康诺亚-B2023年度报告

( 於開曼群島註冊成立的有限公司 )股份代號 : 2162 26810121632395184101106107108110111113176 0.0001 2021202145 20222022121 % Bo CHENChangyu WANG Bo CHENChangyu WANG 97927 Floor 4, Willow House, Cricket SquareGrand Cayman KYI-9010Cayman Islands 18D2610219 Changyu WANG 21701 Bo CHEN Campbells Corporate Services LimitedFloor 4, Willow House, Cricket SquareGrand Cayman KY1-9010Cayman Islands 1831717121716 www.keymedbio.com 2162 202178 2023 2023(CM310)NDACDEIL-4RαCM31016 012024 CMG901AZD090120232AstraZeneca ABAstraZeneca ABCMG901CM313CM355CM336CM313(SLE)(ITP)202312CM313ITPIIT2023(ASH)78(ORR)100%1CM313SLEIIb/IIa 2024IND20242CM383AβCM383AβIPADC 18,600LADC2023900CMC Bo CHEN •20231231354AstraZeneca ABAZ •20231231 •202212315078920231231596 (1) • (CM310)IL-4Rα 2023(CM310)III2023CM310202312CM310 20242CM310III (CM310)(CRSwNP)III202312IIICM310P<0.0001 2023CM310IIICM310II CM310II/III CMG901/AZD0901Claudin 18.2 20232KYM Biosciences Inc.KYM70%AstraZenecaABAZ)AZCMG901 202311(ASCO Plenary Series)CMG901(G/GEJ)I89Claudin 18.2G/GEJ(ORR)33%(DCR)70%2.2mg/kgORR42%(mPFS)4.8(mOS) AZCMG901/AZD0901 CM313CD38 2023CM313ICM313 20236CM313I28(EHA)CM313≥2.0 mg/kg 2023CM313Ib/IIaI 202312CM31365(ASH)2023630217887100.0%(7/7)8≥50×109/L11-3 CM326TSLP 2023CM326II20236II 2023CM326Ib/IIa20232Ib/IIa CM326II CM355/ICP-B02CD20xCD3 2023I/IICM355(r/rNHL)PKIVSC613ORR100%SC9ORR100.0%9/9CRR77.8%7/92BDLBCLCR CM336BCMAxCD3 2023I/IICM336I CM350GPC3xCD3 2023I/IICM350I CM338MASP-2 2023CM338A(IgAN)II CM369/ICP-B05CCR8 2023ICM369(r/r NHL)ICM369 CM383Aβ 20242CM383I • 20231231897270400 18,600FDAcGMP T(nTCE)20231231920242CM383 AD=ADC=AR=CRS=CRSwNP=COPD=GEJ=ITP=mAb=MM=Ph=RRMM= •(CM310)IL-4Rα (CM310)A4α(IL-4Rα)IL-4RαIL-4Rα(CM310)4 (IL-4)13 (IL-13)IL-4IL-13IICM310II 2023CM310III2023 202312 • • • •1 • •CXSS2300090 • 202310CM310IIIIIICM310PKPD5001:1CM310600mg-300mg21675%(EASI-75)(IGA)01≥2CM310EASI24.8424.05CM310IGA352.2%52.6%CM310IGA447.8%47.4% 16CM31016EASI-7566.9%IGA01IGA 0/1≥244.2%25.8%16.1%(P<0.0001)16CM31016(PP-NRS)≥435.9%(DLQI)8.711.7%4.4(P<0.0001)CM310(TEAE)TEAE 20242CM310III 2023CM310III202312IIICM3101801:1CM310 300mg21224(NPS)(NCS)IIICM310P<0.0001 2024 20237CROWNS-1eClinicalMedicineIF15.1CROWNS-1CM310(eCRSwNP)IICM31016CTLund-Mackay CTCM310eCRSwNP≥55≥27%CRSwNPRCTCM310eCRSwNPII 2023CM310IIICM310II (CM310)II/III •CMG901/AZD0901Claudin 18.2 CMG901Claudin 18.2Claudin 18.2E (MMAE)Claudin 18.2Claudin 18.2CMG901FDAClaudin 18.2 2023CMG901I202311(ASCO Plenary Series)CMG901ICMG90120237242.2mg/kg2.6mg/kg3.0mg/kg113445019274%PD-1/PD-L1≥354%31%8%89Claudin 18.2(ORR)33%(DCR)70%2.2mg/kgORR42%(mPFS)4.8(mOS)CMG901CMG901Claudin18.2 20232KYM70%AZAZCMG901KYM631,125632023331KYMAZKYMAZCMG901 AZCMG901/AZD0901 •CM313CD38 CM313CD38CM313CD38CM313 2023CM313ICM31320236CM313I28(EHA)I(NCT04818372)CM313CM31316.0 mg/kg≥20%1229(ORR)34.5%(mPFS)4.3(OS)CM313CM313≥2.0 mg/kg CM313CM3132023CM313Ib/IIaI 202312CM31365(ASH)CM3132023630217887254018-5662kg52-93kgITP3012-2008 × 109/L2-247100.0%(7/7)8≥50 × 109/L11-34/7(57.1%)≥50 × 109/L16261132371750 × 109/L50 × 109/L216(6/2128.6%)(IRR)IRR12(CTCAE)5.0 •CM326TSLP CM326(TSLP)TSLPTSLPTSLPCM326(CM310) 2023CM326II20236II2023CM326Ib/IIa20232Ib/IIa CM326II •CM355/ICP-B02CD20xCD3 CM355BCD20xCD3T(TDCC) I VS CI VS CC M355( F L )B(DLBCL)613ORR100%SC9ORR100.0%(9/9)(CRR)77.8%(7/9)2CRDLBCLCM355NHLCM35520243CDENHLI/IICM355SCIVB BCM355 •CM336BCMAxCD3 CM336BCMAxCD3BCMACM336BCMABCMATCD3T CM3362023I/IICM336I •CM350GPC3xCD3 CM350GPC3xCD3(HCC)CM350GPC3GPC3TCD3TGPC3CD3TT CM3502023I/IICM350I •CM338MASP-2 CM3382(MASP-2)CM338IgA 2023CM338A(IgAN)II •CM369/ICP-B05CCR8 CM369C-C8(CCR8)T(Treg)CM369TregCCR8(ADCC)Treg(TME)CM369Treg ICM369NHL150150NHLCM3693TNHL1NHLPRCM369 •CM383Aβ CM383(Alzheimer’s Disease)β(Aβ)AβCM383AβCM383AβCM383Aβ CM383CM383CM383I 18A.08(3)CM310CMG901CM313CM326 CM355 CM336 CM350 CM338 CM369CM383 CRO(PI) 18,600FDAcGMP NDA/BLA •T(nTCE) nTCETTT nTCETCM355CM336CM350T • (Fc) • CRO • (CMC) •(ADC) ADC(payload)(linker) CMG901AZD0901MMAEADCADC cGMP 1. AZ 2. 1284432 3. (i)CRO(ii)(iii)(iv)(i)67(ii)26(iii)1431 4. (i)(ii)(iii)287 5. 9 6. 50%5 8. 20231231202212313,1754562,719AZ 202312312,9398511,694174220202312313142922046192023123117 202312312022123140298304AZ 2023123146820221231646 2023123172202212318 9. 2023123123%2022123115%8 10. 202312313781317 20231231941 20231231146 11. 2 0 2 31253,543,6001 20236150,598,90418.6992% 2023123120231231 12. 20231231 13. 20231231228 14. 20231231441237 15. 202312318979 20214520212022121202220221212022128202120221,419,7680 Bo CHEN502018423202143Chen201612201812Chen ChenChen201162013120153Chen187768818020161220183Chen Chen19967Chen20039• Changyu Wang59202133202143Wang Wang251998420013Chiron Corporation2001420098Medarex, Inc.Bristol Myers SquibbBMY20099201312Bristol-Myers Squibb2014120162Pfizer Inc.PFEWangPD-1Nivolumab2014 Wang198371988919948(University of Colorado Medical Center) 502018621202143 18