康诺亚-B2024中期报告

Keymed Biosciences Inc.康諾亞生物醫藥科技有限公司 ( 於開曼群島註冊成立的有限公司 )股份代號 : 2162 2682234353637394143 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 T(nTCE)11 AD=ADC=AR=CRS=CRSwNP=COPD=GEJ=ITP=mAb=MM=Ph=RRMM=SAR= •(CM310)IL-4Rα (CM310)A4α(IL-4Rα)IL-4RαIL-4Rα(CM310)4 (IL-4)13 (IL-13)IL-4IL-13IICM310II 20246III2024(European Academy of Allergy and Clinical Immunology, EAACI)IIIPKPD500AD1:1300 mg600 mg16300 mg600 mg36AD1675% (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%)5216AD 2024(CRSwNP)III52620246 2024(SAR)IIIIIISARIII1081:1600 mg+300 mg2282(rTNSS)III20244 20242III20245III (CM310)II/III •CMG901/AZD0901Claudin 18.2 CMG901Claudin 18.2Claudin 18.2E (MMAE)Claudin 18.2Claudin 18.2CMG901FDAClaudin 18.2 AstraZeneca ABCMG901(AZD0901) C l a u d i n1 8 . 2CMG901(AZD0901)III2024320244 20246CMG901(AZD0901)I2024(ASCO)202311ASCO10.1 20242242.2 mg/kg2.6 mg/kg3.0 mg/kg113445019274%PD-1/PD-L189Claudin 18.2≥20%Claudin 18.2≥2+(ORR)35%(DCR)70%2.2 mg/kgORR48%93Claudin 18.2(mPFS)4.8(mOS)11.8113≥355%32%8%CMG901 •CM313CD38 CM313CD38(ADCC)(CDC)(ADCP)FcCM313 2024CM313ICM313I/II CM313CM3132024CM313Ib/IIa 20246A Novel Anti-CD38 Monoclonal Antibody for Treating Immune ThrombocytopeniaCM3132212181695.5%(21/22CM3138≥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)CM313CM31395.5% 20246CM313 •CM326TSLP CM326(TSLP)TSLPTSLPTSLP 20243CM326(CRSwNP)Ib/IIaCM326CRSwNP20245CM326II CM326II •CM355/ICP-B02CD20 x CD3 CM355B(NHL)CD20xCD3T(TDCC) 20248(IV)(SC)IVSCCM355(FL)B(DLBCL)15CM355≥6ORR100%11SCORR100%(11/11)(CRR)63.6%(7/11)2DLBCL(CR)CM355NHLCM355IND20246CDE CM355BNHLI/IICM355SCIVBCRCD19CD20BBBCM355 •CM336BCMA x CD3 CM336BCMAxCD3BCMATCD3TT(TDCC)2024CM336I/III/II CM336 •CM350GPC3 x CD3 CM350GPC3xCD3(HCC)CM350GPC3TT 2024I/IICM350I/II •CM369/ICP-B05CCR8 CM369C-C8(CCR8)T(Treg)CM369TregCCR8(ADCC)Treg(TME)CM369Treg ICM369NHL150150NHLCM369(DLT)3(TRAEs)T202481NHL63(50%)(PR)CM369 •CM383Aβ CM383(Alzheimer’s Disease)β(Aβ)AβCM383AβCM383AβCM383Aβ CM383CM383I20246 •CM380GPRC5D×CD3 CM380GPRC5DxCD3GPRC5DTCD3TT(TDCC) CM380CM380I/II 18A.08(3)CM310CMG901CM313CM326 CM355 CM336 CM350 CM369 CM383 CM380 CRO(PI) 18,600FDAcGMP NDA/BLA •T(nTCE) nTCETTT nTCETCM355CM336CM350CM380T • (Fc) • CRO • (CMC) •(ADC) ADC(payload)(linker)CMG901AZD0901MMAEADCADC cGMP 1. AZCMG901 2. 23416 3. (i)CRO(ii)(iii)(iv)2024630202363025081331 4. (i)(ii)(iii)2024630202363082890 5. 6. 7. AZ 9. 2024630202312312,7191422,577 20246302,7887101,73013721120246305603016534421 20246303662023630402023AZCMG901 2024630402023630444 202463026420236304 20246301372024630 10. 2024630692311388 2024630932 202463031%2023123123%8 11. 20246302024630 12. 2024630 13. 2024630223 14. 202463044180185 15. 20246301,1168 2021452021202212120222022121202212820212022821,9810 C1 C.2.1ChenChenChen F .2.2ChenChangyu WANGF.2.22024625 2024630 2024630 241034 13.2013.2113.22 20245QuantumPharm Inc.2228 13.51B(1) 2024630 53.367,004,0002,841202178 2024630 20247BelenosBiosciences, Inc.BelenosBelenosCM512CM53615Belenos30.01%170CM512CM536Belenos202479 2024630XVXV78352 (1)L (2)Bo CHENMoonshot Holdings LimitedMoonshot65.36%Changyu WANGMoonshot13.31%13.31%8.02% 2024630XVXV78352 2024630XV23336 (1)L(2)Bo CHENMoonshot65.36%Changyu WANGMoonshot13.31%13.31%8.02%(3)Boyu Capital Group Holdings Ltd.XYXY Holdings Ltd.Xiaomeng TONGSpringAquila Limited13,623,979Boyu Capital Opportunities Master Fund1,456,500 2024630336 2021 20214520212021 (a)2021 20212021 (b) 2021 (c) 2021 (d) 2021203177202120212021 20212021 (e) 20212021 2021 20212021203177 20212021365 (f) (g) (a)(b)2021(c)(d)20212021121% (a)(60) (b)(30) 14A.73(6) (h) 17,976,15320246306.43%202411202463020219,873,1439,865,4103.53%3.53%Keymed Talent Success TrustEagle Hero Management Limited20212021 2021 (1) (2)25%75%32.89 (3) (4) 202312312023 2022 202212120222022 (a)2022 20222022 (b) 2022 (c) 2022202220221.00 (d) 2022(i) 2032120(ii)202220222022 (e) 20222022 (1)(2) (f) (a)(60) (b)(30) 20222022(i)2022(ii)(iii)2022 (g) 5,594,71120246302.0%2024630279,735,5661%202463020225,594,7112.0%20246302,349,5002022 10% 20246302022 35642024630343434 24102410 34 2024827 2024630 20242023 (336,603)48,145 1,738 (334,865)48,146 (334,807)46,968(58)1,178 2024630 2024630 2024630 1. 2018423Floor 4, Willow House, Cricket Square, Grand Cayman KY1-9010,Cayman Islands 2024630 2.1 3420231231 2.2 20231231 16120201202277 3. (a) (b) 20246308 54,261,0002023630326,450,0004 4. (a) (b) CMG901 20232KYM Biosciences Inc.70%30%K Y MA s t r a Z e n e c aA BA ZA ZC l a u d