百济神州2023年度报告

Cancer has no borders. Neither do we. 2 4 8 51 141 237 268 273 368 373 Margaret Han DuganRanjeev Krishana Donald W. GlazerMichael GollerAnthony C. HooperAlessandro Riva Olivier Brandicourt1Margaret Han DuganDonald W. GlazerMichael GollerAnthony C. Hooper2Ranjeev KrishanaAlessandro RivaCorazon (Corsee) D. Sanders Alessandro RivaMargaret Han DuganMichael GollerCorazon (Corsee) D. Sanders Anthony C. HooperOlivier Brandicourt4Margaret Han DuganRanjeev KrishanaCorazon (Corsee) D. Sanders Anthony C. Hooper3Olivier Brandicourt1Corazon (Corsee) D. Sanders *2024122Thomas MalleyMalleyMalleyMalley 1.20241232.AnthonyC.Hooper20234172023416Anthony C. Hooper3.20239134.2024319 (FCG, HKFCG)Vistra Corporate Services (HK) Limited Mourant Ozannes 183171712-1716 Ernst & Young LLP Mourant Governance Services (Cayman) Limited94 Solaris Avenue, Camana BayGrand Cayman KY1-1108Cayman Islands Mourant Governance Services(Cayman) Limited94 Solaris AvenueCamana BayGrand Cayman KY1-1108Cayman Islands 06160 www.beigene.com •••••• •••••••••••• ••••••••ADS 20232520221011 3®BTK®PD-1®PARP1PARP2®®®14 CRO3,000CRO1304522,00040 CMO 201010,000 13 1.3,000(CRO)75% 2.1,100153®®®R/RCLL(PFS)(ORR)BCL-2sonrotoclaxBTK(CDAC)BGB-16673KRASPRMT5 CDK4 CDK2B7H3 ADCCEA-ADC B7H4-ADC MUC1 × CD16AClaudin6 ×CD3CDACADCmRNA 3.®®®29375,000800ALPINE®BTK2022ASH®202312FDA®®R/R CLL3ALPINEPFS®2023®2022128.5%®sonrotoclaxBCL2BTK-CDACCLLBPD-1®12PD-1/PD-L1®20247(ESCC)®KRASPRMT5 CDK4 CDK2B7H3 ADCCEA-ADC B7H4-ADC MUC1 × CD16AClaudin6 × CD3 4.3,700500®2023CLLSLL®17®®BTKPD-1/PD-L1®652023®®(EMA) 5.2023123132222024 2024226 1.2.3.274.ESCCESCCNSCLCNSCLCNSCLCEGFRALKNSCLC5®®FDABRAF V600ENSCLC6.(VEGF)7.8.9.BMS®®2023123120241231 ALK=BLA=BRAF=BCLL=EGFR=ESCC=GC=GEJC=HCC=MAA=MCL=MEK=(MAPK)(ERK)mTOR=MZL=NPC=NSCLC=R/R=SLL=UC=VEGFR=WM= ® ®zanubrutinibBTKBTK®BTK ® ®201911MCLWMCD20(R/R)MZLMCLMZL20231®(FDA)CLLSLL202312FDA®®(R/R)CLL3ALPINEPFSFDA®R/RFLsNDA(PDUFA)FDA20243 ®ECWMR/R MZLCLL202311(EC)®R/RFL®BTK ®NMPACLLSLLWMR/R CLL/SLLR/RWMMCL®NHSANRDL 20242®65 2022BTK852028BTK150®20222023 ® ®1PD-1IgG4FcγFcγRFcγR®T 12 •PD-L1•NSCLC•NSCLC•NSCLC•ESCC•ESCC•NPC•HCC•(HCC) •cHL•12PD-L1UC•MSI-HdMMR 2020cHLUCNRDL2021NSCLCNSCLCHCCNRDL2022NSCLCMSI-HESCCNPCNRDL2023PD-L1ESCCNRDL NMPAES-SCLCGC/GEJPD-L1NSCLCsBLA EC®ESCC FDA®ESCCBLAFDA®ESCCBLA 171134290 ® 2022PD-1/PD-L13602022PD-1/L122 2025500 ® ®1PARP1PARP2PARP-DNA ®20215B R C AgBRCA®®2021NRDL ® ®XGEVA®denosumabRANKRANKLMMSREGCTB®70®20195GCTB202011SRE20207®202012®GCTBNRDL202320241SRE ® ®BLINCYTO®blinatumomabCD-19CD3TT(BiTE)60(ALL)®202012R/R ALL20224R/RBALL20218® ® ®KYPROLIS®carfilzomib60R/R MM®20217R/R MM20221®®20233NRDL (BMS)2024 ® ®REVLIMID®lenalidomide2013MM20182®NMPAMM 20176®NRDL201911®R/RMMNRDL202011NMPA®sNDA ® ®VIDAZA®azacitidineDNA®20174-2(MDS)(CMML)20%30%(AML)20181® ®®ABRAXANE®20203ABRAXANE®2020325NMPABMSABRAXANE®BMSBMSABRAXANE®BMS®®2023123120241231 EUSA Pharma EUSA Pharma ® ®SYLVANT®siltuximab-6IL-6HIV-8HHV-8CastlemaniMCD®202112HIVHHV-8CastlemanMCDiMCD20241® ® ®QARZIBA®βdinutuximab betaGD2NMPA12R/R202112® ®(BAT1706) ®®®NSCLC ®202111NMPA2021NSCLC ® ® ®®®20236NMPA2023NRDL®20239NMPA 2023123165 1495%NRDLNRDL2017NRDL2022NRDLNRDL 2023NRDL •1113NRDL•4•8 NRDL202312NRDLNRDL202411 •11 PD-L1202322023NRDL®ESCC202352023NRDL (EGFR)(ALK)(NSCLC)EGFRALKNSCLC202212023NRDL (MSI-H)(dMMR)202232023NRDL ESCC202242023NRDL NPC202262023NRDL (EGFR)(ALK)202162021NRDL (HCC)202162021NRDL 202112021NRDL PD-L112(UC)202042020NRDL 2(cHL)2019122020NRDL •®5 ®(CLL)(SLL)202342023NRDL®(WM)202342023NRDL®(WM)202162021NRDL20235®(MCL)202062020NRDL®(CLL)(SLL)202062020NRDL20235 •®1 ®202362023NRDL •® ®HIVHHV-8MCD2021122023NRDL •® ®2020112023NRDL®(GCTB)2020NRDL •® ®gBRCA202152021NRDL •® ®2202172023NRDL NRDL®20172019®20182020 20184+71120182019 NRDL (Medicare)(Medicaid)PBM myBeiGene(Co-Pay)®® 2024226 2024226 ^ BiTE®^^BiTE®† XmAb®Xencor*Mirati20241†† ZW251MapKureSpringWorks AML=BC=BTC=CRC=GC=GEA=GEJC=HCC=LNP=MDS=NSCLC=SCLC= (SEC) ®BTK B24BTK®BTKR/R CLLBTK ®202312532®A d i u mP h a r m aN e w B r i d g ePharmaceuticalsErkimNanolekMedison ®111163322 •ROSEWOOD(FL)(NCT03332017) •M A G N O L I A( M Z L )(NCT03846427) •CD79BB2(NCT05068440) •A S P E N( W M )(NCT03053440) •SEQUOIA(CLL/SLL)(NCT03336333) •ALPINE(CLL/SLL)(NCT03734016) •MANGROVE(MCL)(NCT04002297) •MAHOGANY(FL)(NCT05100862)•B2•(NCT05707377)•(NCT04643470) NatureMedicine20231292(NCT04271956)®PD-1®RichterRTCLLALPINE2023ASH202312R/RCLLPFSHR0.65p=0.0024ROSEWOODR/R FLMCLMZLCLL/SLLsonrotoclaxCLL/SLL3sonrotoclax ®®CLL/SLL202312FL20231110 ®PD-1 PD-1 1713342 •NSCLC3(NCT03358875)•NSCLC3NCT03594747NCT03663205•SCLC3(NCT04005716)•NSCLC3(NCT04379635) •HCC3(NCT03412773)•HCC2(NCT03419897) •3(NCT03777657) •(cHL)3(NCT04486391) •cHL2(NCT03209973) •3(NCT03967977)•2(NCT04004221) ESCC •ESCC3(NCT03430843)•ESCC3(NCT03783442)•E S C C3(NCT03957590) •MSI-H/dMMR2(NCT03736889)•3(NCT03924986) 2023123013,0003,50011 ®PARP1PARP2 PARP1