百濟(jì)神州 2024年年度報(bào)告-臨床試驗(yàn)更新-Clinical Trials Appendix

吟

ClinicalTrialsAppendix

Q42024ResultsUpdate

February27,2025

Disclosures

Certainstatementscontainedinthispresentationandinanyaccompanyingoralpresentation,otherthanstatementsoffactthatareindependentlyverifiableatthedatehereof,mayconstituteforward-lookingstatements.Examplesofsuchforward-lookingstatementsincludestatementsregardingtheprojected

datesforupcomingregulatoryapprovals;andBeiGene’sresearch,discovery,andpre-clinicalandearly-stageclinicalprogramsandplans.Actualresultsmaydiffermateriallyfromthoseindicatedintheforward-lookingstatementsasaresultofvariousimportantfactors,includingBeiGene’sabilityto

demonstratetheefficacyandsafetyofitsdrugcandidates;theclinicalresultsforitsdrugcandidates,whichmaynotsupportfurtherdevelopmentor

marketingapproval;actionsofregulatoryagencies,whichmayaffecttheinitiation,timingandprogressofclinicaltrialsandmarketingapproval;BeiGene’sabilitytoachievecommercialsuccessforitsmarketedmedicinesanddrugcandidates,ifapproved;BeiGene’sabilitytoobtainandmaintainprotectionof

intellectualpropertyforitstechnologyandmedicines;BeiGene’srelianceonthirdpartiestoconductdrugdevelopment,manufacturing,commercialization,andotherservices;BeiGene’slimitedexperienceinobtainingregulatoryapprovalsandcommercializingpharmaceuticalproducts;BeiGene'sabilityto

obtainadditionalfundingforoperationsandtocompletethedevelopmentofitsdrugcandidatesandachieveandmaintainprofitability;andthoserisksmorefullydiscussedinthesectionentitled“RiskFactors”inBeiGene’smostrecentperiodicreportfiledwiththeSEC,aswellasdiscussionsofpotentialrisks,

uncertainties,andotherimportantfactorsinBeiGene’ssubsequentfilingswiththeSEC.Allinformationinthispresentationisasofthedateofthispresentation,andBeiGeneundertakesnodutytoupdatesuchinformationunlessrequiredbylaw.

2

OurPipelineSnapshot

Acrossthreetherapyareas:

Hematology

SolidTumor

Inflammation

andImmunology

*Includesinvestigatorinitiatedtrials(IITs)

150+

40+

ClinicalstudiesrunbyBeiGene

24,000+

Patientsenrolledinclinicaltrialsglobally*

Clinical

andcommercial

stageassets

70+

ApprovalsforBRUKINSA?(zanubrutinib)globally

3

BeiGene:UpcomingRegulatoryAction

Catalysts1H2025-1H2026

PotentialApprovals

1H,2026

BRUKINSA-114TabletformulationUK

BRUKINSA-additional~5globalapprovalsTEVIMBRA-3022LESCCCA

TEVIMBRA-304ILNonSqNSCLCBRTEVIMBRA-3051LGCCA

TEVIMBRA-3062LESCCCA

TEVIMBRA-307ILSqNSCLCBRTEVIMBRA-3091LNPCUK

TEVIMBRA-3121LES-SCLCUK

TEVIMBRA-315Neo/adjNSCLCUKTEVIMBRA-AltDosingQ6WEU,CN

TEVIMBRA-additional~18globalapprovals

1H,2025

Q1

TEVIMBRA-3022LESCCJP

TEVIMBRA-3061LESCCUS*,JP

Q2

BRUKINSA-additional~12globalapprovalsTEVIMBRA-3051LGCAU

TEVIMBRA-3022LESCCUSAltDosingQ2/4WTEVIMBRA-additional~5globalapprovals

2H,2025

BRUKINSA-114TabletformulationUS,EU,AUBRUKINSA-additional~10globalapprovals

TEVIMBRA-3051LGCBR,UK

TEVIMBRA-3061LESCCBR,UK

TEVIMBRA-3091LNPCAU,CA,EUTEVIMBRA-3121LES-SCLCEU

TEVIMBRA-315Neo/adjNSCLCEU

TEVIMBRA-AltDosingQ2/4/6WUS,AU(Q2/4W)TEVIMBRA-additional~45globalapprovals

*Duetoadelayinschedulingclinicalinspections,thetargetPDUFAdateofJuly2024wasdeferred

BR-Brazil;CN-China;AU-Australia;JP-Japan;UK-UnitedKingdom;CA-Canada;EU-EuropeanUnionRefertoGlossaryforotherabbreviations

4

BeiGene:ProjectMovementsSinceQ32024Update

Newto

Newto

Newto

New

Phase1/1b

PhaseII

PivotalTrial

Submission1

Approved

BG-60366-101(EGFR-CDAC)

BGB-11417-302(BCL2i)

Zanubrutinib114

Zanubrutinib212

BG-89894(MAT2Ai)*

(tablet)inUS,CH,AU

Zanubrutinib212

(R/RFL)inIL,SG

Zanubrutinib206

BG-C477-101(CEAADC)

(R/RFL)inIL,MX,SA

(R/RMCL)inUK

BG-T187-101(EGFRxMET)

Zanubrutinib304,305(R/R&TNCLL,CLLPFS,WM)inTR;(CLL

Zanubrutinib304,305

BGB-53038-101(Pan-KRASi)BG-C137-101(FGFR2bADC)BGB-21447-102(BCL2i2G)

PFSupdate)inUY,SA,MX

Zanubrutinib214(R/RMZL)inMY

Tislelizumab302

(2LESCC)inPH,SA,TW

(R/R&TNCLL)inJP,RU;(PFSupdate)inEC,SG,RU

Zanubrutinib114

(tablet)inCA

BGB-B455-101(Claudin6xCD3)

Tislelizumab305

(1LGC)inHK,IL,MO,PH,SA

Tislelizumab306

(1LESCC)inHK,PH,SA,UK

Tislelizumab303,304,307

(1L/2LNSCLC)inHK,MO,PH,TW,SA

Tislelizumab309

(1LNPC)inEU,KR,SG

Tislelizumab312

(ES-SCLC)inEU,IS,NO

Tislelizumab315

(Neo/adjNSCLC)inEU,IS,NO

Tislelizumab-AltDosingQ4W2LESCCinUS;Q2/4WinAU;Q6WinCN

Tislelizumab302

(2LESCC)inHK,ID,MY,NZ

Tislelizumab305

(1LGC)inEU,IS,LI,NO,MO,US

Tislelizumab306

(1LESCC)inAU,EU,IS,LI,NO

Tislelizumab303,304,307

(1L/2LNSCLC)inID,NZ,UK

Tislelizumab303,307

(1Lsq/2LNSCLC)inIL

Tislelizumab312

(1LES-SCLC)inMO

Tislelizumab315

Neoadj/adjNSCLCinCN

5

AR-Argentina;AU–Australia;BR-Brazil;CA–Canada;CH–Switzerland;CN-China;EC–Ecuador;HK–HongKong;ID–Indonesia;IL-Israel;IN-India;IS-Iceland;JP–Japan;KR–SouthKorea;LI-Liechtenstein;MO–Macao;MX–Mexico;MY–Malaysia;NO-Norway;PH–Philippines;RS–Serbia;RU–Russia;SA–SaudiArabia;SG-Singapore;TH–Thailand;TR–Turkey;UK–UnitedKingdom;US–UnitedStates;UY–Uruguay;NZ–NewZealand;TW–Taiwan

?InlicensedfromCSPC

GlobalClinicalDevelopmentPipeline

Updated:26February2025

Phase1

Phase2

Phase3

Registration

SonrotoclaxBCL2i

●101B-cellmalignancies

●102B-cellmalignancies

●103AML/MDS

●105MMt(11;14)

●108Doseramp-upBGB-43395

CDK4i

●101/102BC&SolidtumorsBGB-53038

PanKRASi

●101SolidtumorsBG-C90741

B7H4ADC

●101SolidtumorsBG-60366

EGFRCDAC

●101SolidtumorsBG-58067

MTACoop.PRMT5i

●101SolidtumorsBG-898942

MAT2Ai

●101SolidtumorsBGB-45035

IRAK4CDAC

●101Immunology&InflammationBG-685013

CDK2i

●101BC&SolidtumorsBG-C354

B7H3ADC

●101SolidtumorsBG-C477

CEAADC

●101SolidtumorsBG-C137

FGFR2bADC

●101SolidtumorsBG-T187

EGFRxMETTsAb

●101Solidtumors

BGB-16673BTKCDAC

●101B-cellmalignancies

●102B-cellmalignancies

●104B-cellmalignanciesBGB-21447

BCL2i2G

●101B-cellmalignancies

●102MetastaticbreastcancerXaluritamig4STEAP1

xCD3XmAb?

●20180146mCRPCBGB-R046

IL-15prodrug

●101SolidtumorsBGB-B2033

GPC3x4-1BBBsAb

●101SolidtumorsBGB-B3227

MUC1xCD16ABsAb

●101SolidtumorsBGB-15025

HPK1i

●101SolidtumorsBGB-26808

HPK1i

●101SolidtumorsBGB-30813

DGKζi

●101SolidtumorsBGB-A3055

CCR8mAb

●101SolidtumorsBGB-24714

SMACmimetic

●101SolidtumorsTislelizumab

PD1mAb

●103SubQformulation

BGB-B455CLDN6xCD3BsAb

●101Solidtumorst

ZanubrutinibBTKi

●215B-cellmalignancies

●218CD79BR/RDLBCLBGB-16673

BTKCDAC

●101R/RCLL

●102R/RCLLSonrotoclax

BCL2i

●201R/RMCL

●202R/RCLL

●203R/RWM

●204TNCLL/SLL

Blinatumomab4CD3xCD19BiTE?

●20190359PediatricR/RBP-ALL

LBL-0075LAG3mAb

●201MSS-CRC

●2021LESCCBGB-A445

OX40mAb

●201Melanoma,UCUmbrellaStudies

IOCombos

●LC-2011LNSCLC

●LC-202NeoadjNSCLC

●HNSCC-2011LHNSCC

Tarlatamab4DLL3xCD3BiTE?

●202302733LSCLC

ZanubrutinibBTKi

●306TNMCL

●308R/RMZL,R/RFL

●309pMN

Sonrotoclax

BCL2i

●301TNCLL

●302R/RMCLtTislelizumab

PD1mAb

●3101LUBC

●314R/RcHLPamiparib

PARPi

●3022LMTxgBRCAmPSOCOciperlimab

TIGITmAb

●3021LNSCLCPDL1-highZanidatamab6

HER2BsAb

●3011LHER2+GEA

Tarlatamab4DLL3xCD3BiTE?

●202100042LSCLC

●202000411LES-SCLC

●20230016LS-SCLC

ZanubrutinibBTKi

●114Tabletformulation(US,EU,Others)

TislelizumabPD1mAb

●3121LES-SCLC(EU)

●315Neo/adjNSCLC(EU)

●3061LESCC(US,JP)

●3022LESCC(JP)

●3022LESCCaltdosing(US)

●3091LNPC(EU)

Zanidatamab6HER2BsAb

●203HER2+2LBTC(CN)

●Breast/Gyn

.GI

●Heme

Lung

●Pan-Tumor/Other

●Non-Oncology

Registrationincludesselectacceptedsubmissionsinmajormarkets.?Trialislistedonbutmaynothavesubjectsenrolled.

1)DualityBiocollaboration,2)CSPCcollaboration,3)Ensemcollaboration,4)Amgencollaboration,5)LeadsBiolabscollaboration,6)Zymeworks/Jazzcollaboration.

Pleaserefertoourmostrecent10-Kfilingforafulllistofourcommercialproducts,includingin-licensedproducts,aswellascommercialrightsandcollaborationdetails

6

12InnovativeSolidTumorNMEsEnteredtheClinicIn2024In

PriorityTumorTypeswithDiverseModalitiesandMechanisms

LungBreast/Gynecologic

GIPan-Tumor

PanKRASi

CDK4i

PanKRASi

DGKζi

MTACooperativePRMT5i

CDK2i

MTACooperativePRMT5i

HPK1i

BCL2i2G

KAT6A/B*

B7H4ADC

Claudin6xCD3

Smallmolecule

MAT2Ai

CEAADC

B7H3ADC

EGFRCDAC

EGFRxMETTsp

Proteindegrader

MAT2Ai

FGFR2bADC

CEAADC

GPC3x4-1BB

Bi/Tri-specific

mAb

Cytokinetherapy

SMACMimetic

CCR8

IL-15prodrug

MUC1xCD16A

ADC

7

BeiGenehasglobalrightsforCDK2(Ensempartnership),B7H4ADC(DualityBio

partnership),MAT2A(CSPCZhongqiPharmaceuticalTechnology);*Notyetintheclinic

BeiGene:BuildingLeadershipinSolidTumors

withInnovativeNMEs

Phase2

Phase1

Phase3

Breast/

GynecologicCancers

BGB-C9074-101B7H4-ADC

Breast(otherST)

BGB-43395-101/102CDK4i

Breast(otherST)

BGB-21447*BCL2i2G

HR+BC

BG-68501-101CDK2i

Breast(otherST)

BGB-24714-101SMAC

SolidTumors

BGB-B455

Claudin6xCD3

Gyn(otherST)?

Gastro-

intestinal

BG-53038-101Pan-KRASi

GIandlung

BGB-B2033-101GPC3x4-1BB

SolidTumors

BG-C137-101FGFR2bADC

GI

BGB-LBL-007-201LAG-3

MSS-CRC

BGB-LBL-007-202LAG-3

1LESCC

ZWI-ZW25-301

ZanidatamabHER2

1LHER2+GEA

BG-C477-101CEAADC

GIandLung

BGB-B3227-101MUC1xCD16A

LungandGI

Lung

AMG75720230298

TarlatamabDLL3xCD3

2L+SCLC(CN)

BGB-C354-101B7H3ADC

Lung,GIandHNSCC

BGB-58067-101

MTA-coopPRMT5i

LungandGI

BG-T187

EGFRxMETTsp

LungandGI

BGB-LC-201Umbrella

1LNSCLC

BGB-LC-202Umbrella

NeoadjuvantNSCLC

AMG75720230273

TarlatamabDLL3xCD3

3LSCLC(CN)

AdvanTIG-302

OciperlimabTIGIT

1LNSCLC(PDL1high)

AMG75720210004

TarlatamabDLL3xCD3

2LSCLC(CN)

AMG75720200041

TarlatamabDLL3xCD3

1LES-SCLC(CN)

AMG75720230016

TarlatamabDLL3xCD3

LS-SCLC(CN)

BG-60366-101EGFR-CDAC

Lung

BG-89894MAT2Ai

LungandGI

BGB-A3055-101CCR8

SolidTumors

BGB-R046-101Pro-IL15

SolidTumors

BGB-30813-101

DGKζ

SolidTumors

BGB-A317-A445-201BGB-A445OX40

MelanomaandUC

Pan-tumor/Other

BGB-HNSCC-201Umbrella

1LHNSCC

BGB-26808-101HPK12G

SolidTumors

AMG50920180146

XaluritamigSTEAP1xCD3

mCRPC(CN)

BGB-15025-101HPK1

SolidTumors

RefertoGlossaryabbreviations

*Additionally,inPh1inHemeindications.

8

?Trialislistedon,butmaynothavesubjectsenrolled

BeiGene:BuildingLeadershipinSolidTumorsWithLCM

BGB-A317-209

TislelizumabPD-1

LateLineMSI-HordMMR

BGB-A317-204

TislelizumabPD-1

2LUC

Phase1Phase2Phase3Approved

Breast/

GynecologicCancers

BGB-290-302

PamiparibPARPi

2L+MTxOC

BGB-290-102

PamiparibPARPi

2L+gBRCAmOC

Baituowei(Goserelin)

Breast,Prostate

Gastro-

intestinal

BGB-A317-209

TislelizumabPD-1

ResectMSI-H/dMMRCRC

BGB-A317-301

TislelizumabPD-1

1LHCC

BGB-A317-302

TislelizumabPD-1

2LESCC

BGB-A317-208

TislelizumabPD-1

2L/3L+HCC

BGB-A317-305

TislelizumabPD-1

1LGC

BGB-A317-306

TislelizumabPD-1

1LESCC

Lung

BGB-A317-304

TislelizumabPD-1

1LNon-sq.NSCLC

BGB-A317-307

TislelizumabPD-1

1LSq.NSCLC

BGB-A317-303

TislelizumabPD-1

2/3LNSCLC

BGB-A317-312

TislelizumabPD-1

1LES-SCLC

BGB-A317-309

TislelizumabPD-1

1LNPC

BGB-A317-315

TislelizumabPD-1

Neo-adj./adj.NSCLC

BGB-A317-103

TislelizumabPD-1

Subcutaneous

Pantumor/Other

BGB-A317-310

TislelizumabPD-1

1LUBC

BGB-A317-290-LTE1

MultipleBeiGeneassets

LTESolidTumors

9

RefertoGlossaryabbreviations

BeiGene:aLeaderinHematology/I&Iportfolio-InnovativeNMEs

Phase1

Phase2

Phase3

AML/MDS,

MultipleMyeloma,OtherHeme

B-Cell

BGB-11417-103

SonrotoclaxBCL2i

AML/MDS

BGB-11417-105

SonrotoclaxBCL2i

MultipleMyelomat(11;14)

BGB-11417-301

SonrotoclaxBCL2i

TNCLLcombo+zanu

BGB-21447-101BCL2i2G

B-CellMalignancies

BGB-11417-101

SonrotoclaxBCL2i

mono&combow/zanu

BGB-16673-102BTKCDAC

B-CellMalig.(China)

BGB-16673-104BTKCDAC

B-CellMalig.combos

BGB-11417-201

SonrotoclaxBCL2i

R/RMCL

BGB-11417-203

SonrotoclaxBCL2i

R/RWM

BGB-16673-101/102BTKCDAC

R/RMCL&R/RCLL

BGB-11417-202

SonrotoclaxBCL2i

CLL/SLL(China)

BGB-11417-204

SonrotoclaxBCL2i

TNCLL

BGB-11417-102

SonrotoclaxBCL2i

B-CellMalig.(China)

BGB-16673-101BTKCDAC

B-CellMalig.

BGB-11417-302

SonrotoclaxBCL2i

R/RMCL

I&I

RefertoGlossaryabbreviations

BGB-45035-101IRAK4CDAC

Healthyvolunteers

10

BeiGene:aLeaderinHematology/I&IWithLCM

Phase1

Phase2

Phase3Approved

AML/MDS,

MultipleMyeloma,OtherHeme

BLINCYTO?

CD3/CD19BiTE

PediatricR/RBP-ALL

BGB-A317-314

TislelizumabPD-1

R/RcHL(China)

BGB-3111-308

ZanubrutinibBTKi

R/RMZL,R/RFL

BGB-A317-203

TislelizumabPD-1

R/RcHL

BGB-3111-206

ZanubrutinibBTKi

R/RMCL

BGB-3111-214

ZanubrutinibBTKi

R/RMZL

B-Cell

BGB-3111-215

ZanubrutinibBTKi

Prev.BTKiTxintolerant

BGB-3111-111

ZanubrutinibBTKi

R/RCLL/SLL,WM,

MCL(JP)

BGB-3111-306

ZanubrutinibBTKi

TNMCL

BGB-3111-212

ZanubrutinibBTKi

R/RFL

BGB-3111-218

ZanubrutinibBTKi

CD79BR/RDLBCL

BGB-3111-304

ZanubrutinibBTKi

TNCLLVencombo

BGB-3111-LTE1ZanubrutinibBTKi

B-cellmalignancies

BGB-3111-302

ZanubrutinibBTKi

TNWM

BGB-3111-304

ZanubrutinibBTKi

TNCLL/SLL

BGB-3111-305

ZanubrutinibBTKi

R/RCLL/SLL

I&I

BGB-3111-309

ZanubrutinibBTKi

PMN

RefertoGlossaryabbreviations

11

Trialdetail

?BRUKINSA?(zanubrutinib)

?Sonrotoclax

?BGB-16673BTKCDAC

?TEVIMBRA?(tislelizumab)

?OtherHematologyAssets

?OtherSolidTumorAssets

?ImmunologyandInflammationAssets

12

BRUKINSA?

Foundationalassetinhematologyportfolio

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

Maintenance

BGB-3111-111Phase2NCT04172246B-CellMalignancies55TEAEsandORR

BGB-3111-215Phase2NCT04116437intolerant90TEAEsMaintenance BGB-3111-218Phase2NCT05068440CD79bR/RDLBCL66ORRMaintenance

(JP)PreviousBTKiTx-ibru/acala

BGB-3111-304Phase3NCT03336333TNCLL/SLL590VenetoclaxPFSMaintenance

BGB-3111-306Phase3NCT04002297TNMCL510RituximabPFSMaintenance

BGB-3111-308Phase3NCT05100862R/RMZLandFL750PFSEnrolling

Rituximab,

Obinutuzumab BGB-3111-LTE1Phase3NCT04170283B-CellMalignancies500TislelizumabTEAEsEnrolling BGB-3111-206Phase2NCT03206970R/RMCL86ORRApproved BGB-3111-212Phase2NCT03332017R/RNHL-FL217ObinutuzumabORRApproved BGB-3111-214Phase2NCT03846427R/RMZL68ORRApproved

BGB-3111-302Phase3NCT03053440TN&R/RWM201CR\VGPRApproved

BGB-3111-305Phase3NCT03734016R/RCLL652ORRApproved

RefertoGlossaryabbreviations

13

Sonrotoclax

Potentialbest-in-classBCL2inhibitorwithdifferentiatedprofile

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

BGB-11417-101Phase1NCT04277637B-CellMalignancies437

Zanubrutinib,Obinutuzumab

TEAEs,MTDMaintenance

BGB-11417-102

Phase1

NCT04883957

B-CellMalignancies

64

TEAEs,MTD

Maint.(CN)

BGB-11417-103

Phase1

NCT04771130

AML/MDS

260

Azacitidine

TEAEs,CR,mOR

Enrolling

BGB-11417-105

Phase1

NCT04973605

R/RMMwitht(11;14)

167

Dexamethasone,Carfilzomib

TEAEs,ORR,VGPR,CR

Enrolling

BGB-11417-201

Phase2

NCT05471843

Post-BTKiMCL

126

TEAEs,ORR

Maintenance

BGB-11417-202

Phase2

NCT05479994

Post-BTKiCLL/SLL

100

ORR

Maintenance

BGB-11417-203

Phase2

NCT05952037

R/RWM

105

Zanubrutinib

MRR

Enrolling

BGB-11417-204

Phase2

NCT06637501

TNCLL

87

Zanubrutinib

CR/CRi

Enrolling

BGB-11417-301

Phase3

NCT06073821

TNCLL/SLL

640

Zanubrutinib

PFS

Enrolling

BGB-11417-302Phase3NCT06742996R/RMCL300ZanubrutinibPFSStartUp

RefertoGlossaryabbreviations

14

BGB-16673BTKCDAC

Potentialfirst-in-classBTKdegrader

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

BGB-16673-101Phase1/2NCT05006716B-CellMalignancies466TEAEsEnrolling

BGB-16673-102

Phase1

NCT05294731B-CellMalignancies

127

TEAEs,RP2D,ORR

Enrolling

BGB-16673-104Phase1/2NCT06634589B-CellMalignancies170

Sonrotoclax,Zanubrutinib

DLTs,TEAEsEnrolling

RefertoGlossaryabbreviations

15

Phase1-OtherHematologyAssets

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

BGB-21447-101Phase1NCT05828589B-cellmalignancies85DLTs,AEs,TLSEnrolling

RefertoGlossaryabbreviations

16

TEVIMBRA?

Poisedforglobalpatientimpact

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

BGB-A317-310Phase3NCT039679771LUBC436ChemotherapyOS(ITT)Enrolling

LAG3,OX40,HPK1,Chemotherapy

ORRMaintenance

BGB-LC-201Phase2NCT056357081LNSCLC319

BGB-LC-202

Phase2

NCT05577702

Neo/adjNSCLC

120

LAG3,Chemotherapy

MPR

Maintenance

BGB-A317-103

Phase1

NCT06091943

Subcutaneousadministration

69

BioavailabilityandSafety

Maintenance

BGB-HNSCC-201

Phase2

NCT05909904

1LHNSCC

160

LAG3,TIM3

ORR

Maintenance

BGB-A317-311

Phase3

NCT03957590

LocalizedESCC

366

Chemotherapy+Radiotherapy

PFS

Maintenance

BGB-A317-312

Phase3

NCT04005716

1LES-SCLC

455

Chemotherapy

OS

Approved*

BGB-A317-315

Phase3

NCT04379635

Neo/adjNSCLC

450

Chemotherapy

MPR,EFS

Approved*

BGB-A317-203

Phase2

NCT03209973

R/RcHL

68

ORR

Approved*

BGB-A317-204Phase2NCT040042212LUC110ORRApproved*

*ApprovedonlyinChina

RefertoGlossaryabbreviations

17

TEVIMBRA?

Poisedforglobalpatientimpact

Combination

TrialPhaseCT.govPopulationTotalPatientsMolecule(s)PrimaryEndpoint(s)Status

BGB-A317-208Phase2NCT034198972L+HCC250ORRApproved*

BGB-A317-209

Phase2

NCT03736889

LateLineMSI-HordMMRSolidTumors

150

ORR

Approved*

BGB-A317-301

Phase3

NCT03412773

1LHCC

680

OS

Approved*

BGB-A317-302

Phase3

NCT03430843

2LESCC

489

OS

Approved

BGB-A317-303

Phase3

NCT03358875

2/3LNSCLC

805

OS(PDL1+),OS

Approved

BGB-A317-304

Phase3

NCT03663205

1LNon-sq.NSCLC

334

Chemotherapy

PFS

Approved

BGB-A317-305

Phase3

NCT03777657

1LGC

978

Chemotherapy

OS

Approved

BGB-A317-306

Phase3

NCT03783442

1LESCC

650

Chemotherapy

OS

Approved

BGB-A317-307

Phase3

NCT03594747

1LSq.NSCLC

342

Chemotherapy

PFS

Approved

BGB-A317-309Phase3NCT039249861LNPC263ChemotherapyPFSApproved*

*ApprovedonlyinChina

RefertoGlossaryabbreviations

18

Phase1-OtherSolidTumorAssets

Trial

BGB-290-102

Asset

Pamiparib

MOA

PARPi

Phase

Ph1

CT.gov

NCT03333915

Population

Ovarianandbreastcancer

Total

Patients

128

CombinationMolecule(s)

PrimaryEndpoint(s)

TEAE,SAE,ORR

Status

Approved

AMG50920180146

Xaluritamig

STEAP1xCD3

Ph1

NCT04221542

mCRPC

9(CN)

TEAE,DLTs

Enrolling

BGB-24714-101

BGB-24714

SMAC

Ph1

NCT05381909

SolidTumors

229

Chemotherapy

AE,TEAE,SAE,DLT,MTD,RDFE,ORR

Expansion

BGB-A317-15025-101

BGB-15025

HPK1

Ph1

NCT04649385

SolidTumors

169

Tislelizumab

AE,SAE,DLT,MTD,RDFE,ORR

Maintenance

BGB-A317-30813-101

BGB-30813

DGKζ

Ph1

NCT05904496

SolidTumors

81

Tislelizumab

TEAE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-A317-A3055-101

BGB-A3055

CCR8

Ph1

NCT05935098

SolidTumors

89

Tislelizumab

TEAE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-C9074-101

BGB-C9074

B7H4ADC

Ph1

NCT06233942

SolidTumors

89

Tislelizumab

TEAE,SAE,DLT,MTD,RDFE,ORR,RP2D

Doseescalation

BG-68501-101

BG-68501

CDK2i

Ph1

NCT06257264

SolidTumors

108

BGB-43395,Fulvestrant

AE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-C354-101

BGB-C354

B7H3ADC

Ph1

NCT06422520

SolidTumors

85

Tislelizumab

AE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-B2033-101

BGB-B2033

GPC3x4-1BB

Ph1

NCT06427941

SolidTumors

140

Tislelizumab

AE,SAE,DLT,MTD,RP2D

Doseescalation

BGB-B3227-101

BGB-B3227

MUC1xCD16A

Ph1

NCT06540066

SolidTumors

75

Tislelizumab,Chemotherapy

AE,SAE,DLT,MTD,RDFE

Doseescalation

RefertoGlossaryabbreviations

19

Phase1-OtherSolidTumorAssets

Trial

BGB-43395-101

Asset

BGB-43395

MOA

CDK4i

Phase

Ph1

CT.gov

NCT06120283

Population

SolidTumors

Total

Patients

225

CombinationMolecule(s)

Fulvestrant,Letrozole

PrimaryEndpoint(s)

AE,SAE,DLT,MTD,RDFE,ORR

Status

Doseescalation

BGB-43395-102

BGB-43395

CDK4i

Ph1

NCT06253195

SolidTumors

78

Fulvestrant,Letrozole

AE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-A317-26808-101

BGB-26808

HPK12G

Ph1

NCT05981703

SolidTumors

90

Tislelizumab

AE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BGB-R046-101

BGB-R046

IL-15prodrug

Ph1

NCT06487858

SolidTumors

74(CN)

Tislelizumab

AE,SAE,DLT,MTD,RDFE,ORR

DoseEscalation

BG-C477-101

BG-C477

CEAADC

Ph1

NCT06596473

SolidTumors

21

Chemotherapy

AE,SAE,DLT,MTD,RDFE,ORR

Doseescalation

BG-T187-101

BG-T187

EGFRxMETTsp

Ph1

NCT06598800

SolidTumors

87

AE,SAE,DLT,MTD,RDFE,ORR

DoseEscalation

BG-60366-101

BG-60366

EGFRCDAC

Ph1

NCT06685718

SolidTumors

93