн㢟৽ᓄˈᑨ㿱˄ਁ⭏⦷≥5%˅Ⲵн㢟৽ᓄ઼≥3 㓗н㢟৽ᓄ㿱㺘 1DŽ㺘 1 HS006-III ᵏѤᒺ⹄ウѝᑨ㿱˄ԫа㓴ѝਁ⭏⦷≥5%˅Ⲵн㢟৽ᓄ㊫/俆䘹ᵟ䈝࡛n˄˄%˅˅ ≥3 㓗㓗 n˄˄%˅˅Hi-CHOP R-CHOP Hi-CHOP R-CHOP(N = 327) (N = 156) (N = 327) (N = 156)ᙫփн㢟৽ᓄ 287 (87.77) 128 (82.05) 184 (56.27) 91 (58.33)䓛ᙗ⯮⯵৺㔉㦟䜘ս਴⿽৽ᓄ 126 (38.53) 43 (27.56) 3 (0.92) 2 (1.28)ਁ✝ 72 (22.02) 20 (12.82) 3 (0.92) 0ሂᡈ 67 (20.49) 12 (7.69) 0 05澳澳࣋33 (10.09) 14 (8.97) 0 0਴਴㊫Ựḕ 230 (70.34) 106 (67.95) 161 (49.24) 75 (48.08)ⲭ㓶㜎䇑ᮠ䱽վ 145 (44.34) 68 (43.59) 109 (33.33) 53 (33.97)ѝᙗ㋂㓶㜎䇑ᮠ䱽վ 141 (43.12) 62 (39.74) 110 (33.64) 58 (37.18)⏻ᐤ㓶㜎䇑ᮠ䱽վ 106 (32.42) 47 (30.13) 81 (24.77) 33 (21.15)㹰ሿᶯ䇑ᮠ䱽վ 56 (17.13) 28 (17.95) 12 (3.67) 5 (3.21)щ≘䞨≘ส䖜〫䞦ॷ儈 46 (14.07) 24 (15.38) 0 0≘䞨≘ส䖜〫䞦ॷ儈 39 (11.93) 18 (11.54) 0 0փ䟽䱽վ 16 (4.89) 12 (7.69) 0 1 (0.64)㹰ң䞨㝡≒䞦ॷ儈 17 (5.20) 5 (3.21) 0 0㹰঻ॷ儈 19 (5.81) 2 (1.28) 2 (0.61) 1 (0.64)γ-䉧≘䞠䖜〫䞦ॷ儈 10 (3.06) 8 (5.13) 1 (0.31) 1 (0.64)㛳㛳㛐㌫㔏⯮⯵ 92 (28.13) 43 (27.56) 5 (1.53) 3 (1.92)〈 27 (8.26) 15 (9.62) 1 (0.31) 1 (0.64)ᚦᗳ 26 (7.95) 10 (6.41) 0 0અੀ 22 (6.73) 9 (5.77) 0 0㞩⌫ 16 (4.89) 8 (5.13) 2 (0.61) 1 (0.64)㞩㛰 10 (3.06) 9 (5.77) 0 0㹰㹰⏢৺⏻ᐤ㌫㔏⯮⯵ 112 (34.25) 51 (32.69) 37 (11.31) 18 (11.54)䍛㹰 103 (31.50) 43 (27.56) 21 (6.42) 8 (5.13)ࡦ9 (2.75) 8 (5.13) 9 (2.75) 8 (5.13)ԓ㊫⯮⯵ 83 (25.38) 36 (23.08) 5 (1.53) 5 (3.21)䘰 26 (7.95) 13 (8.33) 0 0վⲭ㳻ⲭ㹰⯷ 24 (7.34) 11 (7.05) 0 0儈㹰㌆⯷ 7 (2.14) 12 (7.69) 0 2 (1.28)਴਴㊫⾎㓿㌫㔏⯮⯵ 38 (11.62) 23 (14.74) 1 (0.31) 0䘰 16 (4.89) 11 (7.05) 0 0બબ੨㌫㔏ǃ㜨৺㓥䳄⯮⯵ 94 (28.75) 40 (25.64) 18 (5.50) 9 (5.77)㛪䜘⚾⯷ 40 (12.23) 17 (10.90) 9 (2.75) 5 (3.21)ૣభ 26 (7.95) 11 (7.05) 0 0䰤䍘ᙗ㛪⯮⯵ 26 (7.95) 8 (5.13) 5 (1.53) 3 (1.92)ᝏḃ㊫⯮⯵ 81 (24.77) 41 (26.28) 32 (9.79) 18 (11.54)ᝏḃᙗ㛪⚾ 33 (10.09) 15 (9.62) 16 (4.89) 13 (8.33)кબ੨䚃ᝏḃ 18 (5.50) 9 (5.77) 3 (0.92) 1 (0.64)ⳞⳞ㛔৺Ⳟл㓴㓷㊫⯮⯵ 63 (19.27) 33 (21.15) 0 0㝡ਁ 45 (13.76) 20 (12.82) 0 0Ⳟ⯩ 10 (3.06) 10 (6.41) 0 0⢩⢩ᇊн㢟৽ᓄ䗃⏢৽ᓄ⌭䍍࿕অᣇ൘Ѥᒺ䈅傼ѝᴹ 31.19%Ⲵᛓ㘵ਁ⭏Ҷ䗃⏢৽ᓄˈѫ㾱㺘⧠Ѫሂ⧠6澳澳൘俆⅑䶉㜹䗃⌘ᔰ࿻ਾ 30䫏̚2ˈ൘ѝᯝ䗃⌘ԕਾˈ䘉Ӌ⯷⣦а㡜䜭ᱟਟԕ䘶䖜ⲴDŽབྷཊᮠѕ䟽〻ᓖѪ 1̚2 㓗ˈӵᴹ 1.22%˄4˅ ਁ⭏3 㓗䗃⏢৽⧠㠤ભᙗ䗃⏢৽ᓄˈҏᵚਁ⭏㛯ⱔⓦ䀓㔬ਸᖱDŽ˄㿱Ǐ⌘᜿һ亩ǐ˅ᝏᝏḃ⌭䍍࿕অᣇਟሬ㠤ᛓ㘵 B⯛⨳㳻ⲭ䱽վቁ㿱˄ਁ⭏⦷˘5%˅DŽ൘᧕ਇ⌭䍍࿕অᣇ㚄ਸ CHOP ॆ⯇ᯩṸ⋫⯇Ⲵᛓ㘵ѝˈᝏḃ㊫н㢟৽ᓄਁ⭏⦷Ѫ 24.77%ѝѕ䟽˄≥3 㓗˅ᝏḃⲴਁ⭏⦷Ѫ 9.79%DŽᑨ㿱ᝏḃवᤜ˖ᝏḃᙗ㛪⚾ǃкબ੨䚃ᝏḃǃቯ䐟ᝏḃǃᑖ⣦⯡⯩ǃ 啫૭ஹᝏḃǃ Ⳟ㛔䖟㓴㓷ᝏḃ઼㛳㛐ᝏḃDŽ䘋㹼ᙗཊ⚦ᙗⲭ䍘㝁⯵˄PML˅DŽ҉ර㛍⚾⯵∂˄HBV◰⍫᧕ਇ⌭䍍࿕অᣇ㚄ਸ CHOPᴹ 7˄2.14%˅ਇ䈅㘵ਁ⭏ HBV◰⍫ˈ6ѕ䟽〻ᓖѪ 1̚2 㓗ˈ1Ѫ 3 㓗 HBV◰⍫һԦDŽ䈅傼ᡆሬ㠤↫ӑDŽ ˄㿱 Ǐ⌘᜿һ亩ǐ˅㹰⏢㌫㔏н㢟৽ᓄ൘᧕ਇ⌭䍍࿕অᣇ㚄ਸ CHOP ॆ⯇ᯩṸ⋫⯇Ⲵ਴㌫㔏н㢟৽ᓄѝˈ㹰⏢㌫ѝˈ3̚4 㓗Ⲵѝᙗ㋂㓶㜎䇑ᮠ䱽վⲴн㢟৽ᓄਁ⭏⦷Ѫ 33.64%˗3̚4 㓗ⲭ㓶㜎䇑ᮠ䱽վⲴਁ⭏⦷Ѫ 33.33%˗3̚4 㓗䍛㹰ਁ⭏⦷Ѫ 6.42%˗3̚4 㓗㹰ሿᶯ䇑ᮠ䱽վਁ⭏⦷Ѫ 3.67%˗ᵚਁ⭏ 3̚4㜭㺠ㄝDŽ1㦟DŽᵚਁ⭏ሬ㠤↫ӑⲴ㹰⏢㌫㔏н㢟৽ᓄDŽቁ⌭䍍࿕অᣇ㚄ਸ CHOPቁⲴਁ⭏⦷վҾ 5%ݽ⯛⨳㳻ⲭ G 䱽վ˄1.22%⯛⨳㳻ⲭ M 䱽վ˄0.92%ቁ˄0.92%˅ǃ⨳㳻ⲭ䱽վ˄0.31%˅ǃվщ⿽⨳㳻ⲭ㹰⯷˄0.31%˅ˈѕ䟽〻ᓖ൷Ѫ7澳澳1 㓗DŽHi-CHOP 㓴о R-CHOP ⴨∄ˈIgGǃIgM ઼ IgA ൷ᵚ᰾ᱮ䱽վDŽ㛐㛐ệ䱫઼㛐クᆄ⌭䍍࿕অᣇ㚄ਸCHOPޡ5ᛓ㘵ਁ⭏㛐ệ䱫˄3˅઼㛐クᆄ ˄2˅ˈ ਁ⭏⦷Ѫ1.53%ѝ1㛐ệ䱫ѕ䟽〻ᓖѪ2։4ѕ䟽〻ᓖ൷ 3~4 㓗DŽᵚਁ⭏ሬ㠤↫ӑⲴ㛐ệ䱫઼㛐クᆄн㢟৽ᓄDŽᗳ㜿н㢟৽ᓄ⌭䍍࿕অᣇ㚄ਸ CHOP ⋫⯇Ⲵᗳ㜿н㢟৽ᓄਁ⭏⦷Ѫ 15.60%DŽᑨ㿱˄ਁ⭏⦷≥1%䗷䙏˄3.98%˅ǃᇔкᙗᵏཆ᭦㕙˄2.75%˅ǃᇔᙗᵏཆ᭦㕙 ˄2.14%䗷㕃 ˄2.14%˅ǃ ᗳ㜿⯮⯵ ˄1.83%˅ǃ ᗳᖻཡᑨ˄1.53%˅DŽѕ䟽˄≥3 㓗˅ᗳ㜿н㢟৽ᓄਁ⭏⦷Ѫ 0.92%㺠ㄝ 2઼ᙕᙗᗳ㚼ệ↫ 1DŽ1䗷䙏ǃ1ᐖᗳᇔ㺠ㄝǃ1㺠ㄝᛓ㘵㦟ˈᵚਁ⭏ሬ㠤↫ӑⲴᗳ㜿н㢟৽ᓄDŽ⾎㓿㌫㔏н㢟৽ᓄ⌭䍍࿕অᣇ㚄ਸ CHOP ⋫⯇Ⲵ⾎㓿㌫㔏н㢟৽ᓄਁ⭏⦷Ѫ 11.62%DŽѫ㾱Ѫ䘰˄4.89%˅ǃᔲᑨᝏ㿹˄2.14%˅ˈ䘈वᤜ⾎㓿∂ᙗ˄1.22%˅ǃཤᲅ˄0.92%˅ǃཤⰋ˄0.92%ཤⰋǃᑖ⣦⯡⯩ਾ⾎㓿Ⰻǃᝏ㿹䳌⺽ǃⶑⵐ䍘䟿ᐞǃ 䇠ᗶਇᦏǃ 䴷仔਴ ˄0.31%˅DŽ1⭘㦟⢙ˈᵚਁ⭏ሬ㠤↫ӑⲴ⾎㓿㌫㔏н㢟৽ᓄDŽ⯛৏ᙗ䇑 488ѝ 433㧧ਆҶᴹ⯛৏ᙗᮠᦞˈᣇ㦟ᣇփ˄ADA˅䱣ᙗਁ⭏⦷Ѫ 1.8%˄8/433˅ˈADA ┤ᓖ㤳തѪ 1:10~1:80ˈᵚਁ⧠ѝ઼ᣇփ䱣ᙗᛓ㘵DŽǏ⾱ᗼǐᐢ⸕ሩᵜ㦟Ⲵԫօ䖵ᯉ઼啐㳻ⲭ䗷᭿Ⲵᛓ㘵⾱⭘⌭䍍࿕অᣇDŽǏ⌘᜿һ亩ǐ˅ ᡰ8澳澳⭘㦟૱Ⲵ୶૱਽઼ᢩਧDŽ⌭䍍࿕অᣇਟԕᕅ䎧䗃⏢৽ᓄˈਟ㜭о㓶㜎ഐᆀ઼ /ᆳॆᆖӻ䍘Ⲵ䟺᭮ѕ䟽Ⲵ䗃⏢৽ᓄо䗷᭿৽ᓄᡆ㓶㜎ഐᆀ䟺᭮㔬ਸᖱDŽ䗃৽ᓄ⧠≥3⧠൘⌭䍍࿕অᣇ䗃⌘ᔰ࿻ਾⲴ 30䫏ˉ2ˈ वᤜሂᡈǃ ਁ✝ǃ 㹰঻ॷ儈ǃ ሂ✝н㙀ਇǃⳞ⯩ǃփ⑙ॷ儈ǃᗳ⦷ॷ儈ㅹDŽ൘ѝ→䗃⌘ԕਾˈ䘉Ӌ⯷⣦а㡜䜭ᱟਟԕ䘶䖜ⲴDŽ ᔪ䇞䟷⭘㤟⎧᣹᰾઼ሩ҉䞠≘ส䞊ሩ䗃⌘⯷⣦䘋㹼⋫⯇DŽ ↔ཆˈ 䘈ѝˈ ᖃ⯷⣦ᆼធ 50%ྲӾ 100 mg/hࡠ50 mg/hਁ⭏䶎㠤ભᙗ䗃⏢৽ᓄⲴᛓ㘵䜭㜭ᆼᡀᮤњ⯇〻Ⲵ⌭䍍࿕অᣇ⧠ѕ䟽䗃⏢৽ᓄDŽཆઘ㹰ᚦᙗ⏻ᐤ㓶㜎ᮠⴞ儈˄>25 × 109/L˅ᡆ㛯ⱔ䍏㦧䖳儈Ⲵᛓ㘵ˈਁ⭏ѕ䉘᝾༴㖞DŽ 俆⅑䘋㹼䗃⌘ᰦᓄሩᛓ㘵䘋㹼ᇶធ䗃⌘䙏ᓖˈ ᡆ㘵൘ㅜањ⋫⯇ઘᆼᡀ㔉㦟DŽ ྲ᷌⏻ᐤ㓶㜎ᮠⴞӽ❦བྷҾ25 × 109/L൘ਾ㔝Ⲵ⋫⯇ઘᵏѝӽᓄ᤹↔ᯩᔿ㔉㦟DŽ䎵᭿৽ᓄ/䙏ਁ䗷᭿ᙗ৽ᓄ༷⭘Ҿ⋫⯇ਁ⭏⌭䍍࿕অᣇ⴨⭘㛮к㞪㍐ǃᣇ㓴㜪㦟઼㌆Ⳟ䍘◰㍐DŽ㛪䜘һԦһԦਟ㜭㔗ਁ䟽ˈҏਟ㜭ѤԆѕ䟽䗃⏢ᡆ㘵㛪9澳澳䉘᝾DŽሩҾ䗃⌘ˈᒦф䘋㹼〟ᶱⲴሩ⯷⋫⯇DŽ㹰㹰⏢㌫㔏н㢟৽ᓄᙗˈնᱟഐ൘ѝᙗ㋂㓶㜎䇑ᮠ<1.5×109/L ઼/ᡆ㹰ሿᶯ䇑ᮠ<75×109/L Ⲵᛓ㘵ⲴѤᒺ㓿傼ᴹ䲀ˈ㘳㲁⭘Ҿ䘉㊫Ӫ㜭л䱽Ⲵড䲙Ӫ㗔ˈᵚӗ⭏僘儃∂ᙗDŽᵜ૱㚄ਸ CHOP㹰㓶㜎䇑ቁˈਾ㔝ઘᵏਟ㔉Ҹ⴨ᓄⲴ⭏䮯ഐᆀ[◰ഐᆀ˄G-CSF˅ǃ㋂㓶㜎-◰ഐᆀ˄GM-CSF˅]DŽᇊᱟ੖䗃⌘㹰ሿᶯ˗ਁ⭏3 㓗ᡆ 4䟿㹰ሿᶯ⭏㓒㓶㜎⭏ᡀ㍐˄EPO˅㊫䖫㠣䖫ᓖᰦਟ䟽ᯠॆ⯇DŽ㛯ⱔⓦ䀓㔬ਸᖱ൘Ѥᒺ⹄ウѝˈ ᵜ૱ᵚਁ⭏㛯ⱔⓦ䀓㔬ਸᖱDŽ 㘼㛯ⱔⓦ䀓㔬ਸᖱᱟ਼䶦⛩㦟ྲ˖ 儈㛯ⱔ䍏㦧ᡆཆઘ㹰ᚦᙗ⏻ᐤ㓶㜎ᮠⴞ儈 ˄>25 × 109/L㛯ⱔⓦ䀓㔬ਸᖱⲴ亴䱢䰞仈DŽ 䟷⭘⌭䍍Ⲵ઼䘲ᖃⲴᇎ傼ᇔⴁ⍻DŽ ሩҾਁ⭏ᘛ䙏㛯ⱔѝˈ ሩփᖱ઼⯷лˈਟԕ㔗㔝㔉Ҹ⌭䍍࿕অᣇ⋫⯇DŽфণᰦਟ⭘Ⲵ⧟ຳѝˈ㘼ф൘㓿傼ѠᇼⲴ㛯ⱔᆖ /㹰⏢ⴁ㿶лሩᛓ㘵䘋㹼⌭䍍࿕অᣇ䗃⌘⋫⯇DŽ10澳澳ᝏᝏḃᵜ૱⋫⯇ᵏ䰤ਟਁ⭏ѕ䟽ᝏḃˈवᤜ㠤ભᙗᝏḃDŽ൘ᮤњ⋫⯇䗷〻൷ਟ㜭ਁਟᚒ༽DŽᙗᝏḃⲴᛓ㘵DŽ⭘ᵜ૱⋫⯇ˈᒦ䘋㹼䘲ᖃⲴᣇᝏḃ⋫⯇DŽ◰⍫⧠8ѝ1ѕ䟽〻ᓖ≥3 㓗ˈ1ѝ6䖜ᖂѪᚒ༽ˈ2ֻлሬ㠤᳤ਁᙗ㛍⚾ǃ 㛍㺠ㄝ઼↫ӑDŽ ᓄ൘ሩᡰᴹᛓ㘵ṩᦞᖃൠᤷই䘋㹼҉㛍⯵∂ ˄HBV˅ Ⲵㆋḕˈ㠣ቁᓄवᤜ҉㛍㺘䶒ᣇ৏˄HBsAg˅઼҉㛍Ṩᗳᣇփ˄HBcAb˅ᤷḷˈҏਟ䙊䗷⭘⌭䍍࿕অᣇᓄ૘䈒㛍⯵䘋㹼༴⨶ˈ ԕ亴䱢҉⧠ HBVᵜ૱৺դ䲿㦟⢙Ⲵ⋫⯇ˈᒦ৺ᰦ༴⨶DŽᗳ㹰㇑н㢟৽ᓄ㺠ㄝǃᗳ㔎ⰋǃᗳᖻཡⲴⴁ⍻DŽ䗷䙏ǃᇔᙗᡆᇔкᙗᵏཆ᭦㕙ǃᗳ㚼㕪㹰ǃᗳ⭥മ ST-T ᔲᑨㅹˈቊᵚਁ⭏䗷ড৺⭘ᵜ૱ᵏ䰤ਁ⭏ѕ䟽ᡆড৺⭏ભⲴ䗃⌘DŽሩਁ⭏ᴹѤᒺ᜿ѹⲴᗳᖻཡᑨǃᴹᗳ㜿⯵ਢᡆᗳ㜿∂ⴁ⍻DŽ㛐ệ䱫઼㛐クᆄ11澳澳Ѥᒺ䈅傼ѝ᧕ਇᵜ૱⋫⯇Ⲵਇ䈅㘵ѝˈ5ᛓ㘵ਁ⭏㛐ệ䱫઼㛐クᆄн㢟һѝ2оঅᣇ઼/ᡆ CHOPˈ3˗2ਁ⭏൘⋫⯇㔃ᶏਾˈ3ਁ⭏൘⋫⯇ᵏ䰤˄ㅜ 1 ઘᵏǃㅜ 3 ઘᵏǃㅜ 4ѝ 1൘ㅜ 4⭘㦟⢙ˈਖ 2㔗㔝⋫⯇ᵚਇᖡ૽DŽ5ᛓ㘵ѝˈ4⯺᜸ˈ1⯵ᛵྭ䖜DŽ਼㊫ӗ૱㚄ਸॆ⯇⋫⯇Ⲵ NHL ᛓ㘵ਟਁ⭏㞩Ⰻǃ㛐ệ䱫઼㛐クᆄˈ㛐クᆄᒣ൷ਁ⭏ᰦ䰤Ѫ 6 ཙ˄㤳ത 1̚77ሬ㠤↫ӑˈ㛐クᆄ仾䲙Ⲵᑨ㿱ড䲙ഐ㍐Ѫ㞩䜘⏻ᐤⱔ઼਼ᰦ䘋㹼ॆ⯇ǃ⌬ቬᶮㅹ㦟⢙⋫⯇DŽᱟ⭘ᵜ૱⋫⯇ˈᒦ䘋㹼㞩䜘 X 㓯ᡆ CTᆸ⋫⯇ㅹ᧚ᱟ਼ᰦ䘋㹼ॆ⯇઼⧠ਟ㜭Ⲵ㛐ệ䱫઼㛐クᆄ⯷⣦ˈቭᰙ᰾⺞䇺ᯝˈᒦ㔉Ҹਸ䘲Ⲵ⋫⯇DŽ䟽䟽ᓖⳞ㛔㋈㟌৽ᓄ㛯ⱔᙗཙ⯡⯞ǃ ਢ㪲᮷ᯟ-㓖㘠䘺㔬ਸᖱǃ㤄㰃ṧⳞ⚾ǃ≤⌑བྷ⯡ᙗⳞ⚾઼ѝ∂ᙗ㺘Ⳟൿ↫ᶮ䀓⯷ᱟ਼Ⲵ↔㊫һԦਁ⭏ˈDŽ䘋㹼ᙗཊ⯵⚦㝁ⲭ䍘⯵൘Ѥᒺ⹄ウѝˈ ᵜ૱ᵚਁ⭏䘋㹼ᙗཊ⯵⚦㝁ⲭ䍘⯵DŽ ն䘋㹼ᙗཊ⯵⚦㝁ⲭ䍘⯵ᱟ਼䶦⛩㦟⢙ᐢ⸕Ⲵн㢟৽ᓄDŽ ५⭏൘⋫⯇ᛓ㘵ᰦˈ ሩᣕ੺ᴹ⾎㓿ᆖ⯷⣦Ⲵᛓࠪ⭘Ⲵॆ⯇ᡆ㘵䟿DŽㅜҼᚦᙗ㛯ⱔᵜ૱⋫⯇ቊᰐᙕᙗ儃㌫ⲭ㹰⯵ ˄AML˅ ઼僘儃໎⭏㔬ਸᖱ ˄MDS˅ ㅹㅜҼᚦᙗ㛯ⱔਁ⭏DŽ਼㊫ӗ૱㚄ਸॆ⯇⋫⯇ NHL ᛓ㘵ਾਟਁ⭏ AML ઼ MDS ㅹㅜҼᚦᙗ㛯ⱔˈҏᴹᒤ喴≥60 ኱Ⲵ DLBCL࿕᱄অᣇ㚄ਸ CHOP ॆ⯇ਾਁ⭏12澳澳AMLᱟሩҾᒤ喴≥60ᰦᓄ৺ᰦ䇺ᯝǃቭᰙ⋫⯇DŽݽ⯛᧕⿽ᙗ䘋㹼䗷⹄⭘⍫⯵∂⯛㤇䘋㹼᧕⿽DŽ⭘ᵜ૱⋫⯇Ⲵᛓ㘵ਟԕ᧕ਇ䶎⍫⯛㤇᧕⿽ˈնሩ䶎⍫⯛㤇Ⲵᓄㆄ⦷ਟ㜭Պሩཊ⿽ᣇ৏˄㛪⚾䬮⨳㧼ǃ⭢ර⍱ᝏǃ㞞㞪⚾ǃ仾⯩઼≤Ⰸ˅⭘਼㊫ӗ૱⋫⯇ਾ㠣ቁ㜭㔤ᤱ 6 њᴸDŽⲴᖡ૽ˈቭ㇑㦟⨶ᆖ⢩ᙗ઼䗴ӺѪ㔉㦟 ˄ᣇ㓴㜪㦟˅ˈᓄ⢒䇠䘉Ӌ䗃⏢৽ᓄⲴ⋫⯇DŽ䗃⏢৽ᓄਾˈ⣦ᘱっᇊਾᛓ㘵ᯩਟ傮傦ᡆ᫽֌ᵪಘDŽޘᙗ઼⯇᭸ቊн᰾⺞DŽޘᙗ઼⯇᭸ቊн᰾⺞DŽǏᆅྷ৺ପңᵏྷྣ⭘㦟ǐ䚯ᆅ⭘⌭䍍࿕অᣇⲴ䗷〻ѝ৺⋫⯇ਾⲴ 12 њᴸˈᗵ享䟷ਆᴹ᭸Ⲵ䚯ᆅ᧚ᯭDŽᆅྷ⯛⨳㳻ⲭ IgG ਟ䙊䗷㛾ⴈቿ䳌DŽਁ㛢∂ᙗ⹄ウDŽ ൘Ѥᒺ䈅傼ѝˈ 䘈⋑ᴹሩ⇽Ӣ᳤䵢Ҿ⌭䍍࿕অݯBǃ㢟ྭሩ➗ᴹᣕ੺а䗷ᙗ B 㓶13澳澳ቁDŽ 䢤Ҿ↔ˈ ᆅྷᓄ⾱⭘⌭䍍࿕অᣇˈ 䲔䶎ਟ㜭Ⲵ㧧⳺儈Ҿ仾䲙DŽ⭏࣋ᵜ૱ਁ㛢∂ᙗ⹄ウDŽପңᵏྷྣDŽ ᐢ⸕⇽փⲴIgGң≱ˈ ഐ↔⌭䍍࿕অᣇнᗇ⭘ҾପңⲴ⇽ӢDŽㄕ⭘㦟ǐቊᵚ⺞ᇊᵜ૱൘ 18ᙗ઼ᴹ᭸ᙗDŽǏ㘱ᒤ⭘㦟ǐ㘱ᒤᛓ㘵ˈ㔃᷌ᨀ⽪ᵜ૱ਟ⭘Ҿ㘱ᒤᛓ㘵ˈᰐ⢩↺⾱ᗼDŽޕ181 ਽˄37.09%˅ᒤ喴˚60 ኱Ⲵᛓ㘵ˈቊᵚ㿲ᒤ喴˚60 ኱оᒤ喴≤60 ኱Ⲵᛓ㘵Ⲵн㢟৽ᓄਁ⭏⦷ᆈ൘ᐞᔲ˄ 87.29% vs.89.58%˅ˈվ䫐㹰⯷˄2.05% vs. 0.82%˅઼儈㹰঻˄1.84% vs. 0.82%˅н㢟৽ᓄ൘㘱ᒤᛓ㘵ѝᴤѪᑨ㿱DŽǏ㦟⢙⴨ӂ֌⭘ǐԆ㦟⢙Ⲵ⴨ӂ֌⭘⹄ウቊᵚᔰኅDŽᴹӪᣇ啐ᣇփ˄HAMA˅ᡆӪᣇ፼ਸᣇփ˄HACAަ䲶ᣇփ⋫⯇ᰦਟ㜭ਁ⭏䗷᭿ᡆ䎵᭿৽ᓄDŽǏ㦟⢙䗷䟿ǐ䟿Ѫ1053.9mg˄625mg/m2˅ˈ⭘Ҿᕕ╛ᙗབྷ Bᙗⴁ⍻DŽᇊᵏⴁ⍻㹰㓶㜎䇑ᮠⲴᗵ㾱ᙗˈᖃᛓ㘵༴൘ B 㓶㜎㙇ㄝ⣦ᘱᰦˈ14澳澳བྷDŽǏǏѤᒺ㦟⨶ǐࡦ䲶ᣇփˈ㜭⢩ᔲᙗൠо䐘㟌ᣇ৏ CD20 㔃ਸDŽCD20ࡽB ઼ᡀ⟏ B ⏻ᐤ㓶㜎㺘䶒ˈ⌭䍍࿕অᣇо B 㓶㜎кⲴ CD20⯛৽ᓄӻሬ B䘋㛯ⱔ㓶㜎ӑDŽB䎆Ⲵ㓶㜎∂֌⭘˄CDC䎆Ⲵ㓶㜎ӻሬⲴ㓶㜎∂֌⭘˄ADCC˅DŽ㦟᭸ᆖ൘ NHL ᛓ㘵ѝˈᵜ૱ 375mg/m2䟿㔉㦟ਾˈਟ䗵䙏ᱮ㪇䱽վਇ䈅㘵ཆઘ㹰B 㓶㜎≤ᒣ˄CD19+ǃCD20+৺ CD19+/CD20+˅ˈሿᑵᨀॷ T 㓶㜎 CD3+/CD8+≤ᒣˈ նሩT 㓶㜎 CD3+/CD4+≤ᒣ৺ NK 㓶㜎≤ᒣ ˄CD3-/CD16+/CD56+˅ᖡ ૽нབྷDŽ6 ઘᵏ㔉㦟ਾˈᵜ૱㦟᭸ᤱ㔝ᰦ䰤䮯ˈ㜭ᴹ᭸␵䲔 B 㓶㜎ǃ◰⍫ CD3+/CD8+T㓶㜎DŽᵜ૱ሩ QTc 䰤ᵏⲴ▌൘ᖡ૽ቊн᰾⺞DŽᆖ⹄ウ HISUN-2014L01 ѝˈNHL ᛓ㘵᧕ਇ 375 mg/m2 ⌭䍍࿕অᣇঅ⅑㔉㦟ਾˈCmax Ѫ 210.18±11.32 μg/mLˈ ᒣ൷㓸ᵛ⎸䲔ॺ㺠ᵏѪ237.49 ሿᰦDŽ ᧕ਇ⇿ઘ䶉㜹䗃⌘㔉㦟ˈ䘎㔝 4 ઘਾˈCmax Ѫ 381.51±73.01μg/mLˈᒣ൷㓸ᵛ⎸䲔ॺ㺠ᵏѪ356.37 ሿᰦDŽ⹄ウ HISUN-CD20-2018L01 ѝˈ᧕ਇ 375mg/m2 ⌭䍍࿕অᣇ㚄ਸCHOP ᯩṸˈ3 ઘѪ 1ޡ6 њઘᵏ⋫⯇ਾˈ ᒣ൷Cmax䲿⵰⌭䍍࿕অᣇˈCmax Ӿ俆⅑㔉㦟ਾⲴ 185.59±42.62 ug/mLㅜ 6 ⅑㔉㦟Ⲵ234.14±58.78 ug/mLDŽ᤹ 375mg/m2 ⇿ 3 ઘ 1ǃᒤ喴ǃส㓯ⲭ㳻ⲭǃส㓯㛯ⱔփ〟ሩ PK ᳤䵢Ⲵᖡ૽ሿDŽ㚄ਸ CHOP֯NHL ᛓ㘵Ⲵ HS006 ᳤䵢л䱽ˈAUCss ઼ Cmin,ss䱽վ 25%઼ 33%ˈሩ᳤䵢ᖡ૽䖳བྷˈն䶎㚄ਸ CHOP15澳澳ॆ⯇ᛓ㘵Ⲵṧᵜ䟿˄N=14˅ঐᙫṧᵜ䟿˄N=376˅Ⲵ 3.7%<10%ˈഐ↔ CHOP ॆ⯇ሩ᳤䵢Ⲵᖡ૽ᴹᖵᴤཊ⹄ウᮠᦞ⺞䇔DŽ376⌭䍍࿕অᣇǃঅ㦟ᡆо CHOP 㚄ਸ⋫⯇Ⲵ NHL ᛓ㘵ᆖ㔃ᶴ⁑රѪ㓯ᙗ઼䶎㓯ᙗ䎆˅ᒦ㹼⎸䲔ⲴҼᇔ⁑රˈᴰ㓸⁑රѝཞᇔ␵䲔⦷˄CLᐳᇩ〟˄Vc˅ǃᇔ䰤␵䲔⦷˄Qᐳᇩ〟˄Vp䎆␵䲔⦷˄CLT˅৺ CL T 䲿ᰦ䰤ਈॆⲴ䙏⦷ᑨᮠ˄ Kdes˄RSE%Ѫ 0.0110L/h(5.5)ǃ3.58 L(1.5)ǃ0.0151 L/h(12.1)ǃ2.71 L(6.1)ǃ0.00645 L/h(13.4)ǃ0.000345h-1(13.0)DŽᱟ੖㚄ਸ CHOP䰤Ⲵ PK ᴹᐞᔲˈփ㺘䶒〟ǃᒤ喴ǃส㓯ⲭ㳻ⲭ৺ส㓯㛯ⱔփ〟ሩ PK ᴹᖡ૽DŽ䚇䚇Ր㦟⨶ᆖᵜ૱൘䚇Ր㦟⨶ᆖⲴ⹄ウቊᵚᔰኅDŽǏѤᒺ䈅傼ǐ⋫ᕕ╛བྷ B 㓶㜎ᙗ䶎䴽ཷ䠁⏻ᐤⱔ൘а亩ཊѝᗳǃ䲿ᵪǃৼⴢǃ䱣ᙗ㦟ᒣ㹼ሩ➗Ⲵ IIIޡ483⋫Ⲵᕕ╛བྷ B 㓶㜎ᙗ䶎䴽ཷ䠁⏻ᐤⱔ˄䶎⢩ᤷර˅ᛓ㘵᤹➗᤹ 2˖1ֻ᧕ਇҶ 375mg/m2 Ⲵᵜ૱˄ㅜ 0߶CHOP˄⧟⼧䞠㜪 750mg/m2ˈㅜ 1 ཙ˗䱯䴹㍐ 50 mg/m2ˈㅜ 1 ཙ˗䮯᱕ᯠ⻡ 1.4 mg/m2ˈᴰབྷ䟿儈䗮 2mgˈㅜ 1 ཙ˗ԕ৺ㅜ 1-5 ཙ⌬ቬᶮ 100 mg/ཙ˅ˈ3 ઘѪ 1ޡ6 њઘᵏDŽ൘⋫⯇ઘᵏⲴㅜ 1⭘ᵜ૱ᡆ㖾㖇ॾDŽሩᡰᴹᛓ㘵˄ᵜ૱㚄ਸ CHOP=327ˈ㖾㖇ॾ㚄ਸ CHOP=156˅䘋㹼⯇᷀DŽᛓ㘵ᒤ喴൘ 18-75 ઘ኱ѻ䰤ˈᒣ൷ᒤ喴 54.9ѝ˚60 ઘ኱Ⲵᛓ㘵ঐ 36.23%˗ᡰᴹᛓ㘵ѝ⭧ᙗঐ 54.24%ˈྣᙗঐ 45.76%˗ECOG࠶0-2ަѝ 0-1ঐ 98.34%˗IPI࠶0-1ঐ 50.72%ˈ2ঐ 25.26%ˈ3ঐ 23.60%ˈ4ঐ 0.41%˗Ann Arborᵏ I-II ᵏঐ 49.07%ˈIII-IV ᵏঐ 50.93%DŽє㓴൘亴⋫⯇Ӫਓ㔏䇑ᆖ઼⯮⯵⣦ᘱᯩ䶒㓴䰤൷㺑DŽѝս䲿䇯ᰦ䰤 29.6 њᴸ˄㤳ത˖0.07~39.1 њᴸ˅DŽ16澳澳ᵜ⹄ウѫ㾱㓸⛩Ѫ⋫⯇ 6 њઘᵏ㔃ᶏᰦⲴᇒ㿲㕃䀓⦷˄ORR˅ˈᇊѹѪṩᦞCheson2007⭡⤜・⯇᭸䇴ԧငઈՊ˄BIRCޘ㕃䀓⦷ǃᰐ䘋ኅ⭏ᆈᰦ䰤઼ᙫ⭏ᆈᵏㅹDŽHS006 㓴⋫⯇ਾㅜ 6 ઘᵏ㔃ᶏᰦⲴ ORR˄95%CI˅Ѫ 83.49%˄79.01,87.34%˅ˈ㖾㖇ॾ㓴Ѫ 81.41%˄74.41,87.18%˅ˈє㓴⦷ᐞ˄95%CI˅Ѫ 2.08%˄-5.24,9.39%˅ˈ٬10%ˈਟ䇔Ѫ HS006Ҿ㖾㖇ॾ㓴DŽ㺘 2 HS006 㚄ਸ CHOP࿕᱄অᣇ㚄ਸ CHOP Ⲵ⯇᭸ሩ∄˄FAS 䳶˅㛯㛯ⱔ䇴ՠ 䈅傼㓴(N=327) ሩ➗㓴(N=156) P㕃㕃䀓⦷㕃䀓(CR) 246( 75.23) 106( 67.95)㕃䀓(PR) 27( 8.26) 21( 13.46)⋫⯇ਾ 6 ઘᵏ ORR(%) 273( 83.49) 127( 81.41) 0.571795%CI ( 79.01, 87.34) ( 74.41, 87.18)є㓴⦷ᐞ a 2.0895%CIa ( -5.24, 9.39)㕃䀓ᤱ㔝ᰦ䰤ѝսᰦ䰤 NE(NE,NE) NE(NE,NE)1 ᒤ DOR ⦷ 87.38(82.76,90.83) 82.41(74.68,87.97)2 ᒤ DOR ⦷ 81.91(76.49,86.19) 74.42(65.37,81.43)3 ᒤ DOR ⦷ 70.73(53.84,82.40) 68.72(55.90,78.51)ᰐ䘋ኅ⭏ᆈᰦ䰤ѝսᰦ䰤 NE(NE,NE) NE(NE,NE)1 ᒤ PFS ⦷ 88.08(83.62,91.39) 80.86(73.13,86.58)2 ᒤ PFS ⦷ 82.51(77.29,86.64) 73.53(64.78,80.44)3 ᒤ PFS ⦷ 78.03(71.72,83.09) 70.90(61.63,78.32)ᙫ⭏ᆈᰦ䰤ѝսᰦ䰤 NE(NE,NE) NE(NE,NE)1 ᒤ OS ⦷ 96.26(93.51,97.86) 94.15(89.05,96.91)2 ᒤ OS ⦷ 92.18(88.65,94.65) 85.43(78.71,90.15)3 ᒤ OS ⦷ 87.70(82.29,91.54) 83.14(75.68,88.48)ǏǏ㦟⨶∂⨶ǐ㦟⨶֌⭘䲶ᣇփˈ㜭⢩ᔲᙗൠо䐘㟌ᣇ৏ CD20 㔃ਸDŽCD20ࡽB ઼ᡀ⟏ B ⏻ᐤ㓶㜎㺘䶒ˈ⌭䍍࿕অᣇо B 㓶㜎кⲴ CD20⯛৽ᓄӻሬB 㓶㜎ⓦ䀓DŽBਟ㜭वᤜ˖ 㺕փ17澳澳䎆Ⲵ㓶㜎∂֌⭘˄CDC䎆Ⲵ㓶㜎ӻሬⲴ㓶㜎∂֌⭘˄ADCC˅DŽ∂∂⨶⹄ウઘᚒ༽ᵏॱҼઘ䟽༽㔉㦟∂䟿Ѫ 0ǃ5ǃ25ǃ50 mg/kgޣⲴ᰾ᱮᔲᑨDŽ䚇Ր∂ᙗᵜ૱ᵚᔰኅ䚇Ր∂ᙗ⹄ウDŽ⭏⇆∂ᙗᵜ૱ᵚᔰኅ⭏⇆∂ᙗ⹄ウDŽ࿕᱄অᣇ⌘ሴ⏢᮷⥞ᮠᦞᱮ⽪˖ ྺၐ伏㸩⥤ಘᇈᖒᡀᵏ ˄Ӕ䝽ਾ20 ཙ㠣 50 ཙ˅ 䶉㜹㔉㦟ˈ Ӕ䝽ਾㅜ20ǃ21ǃ22࿕᱄অᣇ 15ǃ37.5ᡆ 75 mg/kg/ ཙˈㅜ 29ǃ36ǃ43ǃ50 ཙ⇿ઘ 1࿕᱄অᣇ 20ǃ50 ᡆ 100mg/kg/䟿 100 mg/kg/䟿 2g ᳤䵢≤ᒣⲴ 80%˄สҾ AUC࿕᱄অᣇਟԕ䘿䗷⥤㛾ⴈDŽ ᳤䵢Ҿ㦟⢙Ⲵᆀԓᵚ㿱㠤⮨᭸ᓄˈ ਟ㿱⏻ᐤ㓴㓷B࿕᱄অᣇ 0ǃ15ǃ75 mg/kgˈ⇿ཙ 1 ⅑ˈ䘎㔝 3࿕᱄অᣇ 0ǃ20ǃ100 mg/kgˈ⇿ઘ 1ӾӔ䝽ਾㅜ20 ཙ㠣ӗਾㅜ 78 ཙˈ ӾӔ䝽ਾㅜ 76 ཙ㠣ㅜ 134 ཙˈ ԕ৺ӾӔ䝽ਾㅜ132 ཙ㠣ӗਾㅜ 28 ཙDŽ ൘к䘠н਼㔉㦟ᰦ⢙ᆀԓѝ൷ਟ㿱BDŽ ӗਾ6њᴸ B㜭ᚒ༽↓ᑨDŽ㠤ⱼᙗᵜ૱ᵚᔰኅ㠤ⱼᙗ⹄ウDŽǏ䍞㯿ǐҾ 2̚8DŽǏव㻵ǐ18澳澳⬦㻵ˈ1 ⬦/ⴂDŽǏǏᴹ᭸ᵏǐ24 њᴸDŽǐYBS00322023᮷ਧǐᆇ SXXXXXXXXǏкᐲ䇨ਟᤱᴹӪǐਨൠ൰˖⎉⊏ⴱਠᐎᐲὂ⊏४⮿⑟བྷ䚃 1 ਧ䛞᭯㕆⸱˖318000⭥䈍ਧ⸱˖4006063939㖁 ൰˖http://www.bioraypharm.com/Ǐ⭏ӗԱъǐਨ⭏ӗൠ൰˖⎉⊏ⴱᶝᐎᐲᇼ䱣४㜕ਓ䭷⎧↓䐟 8 ਧ䛞᭯㕆⸱˖311404⭥䈍ਧ⸱˖4006063939Րⵏਧ⸱˖0571-63288122㖁 ൰˖http://www.bioraypharm.com19