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1、Redefining Global BiotechJ A N U A RY 9,2 0 2 3J.P.Morgan 41stAnnual Healthcare ConferenceJP Morgan Healthcare Conference 2023Certain statements contained in this presentation and in the accompanying oral presentation,other than statements of fact that are independently verifiable at the date hereof
2、,may constitute forward-looking statements.Examples of such forward-looking statements include statements regarding BeiGenes research,discovery,and pre-clinical and early-stage clinical programs and plans;recent clinical data for BeiGenes product candidates and approvals of its medicines;the conduct
3、 of late-stage clinical trials and expected data readouts;additional planned commercial product launches;and the advancement of and anticipated clinical development,regulatory milestones and commercialization of BeiGenes medicines and drug candidates.Actual results may differ materially from those i
4、ndicated in the forward-looking statements as a result of various important factors,including BeiGenes ability to demonstrate the efficacy and safety of its drug candidates;the clinical results for its drug candidates,which may not support further development or marketing approval;actions of regulat
5、ory agencies,which may affect the initiation,timing and progress of clinical trials and marketing approval;BeiGenes ability to achieve commercial success for its marketed medicines and drug candidates,if approved;BeiGenes ability to obtain and maintain protection of intellectual property for its tec
6、hnology and medicines;BeiGenes reliance on third parties to conduct drug development,manufacturing and other services;BeiGenes limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete
7、the development and commercialization of its drug candidates and achieve and maintain profitability;the impact of the COVID-19 pandemic on BeiGenes clinical development,commercial,regulatory and other operations,as well as those risks more fully discussed in the section entitled“Risk Factors”in BeiG
8、enes most recent periodic report filed with the SEC,as well as discussions of potential risks,uncertainties,and other important factors in BeiGenes subsequent filings with the SEC.All information in this presentation is as of the date of this presentation,and BeiGene undertakes no duty to update suc
9、h information unless required by law.Some of the clinical data in this presentation relating to BeiGenes investigational drug candidates is from pre-clinical studies or early phase,single-arm clinical trials.When such data or data from later stage trials are presented in relation to other investigat
10、ional or marketed drug products,the presentation and discussion are not based on head-to-head trials between BeiGenes investigational drug candidates and other products unless specified in the trial protocol.BeiGene is still conducting pre-clinical studies and clinical trials and,as additional patie
11、nts are enrolled and evaluated,data on BeiGenes investigational drug candidates may change.This presentation and the accompanying oral presentation contain data and information obtained from third-party studies and internal company analysis of such data and information.BeiGene has not independently
12、verified the data and information obtained from these sources.Forward-looking information obtained from these sources is subject to the same qualifications noted above.2DisclosuresOur vision is to create impactful medicines that will be affordable and accessible to far more cancer patients around th
13、e worldCANCER HAS NO BORDERS NEITHER DO WE3Founded2010BeiGeneGlobalBeiGene4Numbers as of December 2022 except cash balance as of Q3 2022 and YoY product revenue growth for Q3 2022 YTD 40 offices,9,000+colleagueson 5 continents$1B+in annual product revenue+109%product revenue growth$5B+cash balance3,
14、500+global commercial team16 approved products950+oncologyresearch team2,700 global clinical development&medical affairsteamIn-house manufacturing plus U.S.expansion under construction 60+pre-clinical programs,the majority with first-in-class potential50 assets in clinical and commercial stages20 in
15、dustrycollaborationsJP Morgan Healthcare Conference 20235Truly Unique with Hard to Replicate Competitive Advantages Truly global commercial footprint(3,500+)Driving broader access to medicines,with expected rapidly growing revenue and near-term potential milestonesFinancial strength,disciplined inve
16、stments,and operational effectiveness Contributing to long-term value creationCost and time advantaged clinical development Due to unique approach more globally inclusive,superior technology,pre-dominantly internal(CRO-free)Cornerstone commercial medicines that are key to combinations for future,com
17、plemented by a strong,deep,and innovative clinical portfolioOne of the worlds largest oncology research teams(950+)Validated by clinical results,global approvals,and major global pharma collaborationsDeep Oncology Research Expertise With Proven Track Record of InnovationScience-driven culture from i
18、nceptionOne of the largest and most productive oncology research teams,with lower cost and higher efficiencyStrength and quality validated by clinical results,global approvals,and major pharma/biotech partnerships that have generated$1.4 billion collaboration feesProlific first decade and expect 10+
19、INDs per year starting in 20246Well positioned to expand partnerships and drive collaboration success JP Morgan Healthcare Conference 2023BTK-Higher exposure,better selectivity,targeted inhibitionPD-1-Fc function silencedTIGIT-Intact Fc function,first waveBCL2-Higher potency,increased selectivity,an
20、d shorter half lifeBTK Degrader-Potentially first-in-class,eliminates both kinase and non-kinase function of BTK,should inhibit BTKi resistant strainsOX-40-Only OX-40 Ab not interfering with OX-40 ligand bindingHPK-1-Potentially first-in-class intracellular checkpoint inhibitorCEA-41BB-Potentially f
21、irst-in-class immune activator,converting immune cold tumor to hotDifferentiated Biological Hypothesis and First-in-Class Programs Based on Deep Oncology Insights from the Bench7Differentiatedbiological hypothesisPotential first-in-class,or first waveJP Morgan Healthcare Conference 20238 8Productive
22、 Research and Path to Global Oncology Leadership Prolific First DecadeEntering a New Era of Discovery2016-2020TIM-3TIGITBCL-2OX40PI3Kd*Approved 2019-2021SM,Small Molecule;mAb,Monoclonal Antibody;ADC,Antibody Drug Conjugate;TAA,Tumor Associated Antigen;CDAC,Chimeric Degradation Activating Compound(ta
23、rgeted protein degradation);BsAb,Bispecific Antibody;TsAb,Trispecific Antibody;CAR-NK,Chimeric Antigen Receptor-Natural Killer Cell2013-2015BRAFBTK*PARP*PD-1*2021-2023HPK-1TYK2SMAC mimetic BTK-Targeted CDAC(Chimeric Degradation Activating Compound)CEA x 4-1BB bispecific2024+10 New Moleculesin the Cl
24、inicExpected Annually4+NMEs in 2023SM and mAb:20+New programsADC:10+TAAsPro-CytokineCDAC:Total 7+programsBsAb/TsAb:10 new programsmRNA TherapyCell therapy:CAR-NK and moreInternal Clinical Development Enables BeiGeneto Build Unique Competitive AdvantagesPredominantly internalLargely CRO-freeOperating
25、 at sites and geographies where CROs are not present or strongInherent cost advantageBroader globally,in 45+countries and growing,with an internal team of 2,700Advanced technology and operational excellenceOne of few highly experienced late-stage global oncology biotechs15 global phase 3 registratio
26、n trials conducted35+filed or potentially registration-enabling trials110+clinical trials initiated20,000+subjects enrolled9JP Morgan Healthcare Conference 202310Unique Model Drives Speed,Cost,and Quality Advantages Ociperlimab(TIGIT)2 Phase 3 and 5 Phase 2 proof of concept studies initiated within
27、2 years of entering clinic Faster enrollment due to geographic reach(45+countries)Already achieved 30%cost savings through:More inclusive enrollment in sites with lower costs Faster trial completion lowers cost across all sites Lower cost internally vs CROs Best-in-class clinical and quality managem
28、ent systems 30+satisfactory inspections by FDA,EMA,Swissmedic,China NMPA,Korean MFDA,Italian AIFA,and global partnersCostBeiGenes strategy is to dramatically reduce the cost and time of clinical trials,which account for over 75%1of the cost and time of delivering medicines to patients 1.DiMasi JA,Gr
29、abowski HG,Hansen RA.Innovation in the pharmaceutical industry:new estimates of R&D costs.Journal of Health Economics 2016;47:20-33.QualitySpeedCornerstone CommercialMedicinesComplemented by Deep and Innovative Clinical PortfolioTwo strong commercial cornerstone medicines backbone for combinationsBR
30、UKINSATislelizumabComplemented by a broad portfolio of additional medicinesTIGITBCL2BTK DegraderOX-40HPK-1CEA-41BB11JP Morgan Healthcare Conference 202312BRUKINSA Superiority to Ibrutinib Core to Hematology Franchise*Superior to ibrutinib in ORR&PFS for R/R CLL in ALPINE trial.*Pending approval in t
31、he U.S.,January 2023 PDUFAComplete and sustained target inhibition in disease originating tissuesMaintains therapeutic concentrations over 24 hoursEqually or more selective than any approved BTKiBest-in-Class Hypothesis35trials across 28marketsTwo head-to-head studies versus ibrutinib 800+subjects P
32、ositioned to have most comprehensive label of any next generation BTKi(CLL*,MCL,WM,MZL)Broad Global Clinical Program 4,800+SubjectsFirst and only BTKi to demonstrate superior efficacy versus ibrutinib ORR and PFSFavorable safety versus ibrutinib with improved cardiac profile-Afib,and 0%vs 1.9%sudden
33、 cardiac death in AlpineDosing flexibility QD/BIDDemonstrating Clinical Advantages13ALPINE:BRUKINSA PFS&ORR Superiority to Ibrutinib in R/R CLL/SLL 2022 ASH Late Breaker&Concurrent NEJM ManuscriptBRUKINSA PFS by IRC Significantly Superior toIbrutinibBRUKINSA Improved PFS in Patients with del(17p)/TP
34、53mutData cutoff:8 Aug 2022.Brown J et al.NEJM 2022.DOI:10.1056/NEJMoa2211582JP Morgan Healthcare Conference 2023CR+VGPR rates by investigator were 36.3%(BRUKINSA)vs 25.3%(ibrutinib)14ASPEN:Efficacy of BRUKINSA vs Ibrutinib in Patients with WMData cutoff:October 31,2021.Tam CS et al.Poster presented
35、 at ASCO 2022.Abstract 7521Progression-Free SurvivalJP Morgan Healthcare Conference 202315PFS for BRUKINSA Treated Patients with R/R CLL or MCLR/R MCL2R/R CLL/SLL1Median PFS=61.4 months(95%CI:(50.4,NE)Median PFS=33.0 months(95%CI:19.4-NE)90.6%58.3%1.Cull G et al.BJH.2021 doi:10.1111/bjh.17994 2.Song
36、 Y et al.Blood.2022.139(21):31483158.2JP Morgan Healthcare Conference 202316PFS for BRUKINSA Treated Patients with R/R MZL or FLMedian PFS=27.4 months(95%CI:16.1,NE)Median PFS=NE months(95%CI:27.6,NE)70.9%55.7%R/R MZL1BRUKINSA+Obinutuzumab in R/R FL21.Opat S et al.Oral presentation presented at ASH
37、2022.Abstract 234 2.Zinzani et al.Poster presented at ASCO 2022.Abstract:7510.JP Morgan Healthcare Conference 2023JP Morgan Healthcare Conference 2023*Cardiac deaths.One death not listed due to myocardial infarction with ibrutinib discontinuation due to diarrhea 14 days prior to the fatal event.Lowe
38、r rate of serious cardiac adverse events reported with BRUKINSA Fatal cardiac events:BRUKINSA,n=0(0%)Ibrutinib,n=6(1.9%)Data cutoff:8 Aug 2022ALPINE:BRUKINSA-Lower Rates of Serious Cardiac Events,Treatment Discontinuation Due to Cardiac AEs&No Fatal Cardiac EventsBRUKINSA(n=324)Ibrutinib(n=324)Serio
39、us cardiac adverse events6(1.9%)25(7.7%)Cardiac adverse events leading to treatment discontinuation1(0.3)14(4.3)Ventricular extrasystoles1(0.3)0Atrial fibrillation05(1.5)Cardiac arrest02(0.6)*Cardiac failure02(0.6)Cardiac failure acute01(0.3)*Congestive cardiomyopathy01(0.3)*Myocardial infarction01(
40、0.3)*Palpitations01(0.3)Ventricular fibrillation01(0.3)173 deaths occurred within 4 months of ibrutinib initiation(all with cardiac comorbidities)3 deaths occurred 2-3 years after ibrutinib initiation,1 in a patient without any previous cardiac history18Pooled Safety Data:Cardiovascular Disorders in
41、 Patients with B-Cell Malignancies-BRUKINSA(10 Trials)or Ibrutinib(ASPEN&ALPINE)Data cutoff:March 31,2021.aIncluding ventricular tachyarrhythmia(SMQ narrow),ventricular arrhythmias and cardiac arrest(high-level term MedDRA v24.0).bSymptomatic idiopathic ventricular arrhythmia was defined as a ventri
42、cular arrhythmia occurring in structurally normal hearts in the absence of myocardial scarring as well as active infections and grade 2 per CTCAE.cIncluding hypertension(SMQ narrow).dPooledanalysis of 10 clinical studies of zanubrutinib.1*p0.05 for EAIR difference between treatments.Tam et al.LL&M 2
43、022.Abstract 1324736.CategoryPooled analysisB-cell malignanciesdBRUKINSA(N=1550)Ibrutinib(N=422)Median treatment duration,months26.6419.96Any cardiovascular AE,n(%)Atrial fibrillation/flutter*60(3.9)60(14.2)EAIR:0.13 vs 0.82 person-month(p 0.0001)Ventricular arrhythmia(grade 2)a11(0.7)6(1.4)Symptoma
44、tic Idiopathic(grade 2)b5(0.3)*6(1.4)*EAIR:0.14 vs 0.87 per 100 person-years(p=0.0028)Hypertensionc,*225(14.5)85(20.1)Any cardiovascular medical history,n(%)Atrial fibrillation/flutter101(6.5)26(6.2)Ventricular arrhythmiaa14(0.9)1(0.2)Hypertensionc669(43.2)206(48.8)JP Morgan Healthcare Conference 20
45、23BeiGenes Global Internal Discovery Pipeline Asset ProgramPhase 1Phase 2Phase 31L and R/R WMR/R CLL/SLLMature B-cell malignanciesR/R MZL+rituximab1L MCL and R/R MZL+CYP3A inhibitorsB-cell malignancies+/-venetoclax(Bcl-2 inhibitor)1L CLL/SLL+obinutuzumab(anti-CD20)R/R FL2L advanced ESCC,1L HCC,2L/3L
46、 NSCLCPreviously treated HCC,R/R cHL+chemotherapy1L advanced ESCC,1L GC/GEJC+zanidatamab(anti-HER2 bi-specfic antibody)+chemotherapyGEA+surufatinib(VEGFR,FGFR,CSF-1R inhibitor)Solid tumors+fruquintinib(VEGFR)*Solid tumors1L PD-L1 high NSCLC2L PD-L1+ESCC2/3 L Cervical cancerSolid tumors+tislelizumab+
47、chemotherapy1L NSCLC1L unresectable NSCLC1L LS-SCLC Surzebiclimab (BGB-A425,anti-TIM-3)+tislelizumabSolid tumors BGB-A445(anti-OX40)+tislelizumabSolid tumors+tislelizumabSolid tumors+/-zanubrutinibB-cell lymphoid malignancies+/-tislelizumabB-cell malignancies BGB-15025(HPK1 inhibitor)+tislelizumabSo
48、lid tumors monotherapy1L maintenance platinum-sensitive GC+temozolomideSolid tumors BGB-3245(BRAF inhibitor)monotherapySolid tumors with BRAF mutations Lifirafenib(RAF inhibitor)+mirdametinib(MEK inhibitor)Solid tumors+/-zanubrutinibMature B-cell malignancies monotherapyR/R MCL+azacitidine+/-posacon
49、azoleMyeloid malignancies+dexamethasone+/-carfilzomibR/R multiple myeloma with t(11;14)BGB-16673 (BTK-targeted CDAC)monotherapyB-cell malignancies BGB-23339(TYK2 inhibitor)*monotherapyInflammation and immunology BGB-24714(SMAC mimetic)+/-chemotherapySolid tumors BGB-B167(CEA x 4-1BB bispecific)+/-ti
50、slelizumabSolid tumors BGB-11417(Bcl-2 inhibitor)BGB-10188(PI3K inhibitor)Pamiparib(PARP 1/2 inhibitor)Zanubrutinib (BTK inhibitor)monotherapy Tislelizumab (anti-PD-1)monotherapy Ociperlimab(anti-TIGIT)+tislelizumab +tislelizumab+concurrent chemoradiotherapyFor our full pipeline,including single-cou
51、ntry trials,please visit in the U.S.;*First-in-human trial,healthy subjects;This combination is beingstudied in the third cohort of NCT03336333.As of January 2023.As of January 5,2023JP Morgan Healthcare Conference 2023 Molecule/Asset Indications Phase Commerical Rights Sotorasib(KRAS G12C)Solid tum
52、ors,CRC,NSCLC Phase 3 China tarlatamab(DLL3)SCLC Phase 2 China acapatamab(PSMA)Prostate Cancer,NSCLC Phase 1 China AMG 176(Mcl-1,SM)Hematologic malignancies Phase 1 China AMG 427(FLT3)AML Phase 1 China AMG 509(STEAP1 XmAb2+1 T-cell engager)Prostate cancer Phase 1 China AMG 199(MUC17)GC/GEJC Phase 1
53、China AMG 650(oral small molecule)Solid tumors Phase 1 China AMG 256(Anti-PD-1 x IL21 mutein)Solid tumors Phase 1 China Sitravatinib(multi-kinase inhibitor)+Tislelizumab NSCLC Phase 3 Asia ex-Japan,Australia,New Zealand Sitravatinib(monotherapy)+Tislelizumab HCC,GC/GEJC Phase 2 Asia ex-Japan,Austral
54、ia,New Zealand Sitravatinib(monotherapy)+Tislelizumab Solid tumors Phase 1 Asia ex-Japan,Australia,New Zealand Zanidatamab(HER2,bispecific antibody)+Chemotherapy+Tislelizumab GEA Phase 3 Asia ex-Japan,Australia,New Zealand Zanidatamab(monotherapy)BTC Phase 2 Asia ex-Japan,Australia,New Zealand Zanid
55、atamab+Chemotherapy+/-Tislelizumab BC,GC,GEA Phase 2 Asia ex-Japan,Australia,New Zealand ZW49(HER2,bispecific ADC)HER2 expressing cancers Phase 1 Asia ex-Japan,Australia,New Zealand BGB-32451(BRAF)Solid tumors Phase 1 Asia ex-Japan SEA-CD70(anti-CD70)MDS,AML Phase 1 Asia ex-Japan,Australia,New Zeala
56、nd DKN-01(DKK1)+Tislelizumab Chemotherapy GC/GEJC Phase 2 Option for Asia ex-Japan,Australia,New Zealand LBL-007(anti-LAG-3)+Tislelizumab Advanced solid tumors Phase 2 Ex-China ABI-H3733(HBV core inhibitor)Chronic hepatitis B virus Phase 1 China20Pipeline from Collaborations BiTE molecule,Half-life
57、extended BiTE XmAb is a registered trademark of Xencor,Inc.Mirati is also conducting its own clinical studies with sitravatinib,including the Phase 3 SAPPHIRE trial in non Sq NSCLC,ZW25,*Assembly is conducting Phase 2 triple combination studies with VBR and a Phase 1 study of ABI-H3733,1 By MapKure,
58、a JV with SpringWorks.JP Morgan Healthcare Conference 2023JP Morgan Healthcare Conference 202321Growing Commercial Portfolio:16 Approved AssetsProductOur Commercial Rights&Regulatory StatusPartnerGlobal|Approved in more than 60 markets including U.S.,China,EU and other marketsOutside North America,J
59、apan,UK,AU,EU and six other European countries|Approved in China BLA Accepted in U.S.4 MAA accepted in EU5Global|Approved in ChinaMainland China|Approved in ChinaMainland China|Approved in ChinaMainland China|Approved in ChinaMainland China|Approved in ChinaMainland China|Approved in ChinaGreater Ch
60、ina|Approved in ChinaMainland China|Approved in ChinaPOBEVCY(Avastin biosimilar)Greater China|Approved in ChinaTAFINLAR(dabrafenib)China Broad Markets7|Approved in ChinaMEKINIST(trametinib)China Broad Markets7|Approved in ChinaVOTRIENT(pazopanib)China Broad Markets7|Approved in ChinaAFINITOR(everoli
61、mus)China Broad Markets7|Approved in ChinaZYKADIA(ceritinib)China Broad Markets7|Approved in ChinaTislelizumab1.Approved under accelerated approval.Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.2Conditionally ap
62、proved.The full approval of any particular indication will depend on the results of required post-marketing study(ies).3.The approval is applicable to all 27 EU member states,plus Iceland,Lichtenstein and Norway.4.For patients with unresectable recurrent locally advanced or ESCC after prior systemic
63、 therapy.5.For patients with advanced or metastatic ESCC after prior systemic chemotherapy and for patients with NSCLC including:locally advanced or metastatic NSCLC after prior chemo,in combination with chemo for 1L advanced or metastatic squamous NSCLC,and in combination with chemo for 1L locally
64、advanced or metastatic non-squamous NSCLC with no EGFR or ALK positive mutations.6.Following progression on or after vascular endothelial growth factor(VEGF)-targeted therapy.7.Rights to promote and market in Chinas broad markets pursuant to a Market Development Agreement with an affiliate of Novart
65、is Pharma AG.JP Morgan Healthcare Conference 2023JP Morgan Healthcare Conference 202322Broad Based Strategic PartnershipsOncology pipeline assetsChina Rights to Commercial ProgramsAPAC/Asia Rights to Pre-clin/Clinical ProgramsClinical CollaborationGlobal CollaborationJV with SpringWorksPlatform Lice
66、nseAcquired by Recordati(2021)Tisle&TIGITTransformational CollaborationsClinical CollaborationsIn-Licensed Assets3,500+Global Commercial Team Positioned for Success in Largest MarketsEstablished and growing presence in China,North America,and Europe+109%YOY product revenue growth to$916M in Q3 YTD 2
67、022Building commercial infrastructure in Asia-Pacific,including Japan,and ROWOpportunities to expand revenue by leveraging commercial infrastructure globally to drive collaboration successTopline momentum expected to continue as pace of global launches accelerates with CLL approvals23JP Morgan Healt
68、hcare Conference 202324BRUKINSA:Now Approved in Over 60 Markets12United StatesChinaNicaraguaOmanParaguayPeruPhilippinesQatarSouth KoreaSwitzerlandUruguayArgentinaBahrainDominican RepublicEl SalvadorGuatemalaHondurasHong KongKuwaitLiechtensteinMexicoAustraliaAustriaBelgiumBrazilBulgariaFinlandGermany
69、GreeceHungaryIcelandIrelandIsraelItalyLatviaLithuaniaLuxembourgMaltaNorwayPolandPortugalRepublic of CyprusRomaniaRussiaSaudi ArabiaScotlandSingaporeSlovakiaSloveniaSwedenThe NetherlandsUAEWalesCanadaChileCroatiaCzech RepublicEcuadorEnglandEstonia20022JP Morgan Healthcare Conference 202360
70、+40+JP Morgan Healthcare Conference 202325Potential for Substantial BRUKINSA GrowthBRUKINSA Global Product Revenues$20.4B BTKi Global Market by 2026*Current BRUKINSA label addresses 15%of the global market,significant expansion with CLL*Deutsche Bank Report 2022,*pending approval in the U.S.*JP Morg
71、an Healthcare Conference 202326Tislelizumab Well Positioned for Global SuccessPD-1 represents the largest and growing oncology classFuture success in combination therapies,and BeiGene well positioned with robust IO pipelineTisle successfully achieved#1 value market share in China despite late to mar
72、ket;future filings in ROWExpect pending inspections to proceed in China and clear way for approvals in U.S.Eligible for$1.5 billion collaboration revenue from Novartis in NA,EU,Japan20212022e2023e2024e2025e2026eUSROW$38B$43B$32B$47B$51B$55B$55B PD-1/PD-L1 Class Global Market by 2026*Source:Cowen glo
73、bal PD-1/PD-L1 market estimate,September 2022Financial Strength,Discipline,and Operating Leverage to Accelerate Growth$5.1B cash position at Q3 2022Substantial revenue growth and meaningful operating leveragePoised to accelerate global product revenue growth with anticipated CLL approvals Eligible f
74、or up to$3.6B*collaboration revenueProduct revenue growth significantly outpacing operating expense growth,driving operating leverage*$3.6B collaboration revenue includes regulatory and commercial milestones and option exercise for TIGIT(up to$700M by end of 2023)27Rigorous financial disciplineCommi
75、tted to diligent financial investments and operational efficiencies to drive long-term value JP Morgan Healthcare Conference 2023282023 Milestones and Catalysts BRUKINSA(zanubrutinib,BTK Inhibitor)Tislelizumab(anti-PD-1 Ab)FDA decision on sNDA for treatment of CLL/SLL(PDUFA)Regulatory submissions in
76、 US and EU for PFS superiority vs.ibrutinib in R/R CLL-ALPINEApproval in China for TN CLL/SLLApprovals in Canada and Australia for CLL/SLL1H 20232H 2023ApprovalRegulatory submissionApprovalApprovalApprovalApprovalApprovalApprovalRegulatory submissionRegulatory submissionRegulatory submissionRegulato
77、ry decision in US for 2L ESCC,in collaboration with Novartis*Approvals in China for 1L GC&1L ESCCApprovals in Australia for NSCLC&2L ESCCSBLA submission in China for 1L ES-SCLC&gastric cancerApprovals in EU for NSCLC&2L ESCC,in collaboration with NovartisSubmissions in US for 1L gastric cancer&1L ES
78、CC/in EU for 1L gastric cancer,1L ESCC&1L NPC,in collaboration with NovartisBLA submission in Japan for 1L/2L ESCCApprovals in China in 1L HCC*Pending regulatory inspectionsJP Morgan Healthcare Conference 2023292023 Milestones and Catalysts(contd)Ociperlimab(anti-TIGIT Ab)BGB-11417(BCL-2)Ph2 data av
79、ailable in multiple indications to inform subsequent developmentComplete enrollment in Ph3 AdvanTIG 302 in 1L NSCLCInitiate global pivotal trial in 1L CLL in combo with BRUKINSAData readouts from ongoing studies1H 20232H 2023Study progressStudy readoutData readoutData readoutStudy progressData reado
80、utBGB-A445(anti-OX40)BGB-15025(HPK1 inhibitor)LBL-007(anti-LAG-3)BGB-16673(BTK Degrader)Data readoutStudy progressStudy progressStudy progressAdditional Early ProgramsInitial data readout on from Phase I studyRP2D for both monotherapy and combination trialsRP2D for both monotherapy followed by initi
81、ation of dose expansion combination with tizlelizumabRP2D for combination trialsInitiate 15 novel IO combos across 6 trials with tislelizumab including LAG3,OX40,TIM3,TIGIT,and HPK1,targeting multiple new tumor types including HNSCC,CRC,UBC,RCC,melanomaJP Morgan Healthcare Conference 202330Positione
82、d for an Exciting 2023 and BeyondLaunch Executionwith BRUKINSA CLL rolloutPipeline AdvancementBCL2BTK DegraderOX40TIGITFinancial Disciplinewith operating efficienciesRedefining Global Biotech500,000+Patients31JP Morgan Healthcare Conference 2023AbbreviationMeaningAbbreviationMeaningADC Antibody drug
83、 conjugateMZL Marginal zone lymphomaAE Adverse eventNA Not assessedALK Anaplastic lymphoma kinaseNE Not evaluableBID Bis in dieNME New molecule entity BLA Biologics license applicationNPC Nasopharyngeal carcinomaBRAF B-rapidly accelerated fibrosarcomanPR Nodular partial responseBsAb Bispecific antib
84、odyNSCLC Non-small cell lung cancerCAR-NK Chimeric antigen receptor-natural killer cellORR Overall response rateCDAC Chimeric degradation activating compoundOS Overall survivalCI Confidence interval PBMC Peripheral blood mononuclear cellCLL Chronic lymphocytic leukemiaPD Progressive diseaseCR Comple
85、te responsePFS Progression-free survivalCRi Complete response with incomplete bone marrow recoveryPR Partial responseCTCAE Common terminology criteria for adverse eventsPR-L Partial response with lymphocytosisDC Discontinued prior to first assessmentQD Quaque dieERK Extracellular-signal regulated ki
86、nase R/R Relapsed/refractoryHCC Hepatocellular carcinomaSD Stable responseHR Hazard ratioSLL Small lymphocytic lymphomaITT Intent to treatSM Small moleculemAb Monoclonal antibodySMAC Second mitochondrial-derived activator of caspase MCL Mantle cell lymphomaSMQ Standardized MedDRA queryMedDRA Medical
87、 Dictionary for regulatory activitiesTAA Tumor associated antigenMEK Mitogen-activated protein kinase(aka MAPK)TsAb Trispecific antibodyMSI Microsatellite instability-highUC Urothelial carcinomamTOR Mammalian target of rapamycinVEGFR Vascular endothelial growth factor receptorWM Waldenstrms macroglobulinemiaAbbreviations