科伦博泰生物-B：截至2025年6月30日止六个月之中期业绩公告

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 6990 2025630 202563020246302410 12025202463075.875.4 2 2025 •ADC o10ADCsac-TMT佳 泰 萊®NDAHER2+ BC舒 泰 萊®3 oSac-TMT 20245ASCOsac-TMTTNBC3Sac-TMTPFSOS顯 著BICRsac-TMTPFS6.7(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, NE)9.4(95% CI: 8.5, 11.7)HR 0.53(95% CI:0.36, 0.78, p=0.0005)47%Sac-TMTORR45.4%ORR12%TROP2(H-score>200)sac-TMTPFS(8.3)ORR(52.1%) sac-TMTTNBC3 oHR+/HER2- BC20255sac-TMTHR+/HER2- BCNDAsac-TMTHR+/HER2- BC3 oEGFRNSCLC20253sac-TMTEGFR-TKIEGFRNSCLCsac-TMTORRPFSOSLCTROP2 ADC 20256ASCOsac-TMTEGFRNSCLCsac-TMTBIRCORR45.1%15.6%p=0.0004BIRCPFS6.92.8(HR)=0.30p<0.0001INVPFS7.92.8(HR=0.23)36.4%sac-TMTOSHR=0.49p=0.007)OSRPSFT9.3sac-TMT(HR=0.36) sac-TMTEGFRNSCLC3 oEGFRNSCLC(i)sac-TMT®4PD-L1NSCLC(ii)sac-TMTPD-L1NSCLCsac-TMT3 o20225sac-TMT14sac-TMT(BCLCGI)3sac-TMT2 osac-TMT (The British Medical Journal) •Sac-TMTEGFRNSCLC(OptiTROP-Lung03) -(Nature Medicine) 20251017212025ESMOsac-TMT oHER2 ADCA166舒 泰萊®5 20251NDAHER2HER2+BCT-DM1BICRPFS 3L+HER2+ BC2NDA ADCHER2+BC2 o SKB315 (CLDN18.2 ADC)SKB315CLDN18.2SKB3151bGC/GEJCSKB31512025102025ESMO SKB410/MK-3120Nectin-4 ADCSKB4101SKB410/MK-31201/2 SKB571/MK-2750SKB571ADCLCCRC2 SKB518SKB535/MK-6204SKB445SKB518SKB535SKB445FICADCSKB5182SKB535SKB4451SKB535 SKB500SKB501SKB500SKB501ADC20241112SKB501SKB500IND SKB107SKB107RDCSKB107IND202531 oN01 科 泰 萊®(1)NPC(2)NPC N01達 泰 萊®N01FOLFOXFOLFIRIRAS oPD-L1A167科 泰 萊®202412NPC20251NPCPD-L1 320255ASCOPFSORRDoRPD-L1PFSPFS7.9HR=0.4795%CI:0.33-0.66 p<0.000153%ORR81.7%74.5%DoR11.75.8HR=0.4895%CI:0.32-0.701HR=0.6295%CI:0.32-1.2238% oN01EGFR mAbA140達 泰 萊®20252N01FOLFOXFOLFIRIRAS3N01愛 必 妥®N01ORRN01愛 必 妥®71.0%77.5%ORR0.93 [95% CI: 0.87, 0.99]N01DoRPFS愛 必 妥®PFS:10.910.8HR:1.03 [95%CI: 0.83, 1.28]DoR:10.29.5N01愛必 妥® oA400/EP0031RET1L2L+RET+ NSCLCRET+ MTC1b/2Ellipses Pharma2 20255ASCOA400RETMTCIORR63.0%DCR 100%MKIORR56.3%(9/16)62.5%(5/8)DoR25.8PFS24PFS77.8% oSKB378/WIN378TSLP對120251SKB378COPDINDWindward Bio2POLARIS A296STING1 sac-TMT佳 泰 萊®科 泰 萊®N01達 泰 萊®2025舒 泰 萊®6為A400NDA 2025309.8佳 泰 萊®97.6% 303002,0001,000CSCO2025CSCO2025CBCS&CSOBO202520242025 350 202560+400+DTP20254,500 2025佳 泰 萊®29科 泰 萊®25達 泰 萊®15佳 泰 萊®科 泰 萊®達 泰 萊® 佳 泰 萊®720萊® oADC Sac-TMT:sac-TMTsac-TMT14sac-TMT3 oSac-TMTNSCLC oSac-TMTECoSac-TMTECoSac-TMTTPCCCoSac-TMT2LOC ➢GISac-TMT3L+GEA sac-TMT2 ADCsac-TMTADCSKB410/MK-3120SKB571/MK-2750 SKB535/MK-6204ADCADCADCADCADCADCADC oEllipses Pharma20213Ellipses PharmaEllipses PharmaA400Ellipses PharmaEP003120243A400/EP0031FDARETNSCLC20244A400/EP0031FDA22025630EP003136 oWindward Bio20251HarbourBioMedWindward BioHarbour BioMedWindward Bio SKB378/WIN378 Harbour BioMed9.7SKB378/WIN378Windward BioHarbour BioMedWindwardBioWindward BioHarbour BioMed 20255WindwardBio(i)20252(ii)Windward Bio20255 (ESG)ESGESGESGESGESGESGESG20255ExtelESG H2025612331.805,918,000H1,943.0 2025630 2025630 2025630 11 1. 342025818 202420252 34 2024 2410 2. 21 3. (a) 4. (i) 20081125%25% 15%2020123202310162020202615% (ii) 202516.5%202416.5%2025630 (iii) 10% 20256,50046,715 5. (a) (i) 63020252024 (b) 20252024630 6. (a) 202520246301231 202,04257,842 60 112233 8. (a) 2025612331.85,918,000H1,943.01,777,4347 5,9181,771,516 (b) 7202561210.91481 I. ADCsac-TMTSac-TMTTROP2 ADCHER2HER2 ADC30sac-TMTN01 ADCADCADCADCOptiDCTMcGMP ADCADCEllipsesPharmaWindward Bio BCNSCLC GIGCCRCsac-TMTN01 •ADC oSac-TMTSKB264/MK-2870®–TROP2 ADCoA166®1NDAHER2 ADCHER2+oSKB315CLDN18.2 ADCoSKB410/MK-3120Nectin-4 ADCoSKB571/MK-2750LCCRCADCoSKB518SKB535/MK-6204SKB445FICADCoSKB500SKB501ADCoSKB107RDC • oA167®PD-L1oN01A140達 泰 萊®(EGFR)EGFRoA400RETNSCLCMTCREToA296STING Sac-TMTTROP2 ADCSKB264/MK-2870佳 泰 萊® Sac-TMTTROP2ADCTROP2BCNSCLC GISac-TMTTROP2 ADCADCADC Sac-TMTIDAR7.4Sac-TMTTROP2TROP2KL610023KL610023IDNAKL610023KL610023ADC sac-TMTsac-TMT sac-TMTTROP2 ADCsac-TMT TNBC202411sac-TMT21TNBCSac-TMTADC 20245ASCOsac-TMTTNBC3Sac-TMTPFSOSSac-TMTBICRPFS6.795%CI:5.5,8.02.595%CI:1.7,2.7HR0.3295%CI:0.24,0.44,p0.0000168%Sac-TMTOS95%CI:11.2,NE9.495%CI:8.5,11.7HR0.5395%CI:0.36,0.78,p=0.000547%Sac-TMTORR45.4%ORR12%TROP2H-score200sac-TMTPFS8.3ORR(52.1%) sac-TMTTNBC3 HR+HER2- BC20255sac-TMTHR+HER2- BCNDAsac-TMTHR+HER2- BC3 EGFRNSCLC20253sac-TMTEGFR-TKIEGFRNSCLCsac-TMTORRPFSOSLCTROP2 ADC 20256ASCOsac-TMTEGFRNSCLCsac-TMTBIRCORR45.1%15.6%p=0.0004BIRCPFS6.92.8HR=0.30p<0.0001INVPFS7.92.8HR=0.2336.4%sac-TMTOSHR=0.49p=0.007OS, RPSFT9.3sac-TMTHR=0.36 sac-TMTEGFRNSCLC 3 EGFRNSCLC(i)sac-TMT可 瑞 達®2PD-L1NSCLC(ii)sac-TMTPD-L1NSCLCsac-TMT3 20256sac-TMTNSCLC sac-TMTGCEC CC OC UC CRPCHNSCC 20225sac-TMT14sac-TMTBCLCGI3sac-TMT2 sac-TMT •2025ASCO GUoSac-TMTUC1/2KL264-01/MK-2870-001(NCT04152499)•2025(ASCO)oSac-TMTEGFRNSCLCOptiTROP-Lung03oSac-TMTTNBC 2OptiTROP-Breast05oSac-TMTPD-L1NSCLC-2OptiTROP-Lung01oSac-TMTEGFRNSCLC2 •(British Medical Journal) oSac-TMTEGFRNSCLC(OptiTROP-Lung03) •-(Nature Medicine) oSac-TMTTNBC3(OptiTROP-Breas