百济神州：2022年年度报告

2 4 8 53 151 255 285 290 398 403 Margaret Han Dugan3Ranjeev Krishana Donald W. GlazerMichael GollerAnthony C. HooperAlessandro Riva1 Margaret Han Dugan1Donald W. GlazerMichael GollerAnthony C. Hooper**Ranjeev KrishanaThomas MalleyAlessandro Riva1Corazon (Corsee) D. Sanders Alessandro Riva4Margaret Han Dugan1Michael GollerThomas MalleyCorazon (Corsee) D. Sanders Thomas MalleyAnthony C. HooperCorazon (Corsee) D. Sanders Anthony C. HooperMargaret Han Dugan2Ranjeev KrishanaCorazon (Corsee) D. Sanders *2022131 2022622 **AnthonyC.Hooper2023417202212312023416Anthony C. Hooper (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 1.202221 2.2022225 3.2022913 4.20222120221120 3•2 0 2 2 •••••• •••••••••••• ••••••••ADS•• 3®(BTK)®PD-1®PARP1PARP2®®®13 2,700508030318,000 CMO 2010299,000 12 1.950143®®®(CLL)(PFS)(ORR)BCL-2BGB-11417HPK1BGB-15025BTK(CDAC)BGB-16673OX40LAG-3 TIM-3CDACADCCAR-NKmRNA 2.2,300(CRO)75% 3.®®®29354,800800ALPINE®BTK2022(ASH)®BCL-2PD-1®®PD-1/PDL-1®OX40TIGIT LAG-3TIM-3 4.3,500®®BTKPD-1/PDL-113®®®65®® 5.2023 2023227 1.2.3.(EU)274.(ESCC)(ESCC)(NSCLC)5.®®(NSCLC)6.(VEGF)7.8. ALK=BLA=BRAF=BCLL=EGFR=ESCC=GC=GEJC=HCC=MAA=MCL=MEK=mTOR=MZL=NPC=NSCLC=R/R=SLL=UC=VEGFR=WM= ® ®zanubrutinibBTKBTKBTK ® ®201911(MCL)(WM)CD20(R/R)(MZL)MCLMZL20231®(FDA)(CLL)(SLL) ®(EC)WMMZLCLL ®MCLCLLSLLR/RWM(NMPA)®CLLSLLWMsNDA202112®R/RWMNSHANRDL® 20232®65 (NHL)(HL)2022BTK852026BTK200 ® ®tislelizumab1(PD-1)IgG4Fcγ(FcγR)T ®(NSCLC)NSCLCNSCLC(ESCC)(NPC)PD-L1®(NMPA)(cHL)PD-L112(UC)(HCC)(MSI-H)(dMMR)2020®cHLUCNRDL2021NSCLCNSCLC2/3LHCCNRDL2022NSCLCMSI-HESCC(NPC)NRDL NMPA(CDE)2®(sBLA)(HCC) 1713342 20211®® FDAESCC(BLA) 2022PD-1/PD-L13602022PD-1/L122 2025500 ® ®pamiparib1(PARP1)PARP2PARP-DNA®1,300® ®2 0 2 15BRCA(gBRCA)®®2021 ® ®XGEVA®denosumabRANK(RANKL)(MM)(SRE)(GCTB)®70®20195GCTB202011SRE20207®202012®GCTB2023 ® ®BLINCYTO®blinatumomabCD-19CD3TT(BiTE)60(ALL)®202012ALL20224B20218® ® ®KYPROLIS®carfilzomib60(MM)®20217R/RMM20221®®20233 ® ®REVLIMID®lenalidomide2013(MM)20182®NMPAMM 20176®201911®202011NMPA® ® ®VIDAZA®azacitidineDNA®20174-2(MDS)(CMML)20%30%(AML)20181® ®®ABRAXANE®20203ABRAXANE®2020325NMPAABRAXANE®202110180ABRAXANE®ABRAXANE®ABRAXANE® EUSA Pharma ® ®SYLVANT®siltuximab-6(IL-6)(HIV)-8(HHV-8)Castleman(iMCD)®202112(HIV)-8(HHV-8)Castleman(MCD)MCD(iMCD) ® ®QARZIBA®βdinutuximab betaGD2NMPA12(R/R)202112® ®(BAT1706) ®®®NSCLC ®202111NMPA2021NSCLC ®202011EMAFDABLA 202260 1495%20172022 20231202331 •®9 ®(EGFR)(ALK)(NSCLC)EGFRALKNSCLC202212023NRDL ®(MSI-H)(dMMR)202232023NRDL ®202242023NRDL ®202262023NRDL®(EGFR)(ALK)202162021NRDL®(HCC)202162021NRDL®202112021NRDL®PD-L112(UC)202042020NRDL®2(cHL)2019122020NRDL •®3 ®(WM)202162021NRDL®(MCL)202062020NRDL®(CLL)SLL)202062020NRDL •® ®BRCA(gBRCA)202152021NRDL •®202331 ®2 •®20233 ®2020NRDL ®20172019®20182020 20184+71120182019 (Medicare)(Medicaid)(PBM) myBeiGene(Co-Pay)®® 2023227 SEC ®BTK B24BTK®BTKBTK ®202212526®Adium PharmaNewBridge PharmaceuticalsErkimNanolekMedison ®10105352 ®WM3ASPENNCT03053440®CLL/SLL3SEQUOIANCT03336333CLL/SLL3ALPINENCT03734016CLL3MCL3(NCT04002297)3FLMZL3(NCT05100862)2MCLWMCLL/SLLNCT03206970NCT03332173 NCT03206918MZLMAGNOLIA NCT03846427®FL2ROSEWOODNCT033320172022(EHA)ROSEWOODMCLMZLCLL/SLLCLL/SLL ®®20231202211CLL/SLL10 ®PD-1 PD-1 2113342 •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)•ESCC3(NCT03957590) •MSI-H/dMMR2(NCT03736889)•3(NCT03924986) 2022123111,0004,00011 ®PARP1PARP2 ®pamiparib1(PARP1)PARP2®DNAPARP ®2 0 2 15BRCA(gBRCA)® 3(NCT03519230)2(NCT03427814)1b(NCT03150810) (BGB-A1217)TIGIT (BGB-A1217)TIGITIgG13NSCLCAdvanTIG-301(NCT04866017)AdvanTIG-302(NCT04746924)2022121,6008 202112Ociperlimab AdvanTIG-202(NCT04693234)20232 Lifirafenib(BGB-283)BGB-3245RAF LifirafenibRAFLifirafenibBRAFV600EV600EBRAFKRAS/NRASlifirafenib(MAPK)BRAFBRAFKRAS/NRASlifirafenibNSCLC SpringWorksTherapeutics(SpringWorks)1b(NCT03905148)lifirafenibSpringWorksMEKmirdametinib(PD-0325901) SpringWorksMapKure, LLCRAFBGB-3245MapKureBGB-3245v-RAFB(B-RAF)1(NCT04249843) Sitravatinib 20181MiratiTherapeutics,Inc(Mirati)MiratisitravatinibSitravatinibRETTAMTYRO3AxlMERVEGFR2KITMiratisitravatinib2019sitravatinibNSCLC3SAPPHIRE2022MiratisitravatinibPD-L1ESCC2(NCT05461794) s i t r a v a t i n i bN S C L C3(NCT04921358) BGB-11417Bcl-2 BGB-11417Bcl-2BGB-11417(IND)Bcl-2Bcl-xLBcl-2®2022ASHCLL(AML)(MM)1NCT04883957NCT04277637NCT04771130NCT049736052022BCL-2BGB-11417(NCT05471843)CLL/SLL(NCT05479994)22023 BGB-A445OX40 BGB-A4