科伦博泰生物-B2023年中期报告

四川科倫博泰生物醫藥股份有限公司Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. （於中華人民共和國註冊成立的股份有限公司）股份代號：6990 中 期 報 告2023 247334849505153555671 108 666 3485 • H 183171712-1716 H06990 http://kelun-biotech.com 2410 2023 •SKB264 NSCLC20231SKB264EGFR-TKIEGFRNSCLC 20237EGFRNSCLCTKISKB2643 2023642023ASCOSKB264NSCLC2SKB264 oBC2023630SKB264HR+/HER2- BC 20228TNBC32023813SKB264TNBC3 •A166 oA1663L+HER2+ BC220235NDAo2L+HER2+ BC31bA166HER2+GCCRC • oSKB315SKB3151aSKB315oSKB4102023227SKB410IND2023761aoA167A167RM-NPC3oA1402022112023RASmCRCNDAoA400202365RETA40012023ASCO 20237RET+ NSCLC 20237RET+ MTCIND •BCNSCLC GI •ADC20233175.01,205.5(1) 20231100.0677.0(2)B •20237111,258.91,155.7(3)202383196179.7(4) (1)202333016.8886(2)202312016.7702(3)202371110.91803(4)20238810.91663 I. 2016(ADC)SKB264A166SKB2643TROP2 ADCA166HER2(HER2+)(NDA)HER2 ADC202363012 TNBCBCNSCLCNPCGCOCSCLCUCHNSCCECCCCRPCCRCMTCCKD-aP 1.2.II3.4.1a1b2NDA20236A166HER2+ BC35.6.1a237. 1a/1b ADCADCADCADCOptiDC(cGMP) 2023630Merck Sharp & Dohme LLCADC118ADCADCNature Reviews DrugDiscovery2022EllipsesA400Harbour BioMedA167SKB378 (BC)(NSCLC)(GI)(GC)(CRC)2023630145NDAIND •ADCoSKB264 (sacituzumab tirumotecan)TROP2 ADCoA166 (trastuzumab botidotin)NDAHER2ADCHER2+oSKB315CLDN18.2 ADCoSKB410ADC oA167 (tagitanlimab)PD-L1oA140EGFR32023NDAoA400RETNSCLCMTCRETRET 10ADC SKB264 SKB264TROP2 ADCTROP2BCNSCLC GCOCTROP2 ADCSKB264ADCADC 2022(SABCS)(TNBC)SKB264TNBCORR43.6%DCR80%PFS5.7OS12OS66.4%2023(ASCO)SKB2641/2SKB264NSCLCORRTKIEGFRNSCLC50%ORR60.0%DCR 100%PFS11.19PFS66.7%12OS80.7%EGFRPD-(L)12ORR26.3%DCR 89.5%PFS5.39OS80.4%12OS60.6% SKB264(5)Trodelvy®SKB264TNBC54%78%≥326%49%4%59%≥30%11%DS-10626%≥32%(6) (HR+)2(HER2-)SKB2641/22023102023(ESMO) SKB2642SKB264A167TNBCORR85.7%SKB264BCNSCLC 20228TNBC32023813SKB264TNBC3SKB264NDA2023HR+/HER2- BC320237EGFRNSCLCTKI3 SKB26420227TNBC20231EGFR-TKIEGFRNSCLC2023630HR+/HER2- BC 20225SKB264SKB264TROP2 ADCSKB264 SKB264 A166 A166NDAHER2 ADCHER2+HER2+ BCADCHER2BCGI A16611bA166HER2+ BC2(RP2D)ORR 73.9%HER2+ GCORR31.3%A166®Enhertu®®2023630FDAHER2 ADCA166(7)A166HER2+ A166A1663L+HER2+ BC220235NDA3L+HER2+ BC1bA166T-DM12L+HER2+ BC3HER2+GCCRC A166 SKB315 SKB315CLDN18.2 ADCCLDN18.2CLDN18.2zolbetuximab20236303CLDN18.2CLDN18.2 ADCADCCLDN18.2CLDN18.2SKB315CLDN18.2 20226SKB315SKB315SKB3151a20222 SKB315 SKB410 SKB410ADCSKB410FDA 2023227SKB410IND2023761a 202212ADCSKB410SKB410 SKB410 A167 A167PD-L1PD-L1PD-L1PD-1PD-(L)1PD-(L)1PD-(L)1 A167A167ADC (RM-NPC)A1672A167SKB264TNBCORR85.7%A167 202111NDA20232024A167RM-NPCA167RM-NPC32023630A167ADC2SKB264A167EGFRNSCLC2SKB264A167TNBC2 20188Harbour BioMedA167 A167 A140 A140EGFR3(RAS)mCRC(RM-HNSCC)(LA-HNSCC) 202211A1402023NDAA1403 A140 A400 A400RETRET+RET 2%RETNSCLCMTC2023630RETRET+RETRETA400RET A400RET1/2A400RET+RET+NSCLCRP2DORR74%66.7%A400RETRP2DORR33%83%RET33A400NSCLCMTCRETRET A400RET+1/22023652023ASCOA4001A400RET+ NSCLC20237RET+ NSCLC20237RET+ MTCIND 20213EllipsesA400 A400 SKB3371PD-L1T4(CTLA-4)PD-L1CTLA4 •A28913(LAG-3)PD-(L)1 •A296(STING)(ICI) ADC SKB337A289 A296 (RA)(AA) A223 A223JAK1/2RAAA RAJAKRAJAKJAKRA(MTX)RAJAK1/2Olumiant®RAJAKFDA A223JAK2A223RA122mgA22320(ACR20)35.1%63.6%28.6%50(ACR50)33.7%39.4%5.7% 2mgA223ACR20ACR504mgRAOlumiant®Olumiant®ACR20ACR50ACR2030.8%ACR5020.7%A223RA 202012RA2A22322023RA3A223AAOlumiant®2023630FDAAA20228AA22023 A223 A223A277SKB378SKB336(CKD)(CKD-aP) A277SKB378 SKB336 ADC •ADCADCADCADCADCADCOptiDCADCADCADCADCADCADCADC20236301,200 ADCADCSKB264KthiolpH7.4ADCADC •ADC2023630A167 (PD-L1)A140 (EGFR)3NDASKB337 (PD-L1/CTLA-4)A289 (LAG-3)SKB378 (TSLP)SKB336 XI/XIa (CADD)(ADMET)A400RETA223JAK1/2A296STINGA277κ(KOR)(PROTAC)PROTACIND CRO CRO ADC • ADC • ADCSKB264SKB315SKB410 20225TROP2ADCSKB264MK2870TROP2ADCTROP2 ADCSKB264TROP2 ADCSKB264SKB264TROP2 ADCTROP2 ADCSKB264TROP2 ADC 20226SKB315SKB315 202212ADCSKB410ADCADCADC20233175.01,205.5(8) •Ellipses20213EllipsesEllipsesA400A400 A400IND20226FDAA40020232(AEMPS)2023726A400Ellipses ADC •cGMPADCADC2,000L300L ADC40ADCADC45900,000ADC601.2ADC cGMP2022GMP BCNSCLC GI 20232024NDAA167PD-L120242025SKB264A166A140BCNSCLC GINPC2023100SKB264A166A167A167SKB264A166ADCNDABCLC 20234182023316102022 II. (i)(ii) 20236301,046.232022630344.99203.3%ADC20233175.01,205.5(9) (i)CRO(ii)(iii)(iv)(v)(vi)(vii) 2023630370.572022630119.10211.1% 2022630225.89199.1%2023630675.66 202263065.5%202363064.6% (i)(ii)(iii)(iv)(v)(vi)(vii) 202363024.122022630-13.2637.38 (i)(ii)(iii)(iv)(v)(vi)(vii) 202363089.42202263042.61109.88%(i)(ii) (i)CRO(ii)(iii)(iv)(v) 2023630490.352022630343.7942.6%(i)(ii)(iii) (i)AB(ii)(iii)(iv) 202363078.73202263072.488.6% 2022202363024.6272.41 20081125%25% 15%20201232020202215% 10% 2022630270.8688.5%202363031.13 20221231202363093.0587.26B 202212312023630731.87202212312023630270.0 2023630471.082022630155.0420233175.01,205.5(10)ADCB 2023630 100%20222023630 20236301,124.13202212313,835.070.69% 2023630 202363033.27 2023630 2023630 20236301,309 III. (i)(ii)(iii)(i