培化西海马肽注射液 - 药品说明书 - 桂人药信

培化西海马肽注射液 - 药品说明书 - 桂人药信 - 桂人药信

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ᰕᵏ˖ ᒤ ᴸ ᰕ

ฯฯ㧡⋏㛳⌞ሺ⏨䈪᱄Ҝ⭘

Ǐ㦟㦟૱਽〠ǐ䙊⭘਽〠˖ษ㧛⋉㛭⌘ሴ⏢୶૱਽〠˖൓㖇㧡㤡᮷਽〠˖Pegmolesatide Injection≹䈝᤬丣˖Peimoshatai ZhusheyeǏᡀԭǐᵜ૱⍫ᙗᡀԭѪษ㧛⋉㛭Ǆॆᆖ਽〠˖Nε,22,Nε,22’-({Nα,Nε-Ҽ[ω-⭢≗ส㚊(≗҉✟ส)㗠ส]䎆≘䞠-β-щ≘䞠ส}ӊ㜪สҼ҉䞠ส)-Ҽ(҉䞠ส⭈≘䞠-⭈≘䞠-㣿≘䞠-䞚≘䞠-э≘䞠-ॺ㜡≘䞠-㓴≘䞠-㤟щ≘䞠-⭈≘䞠-щ≘䞠-Ӟ≘䞠-㣿≘䞠-㢢≘䞠-㕜≘䞠-ॺ㜡≘䞠-㋮≘䞠-㝟≘䞠-䉧≘䞠㜪䞠-㋮≘䞠-⭈≘䞠-β-щ≘䞠-䎆≘䞠㜪)⧟(6-15:6’-15’)-ৼҼ⺛ॆ⢙ॆᆖ㔃ᶴᔿ˖䆜⽰䈣ӗȽᗹ㛂ọ↱ȽঈѣȽ䶏㜿㹶ṉṉດȽ㹶㇗䙐䐥㹶ṉᖘᡆૂ㛵ⱚ䘑ኋᡌགྷਇⲺ伄䲟z 㹶㓘㴁ⲳⴤḽ≪ᒩϊJG/ᰬθᛙ㘻ਇ⭕↱ӗȽћ䠃Ⱦz ԛр伄䲟Ⱦz 䠅Ⱦz ᵢ૷⾷↘䙐䗽䶏㜿⌞ሺ㔏㦥Ⱦ

ᆀᔿ˖C231H344N72O64S4•(C2H4O)2nᆀ䟿˖45036.65±4000Da䖵ᯉ˖⼧䞨≒Ҽ䫐ǃ⼧䞨Ҽ≒䫐ǃ≟ॆ䫐ǃ⌘ሴ⭘≤Ǐᙗᙗ⣦ǐѾᰐ㢢Ⲵ▴᰾⏢փǄǏ䘲䘲ᓄ⯷ǐᵜ૱䘲⭘Ҿ⋫⯇ഐធᙗ㛮㜿⯵ᕅ䎧Ⲵ䍛㹰ˈवᤜ˖1˄ESA˅⋫⯇ⲴᡀӪ䶎䘿᷀ᛓ㘵˗2㓒㓶㜎⭏ᡀ㍐⋫⯇ⲴᡀӪ䘿᷀ᛓ㘵Ǆᵜ૱н䘲⭘Ҿ൘䴰㾱・ণ㓐↓䍛㹰Ⲵᛓ㘵ѝᴯԓ㓒㓶㜎䗃⌘ǄǏ㿴㿴Ṭǐ˄1˅0.5mlĩ2.0mg˄2˅1mlĩ4.0mg˄3˅1.5mlĩ6.0mgǏ⭘⭘⌅⭘䟿ǐԆ䍛㹰৏ഐ˄ྲ㔤⭏㍐㕪ѿǃԓ䉒ᡆធᙗ⚾⯷⯮⯵ǃ㹰ㅹ˅Ǆ㔉㦟ᯩᔿѪ⇿ 4 ઘа⅑ˈⳞл⌘ሴǄᵜ૱нᗇ䙊䗷䶉㜹⌘ሴ㔉㦟Ǆ⭘Ǆ1.ᵚ᧕ਇ ESA ⋫⯇Ⲵ䶎䘿᷀ᛓ㘵˖䟿ᖃᛓ㘵㹰㓒㳻ⲭ˄Hb˅≤ᒣվҾ 10.0 g/dL ᰦˈᔰ࿻ᵜ૱⋫⯇Ǆ䟿Ѫ 0.04 mg/kgˈ⇿ 4 ઘа⅑ˈⳞл⌘ሴǄ䟿䈳ᮤ൘䎧࿻⋫⯇䱦⇥ˈᔪ䇞⇿ 2 ઘⴁ⍻ 1 ⅑ Hbっᇊˈ䲿ਾ⇿ 4 ઘⴁ⍻ 1⅑ Hb䍛㹰〻ᓖ৺䗷৫ 4޵Hbˈ⇿ 4 ઘ䘋㹼а⅑֯Hbⴞḷ㤳ത˄а㡜Ѫ 10.0~12.0 g/dLˈਟ৲㘳Ѥᒺᤷই䘋㹼њփॆ䈳ᮤ˅ˈঅ⅑ᴰབྷ㔉㦟䟿Ѫ 0.08 mg/kgᯔփ䟽䇑㇇˅Ǆ䟿䈳ᮤᯩ⌅ྲл˖ྲ᷌ Hb ≤ᒣ൘ 12.0~13.0 g/dL䟿 25%Ǆྲ᷌ Hb ≤ᒣ䎵䗷 13.0 g/dL㔉㦟ⴤ㠣 Hbİ12.0 g/dLቁ25%Ǆ൘䎧࿻⋫⯇䱦⇥ˈྲ᷌ Hbڌ㔉㦟ˈԕ㕃䀓ᘛ䙏ᓄㆄ˖ྲ൘ 2кॷ䎵䗷 1.0 g/dL ᡆ൘ 4кॷ䎵䗷 2.0g/dLቁ25%˗ྲ ൘2кॷ䎵䗷 2.0 g/dL ᡆ൘ 4кॷ䎵䗷 3.0 g/dLቁ 50%Ǆ֯Hb 㔤ᤱ൘ 10.0 g/dLࡲ䟿㓖 25%ᡆ 50%⇿ֻ4䟿Ǆ䟿䈳ᮤ仁⦷нᗇ䎵䗷⇿ᴸ 1 ⅑Ǆ2.↓㹰ᇍ⋫⯇Ⲵ䘿᷀ᛓ㘵˖㓒㓶㜎⭏ᡀ㍐⋫⯇ф㹰㓒㳻ⲭ≤ᒣっᇊⲴᛓ㘵ˈ൘䖜ᦒѪᵜ૱⋫⯇ਾਟ⧠᰾ᱮⲴ HbⲴ㧧⳺仾䲙䇴ՠˈ䉘᝾䖜ᦒǄ䟿㹰ᇍ⋫⯇Ⲵធᙗ㛮㜿⯵ ˄CKDࡍ䟿᤹㺘 1 䘋㹼ᦒ㇇Ǆ ᴯᦒ䗷〻ѝˈ ᛓ㘵൘᧕ਇ㓒㓶㜎⭏ᡀ㍐㔉㦟ਾˈ䴰䰤䳄аઘ᡽㜭᧕ਇ俆⅑ษ㧛⋉㛭㔉㦟ǄǄ㺘 1. 䟿ᦒ㇇㺘䟿˄˄ഭ䱵অս/ઘઘ˅䟿˄ݻ4 ઘઘ˅İ3000 2İ6000ˈ˚3000 4˚6000 6䟿䈳ᮤ⋫⯇ᵏ䰤ᓄṩᦞᛓ㘵 Hb֯Hbⴞḷ㤳ത˄а㡜Ѫ 10.0~12.0 g/dL䟿䘋㹼㔤ᤱ⋫⯇Ǆᵏˈᔪ䇞⇿ 2 ઘⴁ⍻ 1 ⅑ Hbっᇊˈ䲿ਾ⇿ 4 ઘⴁ⍻ 1⅑ Hb䍛㹰〻ᓖ৺䗷৫ 4޵Hbˈ⇿ 4 ઘ䘋㹼а⅑֯Hb䟿Ѫ6 mg䟿൘ᴰ䟿 0.1 mg ᰦˈHb ӽ൘ 11.0~12.0 g/dL㔉㦟Ǆ䟿䈳ᮤᯩ⌅ྲл˖ྲ᷌ Hb ≤ᒣ൘ 11.0~12.0 g/dL䟿 25%Ǆྲ᷌ Hb ≤ᒣ䎵䗷 12.0 g/dL㔉㦟ⴤ㠣 Hbİ11.0 g/dLቁ25%Ǆᵏˈྲ᷌ Hb кॷ䗷Ҿ䗵䙏ˈྲ൘ 2кॷ䎵䗷 1.0 g/dL ᡆ൘ 4 ઘкॷ䎵䗷 2.0 g/dLቁ 25%˗ྲ൘ 2кॷ䎵䗷 2.0 g/dLᡆ൘ 4кॷ䎵䗷 3.0 g/dLቁ 50%ˈԕ㕃䀓ᘛ䙏ᓄㆄǄ֯Hb 㔤ᤱ൘ 10.0 g/dLࡲ䟿㓖 25%⇿ֻ4䟿Ǆ䟿䈳ᮤ仁⦷нᗇ䎵䗷⇿ᴸ 1 ⅑Ǆᓄ֣ᆳ৏ഐˈྲᧂ䲔ሬ㠤 ESAᆳഐ㍐ӽᓄㆄ㕪ཡˈ㘳㲁㔗㔝⋫⯇ሩᛓ㘵ᰐ㧧⳺ˈਟᴤᦒ⋫⯇˄㿱Ǐ⌘᜿һ亩ǐ˅Ǆѝᯝ⋫⯇䙊ᑨᵜ૱Ⲵ⋫⯇኎Ҿ䮯ᵏ⋫⯇ˈਟṩᦞ५ౡ൘ԫօᰦ䰤ѝᯝ⋫⯇Ǆ䟿ྲ᷌┿⭘Ҷ 1䟿ˈ ❦ਾ᤹➗༴ᯩⲴ㔉㦟仁⦷䟽ᯠᔰ࿻᧕ਇษ㧛⋉㛭⋫⯇Ǆ䟿䈳ᮤᛓ㘵Ⲵ⹄ウᮠᦞǄ䟿䈳ᮤ˄৲㿱Ǐ㘱ᒤ⭘㦟ǐ˅Ǆㄕ˖ቊᰐᵜ૱⭘Ҿ 18 ኱ԕлᛓ㘵ⲴѤᒺ⹄ウ䍴ᯉǄǏнн㢟৽ᓄǐѤᒺ䈅傼ѝⲴн㢟৽ᓄ䘁Ⲵн㢟৽৽᱐Ѥᒺᇎ䐥ѝⲴᇎ䱵ਁ⭏⦷Ǆᆹ᚟ᮠᦞᾲ䘠ษ㧛⋉㛭ᐢ൘ѝഭᔰኅ 6 亩Ѥᒺ䈅傼 ˄वᤜ1 亩 I ᵏǃ3 亩 II ᵏ઼ 2 亩 IIIޡ550ѝ 24ᓧਇ䈅㘵ˈ177Ѫ CKD 䶎䘿᷀䍛㹰ਇ䈅㘵ˈ349Ѫ CKD 䘿᷀䍛㹰ਇ䈅㘵Ǆᡚ㠣 2022 ᒤ 5ޡ317ֻCKD 䍛㹰ਇ䈅㘵㦟⢙᳤䵢ı24 ઘˈ275ਇ䈅㘵㦟⢙᳤䵢ı48 ઘǄ൘ 526᧕ਇษ㧛⋉㛭⋫⯇㛮ᙗ䍛㹰ਇ䈅㘵ѝˈᴹ 11.6%Ⲵਇ䈅㘵ਁ⭏ᑨ㿱Ⲵн㢟৽ᓄ˄ᑨ㿱ᇊѹѪਁ⭏⦷ı1%˅ˈ1.0%Ⲵਇ䈅㘵ਁ⭏ѕ䟽н㢟৽ᓄˈ6.1%Ⲵਇ䈅㘵ਁ⭏ CTCAE㓗ı3 㓗Ⲵн㢟৽ᓄˈ1.3%Ⲵਇ䈅㘵ਁ⭏ሬ㠤⭘㦟Ⲵн㢟৽ᓄˈ0.6%㦟Ⲵн㢟৽ᓄˈ0.4%Ⲵਇ䈅㘵ਁ⭏ሬ㠤䟿䈳ᮤⲴн㢟৽ᓄǄษ㧛⋉㛭൘ CKDᙗᮠᦞᶕ㠚 2 亩Ѫᵏ 52 ઘⲴཊѝᗳǃ䲿ᵪǃ䭞IIIѤᒺ䈅傼ˈ वᤜа亩൘CKD 䶎䘿᷀ਇ䈅㘵ѝ䘋㹼Ⲵ III ᵏ⹄ウ HS-20039-301˄N=175˅઼а亩൘ CKD 䘿᷀ਇ䈅㘵ѝ䘋㹼Ⲵ III ᵏ⹄ウ HS-20039-302˄N=372˅Ǆ䭞ᙗ⹄ウѝⲴн㢟৽ᓄHS-20039-301 ⹄ウ൘ HS-20039-301 ⹄ウѝˈਇ䈅㘵᤹ 2:1ޡ173ֻCKD 䶎䘿᷀䍛㹰ਇ䈅㘵᧕ਇҶ⹄ウ㦟⢙⋫⯇ˈษ㧛⋉㛭㓴ᴹ 115㹰ᇍ㓴ᴹ 58ˈѪ 38.33 ઘ઼ 40.04ޡ84ਇ䈅㘵ษ㧛⋉㛭᳤䵢ı24 ઘˈ61ֻਇ䈅㘵ษ㧛⋉㛭᳤䵢ı48 ઘǄ⹄ウѝᴹ 39˄22.5%˅ਇ䈅㘵ਁ⭏Ҷн㢟৽ᓄˈษ㧛⋉㛭㓴ᙫփн㢟৽ᓄਁ⭏⦷Ѫ19.1%㹰ᇍ㓴ᙫփн㢟৽ᓄਁ⭏⦷Ѫ 29.3%Ǆє㓴ਁ⭏⦷ᴰ儈Ⲵн㢟৽ᓄ൷Ѫ㹰঻ॷ儈ˈษ㧛⋉㛭㓴ਁ⭏⦷Ѫ 3.5%㹰ᇍ㓴ਁ⭏⦷Ѫ 8.6%Ǆ㺘 2Ҷ HS-20039-301㹰ᇍ㓴ᑨ㿱 ˄ਁ⭏⦷ı1%˅ Ⲵн㢟৽ᓄˈཊᮠѪ 1~2 㓗Ǆ㺘 2. HS-20039-301 ⹄ウѝᑨ㿱˄ਁ⭏⦷ı1%˅Ⲵн㢟৽ᓄMedDRA ㊫㌫㔏俆䘹ᵟ䈝ษ㧛⋉㛭㓴(N=115)㹰ᇍ㓴(N=58)ᮠ(%) ᮠ(%)਴㊫Ựḕ㹰঻ॷ儈 4(3.5) 5(8.6)ᗳ⭥മ Q T 䰤ᵏᔦ䮯 3(2.6) 1(1.7)щ≘䞨≘ส䖜〫䞦ॷ儈 1(0.9) 1(1.7)MedDRA ㊫㌫㔏俆䘹ᵟ䈝ษ㧛⋉㛭㓴(N=115)㹰ᇍ㓴(N=58)ᮠ(%) ᮠ(%)≘䞨≘ส䖜〫䞦ॷ儈 1(0.9) 2(3.4)ᗳ⭥മ S T ⇥ᔲᑨ 1(0.9) 1(1.7)㜭ᔲᑨ 0 1(1.7)㹰ң䞨㝡≒䞦ॷ儈 0 1(1.7)ᙫ㛶≱䞨ॷ儈 0 1(1.7)㊫⯮⯵儈䫮㹰⯷ 2(1.7) 4(6.9)䫱㕪ѿ⯷ 0 1(1.7)㛍㛶㌫㔏⯮⯵㛍ᦏՔ 2(1.7) 0਴㊫⾎㓿㌫㔏⯮⯵ཤⰋ 2(1.7) 1(1.7)Ⳟ㛔৺Ⳟл㓴㓷㊫⯮⯵ⱉⰂ⯷ 1(0.9) 2(3.4)䓛ᙗ⯮⯵৺㔉㦟䜘ս਴⿽৽ᓄਁ✝ 0 1(1.7)㹰㇑о⏻ᐤ㇑㊫⯮⯵儈㹰঻ 1(0.9) 1(1.7)֣ 1(0.9) 3(5.2)㛳㛐㌫㔏⯮⯵અੀ 0 1(1.7)ᇊⲴн㢟һԦ˗⭘ 23.0 ⡸ MedDRAǄ᧕ਇᵜ૱⋫⯇Ⲵਇ䈅㘵ѝˈᴹ3˄2.6%˅ਁ⭏Ҷѕ䟽〻ᓖı3 㓗Ⲵн㢟৽ᓄˈवᤜ㹰঻ॷ儈˄1.7%˅઼㦘哫⯩˄0.9%˅˗ᰐਇ䈅㘵ਁ⭏ѕ䟽н㢟৽ᓄǄ᧕ਇᵜ૱⋫⯇Ⲵਇ䈅㘵ѝˈᴹ 1˄0.9%䟿л䈳˗ᴹ 1˄0.9%˅㦟ǄHS-20039-302 ⹄ウ൘ HS-20039-302 ⹄ウѝˈਇ䈅㘵൘᧕ਇ 8㓴ᶑԦⲴਇ䈅㘵᤹ 2:1ޡ370ֻCKD 䘿᷀䍛㹰ਇ䈅㘵᧕ਇҶ⹄ウ㦟⢙⋫⯇ˈษ㧛⋉㛭㓴ᴹ 246㹰ᇍ㓴ᴹ 124Ѫ 48.55ઘ઼ 45.63 ઘˈᴹ 233ਇ䈅㘵ษ㧛⋉㛭᳤䵢ı24 ઘˈ214ਇ䈅㘵ษ㧛⋉㛭᳤䵢ı48 ઘǄ⹄ウѝᴹ 83˄22.4%˅ਇ䈅㘵ਁ⭏Ҷн㢟৽ᓄˈษ㧛⋉㛭㓴ᙫփн㢟৽ᓄਁ⭏⦷Ѫ23.2%㹰ᇍ㓴ᙫփн㢟৽ᓄਁ⭏⦷Ѫ 21.0%Ǆษ㧛⋉㛭㓴ਁ⭏⦷ᴰ儈Ⲵн㢟৽ᓄᱟ㹰঻ॷ儈ˈਁ⭏⦷Ѫ 5.7%㹰ᇍ㓴ਁ⭏⦷ᴰ儈Ⲵн㢟৽ᓄѪ儈㹰঻ˈਁ⭏⦷Ѫ6.5%Ǆ㺘 3Ҷ HS-20039-302㹰ᇍ㓴ᑨ㿱˄ਁ⭏⦷ı1%˅ᡆ CTCAEı3Ⲵн㢟һԦཊᮠѪ 1~3 㓗Ǆ㺘㺘 3.HS-20039-302 ⹄ウѝᑨ㿱˄ਁ⭏⦷ı1%˅ᡆ CTCAEı3 㓗Ⲵн㢟৽ᓄMedDRA ㊫㌫㔏俆䘹ᵟ䈝ษ㧛⋉㛭㓴(N=246)㹰ᇍ㓴(N=124)࡛ᮠ(%)ı3 㓗ᮠ(%)࡛ᮠ(%)ı3 㓗ᮠ(%)਴㊫Ựḕ㹰঻ॷ儈 14(5.7) 6(2.4) 4(3.2) 1(0.8)ᗳ⭥മ Q T 䰤ᵏᔦ䮯 5(2.0) 1(0.4) 1(0.8) 0щ≘䞨≘ส䖜〫䞦ॷ儈 1(0.4) 0 2(1.6) 0㹰㇑о⏻ᐤ㇑㊫⯮⯵儈㹰঻ 12(4.9) 7(2.8) 8(6.5) 6(4.8)֣ 2(0.8) 2(0.8) 1(0.8) 1(0.8)㊫⯮⯵儈䫮㹰⯷ 6(2.4) 5(2.0) 7(5.6) 2(1.6)㛮㜿৺⋼ቯ㌫㔏⯮⯵㛮ᙗ儈㹰঻ 1(0.4) 1(0.4) 0 0ᇊⲴн㢟һԦ˗⭘ 23.0 ⡸ MedDRAǄ᧕ਇᵜ૱⋫⯇Ⲵਇ䈅㘵ѝˈᴹ 1˄0.4%䟿л䈳˗ᴹ 5˄2.0%ˈ㛍䞦ॷ儈 2ǃ㹰঻ॷ儈2઼儈㹰঻ 1⭘㦟˗ ᴹ1˄0.4%˅ഐ 㜨㦟Ǆ⌘Ⲵн㢟һԦ˖ᗳ㹰㇑һԦǃ儈㹰঻઼㹰ṃṃຎһԦ㊫㦟⢙ԕ䖳儈 Hb˄13.0 g/dL ৺ԕк˅֌Ѫ䶦ⴞḷᰦˈᛓ㘵↫ӑǃᗳ㹰㇑һԦǃ儈㹰঻˄ı3 㓗˅઼㹰ṃṃຎһԦⲴਁ⭏仾䲙Ǆᵜ㢲ᙫ㔃Ҷ൘ CKD˄㿱㺘 4˅Ǆ㺘㺘 4. ߥMedDRA ㊫㌫㔏俆䘹ᵟ䈝ษ㧛⋉㛭㓴˄䶎䘿᷀Ӫ㗔˅(N=177)ᮠ(%)ษ㧛⋉㛭㓴˄䘿᷀Ӫ㗔˅(N=349)ᮠ(%)ᗳᖻཡᑨ 16(9.0) 43(12.3)ı3 㓗儈㹰঻ 15(8.5) 37(10.6)㹰ṃṃຎһԦ 3(1.7) 17(4.9)ᙗһԦ 3(1.7) 7(2.0)ഐ↫ӑ 3(1.7) 5(1.4)ংѝ 0 4(1.1)ᗳ㚼ệ↫ 0 1(0.3)Ԇᗳ㹰㇑һԦ 0 4(1.1)䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎Ⰻ 0 2(0.6)㺠ㄝ 0 2(0.6)ษ㧛⋉㛭㓴˄䶎䘿᷀ਇ䈅㘵˅˖वᤜ EPOP2bˈHS-20039-301 ѝⲴษ㧛⋉㛭㓴ਇ䈅㘵Ǆษ㧛⋉㛭㓴˄䘿᷀ਇ䈅㘵˅˖वᤜ EPOP2aˈEPOP2cˈHS-20039-302 ⹄ウѝⲴษ㧛⋉㛭㓴ਇ䈅㘵ǄԆᗳ㹰㇑һԦ˖III ᵏ⹄ウ⭡ CECᇊˈIIᇊǄ儈㹰঻वᤜⲴ PTǃ儈㹰঻ᙗ㿶㖁㟌⯵ǃ㹰঻ॷ儈ǃ᫽֌ᙗ儈㹰঻Ǆ㹰ṃṃຎһԦवᤜⲴ PT䶉㜹ⱈ㹰ṃᖒᡀǃᙕᙗ㜹䰝ຎᙗ⯮⯵ǄᗳᖻཡᑨवᤜⲴ PT˖ᗳ⭥മ QTࣘ䗷䙏ǃ ᗳ⭥മ༽ᶱᔲᑨǃ ᐖᶏ᭟䱫┎ǃ ブᙗᗳᖻн喀ǃՐሬ㕪䲧ǃ⊳ቄཛ -ᑅ䠁἞-ᘰ⢩㔬ਸᖱǃᗳ⭥മPR䗷䙏ǃਣᶏ᭟䱫┎ǃҼᓖᡯᇔ䱫┎Ǆഐ↫ӑһԦⲴѝսਁ⭏ᰦ䰤൘䶎䘿᷀Ӫ㗔ѝѪ 19.3ޡ3˅ˈ൘ 䘿 ᷀ Ӫ 㗔 ѝ Ѫ15ޡ5˅ǄংѝһԦ൘䶎䘿᷀Ӫ㗔ѝᵚਁ⭏ǄংѝһԦⲴѝսਁ⭏ᰦ䰤൘䘿᷀Ӫ㗔ѝѪ 29.4 ઘˈѝսᤱ㔝ᰦ䰤Ѫ 1.2 ઘˈ4ਇ䈅㘵ѝᴹ 1ᐢᚒ༽Ǆᗳ㚼ệ↫һԦ൘䶎䘿᷀Ӫ㗔ѝᵚਁ⭏Ǆᗳ㚼ệ↫һԦⲴѝսਁ⭏ᰦ䰤൘䘿᷀Ӫ㗔ѝѪ27.9 ઘˈѝսᤱ㔝ᰦ䰤Ѫ 24.3 ઘˈ䈕 1ਇ䈅㘵ᐢᚒ༽Ǆ㺠ㄝⲴѝսਁ⭏ᰦ䰤൘䘿᷀Ӫ㗔ѝѪ 14.7 ઘˈ ѝսᤱ㔝ᰦ䰤Ѫ0.8 ઘˈ ӵ2⧠䴰㾱տ䲒⋫⯇㺠ㄝ˄ਁ⭏⦷ 0.6%˅ˈ⹄ウ㔃ᶏᰦᵚᚒ༽Ǆ䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎Ⰻ൘䶎䘿᷀Ӫ㗔ѝᵚਁ⭏Ǆ䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎ⰋⲴѝսਁ⭏ᰦ䰤൘䘿᷀Ӫ㗔ѝѪ 31.4 ઘˈѝսᤱ㔝ᰦ䰤Ѫ 20.9 ઘˈӵ 2⧠䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎Ⰻ˄ਁ⭏⦷ 0.6%˅ˈ⹄ウ㔃ᶏᰦᵚᚒ༽ǄᗳᖻཡᑨⲴѝսਁ⭏ᰦ䰤൘䶎䘿᷀Ӫ㗔ѝਁ⭏Ⲵѝսᰦ䰤Ѫ 9.2 ઘˈѝսᤱ㔝ᰦ䰤Ѫ6.4 ઘ˗൘䘿᷀Ӫ㗔ѝѪ 12.1 ઘˈѝսᤱ㔝ᰦ䰤Ѫ 4.1 ઘǄ儈㹰঻ ˄ı3 㓗˅ Ⲵѝսਁ⭏ᰦ䰤൘䶎䘿᷀Ӫ㗔ѝਁ⭏Ⲵѝսᰦ䰤Ѫ15.6 ઘˈ ѝսᤱ㔝ᰦ䰤Ѫ 8.1 ઘˈ15ਇ䈅㘵ѝᴹ 11˄73.3%˅ᐢᚒ༽˗൘䘿᷀Ӫ㗔ѝѪ 14.4 ઘˈѝսᤱ㔝ᰦ䰤Ѫ 2.4 ઘˈ37ਇ䈅㘵ѝᴹ 30˄81.1%˅ᐢᚒ༽Ǆ㹰ṃṃຎһԦⲴѝսਁ⭏ᰦ䰤൘䶎䘿᷀Ӫ㗔ѝਁ⭏Ⲵѝսᰦ䰤Ѫ8.6 ઘˈ ѝսᤱ㔝ᰦ䰤Ѫ 12.1 ઘˈ3ਇ䈅㘵ѝᴹ 2˄66.7%˅ᐢᚒ༽˗൘䘿᷀Ӫ㗔ѝѪ27.9 ઘˈѝսᤱ㔝ᰦ䰤4.1 ઘˈ17ਇ䈅㘵ѝᴹ 12˄70.6%˅ᐢᚒ༽Ǆ㹰ᇍ㓴ѝ䟽㾱Ⲵᗳ㹰㇑һԦਁ⭏⦷䘋㹼∄䖳ǄHS-20039-301 ⹄ウѝˈѪ 0.9%˄1˅઼ 3.4%˄2˅ˈ仾䲙∄0.27˄95%CI˖0.02~3.11Ѫ 0 ઼ 5.2%˄3˅ˈษ㧛⋉㛭㓴༽㹰ᇍ㓴ˈն㓴䰤ᰐ㔏䇑ᆖᐞᔲ˄㿱㺘 5ǃ6˅˗HS-20039-302Ѫ 2.4%˄6˅ ઼4.0%˄5˅ˈ 仾䲙∄0.47˄95%CI˖0.14~1.59Ѫ1.2%˄3˅ ઼4.0%˄5˅ˈ仾䲙 ∄0.28˄95%CI˖0.07~1.17ަ㹰ᇍ㓴ˈն㓴䰤ᰐ㔏䇑ᆖᐞᔲ˄㿱㺘7ǃ8˅Ǆ㺘㺘 5. HS-20039-301˄SS˅

ษ㧛⋉㛭㓴(N=115)㹰ᇍ㓴(N=58) HR৺95%CI 90%CI⅑ֻ ᮠ(%) ⅑ֻ ᮠ(%)ᙗһԦ 1 1(0.9) 2 2(3.4) 0.27(0.02,3.11) 0.27(0.02,3.11)ഐ↫ӑ 1 1(0.9) 2 2(3.4) 0.27(0.02,3.11) 0.27(0.02,3.11)ংѝ 0 0 0 0 - -ᗳ㚼ệ↫ 0 0 0 0 - -⌘˖䟷⭘ Cox仾䲙എᖂ⁑ර䇑㇇ HR४䰤ˈॿਈ䟿Ѫส㓯 Hb㓗Ǆ㺘 6. HS-20039-301˄SS˅

ษ㧛⋉㛭㓴(N=115)㹰ᇍ㓴(N=58) HR৺95%CI 90%CI⅑ֻ ᮠ(%) ⅑ֻ ᮠ(%)Ԇᗳ㹰㇑һԦ 0 0 3 3(5.2) - -㺠ㄝ 0 0 3 3(5.2) - -䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎Ⰻ 0 0 0 0 - -⌘˖䟷⭘ Cox仾䲙എᖂ⁑ර䇑㇇ HR४䰤ˈॿਈ䟿Ѫส㓯 Hb㓗Ǆ㺘㺘 7. HS-20039-302ߥ

ษ㧛⋉㛭㓴(N=246)㹰ᇍ㓴(N=124) HR৺95%CI 90%CI⅑ֻ ᮠ(%) ⅑ֻ ᮠ(%)ᙗһԦ 9 6(2.4) 8 5(4.0) 0.47(0.14, 1.59) (0.17, 1.31)ഐ↫ӑ 4 4(1.6) 4 4(3.2) 0.31(0.07, 1.46) (0.09, 1.14)ংѝ 4 4(1.6) 2 2(1.6) 0.59(0.10, 3.51) (0.13, 2.63)ᗳ㚼ệ↫ 1 1(0.4) 2 2(1.6) 0.22(0.02, 2.44) (0.03, 1.66)⌘˖䟷⭘ Cox仾䲙എᖂ⁑ර䇑㇇ HR४䰤ˈॿਈ䟿Ѫส㓯 Hb㓗Ǆ㺘 8. HS-20039-302ߥ

ษ㧛⋉㛭㓴(N=246)㹰ᇍ㓴(N=124) HR৺95%CI 90%CI⅑ֻ ᮠ(%) ⅑ֻ ᮠ(%)Ԇᗳ㹰㇑һԦ 3 3(1.2) 7 5(4.0) 0.28(0.07, 1.17) (0.08, 0.93)㺠ㄝ 1 1(0.4) 7 5(4.0) 0.09(0.01, 0.77) (0.02.0.54)䴰㾱տ䲒⋫⯇Ⲵнっᇊᗳ㔎Ⰻ 2 2(0.8) 0 0 - -⌘˖䟷⭘ Cox仾䲙എᖂ⁑ර䇑㇇ HR४䰤ˈॿਈ䟿Ѫส㓯 Hb㓗Ǆ⌘Ⲵн㢟һԦ˖㛍㜿∂ᙗǃ㹰঻ॷ儈ǃ⭥䀓䍘ᔲᑨ઼䎵᭿৽ᓄᵜ㢲ᙫ㔃Ҷษ㧛⋉㛭൘ EPOP2cǃHS-20039-301 ઼ HS-20039-302 Ѥᒺ⹄ウѝ↔㊫н㢟ˈਸ䇑वਜ਼ษ㧛⋉㛭㓴 404㹰ᇍ㓴 202ޘᙗᮠᦞǄ㛍㜿∂ᙗ˖Ѫ8.5%઼ 9.4%࠶Ѫ 14.1 ઘ઼ 12.1ѝѕ䟽ㅹ㓗䖳儈˄ı3Ѫ0.7%઼ 0.5%Ǆ ൘⹄ウ㔃ᶏᰦˈ ษ㧛⋉㛭㓴6.7%Ⲵਇ䈅㘵ᚒ㹰ᇍ㓴 7.4%Ⲵਇ䈅㘵ᚒ༽Ǆ㹰঻ॷ儈˖Ѫ25.4%઼ 20.8%ˈ俆⅑ਁ⭏ѝսᰦ䰤Ѫ 11.9 ઘ઼ 8.6ѝѕ䟽ㅹ㓗䖳儈˄ı3Ѫ 12.2%઼ 9.4%Ǆ൘⹄ウ㔃ᶏᰦˈษ㧛⋉㛭㓴20.6%㹰ᇍ㓴 18.3%Ⲵਇ䈅㘵ᚒ༽Ǆ⭥䀓䍘ᔲᑨ˖Ѫ35.8%઼ 41.6%ˈ俆⅑ਁ⭏ѝսᰦѪ 8.2 ઘ઼ 4.7 ઘˈѫ㾱㺘⧠⯷⣦Ѫ儈䫮㹰⯷ǃ儈⼧䞨㹰⯷ǃվ䫮㹰⯷ǃվ䫉㹰⯷ǃѝѕ䟽ㅹ㓗䖳儈 ˄ı3Ѫ8.2%઼ 10.4%Ǆ൘ ⹄ウ㔃ᶏᰦˈษ㧛⋉㛭㓴 33.8%㹰ᇍ㓴 37.6%Ⲵਇ䈅㘵ᚒ༽Ǆ䎵䎵᭿৽ᓄ˖Ѫ11.4%઼ 14.9%ˈ俆⅑ਁ⭏ѝսᰦ䰤Ѫ 12.9 ઘ઼ 25.4ѝѕ䟽ㅹ㓗䖳儈 ˄ı3 㓗˅Ѫ 0.2%઼ 1.5%Ǆ൘⹄ウ㔃ᶏᰦˈษ㧛⋉㛭㓴 10.7%Ⲵਇ䈅㘵ᚒ༽ˈ㹰ᇍ㓴 12.4%Ⲵਇ䈅㘵ᚒ༽Ǆ⯛৏ᙗ᷀⌅Ự⍻Ҷ 526ֻCKD 䍛㹰ਇ䈅㘵Ⲵᣇ㦟ᣇփˈᒦሩᣇ㦟ᣇփˈᴹ2˄0.4%˅ਇ䈅㘵ษ㧛⋉㛭⢩ᔲᙗ㔃ਸᣇփ䱣ᙗ˗൘ᵜ૱⋫⯇ᵏ䰤ˈ30˄5.7%˅ਇ䈅㘵ษ㧛⋉㛭⢩ѝ 5˄1.0%˅ѝ઼ᣇփ䱣ᙗǄᣇ㦟ᣇփ䱣ᙗਇ䈅㘵ᵚਁ⭏䎵᭿৽ǄⲴᣇփ䱣ᙗ⦷ਟ㜭ਇ䈅傼ᯩ⌅ǃṧᵜ༴⨶ǃṧᵜ䟷䳶ᰦ䰤ǃਸᒦ⭘㦟઼ส⹰⯮⯵ㅹཊ⿽ഐ㍐ᖡ૽ǄǏ⾱ᗼǐԕлᛓ㘵⾱⭘˖1ˊ Ⲵᛓ㘵˗2ˊ ᡆԫօа⿽䖵ᯉ䗷᭿Ⲵᛓ㘵ǄǏ⌘⌘᜿һ亩ǐ㹰㓒㳻ⲭ≤ᒣⴁ⍻˖൘ C K D 䶉㜹㹰ṃṃຎǃ 㹰⭘ᵜ૱⋫⯇ᵏ䰤ˈᓄṩᦞ Hb䟿䘋㹼䈳ᮤˈ֯Hb䟿ਾˈᓄ⇿ 2 ઘỰ⍻а⅑ Hb ≤ᒣˈ䟿䈳ᮤ㿱Ǐ⭘⌅⭘䟿ǐǄ㹰঻ⴁ⍻઼⋫⯇ᵏᵜ૱ˈ ᒦ൘у、५⭏Ⲵᤷሬл䘋㹼䱽঻㦟⢙⋫⯇઼侞伏ᒢ亴Ǆ㺕䫱⋫⯇˖ሩҾ㹰␵䫱㳻ⲭਜ਼䟿վҾ100 μg/Lᡆ䖜䫱㳻ⲭ価઼ᓖվҾ20ˁⲴᡰᴹᛓ㘵ˈ઼⋫⯇ᵏ䰤൷ᔪ䇞䇴ԧᡰᴹᤷḷǄᗳ㹰㇑һԦ仾䲙˖ESA ㊫㦟⢙൘ CKD ᛓ㘵ѝᔰኅⲴ䲿ᵪሩ➗⹄ウ㔃᷌ᱮ⽪ˈоվ Hb䶦ⴞḷ ˄㓖10.0~11.0 g/dL˅⴨∄ˈESA ㊫㦟⢙൘ԕ䖳儈 Hb˄㓖 13.0 g/dL˅֌Ѫ䶦ⴞḷᰦˈԆ㧧⳺Ǆሩ ESA ⯇⌅ᓄㆄн䏣Ⲵ CKD ᛓ㘵ਁ⭏ᗳ㹰㇑һԦǃ㹰ṃᖒᡀ઼↫ӑⲴ仾䲙ᴤ儈Ǆᵜᵜ૱⋫⯇ਾ Hb Ⲵᓄㆄ㕪ѿᡆїཡ˖⧠ Hb Ⲵᓄㆄ㕪ѿᡆїཡˈᓄራ᢮৏ഐǄ䫱ǃਦ䞨ᡆ㔤⭏㍐ B12ՔһԦǃ 䳀ᙗཡ㹰ǃ ⓦ㹰ǃ 䟽ᓖ䬍ѝ∂ǃ ส⹰㹰⏢⯵ᡆ僘儃㓔㔤ॆҏਟ㜭ᖡ૽㓒㓶㜎⭏ᡀǄ ᓄ㘳㲁ሶ㖁Ǆѕ䟽䗷᭿৽ᓄ˖਼㊫ӗ૱䙊䗷䶉㜹 ˄ᡆⳞл˅ ⌘ሴ㔉㦟൘ຳཆ⹄ウѝᴮᣕ䚃䗷ѕ䟽Ⲵ䗷䗷䙏ǃⱉⰂᙗⳞ⯩઼㦘哫⯩ㅹǄᵜ૱䙊䗷Ⳟл⌘ሴˈ⋫⯇ਾ਼ṧᆈ൘ਁ⭏ѕ䟽䗷᭿৽ᓄⲴ仾䲙Ǆ⭘㦟ਾ䴰㿲ሏ30䫏ˈྲ᷌⭘ᵜ૱ǄⲴᛓ㘵˖ᛓ㘵ⲴᮠᦞǄԆӪ㗔⭘㦟˖ઈ᝾⭘Ǆ䮠⣦㓶㜎䍛㹰ᛓ㘵᝾⭘Ǆᴹ᰾⺞Ⲵ㦟⢙ᡆ伏⢙䗷᭿ਢǃ ᡆ㓿५ᆖ䇺ᯝⲴ䗷᭿ᙗ⯮⯵ਢ ˄ྲ䗷᭿ᙗଞைǃ 䗷᭿ᙗ㍛Ⲍǃ䗷᭿ᙗ啫⚾ǃ䗷᭿ᙗⳞ⚾ㅹ˅Ⲵᛓ㘵᝾⭘Ǆᚦᙗ㛯ⱔӪ㗔᝾⭘Ǆˈ䘉ਟ㜭ሬ㠤ড৺⭏ભⲴᗳ㹰㇑㌫㔏ᒦਁ⯷ǄⲴᖡ૽˖Ⲵᖡ૽ⲴᮠᦞǄǏᆅྷ৺ପңᵏྷྣ⭘㦟ǐ⢙઼㜊㛾ᴹᖡ૽ˈഐ↔ྺၐ઼ପңᵏྷྣ᝾⭘Ǆㄕ⭘㦟ǐቊᵚ⺞ᇊᵜ૱൘ 18ᙗ઼ᴹ᭸ᙗǄǏ㘱ᒤ⭘㦟ǐ൘ᐢᔰኅⲴ II澝III ᵏ⹄ウѝˈ㓖ᴹ 8%Ⲵᛓ㘵൘ 65ԆӪ㗔ᰐ᰾ᱮᐞᔲǄǏǏ㦟⢙⴨ӂ֌⭘ǐᆳ㦟⢙ѻ䰤ᴹ⴨ሩっᘱ᳤䵢䟿ᰐ᰾ᱮᖡ૽ǄǏ㦟⢙䗷䟿ǐ൘ CKD䟿Ѫ 0.08 mg/kgᯔփ䟽䇑㇇˅ ᡆ6 mg˄ᙫ䟿˅ ˈ⇿ 4 ઘ㔉㦟а⅑Ǆ㦟⢙䗷䟿ਟሬ㠤㦟᭸ᆖ֌⭘᭮བྷˈྲ㓒㓶㜎⭏ᡀ䗷ཊǄǏѤᒺ㦟⨶ǐࡦ㓒㓶㜎⭏ᡀ㍐⁑ᤏ㛭ˈ 䙊䗷о㓶㜎㺘䶒Ⲵ⢩ᔲᙗEPO䘋僘儃㓒㌫ᇊੁ⾆㓶㜎 ˄BFU-EǃCFU-E䘋僘儃䘋㓒㓶㜎Ⲵ⭏ᡀǄ㦟᭸ᆖCKD ᡀᒤᛓ㘵⌘ሴษ㧛⋉㛭ਾ Hb ॷ儈ˈ俆⅑ᓄㆄ˄ᇊѹѪ Hb࣐≥1.0 g/dL˅ѝսᰦ䰤Ѫ 28 ཙǄᆖ੨᭦ᆖᓧਇ䈅㘵অ⅑Ⳟл⌘ሴਾ˄HS-EPOP1䟿㓴㹰⍶ѝษ㧛⋉㛭⎃ᓖⲴ䗮ጠᰦ䰤˄Tmax˅൘ 25~32.5 ሿᰦ˄h˅ˈ↔ਾˈ㹰⍶ѝⲴษ㧛⋉㛭≤ᒣ㕃ធл䱽Ǆ൘0.025~0.08mg/kgǄ䶎䘿᷀ CKDᆖ൘䶎䘿᷀ CKDᆖ⹄ウѝ ˄HS-EPOP2b ⹄ウ˅ ˈ ษ㧛⋉㛭俆⅑Ⳟл㔉㦟ਾ˄0.025 mg/kgǃ0.05 mg/kg ઼ 0.08 mg/kg䟿㓴˅Ⲵ Tmax ѝսᮠ㤳തѪ 42.0~48.0hˈCmaxѪ 49.6 ng/mlǃ127 ng/ml ઼ 175 ng/mlǄ൘ 0.025~0.08 mg/kgˈษ㧛⋉㛭Ⲵ CmaxǃAUC0-t ઼ AUC0-䟿ᡀ∄Ǆ⇿ 4㦟⢙㫴〟Ǆ䘿᷀ CKDᆖ൘㹰⏢䘿᷀ CKDᆖ⹄ウѝ˄HS-EPOP2a ⹄ウ˅ ˈษ㧛⋉㛭俆⅑Ⳟл㔉㦟ਾ˄0.025 mg/kgǃ0.05 mg/kgǃ0.08 mg/kg䟿㓴˅Ⲵ Tmax ѝսᮠ㤳തѪ 47.9~72.0hǄCmaxѪ 53.3 ng/mlǃ119 ng/ml ઼ 221 ng/mlǄ൘ 0.025~0.08 mg/kgˈษ㧛⋉㛭Ⲵ CmaxǃAUC0-t ઼ AUC0-䟿ᡀ∄Ǆ⇿ 4㦟⢙㫴〟Ǆ࠶ᐳᐳփ〟 ˄Vz/F㓖Ѫ 17.4 LǄԓ䉒઼ᧂ⋴䘋㹼㦟⢙ԓ䉒઼⢙ᯉᒣ㺑⹄ウǄ޵৏ර㦟⢙㓿ቯᧂ⋴ˈ ቁ䟿㓿᭮ሴ䟿Ⲵ 57.9%઼ 21.7 %Ǆ൘ 0.025~0.08 mg/kgᓧਇ䈅㘵অ⅑㔉㦟ਾⲴ⎸䲔ॺ㺠ᵏ ˄t1/2˅ 㤳തѪ59.1~73.9 h˗൘䶎䘿᷀ CKD ਇ䈅㘵俆⅑㔉㦟ਾⲴ t1/2 㤳തѪ 58.3~69.7 h˗൘䘿᷀ CKD ਇ䈅㘵俆⅑㔉㦟ਾⲴ t1/2 㤳തѪ 61.6~74.9 hᆖ⁑රՠ㇇ษ㧛⋉㛭Ⲵ㓖Ѫ 0.0918 L/hǄᆖㄕ৺䶂ቁᒤⲴѤᒺ䈅傼ᮠᦞǄ㘱ᒤӪ˖ ᵜ૱ᵚ൘㘱ᒤӪ ˄˚65ᆖ⁑᷀ᱮ⽪ᒤ喴˄20~70 ኱˅ሩ᳤䵢䟿ᰐᱮ㪇ᖡ૽Ǆ᷀㜭ᤷḷ↓ᑨⲴᛓ㘵⴨∄ˈ ษ㧛⋉㛭Ⲵっᘱ᳤䵢䟿ᰐ᰾ᱮᐞᔲǄ䚇Ր㦟⨶ᆖቊᵚ䘋㹼䚇Ր㦟⨶ᆖ⹄ウǄǏѤᒺ䈅傼ǐ䶎䘿᷀ᛓ㘵HS-20039-301᭸III ᵏѤᒺ䈅傼ˈⴞ⋫ CKD㹰ᇍ⭘Ҿ䍛㹰㓐↓⋫⯇Ⲵ⯇᭸઼㓴ᶑԦⲴਇ䈅㘵᤹2:1䝽㠣䈅傼㓴˄ษ㧛⋉㛭㓴˅৺䱣ᙗሩ㹰ᇍ㓴ѝˈਇ䈅㘵Ӫਓᆖส㓯⢩ᖱสᵜа㠤ˈवᤜᒤǃ≁᯿ǃ䓛儈ǃփ䟽ǃBMI ઼䗷᭿ਢㅹǄє㓴ਇ䈅㘵Ⲵ⯮⯵ส㓯⢩ᖱ൷㺑ˈवᤜ㛮ᙗ䍛㹰⯵〻ǃส㓯 Hb㓗৺㹰␵䫱㳻ⲭǃ䖜䫱㳻ⲭ価઼ᓖ઼ส㓯 eGFRㅹᇎ傼ᇔỰḕᤷḷˈє㓴ส㓯 HbѪ 8.902 g/dL ઼ 8.969 g/dLǄᵜ⹄ウѫ㾱⯇᭸㓸⛩Ѫ⯇᭸䇴ՠᵏ˄17~24 ઘ˅Hb⴨ሩส㓯˄ㅜ 0˅Ǆ൘ FAS ѝˈษ㧛⋉㛭㓴ਇ䈅㘵⯇᭸䇴ՠᵏ HbѪ 1.933f1.156 g/dL㹰ᇍ㓴Ѫ 1.516f1.067 g/dLˈ㓴䰤⋫⯇ᐞᔲ˄ษ㧛⋉㛭㓴-㹰ᇍ㓴˅Ⲵṑ↓Ѫ 0.378f0.156 g/dL˄95% CI˖0.070~0.686ˈP=0.0163˅ˈ㓴䰤⋫⯇ᐞᔲⲴ 95% CI л䲀٬1.0 g/dLҶѫ㾱⯇᭸㓸⛩Ǆ㿱㺘 9Ǆ㺘㺘 9 . ⯇᭸䇴ՠᵏ Hb˄FAS˅㔏䇑䟿 ษ㧛⋉㛭㓴(N=115)㹰ᇍ㓴(N=58) 㔏䇑䟿 P٬ส㓯 N(Nmiss) 115(0) 58(0)Mean±Std 8.902±1.005 8.969±1.077M(Q1~Q3) 8.900(8.400~9.600) 9.200(8.300~9.700)Min~Max 5.50~11.30 6.40~11.10⯇᭸䇴ՠᵏ N(Nmiss) 115(0) 58(0)Mean±Std 10.834±1.097 10.486±0.993M(Q1~Q3) 10.880(10.180~11.570) 10.590(10.200~11.150)Min~Max 6.90~13.33 7.78~11.90٬ N(Nmiss) 115(0) 58(0)Mean±Std 1.933±1.156 1.516±1.067M(Q1~Q3) 1.830(1.200~2.830) 1.590(0.770~2.100)Min~Max -1.60~5.73 -1.13~3.83٬ LS Mean±SE 1.920±0.090 1.542±0.127 F=5.88 0.016395%CI (1.742,2.098) (1.291,1.793)

є㓴ѻᐞ 0.378±0.156 -95%CI (0.070,0.686) -㹰ᇍ㓴 Hb 俆⅑ᓄㆄ˄Hb ᓄㆄᇊѹѪ˖൘⹄ウ䗷〻ѝⲴԫаᰦ䰤ˈHbı1.0 g/dL˅Ⲵᰦ䰤ǃᓄㆄ⦷ԕ৺ Hbᓄㆄ䶦ⴞḷ˄Hb ᓄㆄ䶦ⴞḷᇊѹѪ˖ķส㓯 Hbı8.0 g/dL Ⲵਇ䈅㘵ˈ൘䈅傼䗷〻ѝⲴԫаᰦ䰤ˈHbı1.0 g/dL ᒦф Hbı10.0 g/dL˗ĸส㓯 Hb<8.0 g/dL Ⲵਇ䈅㘵ˈ൘䈅傼䗷〻ѝⲴԫаᰦ䰤ˈHbı2.0 g/dL˅Ⲵᰦ䰤ǃ䗮ḷ⦷൷⴨լˈ㔃᷌ᰐ㔏䇑ᆖᐞᔲǄ䘿᷀ᛓ㘵HS-20039-302᭸III ᵏѤᒺ䈅傼ˈⴞ㓒㓶㜎⭏ᡀ㍐⋫⯇Ⲵ CKDѝ㹰⏢䘿᷀ᛓ㘵ঐ 67.6%ˈ㞩㟌䘿᷀ᛓ㘵ঐ 32.4 %ᙗǄਇ䈅㘵൘᧕ਇ8㓴ᶑԦⲴਇ䈅㘵᤹2:1䝽㠣䈅傼㓴 ˄ษ㧛⋉㹰ᇍ㓴ѝˈ ਇ䈅㘵Ӫਓᆖส㓯⢩ᖱสǃ≁᯿ǃ䓛儈ǃփ䟽ǃփ䟽ᤷᮠ˄BMI˅઼䗷᭿ਢㅹǄє㓴ਇ䈅㘵Ⲵ⯮⯵ส㓯⢩ᖱ൷㺑ˈवᤜ CKD ⯵〻ǃ㛮ᙗ䍛㹰⯵〻ǃส㓯 Hb㓗৺㹰␵䫱㳻ⲭǃ䖜䫱㳻ⲭ価઼ᓖㅹᇎ傼ᇔỰḕᤷḷˈє㓴ส㓯Hb൷Ѫ 11.11 g/dLǄᵜ⹄ウѫ㾱⯇᭸㓸⛩Ѫ⯇᭸䇴ՠᵏ˄17~24 ઘ˅Hb⴨ሩส㓯˄-4ǃ-2 ઼ 0 ઘỰ᷀䳶˄FAS㹰ᇍ㓴ਇ䈅㘵⯇᭸䇴ՠᵏHbѪ 0.076 g/dL ઼-0.224 g/dLˈ⁑රṑ↓Ⲵ㓴䰤ᐞᔲ˄ษ㧛⋉㛭㓴-࡙㹰ᇍ㓴˅ Ѫ0.297±0.090 g/dL˄95% CI˖0.119~0.475ˈP=0.0011˅ Ǆ ൘ㅖਸᯩṸ䳶 ˄PPS˅ѝ ˈษ㧛⋉㛭㓴ਇ䈅㘵⯇᭸䇴ՠᵏ HbѪ 0.069 g/dL㹰ᇍ㓴Ѫ-0.223 g/dLˈ⁑රṑ↓Ⲵ㓴䰤ᐞᔲ˄ษ㧛⋉㛭㓴-㹰ᇍ㓴˅Ѫ 0.288±0.092 g/dL˄95% CI˖0.107~0.468ˈP=0.0018ަ95% CI٬1.0g/dL᭸ᡀ・Ǆ ሩѫ㾱⯇᭸㓸᷀ᱮ⽪ˈ ൘PPS㹰ᇍ㓴⯇᭸䇴ՠᵏ HbѪ 0.013 g/dL ઼-0.171 g/dLˈ㓴䰤⋫⯇ᐞᔲ˄ษ㧛⋉㛭㓴-㹰ᇍ㓴˅Ѫ 0.173±0.114 g/dL˄95% CI˖-0.051~0.397ˈP=0.1299˅˗ሩҾ᧕ਇ㞩㟌䘿㹰ᇍ㓴⯇᭸䇴ՠᵏ HbѪ 0.186 g/dL઼-0.327 g/dL ˈ㓴䰤⋫⯇ᐞᔲ˄ษ㧛⋉㛭㓴 -㹰ᇍ㓴˅Ѫ 0.520±0.153 g/dL ˄95% CI ˖0.216~0.823ˈP=0.0009˅Ǆᴹ᭸ᙗ㔃᷌䈖㿱㺘 10 ઼㺘 11Ǆ㺘㺘 10. ⯇᭸䇴ՠᵏ Hb˄FAS˅㔏䇑䟿 HS-20039㓴(N=246)㹰ᇍ㓴(N=124) 㔏䇑䟿 P٬ส㓯 N(Nmiss) 246(0) 124(0)Mean±Std 11.110±0.752 11.114±0.683M(Q1~Q3) 11.170(10.530~11.670) 11.130(10.635~11.600)Min~Max 8.27~12.83 9.63~13.00⯇᭸䇴ՠᵏ N(Nmiss) 246(0) 124(0)Mean±Std 11.186±0.886 10.890±0.799M(Q1~Q3) 11.300(10.630~11.780) 10.765(10.330~11.505)Min~Max 6.57~13.00 8.85~13.68٬ N(Nmiss) 246(0) 124(0)Mean±Std 0.076±0.936 -0.224±0.959M(Q1~Q3) 0.130(-0.670~0.680) -0.195(-0.895~0.355)Min~Max -2.20~2.88 -2.40~2.51٬ LS Mean±SE 0.077±0.055 -0.220±0.075 F=10.82 0.001195%CI (-0.030,0.185) (-0.368,-0.072)

㔏䇑䟿 HS-20039㓴(N=246)㹰ᇍ㓴(N=124) 㔏䇑䟿 P٬є㓴ѻᐞ 0.297±0.090 -95%CI (0.119,0.475) -㺘㺘 11. ⯇᭸䇴ՠᵏ Hb⴨ሩส㓯Ⲵਈॆ˄PPS˅㔏䇑䟿 ษ㧛⋉㛭㓴(N=233)㹰ᇍ㓴(N=114) 㔏䇑䟿 P٬ส㓯 N(Nmiss) 233(0) 114(0)Mean±Std 11.136±0.738 11.143±0.688M(Q1~Q3) 11.170(10.570~11.730) 11.170(10.670~11.630)Min~Max 8.27~12.83 9.63~13.00⯇᭸䇴ՠᵏ N(Nmiss) 233(0) 114(0)Mean±Std 11.205±0.855 10.920±0.780M(Q1~Q3) 11.300(10.650~11.780) 10.780(10.330~11.530)Min~Max 6.57~13.00 9.08~13.68٬ N(Nmiss) 233(0) 114(0)Mean±Std 0.069±0.924 -0.223±0.973M(Q1~Q3) 0.110(-0.640~0.650) -0.305(-0.920~0.380)Min~Max -2.20~2.88 -2.40~2.51٬ LS Mean±SE 0.068±0.055 -0.219±0.077 F=9.85 0.001895%CI (-0.040,0.176) (-0.370,-0.068)

є㓴ѻᐞ 0.288±0.092 -95%CI (0.107,0.468) -൘⅑㾱⯇᭸㓸⛩кˈ ൘FASᴹ60.57%઼ 54.84%ਇ䈅㘵⯇᭸䇴ՠᵏHb 㔤ᤱ൘±1.0 g/dLˈє㓴ѻ䰤ᰐ㔏䇑ᆖᐞᔲ˄P=0.2943ᴹ 64.23%઼66.13%ਇ䈅㘵⯇᭸䇴ՠᵏ Hb 㔤ᤱ൘ 10.0~12.0 g/dLˈє㓴ѻ䰤ᰐ㔏䇑ᆖᐞᔲ˄P=0.7289˅Ǆ൘ PPSᴹ 63.95%઼ 59.65%Ⲵਇ䈅㘵⯇᭸䇴ՠᵏHb 㔤ᤱ൘±1.0 g/dLˈ є㓴ѻ䰤ᰐ㔏䇑ᆖᐞᔲ ˄P=0.4456ᴹ67.81%઼ 71.93%Ⲵਇ䈅㘵⯇᭸䇴ՠᵏ Hb 㔤ᤱ൘ 10.0~12.0 g/dLˈє㓴ѻ䰤ᰐ㔏䇑ᆖᐞᔲ˄P=0.4532˅ǄǏ㦟⨶∂⨶ǐ㦟⨶֌⭘ษ㧛⋉㛭ᱟ⭡ 2᭟ර PEG㓒㓶㜎⭏ᡀ㍐˄EPO˅⁑ᤏ㛭ǄEPO໎◰EPO䎆ᙗ㓶㜎໎⇆Ǆ∂⨶⹄ウ䚇Ր∂ᙗษ㧛⋉㛭 Ames僘儃ᗞṨ䈅傼㔃᷌൷Ѫ䱤ᙗǄ⭏⭏⇆∂ᙗབྷ啐⇿ઘ 1 ⅑Ⳟл⌘ሴษ㧛⋉㛭 0.1ǃ0.5ǃ5mg/kgࡽ4 ઘᔰ࿻㔉㦟ˈ䳼啐ࡽ2 ઘᔰ࿻㔉㦟ˈӔ䝽ᵏ˄10Ựˈ䳼啐ᤱ㔝㔉㦟㠣ྺၐㅜ 6 ཙ˄GD6˅ˈGD14ỰǄ0.5ǃ5mg/kg ਟ㠤㜊㛾⍫㛾⦷䱽վǃ੨᭦㛾⦷ॷ儈ˈ5mg/kgⲴ NOAEL䟿Ѫ0.5mg/kg䟿 6mg/⅑Ⲵ 0.8˄สҾփ㺘䶒〟ᣈ㇇˅Ǆᵜ૱ሩབྷ啐ᰙᵏ㜊㛾ਁ㛢Ⲵ NOAEL䟿Ѫ 0.1mg/kg䟿 6mg/⅑Ⲵ 0.16˄สҾփ㺘䶒〟ᣈ㇇˅Ǆྺၐབྷ啐Ҿ GD6ǃGD10ǃGD15 Ⳟл⌘ሴษ㧛⋉㛭 5ǃ50ǃ100mg/kgˈGD20ỰǄ≥5mg/kg䟿 6mg/⅑Ⲵ 8˅ਟ㿱ᆅ啐∂ᙗ઼㜊㛾-㜿ᡆཆ㿲⮨ᖒǄ ∂ᙗ⢩ᖱवᤜ˖ ᆅ啐փ䟽໎䟽䱽վˈ 㝮㜿䟽䟿໎࠶㓗䖳ᐞˈ㛾啐ቮἾᮠǃ僦Ἶᮠǃᦼ僘ᮠǃ䘌ㄟᤷ僘ᮠǃ䘌ㄟ䐆僘ᮠ䱽վˈ㜨僘㢲ᮠ䱽վǃ僘ᮠ䱽վǃᵚ僘ॆᮠॷ儈ǄҾྺၐ GD 6ǃGD 11ǃGD 16 ᰦⳞл⌘ሴษ㧛⋉㛭 0.01ǃ0.05ǃ0.25mg/kgˈGD28Ựˈ≥0.01mg/kgփ䟽໎䮯㕃ធˈ ᵚ㿱ሩ㜊㛾-㛾Ԅਁ㛢Ⲵ᰾ᱮᖡ૽ˈNOAELࡲ䟿Ѫ0.25mg/kg䟿6mg/⅑Ⲵ 0.8˄สҾփ㺘䶒〟ᣈ㇇˅ˈ ᳤䵢䟿㓖ѪӪփ 0.08mg/kg䟿᳤䵢䟿Ⲵ 3.6˄สҾ AUC ᧘㇇˅Ǆྺၐབྷ啐㠚ྺၐ 15 ཙ㠣 F1⭏ਾ 21 ཙⳞл⌘ሴษ㧛⋉㛭 0.5ǃ3ǃ15mg/kgˈ⇿5 ཙ㔉㦟 1㔉㦟 5 ⅑Ǆ15mg/kg ਟ㠤 3 ਚ䳼啐˄3/28ၙਾㅜ 16-19 ཙѻ䰤↫ӑˈᵚ㿱ሩӢԓྺၐ/Ԇᖡ૽Ǆı0.5mg/kg ਟ㠤 F1䎆ᙗ䱽վˈᵚ㿱ሩ F1㜭˄Ӕ䝽˅Ⲵᖡ૽Ǆᵜ૱ሩӢԓྺၐ/ପңⲴ NOAEL䟿Ѫ 3mg/kg䟿 6mg/⅑Ⲵ 4.8ؽ˄สҾփ㺘䶒〟ᣈ㇇˅Ǆᵜ ૱ ሩF1 ԓ⭏䮯ਁ㛢Ⲵ NOAEL䟿Ѫ 0.5mg/kgਾփ䟽䱽ᑵᓖİ17.22%ˈ⿫ңਾᑵᓖİ12.18%䟿 6mg/⅑Ⲵ 0.8˄สҾփ㺘䶒〟ᣈ㇇˅Ǆ㠤ⱼᙗTg.rasH2 ሿ啐⇿ 3 ઘ 1 ⅑䘎㔝 6䟿䗮 10mg/kg ᵚ㿱㠤ⱼᙗˈ᳤䵢䟿㓖ѪӪփ 0.08mg/kg䟿᳤䵢䟿Ⲵ 50˄สҾ AUC ᧘㇇˅ǄSD བྷ啐⇿ 3 ઘ 1 ⅑䘎㔝 2䟿䗮1mg/kgˈ㔃᷌ᱮ⽪˖඲փ㢟ᙗ䜘㞪ⱔਁ⭏⦷Ѫ 34%~80%Ǆ䳴ᙗབྷ啐㛮к㞪㢟ᙗఌ㔌㓶㜎ⱔਁ⭏⦷ 7%~11%ǃ བྷ啐⭢⣦㞪㢟ᙗ└⌑㓶㜎㞪ⱔⲴਁ⭏⦷3%~20%ˈ བྷ啐Ⳟ㛔㢟ᙗ㓔㔤ⱔਁ⭏⦷Ѫ 2.86%~14.29%儈Ҿ䈕ᇎ傼ᇔশਢሩ➗ᮠᦞ 4.94%ǃ8.64%ǃ6.67%-10.12%䟿㓴ㅜ 51 ઘ㹰⍶᳤䵢䟿㓖ѪӪփ 0.08mg/kg䟿᳤䵢䟿Ⲵ 4-5˄สҾ AUC ᧘㇇˅ǄǏ䍞䍞㯿ǐ㯿˄2̚8ᆈǄǏवव㻵ǐ亴♼ሱ⌘ሴಘ㓴ਸԦ˄ᑖ⌘ሴ䪸˅व㻵ˈ1 ᭟/ⴂǄǏᴹᴹ᭸ᵏǐ24 њᴸǏᢗ߶ǐYBH09582023Ǐᢩ᮷ਧǐ

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