科伦博泰生物-B2024年年度报告

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (A joint stock company incorporated in the People's Republic of China with limited liability)Stock Code6990 24641528588108173178179180182184185241242 108 666 24840 • H 183171712-1716 STOCK CODE H06990 https://kelun-biotech.com 20243sac-TMTSKB264/MK-2870)佳泰 萊®A167科泰 萊®N01A140達 泰 萊®5NMPA佳泰 萊®ADCTROP2 ADC科泰 萊®PD-L123NDA7ADC20 ADC(mAbbsAb)ADCRDC 202412sac-TMT3sac-TMTADCADCNewCoTSLPSKB378/WIN9378Windward Bio 202420243512H 2025 2024 ADC o11ADCsac-TMT萊®NDAHER2+ BC萊®3oSac-TMTSac-TMT21TNBCSac-TMTEGFR-TKIEGFRNSCLCLCTROP2 ADC osac-TMTTROP2 ADCSKB264/MK-2870)萊® TNBC202411sac-TMT21TNBCSac-TMTADC 20245ASCOsac-TMTTNBC3Sac– TMTPFSOSSac-TMTBICRPFS6.7(95% CI: 5.5,8.0)2.5(95% CI: 1.7, 2.7)HR0.32 (95% CI: 0.24, 0.44, p<0.00001)68%Sac-TMTOS(95% CI: 11.2, NE9.4(95% CI: 8.5, 11.7)HR0.53(95% CI: 0.36, 0.78, p=0.0005)47%Sac-TMTORR45.4%ORR12%TROP2H-score> 200)sac-TMTPFS(8.3ORR(52.1% 20243sac-TMTPD-L1TNBCsac-TMTTNBC3 oHR+HER2– BC2L+HR+HER2– BC3 20236sac-TMT2LHR+HER2-BC oEGFRNSCLC20253sac-TMTEGFR-TKIEGFRNSCLCSac-TMTORRPFSOS 202410sac-TMTEGFR-TKIEGFRNSCLCNDA20231sac-TMTEGFR-TKIEGFRNSCLC sac-TMTEGFRNSCLC3 oEGFRNSCLC(i) sac-TMT®4PD-L1NSCLC(ii) sac-TMTPD-L1NSCLCsac-TMT3 osac-TMTGCEC CC OC UC CRPCHNSCC o20225sac-TMT12sac-TMTBCLCGI3sac-TMT2 sac-TMT 2024ASCO •Sac-TMTTNBC3(OptiTROP-Breast01)•Sac-TMTA167PD-L1NSCLC2(OptiTROP-Lung01) 2024ESMO •Sac-TMTCC•Sac-TMTECOC2•sac-TMTTNBC3(OptiTROP-Breast01)PD-(L)1 2024AACR •Sac-TMTNSCLC2 •Sac-TMTGEJ2 •Sac-TMTUC1/2KL264-01/MK-2870-001(NCT04152499) oHER2 ADCA166萊®5 20251NDAHER2HER2+BCT-DM1BICRPFS 3L+HER2+ BC2NDAADCHER2+BC2 o SKB315 (CLDN18.2 ADC)SKB315CLDN18.2SKB315CLDN18.2SKB3151b SKB410/MK-3120 (Nectin-4 ADC)SKB410Nectin-4 ADCSKB4101SKB4101/2 SKB571/MK-2750SKB571bsADCLCCRC1 SKB518SKB535/MK-6204SKB445SKB518 SKB535SKB445FICADC1SKB535SKB53521 SKB500SKB501SKB500SKB501ADC20241112SKB501SKB500IND SKB107SKB107RDC20251SKB107IND • oN01 萊®(1)NPC(2)NPCN01萊®N01FOLFOXFOLFIRIRAS oPD-L1A167萊®202412NPC20251NPCPD-L1 1LNPC 3PFSORRDoRPD-L1PFSPFS7.9HR=0.4795%CI0.33-0.66 p<0.0001)53%ORR81.7%74.5%DoR11.75.8HR=0.4895% CI 0.32-0.70)1HR=0.6295% CI 0.32-1.22)38% 3L+NPC NPC221.7132FASIRCORR26.5%DoR12.4OS16.233.9%3The Lancet Regional Health-Western Pacific oN01EGFR mAbA140萊®20252N01FOLFOXFOLFIRIRAS3N01愛®N01ORRN01愛®71.0%77.5%ORR0.93 [95% CI: 0.87, 0.99]N01DoRPFS愛®PFS10.910.8HR1.03 [95% CI: 0.83, 1.28]DoR10.29.5N01愛® oA400/EP0031RET1L2L+RET+ NSCLCRET+ MTC1b/2Ellipses Pharma2 oSKB378/WIN378TSLP1SKB378COPDIND20251Windward Bio2 oSKB336FXI/FXI1 •sac-TMT萊®萊®N01萊®2025萊®6A400NDA BCNSCLCGI oADC Sac-TMTsac-TMTsac-TMT12sac-TMT3 •BCoSac-TMTTPCpCRTNBCoSac-TMTTPCTNBCPD-L1CPS<10oSac-TMTTPCHR+HER2– BCET•LCoSac-TMTpCRNSCLCoSac-TMTPD-L150%NSCLC oSac-TMTEGFR-TKIEGFRNSCLCoSac-TMTNSCLC • oSac-TMTECoSac-TMTTPCCCoSac-TMT2LOCGISac-TMT3L+GEAoGISac-TMT3L+GEA sac-TMT2 ADCsac-TMTADCSKB410/MK-3120SKB571/MK-2750 SKB535/MK-6204ADCADCADCADCADCADCADC 2024SKB571/MK-275037.5SKB571/MK-2750SKB571/MK-2750 Ellipses Pharma20213Ellipses PharmaEllipses PharmaA400Ellipses PharmaEP0031 20243A400/EP0031FDARETNSCLC20244A400/EP0031FDA220241231A400/EP003133 Windward Bio20251Harbour BioMedWindwardBioHarbour BioMedWindward BioSKB378/WIN378 Harbour BioMed9.7SKB378/WIN378Windward BioHarbour BioMedWindwardBioWindward BioHarbour BioMedHarbour BioMed 2024147.5 •ESGESGESGESGESGESGESGESG20246ESG •H2024516150.003,648,600H541.4 •20241217136.214,423,870601.4 I. ADCsac-TMTSac-TMTTROP2 ADCHER2+NDAHER2ADC30sac-TMTN01 ADC(mAbbsAb)ADCADCADCOptiDCTMcGMP ADCADCEllipses PharmaWindward Bio BCNSCLC GIGCCRCsac-TMTN01 •ADC oSac-TMTSKB264/MK-2870)萊®TROP2 ADCoA166萊®1NDAHER2 ADCHER2+oSKB315CLDN18.2 ADCoSKB410/MK-3120Nectin-4 ADCoSKB571/MK-2750LCCRCbsADCoSKB518SKB535/MK-6204SKB445FICADCoSKB500SKB501ADCoSKB107RDC • oA167萊®PD-L1oN01A140萊®EGFREGFRoA400RETNSCLCMTCREToA296STING Sac-TMTTROP2 ADCSKB264/MK-2870)萊® Sac-TMTTROP2 ADCTROP2BCNSCLC GISac-TMTTROP2 ADCADCADC Sac-TMTIDAR7.4Sac-TMTTROP2TROP2KL610023KL610023IDNAKL610023KL610023ADC sac-TMTsac-TMT sac-TMTTROP2 ADCsac-TMT TNBC202411sac-TMT21TNBCSac-TMTADC 20245ASCOsac-TMTTNBC3Sac-TMTPFSOSSac-TMTBICRPFS6.7(95% CI: 5.5, 8.0)2.5(95% CI: 1.7,2.7)HR0.32 (95% CI: 0.24, 0.44, p<0.00001)68%Sac-TMTOS(95% CI: 11.2, NE9.4(95% CI: 8.5, 11.7)HR0.53(95% CI: 0.36, 0.78,p=0.0005)47%Sac-TMTORR45.4%ORR12%TROP2H-score > 200)sac-TMTPFS(8.3ORR(52.1% 20243sac-TMTPD-L1TNBCsac-TMTTNBC3 HR+HER2– BC2L+HR+HER2– BC3 20236sac-TMT2LHR+HER2– BC EGFRNSCLC20253sac-TMTEGFR-TKIEGFRNSCLCSac-TMTORRPFSOS 202410sac-TMTEGFR-TKIEGFRNSCLCNDA20231sac-TMTEGFR-TKIEGFRNSCLC20248sac-TMT OptiTROP-Lung03NDA sac-TMTEGFRNSCLC3 EGFRNSCLC(i) sac-TMT®2PD-L1NSCLC(ii) sac-TMTPD-L1NSCLCsac-TMT3 sac-TMTGCEC CC OC UC CRPCHNSCC 20225sac-TMT12sac-TMTBCLCGI3sac-TMT2 sac-TMT o2024ASCO oSac-TMTTNBC3(OptiTROP-Breast01)oSac-TMTA167PD-L1NSCLC2(OptiTROP-Lung01) o2024ESMO oSac-TMTCCoSac-TMTECOC2osac-TMTTNBC3(OptiTROP-Breast01)PD-(L)1 o2024AACR oSac-TMTNSCLC2oSac-TMTGEJ2