百济神州2025年度报告

（根據瑞士法律註冊成立的公司） 2 4 8 46 135 238 268 273 369 375 Margaret Han DuganRanjeev Krishana Anthony C. Hooper3Michael GollerAlessandro RivaShalini Sharp3 Olivier BrandicourtMargaret Han DuganMichael GollerAnthony C. HooperRanjeev KrishanaAlessandro RivaCorazon (Corsee) D. SandersShalini Sharp Alessandro RivaMargaret Han DuganMichael GollerCorazon (Corsee) D. Sanders Shalini Sharp1Olivier BrandicourtCorazon (Corsee) D. SandersAnthony C. Hooper2 1.2025312.2025313.2025116 Anthony C. HooperOlivier BrandicourtMargaret Han DuganRanjeev KrishanaCorazon (Corsee) D. Sanders c/o BeOne Medicines I GmbHAeschengraben 27, 4051 Basel, Switzerland 183171712-1716 (FCGHKFCG)Vistra Corporate Services (HK) Limited Computershare Switzerland LtdBaslerstrasse 90, P.O. Box, 4601 OltenSwitzerland 06160 Ernst & Young LLP www.beonemedicines.com Ernst & Young AG •••••• •••••••••••• •••••••••ADS•2025 20255340.2%2.869119.417 (CLL)(BTK)®B2(BCL2)202512BTK(BTK-CDAC) ®BTKALPINE®(R/R)CLL®BTK®BTKCLL(MCL)(WM)(MZL)(FL)®2025B®20253975®MCL3MANGROVEMCL(1L) BCL22025BTKR/RMCLCLL(SLL)B2025(ASH)1/2R/RMCL(FDA)2026R/R MCLBCL2 ®(uMRD)®CLL3CELESTIAL-TNCLL2026®CLL3 BTK-CDAC(BGB-16673)BTKBTKBTK2025ASH32026R/R CLL2FDACLL120CLL 20255(NME)202554(CDK4)(BGB-43395)B7-H4(ADC)(BG-C9074)(MoA)-3(GPC3)4-1BBT(BGB-B2033)5(PRMT5)(BGB-58067)(CEA)ADC(BG-C477) 75%(CRO)ProjectOptimus1(IRA)6,000CRO 201012,000 2025 3,800CROCRO 1,20015(CDAC)ADCCDAC20CDAC(IND) ®® ®30457,900®®BTK-CDACCLLB®BTK-CDAC(CLL) PD-1 PD-1®®HERIZON-GEA-01®® 202512314510202439.8%20262025GAAPGAAP202511 2026226 1.2025Royalty PharmaIMDELLTRA® DLL3=Delta3CD=ALK=BRAF=BMEK=(MAPK)(ERK)mTOR=VEGFR= ® 2025BTK1202028BTK150®20242025 ® ®BTKBTKBTK®B®BTKBTKFDA20256 ®5CLL/SLLWM R/R MCL R/R MZLR/RFL7758 ®201911FDAMCLWMCD20R/RMZL202313®CLLSLL®17p/TP53(PFS)BTK20243®FDAR/R FL20256® ®(EC)WMR/R MZLCLL202311EC®R/RFL®BTK20258EC® ®(NMPA)CLL/SLLWMR/R MCL3L FL®(NHSA)(NRDL) ®202412WMCLL/SLL ® 2025PD-1/PD-L15002025PD-1/L140 2028 ® ®1(PD-1)IgG4Fcγ(FcγR)FcγRT ®(EMA)2723 2021®PD-L1UCNRDL2022(NSCLC)NSCLC(HCC)NRDL2023NSCLCMSI-H(ESCC)(NPC)NRDL2024PD-L1(G/GEJA)ESCCNRDL2025G/GEJAPD-L1(ES-SCLC)HCCNRDL2026IIIIIANSCLCNRDL ® ®XGEVA®denosumabRANK(RANKL)(MM)(SRE)(GCTB)®70®20195GCTB202011SRE20207®202012®GCTB202320241SRE ® ®BLINCYTO®blinatumomabCD-19CD3TT(BiTE)60(ALL)®202012R/RALL20224R/RBALL20218® ® ®KYPROLIS®carfilzomib60R/R MM®20217R/R MM20221®®20233 (BMS) BMSBMS20252®REVLIMID®®VIDAZA®DNA EUSA PharmaRecordati ® ®SYLVANT®siltuximab-6(IL-6)(HIV)-8(HHV-8)Castleman(iMCD)®202112HIVHHV-8MCDiMCD20241® ® ®QARZIBA®βdinutuximab betaGD2NMPA12R/R202112® ®(BAT1706) ®®®NSCLC ®2 0 2 11 1N M P A2 0 2 1NSCLC ® ® ®®®20236NMPA2023NRDL®20239NMPA(BC)2024NRDL 2025123160 (Medicare)(Medicaid) myBeOne Support(co-pay)®®myBeOne Support®® 1495%20172022 202512202611 •® ®IIIIIANSCLC2024102025NRDL®HCC2023122024NRDL®(ES-SCLC)202462024®202442024NRDL1®ESCC202352023NRDL ®EGFRALKNSCLCEGFRALKNSCLC2021122023NRDL ®MSI-HdMMR(CRC)202232023NRDL ®ESCC202242023NRDL ®NPC202262023 ®EGFRALKNSCLC202162021NRDL ®202162021NRDL ®NSCLC202112021NRDL ®PD-L112(UC)202042020NRDL •® ®2F L202452024NRDL®CLLSLL202342023NRDL2®WM202342023NRDL3®MCL202062020NRDL •® ®BC202392024NRDL®202362023NRDL •® ®BRCA(gBRCA)202142021NRDL •® ®(H I V)- 8 (H H V - 8)Castleman(MCD)2021122023NRDL 2025(CHIIDL)NRDLNRDLCHIIDLCHIIDL CHIIDL202512 •® HER2(IHC3+)202552025CHIIDL •® ≥12202182025CHIIDL 20184+71120182019RLD 2026226 2026226 * AML=BC=BTC=GEA=MDS=NSCLC=SCLC=EC=OC=CCA= (SEC) ®BTK ®B®24BTK®®BTKR/R CLLBTK ®30457,900®75265,000 SEQUOIA®CLL2025(ASCO) 2025ASHSEQUOIA®CLL/SLL17p6 R / RF L(Z O)2ROSEWOODZOZO(ORR)(CR)OPFSZO2025ASH CLL/SLLALPINE2025ASH ®53 •MANGROVEMCL(NCT04002297) •MAHOGANY-CD20R/R FLMZL(MAHOGANY) •SEQUOIACLLSLL17p[1]17p[23]3111A+BBinet(IGHV)23(NCT03336333) ®M C LM Z LC L L / S L LC L L / S L L3®B T K -CDAC(BGB-16673) ® (BGB-11417)BCL2 BCL2202622,500 BTKR/RMCLCLL/SLLR/RMCL320mg1/2n=103(IRC)(ORR)52.4%95% CI 42.4 ~ 62.4R/R CLL/SLL2n=100IRCORR77% 20258R/RMCL2(NCT05471843)ORRCR(DOR)PFSFDA202510R/RMCL202511FDABTKR/RMCL12R/RCLL2(NCT05479994)20254612NDA R/RWM®2(NCT05952037)CLL/SLL3(NCT06073821)TN CLL2 1/1b(NCT04277637)2025ASHTNCLL/SLLTEAETLS320 mguMRD4C15MRDNGSFCuMRD4 t(11;14)R/RMM1b/2(NCT04973605)2025ASHt(11;14)R/RMMORR84%CR/sCR32% FDAEMA BGB-16673BTKCDAC BGB-16673BTKCDACBTKBTKBTKBGB-16673BTK1,000CaDAnCeFDA2024BGB-16673BTKBCL2R/RCLL/SLLR/RMCL20257EMABGB-16673PRIMEBTKWM 2025ASHR/RCLL/SLL1CaDAnCe-101BGB-16673 2BCL2BTKR/R CLL(NCT05006716)33NCT06846671NCT06970743NCT06973187CLL2026R/RCLL202510CaDAnCe-304R/R CLL(NCT06634589)B ®PD-1 ®PD-1 1511342HER2+(GEA)4 •3HERIZON-GEA-01HER2®®HER2GEA •3(NCT03967977)•(GEJ)3(NCT07043400)•®MSI-H/dMMR2(NCT03736889) HERIZON-GEA-0120261ASCO(GI)PD-L1®®PFS(OS)37%mPFS428%mOS7GEA®®FDA®BLANMPA(CDE)®®BLA 20251233®15,8005,0009 BGB-58067MTAPRMT5 BGB-58067MTAPRMT5MTAP1(NCT06568614) BG-T187EGFR × MET × MET BG-T187EGFR × MET× MET1(NCT06598800) BG-C0902EGFR × MET × METADC B