康诺亚-B2024年度报告

（於開曼群島註冊成立的有限公司）（股份代號：2162） 26810111735415388105110111112114115117182 0.0001 2021202145 20222022121 % Bo CHENChangyu WANG Bo CHENChangyu WANG 97927 Floor 4, Willow House, Cricket SquareGrand Cayman KYI-9010Cayman Islands 18D2610219 Changyu WANG 24840 Bo CHEN20253242025324 Campbells Corporate Services LimitedFloor 4, Willow House, Cricket SquareGrand Cayman KY1-9010Cayman Islands 1831717121716 www.keymedbio.com 2162 202178 2024 820249EASI-9012(2024)20252IL-4RαIIINature Medicine 20244,30020253001,100220 2024NewCo20247OrbiMedBelenosCM512CM536CM51211OuroMedicinesCM3361.2TPG2025AbingworthVenrockTimberlyneCM313A1.8RTWProliumCM355NewCo 2024102BADC Bo CHEN 3 4 , 3 4 6 , 0 0 02 0 2 340,079,000 • (CM310)IL-4Rα 4336 20246(AD)III2024(European Academy of Allergy and Clinical Immunology, EAACI)202410III52Allergy52EASI-7592.5%88.7%EASI-9077.1%65.6%IGA01≥267.3%64.2%PP-NRS≥467.3%60.5%AD1(0.9%)III20249 2024(CRSwNP) III52III24(NPS)2.3(NCS)0.7P0.000120246202412 2024(SAR)III+2LSMean-1.395%CI-1.3(P=0.0008)(MCID) 0.232024420252 20242III20245III CMG901/AZD0901Claudin 18.2 AstraZeneca AB (AZ)20232CMG901 (AZD0901)AZCMG901 (AZD0901) 20246CMG901 (AZD0901)(G/GEJ)I2024(ASCO)202516IThe Lancet Oncology93Claudin 18.2(mPFS)4.8(mOS)11.8 CM313CD38 2024CM313(SC)I/II CM313CM31320247CM313Ib/IIa2025II 2 0 2 4C M 3 1 3 ( S C )I I2 0 2 41 120246A Novel Anti-CD38 Monoclonal Antibody for Treating ImmuneThrombocytopenia95.5%CM3138≥50 × 109/L866≥50 × 109/L63.6% 2025CM313(SC)IgAII 20251Timberlyne Therapeutics, Inc.TimberlyneCM31330Timberlyne337.5Timberlyne CM512TSLP x IL-13 CM512I20249 20247Belenos Biosciences, Inc.BelenosCM512CM53615Belenos30.01%170BelenosCM512I CM336BCMA x CD3 2024CM336I/III/II 202411Platina Medicines Ltd (PML)PMLCM3361,600Ouro Medicines, LLC (Ouro Medicines)Ouro MedicinesPMLPML6.1PMLCM336 20241266(ASH)CM336I/II20241030682543CM336160mg(CRS)CRS17% (5/68)2CRS12.152% (12/23)(sCR)(CR)3.13/20/80 mg3/20/80/160 mg(ORR)67% (16/24)76% (19/25)19(MRD)MRD95%(18/19)MRD2.1 CM383Aβ CM383IaCM383Ib202411 • CM518D1 (CDH17ADC) CM518D1I/II CM326TSLP 20243CM326(CRSwNP)Ib/IIaCM326CRSwNP 20245CM326II CM326COPD202411CM310CM326 II CM355/ICP-B02CD20 x CD3 I/IICM355(NHL)(IV)(SC)IVSCCM355(FL)B(DLBCL) 20251Prolium Biosciences, Inc.CM355ProliumCM355 CM350GPC3 x CD3 2024I/IICM350I/II CM369/ICP-B05CCR8 ICM369NHLCM369450NHL600CM369(DLT)3(TRAEs)T CM380GPRC5D × CD3 CM380CM380I/II • 202412311,258240400 20,500FDAcGMP 112 AD=ADC=AR=CRS=CRSwNP=COPD=GEJ=ITP=mAb=MM=Ph=RRMM=SAR=IgAN=IgA •(CM310)IL-4Rα (CM310)A4α(IL-4Rα)IL-4RαIL-4Rα(CM310)4 (IL-4)13 (IL-13)IL-4IL-13II 4336II 20246III2024(European Academy of Allergy and Clinical Immunology, EAACI)IIIPD500AD1:1300 mg600 mg16300 mg600 mg36AD 1675% (EASI-75)(IGA)01≥2EASIIGA(PP-NRS)47623852EASI-7592.5%88.7%EASI-9077.1%65.6%IGA01≥267.3%64.2%PP-NRS≥467.3%60.5%AD1(0.9%)5216III20249202410III52Allergy 2024(CRSwNP) III52III24(NPS)2.3(NCS)0.7P0.000120246202412 2024(SAR)IIIIIISARIII1081:1600 mg+ 300 mg2282(rTNSS)+2LSMean-1.395%CI-1.3(P=0.0008)(MCID)0.232024420252 20242III20245III 20213CM310(COPD)202411CM326CM310 •CMG901/AZD0901Claudin 18.2 CMG901 (AZD0901)Claudin 18.2Claudin 18.2E (MMAE)Claudin18.2CMG901 (AZD0901)FDAClaudin 18.2 AstraZeneca ABAZ20232CMG901 (AZD0901)AZCMG901 (AZD0901) 20246CMG901 (AZD0901)I2024(ASCO)202516IThe Lancet Oncology20242242.2 mg/kg2.6 mg/kg3.0 mg/kg CMG901 (AZD0901)1134450 19274%PD-1/PD-L189Claudin 18.2≥20%Claudin 18.2≥2+(ORR)35%2.2 mg/kgORR48%93Claudin 18.2(mPFS)4.8(mOS)11.8≥355%32%8%CMG901 •CM313CD38 CM313CD38(ADCC)(CDC)(ADCP)FcCM3132024CM313I/II CM313CM31320247CM313Ib/IIa2025II 20246A Novel Anti-CD38 Monoclonal Antibody for Treating Immune ThrombocytopeniaCM3132212181695.5%(21/22)CM3138≥50 × 109/L≥50 ×109/L2317-24≥50 × 109/L11-3≥30 × 109/L≥21866≥50 × 109/L63.6% (14/22)212068.2%(15/22)84.8% (1/21)CM313 2024CM313(SC)II2024112025CM313(SC)IgAII 20251Timberlyne Therapeutics, Inc.TimberlyneTimberlyneCM313TimberlyneCM31330Timberlyne337.5Timberlyne20246Timberlyne180Timberlyne25.79%TimberlyneBain CapitalVenrock HealthcareCapital •CM512TSLP x IL-13 CM512(TSLP)-13 (IL-13)TSLPIL-13CM512TSLPIL-13TSLP(TSLPR)IL-13/IL-13Rα1IL-4RαTSLPIL-13CM512CM512 CM512I20249 20247Belenos Biosciences, Inc.BelenosBelenosCM512CM53615Belenos30.01%170CM512CM536BelenosBelenosCM512CM536BelenosBelenosCM512CM536BelenosCM512I •CM336BCMA x CD3 CM336BCMA x CD3BCMATCD3TT(TDCC)2024CM336I/III/II 202411Platina Medicines LtdPMLPMLCM3361,600Ouro Medicines, LLCOuro MedicinesOuro MedicinesPMLPML6.1PMLCM336PMLCM336PMLPMLCM336 20241266(ASH)CM336I/II20241030682543CD384CM336160 mg(CRS)CRS17% (5/68)2CRS12.152% (12/23)(sCR)(CR)3.13/20/80 mg3/20/80/160 mg(ORR)67% (16/24)76% (19/25)19(MRD)MRD95%(18/19)MRD2.1CM336 CM336 •CM383Aβ CM383(Alzheimer’s Disease)β(Aβ)AβCM383AβCM383AβCM383Aβ CM383CM383Ia2024CM383Ib202411 •CM518D1 (CDH17ADC) CM518D1(ADC)ADC17 (CDH17)CDH17CM518D1CDH17 CM518D1I/II •CM326TSLP CM326(TSLP)TSLPCM326TSLP 20243CM326(CRSwNP)Ib/IIaCM326CRSwNP20245CM3