凯莱英2023中期报告

Asymchem Laboratories (Tianjin) Co., Ltd.凱 萊 英 醫 藥 集 團（ 天 津 ）股 份 有 限 公 司 ( 於中華人民共和國註冊成立的股份有限公司 ) www.asymchem.com股份代號 : 6821 中期報告2023 w w w . a s y m c h e m . c o m 2 4 5 6 44 58 59 60 61 63 65 67 89 H 183171712-1716 Hao Hong Ye Song 6 Hao Hong 16 24840 H6821A002821 1218 97927 920 39116 Cooley HK835 www.asymchem.com 19B12 CDMO CDMO CDMO(mAb)(ADC)RNA (mRNA)CDMOCROCDMOCDMO CDMOCDMOCDMOCDMO9.1 45.9626.6232.71%CDMO40.6421.3032.41%5.2834.33%23.595.49% 33.2913.9644.17%47.94%7.629.69% 30.9611.6373.41%14.9912.28%21.21%1,100 CDMO CDMOD 1 3432.0912.7660.50%CDMO 2 276III528.556.78%IIIGLP-1KRASJAKTYK2 CDMOCDMO5.2834.33% 1 CDMO29.04%4045II24CDMO76%17CpGGMP19GMP 1500kg10,000L 2 26.07%151CGT24IPSCMSC CAR-NK MAK INDCMCFDA INDHIVIIIII375II127INDIICRO 3 CDMO34.07%12021NDA43 PAIGMP 4CDMO CDMO159.77%43IND14BLACDMOINDADCBLACDMOCBTICGTCDMOCGT CDMOCDMOCGCSCGT CDMO 5 CFCTCSBT40% 1 6 BSL-250L GMP LabIND7050 CDMO3.2322.84% CEPSCenter of Excellence for Process ScienceCEPS30020CEPSCEDCFCT50130 CFCTCenter of FlowContinuous Technology263D CSBTCenter of Synthetic Biology Technology CIMTCentre for Intelligent Manufacture Technology+PATBatchCIMT+PATpHCIMTCIMT IAPMInstitute for Advanced Pharmaceutical MaterialsIAPMIAPMCDMOIAPM CDDFCenter of Drug Delivery and FormulationCDDFLNP3D CBTICenter of Biological Technology and InnovationCBTI TICCRTechnology Innovation Center for Clinical ResearchTICCR CDMO7332319,14575% 1 30060011,529 2 FDANMPA TGAMFDSPMDA40100% 3 4 5 4,595.712,662.0332.71%1,636.436.44%CDMO4,063.862,130.1832.41%527.5934.33%761.659.69%13.79%16.57%323.4722.84%7.04% 343,209.3112%1,275.6360.50%CDMO 276III5285512%6.78%IIIGLP-1KRAS JAK TYK2 CDMOCDMO527.634.33%43741.9% 69010%757 3,83412%44.90%3,3291,39644.17%36047.94%14444.6% 2,16919% 9%19%684% (1)33.51% (2)56.67%7.7 347289 8260% 350.8350.0 323.523%60.2 16.152.736.769%51436.7 1,7403%1,6821,6861,7403.09%36.7%34.6%2% 4.754.654.744.65 1,75233%2,253868 1797% 5301,017 392472.5 12.5%13.9% 1 2,264.11,997.5 2 39.55 CRO (1) (2) 2,253.181,621.40 695.892,539.15 470.29282.752022A 16,791.9714,586.17 0013.772.55 2023630 CDMOCDMOCDMOCDMOCDMO 17,18821,1485.2%4.2%9,67069.0%31.0%12,22715,455CDMOCDMOCDMOCDMO CDMOAPICDMO830CDMO260API CMOCDMOCDMOCDMOCDMOCDMOCDMOCDMOCDMO (ICH)FDAFDAFDACDMOCDMOCDMOEvaluate Pharma1,6661,590 CDMOCDMOCDMOCDMO CDMO CDMO CDMO 1 API 2 3 CDMO 4 CROCDMO CBTICDMOdrug-linkerADC 5 6 CDMO 1 2 3 MAHGQCEVBPGMP 4 5 6 7 8 5,979.09(1)2,120.29 (1)5,591.36387.73 (2) AAA AA82.26A6,720AA131.94A60,900AAH A A A261,464A 13.51B(1) A A10% AAAAAA AA17 A A A AAA AAA 5% AA A1%A10% A AAA60A48 AA60A AA122436A12243648 A AA A A A AA A AA4143,327,450AAAA (1)5% XV(a)XV78(b)352(c) (1)(L)(S)(2)Hao HongALAB71.37%Hao HongALAB(3)Ye SongHao HongYe SongHao Hong(4)43.46%6,555,504A(5)369,655,38127,553,260H342,102,121A (1)(L)(S) (2)29.08%Hao Hong90.7%32,478,6003,418,80010.53%Hao Hong (3)83.00% (4)AsymCore4%2%AsymCore99%44.38%60%40%AsymCore (1)29.08% (2)50,000,000(i)21,881,082(ii)12,198,135(iii)8,000,000(iv)7,920,783411 (3)7,920,783Hao Hong90.74%32,478,6003,418,80010.53%Hao Hong (4)12,198,13544.38%60%40% (5)8,000,00056.18%43.70% XVXV78352 XV23336 (1)(L)(S)(P) (2)JPMorgan Asset Management (Asia Pacific) Limited JPMorgan Chase & Co.99.99%JPMorgan Chase & Co.JPMorgan Asset Management (Asia Pacific) Limited (3)369,655,38127,553,260H342,102,121A XV23336 A 9,145 AAA 5% C.2.1 C.2.1Hao Hong(i)(ii) HaoHong(iii)Hao HongHao HongHaoHong 3.213.10(2)3.213.10(1)3.10(2)3.10A3.213.25 2410 Hao Hong Ernst & Young27/F, One Taikoo Place979 King’s RoadQuarry Bay, Hong Kong 5888343434 2410 34 1. 34 2. 1281212 (a)12 2. (b)8 (c)121212 (d)12 3. (b) 3. 2,225,728,303 3,212,304,000 4. CDMO CDMOFTEFFSFTEFFS CDMO (RSM)(API)CDMO 4. (i)(ii)CDMO(iii)(iv)(mAb)(ADC)CDMO(v)CRO(vi)mRNAFFSCROCROCROFFS 4. 4. 5. 6. 25%15% Asymchem Inc.21%Asymchem Limited19% 7. AHAH1.80664,411,282.20A614,815,414.20H49,595,868.00 8. 361,231,000365,859,000 8. 9. 10. 90 11. 1590 . 12. 13. 14. (a) 15. (a) 15. (b) (c) 15. 16. 16. 17. 17. 17. 18. GLP-1-1 GMP IND iPSC H MFDS NMPA PAI pH