百济神州2024年度报告

Cancer has no borders. Neither do we. 2 4 8 43 129 229 259 264 349 355 Margaret Han DuganRanjeev Krishana Anthony C. Hooper5Michael GollerAlessandro RivaShalini Sharp5 Olivier Brandicourt1Margaret Han DuganMichael GollerAnthony C. HooperRanjeev KrishanaAlessandro RivaCorazon (Corsee) D. SandersShalini Sharp2 Alessandro RivaMargaret Han DuganMichael GollerCorazon (Corsee) D. Sanders Shalini Sharp3Olivier Brandicourt1Corazon (Corsee) D. SandersAnthony C. Hooper4 *2024122Thomas MalleyMalleyMalleyMalley20241025Donald W. Glazer1.20241232.20249273.20249272025314.2025315.20251166.2024319 Anthony C. HooperOlivier Brandicourt6Margaret Han DuganRanjeev KrishanaCorazon (Corsee) D. Sanders Mourant Ozannes (FCG, HKFCG)Vistra Corporate Services (HK) Limited 183171712-1716 Mourant Governance Services (Cayman) Limited94 Solaris Avenue, Camana BayGrand Cayman KY1-1108Cayman Islands Ernst & Young LLP 06160 The offices of Mourant Governance Services(Cayman) Limited94 Solaris AvenueCamana BayGrand Cayman KY1-1108Cayman Islands www.beigene.com •••••• •••••••••••• ••••••••ADS••• 202438146 BTK®sonrotoclaxBCL2BTK-CDAC ®BTKALPINE®(R/R)(CLL)®BTK®BTKCLL(MCL)(WM)(MZL)(FL)CLL®R/R CLL®20242670 SonrotoclaxBCL2sonrotoclax1,800Sonrotoclax®®sonrotoclaxCLL3CELESTIAL BTK-CDACBTKBTK500BTK2024(ASH)20253CLL120CLL 75%(CRO)ProjectOptimus1(IRA)3,700CRO(PoC) 202413(NME)618PoCCDK4B7H4(ADC)(GI)KRAS(MoA)EGFR-CDACPRMT5MAT2ACDK2B7H3 ADCCEA-ADCFGFR2b ADC EGFRxMETIRAK4 CDAC 201011,000 20242025 3,700CROCRO 1,10015MoACDACADCCDAC ®® ®30357,100®®sonrotoclaxBTK-CDACCLLBBTK-CDAC®sonrotoclaxCLL3CLL PD-1 PD-1®®®® 2024123126202373%20252024GAAPGAAP2024 2025227 ALK=BRAF=BMEK=(MAPK)(ERK)mTOR=VEGFR= ® 2024BTK1002028BTK150®20232024 ® ®BTKBTKBTK®B®BTKBTK ® ®5CLL/SLLWM R/R MCL R/R MZLR/RFL70 ®201911(FDA)MCLWMCD20R/R MZL202313®CLLSLL®17p/TP53R/RCLL/SLL(PFS)BTK20243®FDAR/R FL ®ECWMR/R MZLCLL202311EC®R/RFL®BTK ®NMPACLLSLLWMR/R CLL/SLL TN & R/R WMMCL®NHSANRDL ®202412WMCLL/SLL ® 2024PD-1/PD-L14502024PD-1/L134 20255002028 ® ®1(PD-1)IgG4Fcγ(FcγR)FcγRT ®14 •IIIII(NSCLC)••PD-L1 •NSCLC•(EGFR)(ALK)NSCLC•NSCLC•(ESCC)•ESCC•(NPC)•(HCC)••(cHL)•12PD-L1(UC)•(MSI-H)(dMMR) 2020®cHLUCNRDL2021NSCLCNSCLCHCCNRDL2022NSCLCMSI-HESCCNPCNRDL2023PD-L1ESCCNRDL EC®6 •PD-L1TAP)>5%ESCC•ESCC•PD-L1≥50%EGFRALKNSCLC•••PDL1 TAP>5%HER-2G/GEJ FDA®PD-(L)1ESCCPD-L1≥1HER2G/GEJ®ESCC(BLA) ®ESCC(J-NDA)(PMDA) ®2716 ® ®XGEVA®denosumabRANK(RANKL)(MM)(SRE)(GCTB)®70®20195GCTB202011SRE20207®202012®GCTB202320241SRE ® ®BLINCYTO®blinatumomabCD-19CD3TT(BiTE)60(ALL)®202012R/R ALL20224R/RBALL20218® ® ®KYPROLIS®carfilzomib60R/R MM®20217R/R MM20221®®20233 (BMS)20252 •®REVLIMID®•®VIDAZA®DNA EUSA Pharma ® ®SYLVANT®siltuximab-6(IL-6)(HIV)-8(HHV-8)Castleman(iMCD)®202112HIVHHV-8Castleman(MCD)iMCD20241® ® ®QARZIBA®βdinutuximab betaGD2NMPA12R/R202112® ®(BAT1706) ®®®NSCLC ®2 0 2 11 1N M P A2 0 2 1NSCLC ® ® ®®®20236NMPA2023NRDL®20239NMPA2024NRDL 2024123160 (Medicare)(Medicaid) myBeiGene(co-pay)®®®® 1495%20172022 202411202511 •®13 ®(ES-SCLC)202462024 ®202442024NRDL1 ®ESCC202352023NRDL ®EGFRALKNSCLCEGFRALKNSCLC2021122023NRDL ®MSI-HdMMR202232023NRDL ®ESCC202242023NRDL ®NPC202262023 ®EGFRALKNSCLC202162021NRDL®202162021NRDL®NSCLC202112021NRDL®PD-L112(UC)202042020NRDL®2cHL2019122020NRDL •®4 ®2(FL)202452024NRDL®CLLSLL202342023NRDL2®WM202342023NRDL3®MCL202062020NRDL 2CLL/SLLCLL/SLL202062020NRDL •® ®202392024NRDL®202362023NRDL •®202410 ®2202172023NRDL 20184+71120182019(RLD) 2025227 2025227 AML=BC=BTC=GEA=MDS=NSCLC=SCLC=EC=OC=CCA= (SEC) ®BTK ®B®24BTK®®BTKR/R CLLBTK ®30357,100®70180,000 3SEQUOIA15®(TN)CLLSLLPFS54PFS80%2024ASH TNCLLBOVen596%92%(uMRD)uMRDMRD342024ASH ®53 •MANGROVEMCL(NCT04002297) •MAHOGANY(FL)(NCT05100862) ®MCLMZLCLL/SLLsonrotoclaxCLL/SLL3sonrotoclaxBTK-CDAC(BGB-16673) ® Sonrotoclax (BGB-11417)Bcl-2 SonrotoclaxBCL22024121,800 SonrotoclaxR/RMCL(NCT05471843)R/RCLL/SLL(NCT05479994)2R/RWM2(NCT05952037) 3CELESTIAL-TNCLL(NCT06073821)TN-CLLsonrotoclax®2025TN-CLL2(NCT06637501)sonrotoclax®® TN-CLL/SLL1(NCT04277637)2024ASHSonrotoclax®TNCLL/SLLMRD(TLS) BCL2sonrotoclaxR/R MCLR/R CLL BGB-16673BTKCDAC BGB-16673BTK(CDAC)BTKBTKBTKBGB-16673BTK500FDABGB-16673BTKBCL2R/R CLL/SLLR/R MCL 1/2CaDAnCe-101CLL(NCT05006716)2024ASHBGB-16673BTKBTKBTKBCL2CLL/SLLWM •CLL/SLLBGB-16673200mgORR94%2(CR/CRi)57%≥3TEAE≥3TEAE≥10%(20%)(10%)885 •BGB-16673(DCR)93%(VGPR)26%45%≥ 3TEAE≥ 3TEAE≥ 20%860 R/R CLL220253BGB-16673BTKR/R MCLR/R CLL/SLL3 ®PD-1 ®PD-1® 14103423 •®cHLNCT044863913•®3(NCT03967977)•®MSI-H/dMMR2(NCT03736889) 20241235®14,0004,700820243®ESCC(NCT03957590) (BGB-A1217)TIGIT (BGB-A1217)TIGITIgG13AdvanTIG-302(NCT04746924)®NSCLC2024122,000 AdvanTIG-302 BG-60366EGFRCDAC BG-60366EGFRCDACEGFR1(NCT06685718) BG-89894 (SYH2039)MAT2A BG-89894(SYH2039)MAT2A1(NCT06568614)202412 BGB-58067MTAPRMT5 BGB-58067MTAPRMT5MTAP1(NCT06568614) BG-T187EGFRxMET BG-T187EGFRxMET1(NCT06598800) BGB-26808HPK-1 BGB-26808HPK-1BGB-150251(NCT05981703)