百济神州：2021年年度报告

2 4 8 53 152 243 271 277 382 387 Ranjeev Krishana Donald W. GlazerMichael GollerAnthony C. Hooper2Alessandro Riva1 Anthony C. Hooper Margaret Han Dugan1Donald W. GlazerMichael GollerRanjeev KrishanaThomas MalleyAlessandro Riva1Corazon (Corsee) D. Sanders Corazon (Corsee) D. Sanders2Margaret Han Dugan1Michael GollerThomas MalleyAlessandro Riva1 3 Anthony C. HooperMargaret Han Dugan4Ranjeev KrishanaCorazon (Corsee) D. Sanders2 Thomas MalleyAnthony C. HooperCorazon (Corsee) D. Sanders *2022131 1.202221 2.2021224 (FCG, FCS)Vistra Corporate Services (HK) Limited Scott A. Samuels5 Mourant Ozannes 183171712-1716 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 3.20212244.20222255.2021630 3•2 0 2 1 ••••••••• ••••••••••••• ••••••• 3®(BTK)®PD-1®PARP1PARP2®(EU)®®13 2,200309030314,500 CMO 2010238,000 1.700®®®ociperlimabTIGITBGB-11417BCL2202220222023OX40TIM3 PI3KδHPK-150 2.2,200CRO 3.3,100 4.®®®®(WM)®45 5. 2022228 1.2.3.27(EU)4.(ESCC)5.®®(NSCLC)6.(VEGF)7.20211219 ALK=BLA=BRAF=BCLL=HCC=MCL=MEK=mTOR=MZL=NSCLC=R/R=SLL=UC=VEGFR=WM = ® ®zanubrutinib(BTK)BTKBTKB(BCR)BTKBCRBTKBBTK ® ®201911(MCL)(WM)CD20(R/R)(MZL)MCLMZLFDA®(CLL)(SLL)(sNDA)(PDUFA)FDA20221022 ®WM27®(EMA)®MZLCLL ®MCLCLLSLLR/R WM(NMPA)®CLLSLLsNDA202112®WM(NSHA)(NRDL)® ®WMMCLWMMCLR/RMZLR/R MCLR/R WM202222845 (NHL)(HL)BTB85%NHLB2021BTK80552026BTK150 ® ®tislelizumab1(PD-1)IgG4Fcγ(FcγR)T 20222®(NSCLC)NSCLCNSCLC®(NMPA)(cHL)12PD-L1(UC)(HCC)2020®cHLUCNRDL2021NSCLCNSCLCHCC5 NMPA(CDE)3®(BLAs)(MSI-H)(dMMR)(ESCC)(NPC) 1713342 20211®® FDAESCCBLAFDAPDUFA2022712 PD-1/PD-L120213052022PD1/L124 2025500 ® ®pamiparib1(PARP1)PARP2PARP-DNA®1,300® ®2 0 2 15BRCA(gBRCA)®®2021NRDL PARP(OC)(GC)PARP ® ®XGEVA®denosumabRANK(RANKL)(MM)(SRE)(GCTB)®70®20195GCTB202011SRE20207®202012®GCTB GCTB20192,086GCTB®GCTBGCTB® SRE®SRESRE®MMSRE ® ®BLINCYTO®CD-19CD3TT(BiTE)60(ALL)®202012ALL20218® ALL100,0000.69ALL15%®BALLCAR-TtisagenlecleucelFDA25BALLFDAclofarabine ® ®60(MM)®20217R/RMM20221®2006®2018®Ixazomib ® ®2013(MM)20182®NMPAMM 201920,700MMMMMM2006®®®ixazomib2019CD38DARZALEX®®daratumumab®®(CSCO)R/RMM 20176®201911®202011NMPA® ® ®DNA®201742(MDS)(CMML)(AML)20-30%20181® MDS201922,100MDS70MDS2MDS0.41.130%AML2MDS(CCR)®200950%MDS®MDS®201810 ®®ABRAXANE®20203ABRAXANE®2020325NMPAABRAXANE®202110180ABRAXANE®ABRAXANE®ABRAXANE®ABRAXANE® EUSA Pharma ® ®SYLVANT®6(IL-6)(HIV)8(HHV-8)Castleman(iMCD)®202112(HIV)8(HHV-8)Castleman(MCD)MCD(iMCD)6,5007,700Castleman(CD)75%Castleman25%HHV-8MCDHHV-8iMCDMCDCDHHV-8MCD ® ®βdinutuximab betaGD2®NMPA12(R/R)1001959β202112® ®(BAT1706) ®®®NSCLC ®NMPA2021112021(NSCLC) ®202011EMAFDABLA 202143 1495%(BMI)201710-15%201972022 202112202211 •®5202132 ®(EGFR)(ALK)202162021NRDL ®(HCC)202162021NRDL®202112021NRDL®PD-L112UC202042020NRDL®2(cHL)2019122020NRDL ®320211112 • ®(WM)202162021NRDL®(MCL)202062020NRDL®(CLL)(SLL)202062020NRDL •®NRDL ®BRCA(gBRCA)202152021NRDL ®20172019®20182020 2018(VBP)GPO4+7471120182019(QCE)(BE) (Medicare)(Medicaid)(PBM) myBeiGene(Co-Pay)®® 2022228 *232**†R/R∧R/M 1202131202110727202111232021121420222172022224 *232* *∧BiTE∧∧HLEBiTE†MiratisitravatinibSqNSCLC3SAPPHIRE††ZW25†††Assemblyvebicorvir2ABI-H37331 AMLHLEBiTETGC/GEJHCCINDMELMMNHLN/SCLCOCRCCSM(1)MapKureSpringWorks Therapeutics SECSSE ®BTK BTK®BTK124BTK ®20222543®AdiumPharmaNewBridgePharmaceuticalsErkimNanolekMedison ®4352 ®WM3ASPENNCT03053440®CLL/SLL3SEQUOIANCT03336333CLL/SLL3ALPINENCT03734016SEQUOIAALPINE3MCL3(NCT04002297)2MCLWMCLL/SLLNCT03206970NCT03332173NCT03206918MAGNOLIANCT03846427®2ROSEWOODNCT03332017DLBCLCLL/SLLCLL/SLL ®20222FDACLL/SLL(sNDA)(PDUFA)FDA20221022(EMA)MZLCLL102022®CLL/SLLALPINE2022®2ROSEWOOD ®PD-1 PD-1 1713342 •NSCLC3(NCT03358875)•NSCLC3NCT03594747NCT03663205•SCLC3(NCT04005716)•NSCLC3(NCT04379635) •HCC3(NCT03412773)•HCC2(NCT03419897) •3(NCT03777657) •3cHLNCT04486391 •cHL2(NCT03209973) •3(NCT03967977)•2(NCT04004221) ESCC •ESCC3(NCT03430843)•ESCC3(NCT03783442)•E S C C3(NCT03957590) •MSI-H/dMMR2(NCT03736889)•3(NCT03924986) 20221359,0003,00011 ®PARP1PARP2 ®pamiparib1(PARP1)PARP2®DNAPARP ®2 0 2 15BRCA(gBRCA)® 3(NCT03519230)BRCAHER22(NCT03575065)2( N C T03427814)1b /2(NCT03150862) 20223 (BGB-A1217)TIGIT ( B G B - A1217)T I G I TI g G13N S C L CAdvanTIG-301(NCT04866017)AdvanTIG-302(NCT04746924)8006 202112Ociperlimab AdvanTIG-202(NCT04693234)20222 Lifirafenib(BGB-283)BGB-3245RAF LifirafenibRAFLifirafenibBRAFV600EV600EBRAFKRAS/NRASlifirafenib(MAPK)BRAFBRAFKRAS/NRASlifirafenibNSCLC SpringWorks Therapeutics, Inc. (SpringWorks)1b(NCT03905148)lifirafenibSpringWorksMEKmirdametinib(PD-0325901) SpringWorksMapKure, LLCRAFBGB-3245MapKureBGB-3245v-RAFB (B-RAF)1(NCT04249843) Sitravatinib 20181MiratiTherapeutics,Inc(Mirati)MiratisitravatinibSitravatinibRETTAMTYRO3AxlMERVEGFR2KITMiratisitravatinib2019s