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1、1This presentation is for investor relations purposes only Not for product promotional purposesThis presentation is for investor relations purposes only Not for product promotional purposesLegend Biotech Corporate PresentationJANUARY 20242This presentation is for investor relations purposes only Not

2、 for product promotional purposes2DisclaimerThis presentation has been prepared by Legend Biotech Corporation(“Legend Biotech”or the“Company”)solely for information purpose and does not contain all relevant information relating to the Company.The safety and efficacy of the agents and/or uses under i

3、nvestigation discussed in this presentation have not been established,except to the extent specifically provided by marketing authorizations previously received from relevant health authorities.Further,for investigational agents and/or uses,the Company cannot guarantee health authority approval or t

4、hat such agents and/or uses will become commercially available in any country.Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies,publications,surveys and other data obtained from third-party sources and Legend Biot

5、echs own internal estimates and research.While Legend Biotech believes these third-party sources to be reliable as of the date of this presentation,it has not independently verified,and makes no representation as to the adequacy,fairness,accuracy or completeness of,any information obtained from thir

6、d-party sources.While Legend Biotech believes its internal research is reliable,such research has not been verified by any independent source.Statements in this presentation about future expectations,plans and prospects,as well as any other statements regarding matters that are not historical facts,

7、constitute“forward-looking statements”within the meaning of The Private Securities Litigation Reform Act of 1995.These statements include,but are not limited to,statements relating to Legend Biotechs strategies and objectives;statements relating to CARVYKTI,including Legend Biotechs expectations for

8、 CARVYKTI,including manufacturing expectations for CARVYKTI;and statements about regulatory submissions for CARVYKTI,and the progress of such submissions with the FDA,the EMA and other regulatory authorities;and expected results and timing of clinical trials;Legend Biotechs expectations for LB2102 a

9、nd its potential benefits;Legend Biotechs ability to close the licensing transaction with Novartis and potential benefits of the transaction;Legend Biotechs expectations on advancing their pipeline and product portfolio;and the potential benefits of Legend Biotechs product candidates.The words“antic

10、ipate,”“believe,”“continue,”“could,”“estimate,”“expect,”“intend,”“may,”“plan,”“potential,”“predict,”“project,”“should,”“target,”“will,”“would”and similar expressions are intended to identify forward-looking statements,although not all forward-looking statements contain these identifying words.Actual

11、 results may differ materially from those indicated by such forward-looking statements as a result of various important factors.Legend Biotechs expectations could be affected by,among other things,uncertainties involved in the development of new pharmaceutical products;unexpected clinical trial resu

12、lts,including as a result of additional analysis of existing clinical data or unexpected new clinical data;unexpected regulatory actions or delays,including requests for additional safety and/or efficacy data or analysis of data,or government regulation generally;unexpected delays as a result of act

13、ions undertaken,or failures to act,by our third party partners;uncertainties arising from challenges to Legend Biotechs patent or other proprietary intellectual property protection,including the uncertainties involved in the U.S.litigation process;competition in general;government,industry,and gener

14、al product pricing and other political pressures;the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation;as well as the other factors discussed in the“Risk Factors”section of Legend Biotechs Annual Report on Form 2

15、0-F filed with the Securities and Exchange Commission(SEC)on March 30,2023 and Legend Biotechs other filings with the SEC.Should one or more of these risks or uncertainties materialize,or should underlying assumptions prove incorrect,actual results may vary materially from those described in this pr

16、esentation as anticipated,believed,estimated or expected.Any forward-looking statements contained in this presentation speak only as of the date of this presentation.Legend Biotech specifically disclaims any obligation to update any forward-looking statement,whether as a result of new information,fu

17、ture events or otherwise.3This presentation is for investor relations purposes only Not for product promotional purposesLegend Biotech HighlightsYears Since Inception9Employees1,800+Core Technologies:CAR-T,including universal CARCAR-NKgd T33Global Manufacturing Sites for CARVYKTI:1 site in US2 sites

18、 in EU(Ghent)42 sites in China41 Novartis site(CMO)6 Pipeline Programs Covering:Hematologic malignanciesSolid tumors8$1.4 Bnin Cash and Cash Equivalents,Deposits,and Short-Term Investments51.In collaboration with J&J;2.Please read Prescribing Information for full safety information:https:/ delta T c

19、ells;4.EU and China manufacturing site construction is in progress;5.As of September 30,20231 Marketed Product:CARVYKTI(ciltacabtagene autoleucel;cilta-cel)1,2One of the earliest companies to engineer CAR-T cells for the BCMA protein300 Dedicated to R&D4This presentation is for investor relations pu

20、rposes only Not for product promotional purposesKey Milestones Achieved Key MilestonesJanssen collaborationWorldwide collaboration and licensing agreement for LCAR-B38M/JNJ-4528 signed*Legend Founded in 2014Legend Biotech incorporated1st MM Patient1st Multiple Myeloma patient treated in China with a

21、 BCMA CAR-TUS INDFor Phase 1b/2 clinical trial of cilta-cel cleared by FDABelgium ManufacturingState-of-the-art manufacturing facility announced in BelgiumEU PRIME DesignationFor cilta-cel granted by EMABreakthrough DesignationFor cilta-cel received from US FDABLA/MAA AcceptedBLA/MAA filing accepted

22、 for cilta-cel and granted priority review by US FDA and EMANasdaq IPOLegend Biotech accomplishes IPO raising$487 millionBreakthrough DesignationFor cilta-cel granted by China Center for Drug EvaluationChina INDFor registrational trial of LCAR-B38M CAR-T cells cleared by NMPA in China2002

23、0201920212022CARVYKTI Granted Conditional Approval by the European CommissionCARVYKTI(ciltacabtagene autoleucel,cilta-cel)granted Conditional Approval by the ECLB1908 INDCleared by the U.S.FDA for the treatment of gastric and esophageal cancerCARVYKTI Approved by Japans MHLW CARVYKTI(ciltacabtagene

24、autoleucel,cilta-cel)was approved Japans Ministry of Health,Labour and Welfare(MHLW)CARVYKTI Approved by the US FDACARVYKTI(ciltacabtagene autoleucel,cilta-cel)was approved by the U.S.FDA.LB2102 INDCleared by the U.S.FDA for the treatment of extensive stage small cell lung cancer.2023CARTITUDE-4 Pha

25、se 3 Data Presented at ASCOCiltacabtagene autoleucel(cilta-cel)reduced risk of disease progression or death by 74%vs standard regimens for adult patients with RRMM,1-3 lines of prior therapy and refractory to lenalidomide1$785 Million in Gross ProceedsRaised in a registered direct offering and priva

26、te placementssBLA/Type II Variation AcceptedsBLA and Type II variation for CARVYKTI accepted by US FDA and EMA,respectively.FDA set the PDUFA target date for the CARVYKTI sBLA to April 5,2024.1Dhakal et al.ASCO Annual Meeting;June 2-6,2023;Chicago,Il&Virtual;Abstract#LBA106Novartis DealEntered into

27、an exclusive,global license agreement with Novartis Pharma AG for certain Legend Biotech CAR-T cell therapies targeting DLL35This presentation is for investor relations purposes only Not for product promotional purposesCARVYKTI Uptake ContinuesCARVYKTINet Product Sales($MM)U.S.QoQ growth of 23%prima

28、rily driven by:Successful launch executionDeepening market shareCapacity improvementsIncreased number of activated U.S.treatment sites to 64EU QoQ growth of 300%due to launch in GermanyContinued market penetration,geographic expansion,and population in earlier lines of treatment represent significan

29、t growth drivers and opportunity+176%growth vs Q322 U.S.EU245555700Q2 2022Q3 2022Q4 2022Q1 2023Q2 2023Q3 2023YOY GROWTHQ323 OVER Q223 GROWTHU.S.155%23%EUN/A300%GLOBAL176%30%6This presentation is for investor relations purposes only Not for product promotional purpose

30、sA New Standard for CAR-T Launches CARVYKTI-INDUSTRY LEADING EARLY LAUNCH PERFORMANCEFIRST SIX QUARTERS OUTPERFORMING HISTORICAL CAR-T LAUNCHES20500300350400Q1Q2Q3Q4Q5Q6Q7Q8Q9Q10Q11Q12Q13Q14Q15Q16Q17Q18Q19Q20Q21Q22Q23Q24WORLDWIDE SALES OF CAR-T THERAPIES,BY QUARTER OF LAUNCH(IN

31、$MM)KymriahYescartaTecartusBreyanziAbecmaCarvykti391Quarters since launchQuarterly sales($MM)Data Source:Companies public filings.7Pioneer and Leader in Cell Therapy8This presentation is for investor relations purposes only Not for product promotional purposesA Fully Integrated Global Leader in Cell

32、 TherapyMANUFACTURING EXPERTISE DEVELOPED THROUGH GLOBAL COLLABORATION WITH J&J*COMPELLING MM PROGRAM AND AN INNOVATIVE PIPELINECilta-cel demonstrates consistently deep and durable responses across clinical trials with a manageable safety profile De-risked Phase 3 Programs present opportunities to u

33、nlock value in earlier line MM indications Additional pre-/early clinical stage programs targeting both hematologic and solid tumor indicationsCilta-cel development collaboration combines Legends leadership in cell therapy with J&Js*expertise in global drug development Expanding manufacturing capaci

34、ty in the US and China and building large-scale manufacturing facilities in the EUINTEGRATED CELL THERAPY PLATFORMIn-house antibody generation and CAR-T specific functional screening technologiesEarly clinical proof-of-concept,working with KOLs in China,the US and globallyAutologous and allogeneic p

35、latforms enable sustainable growth and scalability to address future commercial demandStrong intellectual property positionKOL,key opinion leaders*Legal entity to the agreement is Janssen Biotech,Inc.;collaboration established in December 2017MARKET-LEADING MULTIPLE MYELOMA(MM)CAR-T THERAPYsBLA and

36、Type II variation to support label expansion accepted by U.S.FDA(PDUFA target action date of April 5,2024)and EMA,respectivelyApplication supported by first randomized Phase 3 study for cilta-cel use as early as 2L9This presentation is for investor relations purposes only Not for product promotional

37、 purposesGlobal R&D StrategyInstitutional R&D Model that accelerates Cell Therapy Discovery and DevelopmentPeople:300 employeesOne of the largest global cell therapy R&D teamsPatients:Potential best-in-class proprietary technology platformsScience:Global innovation developmentUS,China,EuropeCORE TEC

38、HNOLOGIESCAR-TNKgd-TPRODUCT PLATFORMSAutologousAllogeneicDISEASE AREASHematologic malignanciesSolid tumorsCLINICAL DEVELOPMENTClinical programs in ChinaClinical programs in USIP:Strong intellectual property position10This presentation is for investor relations purposes only Not for product promotion

39、al purposesOur Differentiated R&D ApproachDiverse platform for allogeneic treatmentsDiverse allogeneic platforms,including non-gene editing universal CAR-T and NKAntibody screening&engineeringIn-house antibody generation and CAR-T-specific functional screening technologiesArmoring strategy for solid

40、 tumorsMultiple armored CAR-T strategies to overcome challenges in treatment of solid tumorsAntibody Screening PlatformsHigh-throughput antibody screening and engineering capability,including single-domain antibodies generated from llama and conventional antibodiesBinding Domain Selection and Constr

41、uct DesignProprietary methodology to optimize the selection of binding domains and design CAR-T constructs with two or more antigen-binding domainsPre-clinical ValidationRobust in vitro and in vivo screening platforms to prioritize pipeline assets Clinical Proof of ConceptEfficient clinical translat

42、ion with IND and IIT studies,working with KOLs in US and ChinaPotential best-in-class proprietary technology platforms and end-to-end capability11This presentation is for investor relations purposes only Not for product promotional purposesOur PipelineGlobalUSChinaP R E C L I N I C A LP H A S E 2P H

43、 A S E 3P H A S E 1NSCLC(GPC3)Autologous*In collaboration with Janssen,Pharmaceutical Companies of Johnson&Johnson.Phase 1 IIT in China.IND applications have been cleared by the U.S.FDA.Subject to an exclusive license agreement with Novartis Pharma AG.Under the License Agreement,Legend Biotech will

44、conduct a Phase 1 clinical trial for LB2102 in the U.S.and Novartis will conduct all other development for the licensed products.The safety and efficacy of the agents and/or uses under investigation have not been established.There is no assurance that the agents will receive health authority approva

45、l or become commercially available in any country for the uses being investigated.Additionally,as some programs are still confidential,certain candidates may not be included in this list.ALL,acute lymphoblastic leukemia;BCMA,B-cell maturation antigen;DLL3,delta-like ligand 3;GPC3,glypican-3;GCC,guan

46、ylyl cyclase C;HCC,hepatocellular carcinoma;IIT,investigator-initiated trial;MM,multiple myeloma;ND,newly diagnosed;NHL,non-Hodgkin lymphoma;NSCLC,non small cell lung cancer;RRMM,relapsed or refractory multiple myeloma;SCLC,small cell lung cancer.COLORECTAL(GCC)AutologousNHL/ALL(CD19 X CD20 X CD22)A

47、utologousNCT05318963NCT05292898MM(BCMA)Allogeneic CAR-gd TNCT05376345 RRMM(BCMA)LEGEND-2AutologousNCT03090659MM(BCMA)Allogeneic CAR-NKNCT05498545GASTRIC&ESOPHAGEAL&PANCREATIC(CLAUDIN 18.2)AutologousNCT05539430 HCC(GPC3)AutologousNCT05352542RRMM(BCMA)*CARTIFAN-1AutologousNCT03758417 RRMM(BCMA)*CARTIT

48、UDE-1AutologousNCT03548207MM(BCMA)*CARTITUDE-2AutologousNCT04133636RRMM(BCMA)*1-3 Prior Lines CARTITUDE-4AutologousNCT04181827NDMM(BCMA)*Transplant Not Intended 1L CARTITUDE-5AutologousNCT04923893NDMM(BCMA)*Transplant Eligible 1L CARTITUDE-6AutologousNCT05257083SCLC(DLL3)AutologousNCT0568092212This

49、presentation is for investor relations purposes only Not for product promotional purposesOut-licensing Deal with Novartis on CAR-T Therapies Targeting DLL3Legend announced on Nov 13,2023 an exclusive,global license agreement with Novartis to advance certain DLL3-targeted CAR-T therapies,including LB

50、2102,an investigational therapy for small cell lung cancer.Legend announced on Jan 3,2024 closing of the license transaction.AN UPFRONT PAYMENTELIGIBLE MILESTONE PAYMENTS$1.01B up to Tiered Royalties on Net SalesPOTENTIAL APPLICATION OF T-Charge Platform of NovartisFOR MANUFACTURINGDLL3 DEVELOPMEMT

51、AND COSTS Legend to conduct Ph1 for LB2102 in the USNovartis to conduct all other development for the licensed productsPlus$100M 13This presentation is for investor relations purposes only Not for product promotional purposesA Highly Experienced Management TeamYing Huang Chief Executive OfficerLori

52、MacomberChief Financial OfficerGuowei FangChief Scientific Officer&Head of Business DevelopmentMythili KoneruChief Medical OfficerSteve GavelCommercial DevelopmentElizabeth GosenGlobal ManufacturingAlan KickGlobal QualityYuhong QiuGlobal RegulatoryDong GengEarly-stage Drug DevelopmentElaine QianHuma

53、n ResourcesJim PepinGeneral CounselDoug WallaceOperationsSimon WuGeneral Manager,Greater ChinaChong YangCommercial DevelopmentTracy LuoClinical DevelopmentUS Based TeamChina Based Team14This presentation is for investor relations purposes only Not for product promotional purposesLegend and J&J Globa

54、l CollaborationWorldwide collaboration and license agreement to develop and commercialize cilta-cel202320021Eligible for Potential Additional Milestone PaymentsFirst Milestone$25 millionDec 2018Fourth Milestone$30 millionJan 2020Third Milestone$30 millionJul 2019Second Milestone$25 millio

55、nJul 2019Upfront Payment$350 millionQ1 2018Fifth Milestone$75 millionDecember 2020Sixth Milestone$15 millionMay 202150/50United StatesEuropeJapanGreater China50/5050/5050/5070/307th/8th Milestones$50 millionJanuary 20229th Milestone$50 millionApril 2022202210th/11th Milestones$35 million*August 2023

56、*On August 3,2023,Legend Biotech received a payment in the amount of$15 million for the EMAs acceptance of the Type II Variation Application for CARVYKTI,in accordance with Legend Biotechs license and collaboration agreement with Janssen(Janssen Agreement).In September 2023,Legend Biotech received a

57、 milestone payment of$20 million in connection with the FDAs acceptance of the sBLA,in accordance with the Janssen Agreement.15This presentation is for investor relations purposes only Not for product promotional purposesGlobal Manufacturing FootprintEU FacilitiesUS Facilities China FacilitiesRarita

58、n,NJNanjingNanjing 75-acreSomerset,NJUS/EU/JP/ROW Launch/Commercial Site for CARVYKTI GMP OperationalLegend China Clinical Supply Site for Pipeline Programs&Potential China Launch Site for CARVYKTI GMP OperationalPotential Future Commercial Site for CARVYKTI Construction ongoingUS/EU/JP Legend Clini

59、cal Supply Site for Pipeline ProgramsBuilding EGhent,BelgiumGhent,BelgiumFuture Commercial Site for CARVYKTI Clinical production scheduled in January 2024 and commercial production expected in 2H 2024Future Commercial Site for CARVYKTI Construction ongoing16This presentation is for investor relation

60、s purposes only Not for product promotional purposesExpanding Our Manufacturing CapabilitiesBringing cell therapies to market given unique challenges to improve overall supplyState-Of-The-Art CARVYKTI Manufacturing FacilitiesNovartis as CMO for Clinical SupplyJ&J In-House Lentivirus Facilities*Obeli

61、sc Facility in Ghent,Belgium received license from the Federal Agency for Medicines and Health Products in Belgium for clinical supply manufacturingAwaiting Investigational Medicinal Product Dossier approvals from local authoritiesAnticipate manufacturing cilta-cel at Ghent for clinical use in Janua

62、ry 2024 and commercial use in 2H 2024J&J facility in Switzerland now producing Lentivirus in-houseAll commercial Lentivirus now produced in-house and we are self-sufficientAdditional Lentivirus supply is expected to be available from J&J facilities in US and Netherlands in 2024 and 2025,respectively

63、 Signed CMO agreement with Novartis during Q2 2023 On track to produce clinical materials in 1H 2024*All the Lentivirus facilities are owned by J&J.17This presentation is for investor relations purposes only Not for product promotional purposesNEAR-TERM GOALSOutlook:2024 and Beyond Continue to incre

64、ase manufacturing capacity and efficiencyBegin manufacturing from Ghent facilitiesComplete enrollment of CARTITUDE-5 in 1H24Ongoing enrollment of CARTITUDE-6Advance early-stage pipeline programsLaunch lenalidomide refractory 1-3 prior lines indication based on CARTITUDE-4,if approved by regulatory a

65、uthorities.The PDUFA target action date is April 5,2024.CHMP opinion,anticipated in 1Q 2024Move CARVYKTI to earlier lines of therapy;increase penetration in the US and expand into global marketsFocus on unmet medical needs in hematology/oncologyDevelop therapies with transforming potentialIncrease a

66、ccessibility through lower cost and scalable manufacturingBuild a global powerhouse by leveraging external collaborationsLONG-TERM GROWTH STRATEGY1718Cilta-cel Clinical Development19This presentation is for investor relations purposes only Not for product promotional purposesMultiple Myeloma:Blood C

67、ancer with a High Unmet NeedCI,confidence interval;PI,Proteasome Inhibitor;IMiD,immunomodulatory drug;MM,multiple myeloma;OS,overall survival 1.Cancer Stat Facts:Myeloma.https:/seer.cancer.gov/statfacts/html/mulmy.html.Accessed June 2021.2.Facts and Statistics.https:/www.lls.org/facts-and-statistics

68、/facts-and-statistics-overview.Accessed June 2021.3.Globocan 2020 World Fact Sheet:https:/gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf.Accessed June 2021.4.Globocan 2020 World Fact Sheet:World.https:/gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.

69、pdf.Accessed June 2021.5.Globocan 2020 World Fact Sheet:United States of America.http:/gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf.Accessed June 2021.6.Globocan 2020 World Fact Sheet:Europe.https:/gco.iarc.fr/today/data/factsheets/populations/908-europe

70、-fact-sheets.pdf.Accessed June 2021.7.Globocan 2020 World Fact Sheet:China.https:/gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.Accessed June 2021.8.Gandhi UH,et al.Leukemia.2019;33:2266-75.US:Incidence is 32,119,with mortality of 13,4265EUROPE:Incidence is 50,918,with mort

71、ality of 32,4956CHINA:Incidence is 21,116,with mortality of 16,1827176,404 NEW CASES WORLDWIDE IN 2020,accounting for 1%of worldwidenew cancer cases3,41.00.80.60.40.20.001020304050MonthsProportion SurvivingNon-triple-refractory(N=57)Triple-and quad-refractory(N=148)Penta-refractory(N=70)P=0.002POOR

72、SURVIVAL OUTCOMES IN MULTIPLE REFRACTORY MMMedian OS 8 weeks post randomization.cilta-cel,ciltacabtagene autoleucel;HR,hazard ratio;ITT,intent-to-treat;mPFS,median progression-free survival;NE,not estimable;SOC,standard of care.Dhakal et al.ASCO Annual Meeting;June 2-6,2023;Chicago,Il&Virtual;Abstra

73、ct#LBA106CARTITUDE-4:Primary Endpoint PFS(ITT Population)Cilta-cel vs SOC 12-month PFS rate:76%vs 49%SOC performed as expectedPatients progression free and alive,%Progression-free survival,monthsNo.at riskCilta-cel armSOC arm208268894464520224960801003Week 8691215182

74、1242730Cilta-cel armSOC armmPFS:not reached(95%CI,22.8NE)mPFS:11.8 months(95%CI,9.713.8)Bridging phase,patients in cilta-cel arm were receiving the same treatment as the SOC armHazard ratio,0.26(95%CI,0.180.38);P0.0001b,c23This presentation is for investor relations purposes only Not for product pro

75、motional purposesaIncludes preferred terms upper respiratory tract infection,nasopharyngitis,sinusitis,rhinitis,tonsillitis,pharyngitis,laryngitis,and pharyngotonsillitis.bIncludes preferred terms lower respiratory tract infection,pneumonia,and bronchitis.cTreatment-emergent COVID-19 only;includes p

76、referred terms COVID-19,COVID-19 pneumonia,and asymptomatic COVID-19.dWith 1 case of peripheral T-cell lymphoma in the cilta-cel arm.e7 due to COVID-19,and 1 each due to neutropenic sepsis,pneumonia,and respiratory failure.f3 of 7 who died from COVID-19 were unvaccinated prior to cilta-cel.These COV

77、ID-19related deaths contributed to the higher number of fatal events in the first year.g1each due to COVID-19,progressive multifocal leukoencephalopathy,respiratory tract infection,septic shock,and pulmonary embolism.AE,adverse event;cilta-cel,ciltacabtagene autoleucel;TEAE,treatment-emergent advers

78、e event;SOC,standard of care.Dhakal et al.ASCO Annual Meeting;June 2-6,2023;Chicago,Il&Virtual;Abstract#LBA106CARTITUDE-4:TEAEs Hematologic TEAEs most common 8590%neutropenia,almost all grade 3/4 Most high-grade cytopenias resolved to grade 2 by day 30 Grade 3/4 infections similar between arms Secon

79、d primary malignancies:Cilta-cel,4.3%(n=9);most commonly cutaneous/noninvasive and hematologic SOC,6.7%(n=14);most commonly cutaneous/noninvasived Deaths due to TEAEs Cilta-cel,n=10e(7 due to COVID-19f)SOC,n=5g(1 due to COVID-19)Select TEAE 15%,n(%)Safety populationCilta-cel(n=208)SOC(n=208)Any grad

80、e Grade 3/4Any grade Grade 3/4Any AE208(100)201(96.6)208(100)196(94.2)Serious AE92(44.2)67(32.2)81(38.9)70(33.7)Hematologic197(94.7)196(94.2)185(88.9)179(86.1)Neutropenia187(89.9)187(89.9)177(85.1)172(82.2)Anemia113(54.3)74(35.6)54(26.0)30(14.4)Thrombocytopenia113(54.3)86(41.3)65(31.3)39(18.8)Lympho

81、penia46(22.1)43(20.7)29(13.9)25(12.0)Infections129(62.0)56(26.9)148(71.2)51(24.5)Upper respiratory tracta39(18.8)4(1.9)54(26.0)4(1.9)Lower respiratory tractb19(9.1)9(4.3)36(17.3)8(3.8)COVID-19c29(13.9)6(2.9)55(26.4)12(5.8)24This presentation is for investor relations purposes only Not for product pr

82、omotional purposesaThere were no fatal neurotoxicities.bGrade 3 syncope reported as a symptom of grade 2 ICANS.cOther neurotoxicities include AEs reported as CAR-T cell neurotoxicity that are not ICANS or associated symptoms.dCranial nerve palsies most commonly affected cranial nerve VII;supportive

83、measures included corticosteroids(14 patients).No clear risk factors for cranial nerve palsies have been identified,and the mechanism is not understood.eData for cytopenias not shown.AE,adverse event;CAR-T,chimeric antigen receptor T cell;cilta-cel,ciltacabtagene autoleucel;CRS,cytokine release synd

84、rome;DPd,daratumumab,pomalidomide,and dexamethasone;ICANS,immune effector cellassociated neurotoxicity syndrome;MNT,movement and neurocognitive treatment-emergent adverse event.Dhakal et al.ASCO Annual Meeting;June 2-6,2023;Chicago,Il&Virtual;Abstract#LBA106CARTITUDE-4:CRS and CAR-T Cell-Related Neu

85、rotoxicityIn the cilta-cel as-treated population:30 patients had non-ICANS neurotoxicitiesc16 cranial nerve palsies(14 recovered)5 peripheral neuropathies 1 MNT(grade 1)Lower incidence and severity of CRS,ICANS,MNTs,and some cytopeniaseobserved with CARTITUDE-4 vs CARTITUDE-1 Cilta-cel may be better

86、 tolerated when used earlier in treatmentEffective bridging therapy enables better control of tumor burden prior to CAR-T infusionMNTs were lower likely related to patient management strategies implemented to mitigate this riskAEs,n(%)As-treated patients(n=176)Any grade Grade 3/4Median time to onset

87、,daysMedian duration,daysResolved,nCRS134(76.1)2(1.1)83134Neurotoxicitya36(20.5)5(2.8)ICANS8(4.5)0b1028 Otherc30(17.0)4(2.3)Cranial nerve palsyd16(9.1)2(1.1)217714Peripheral neuropathy5(2.8)1(0.6)632013MNT1(0.6)085025Select Programs in Clinical Development26This presentation is for investor relation

88、s purposes only Not for product promotional purposesLB1908(LCAR-C18S):Legend CAR-T Targeting CLDN18.2MOA/SCIENTIFIC RATIONALETARGET Claudins(CLDN)are a family of tight junction proteins1 CLDN18.2 is expressed in gastric cancer and pancreatic cancer2 CLDN18.2 is highly conservative cross species LB19

89、08 targets CLDN 18.2 via a proprietary VHH antibody High selectivity against the closely related CLDN 18.1CLINICAL DEVELOPMENT STRATEGYPOC achieved and 43 patients enrolled-Adult Claudin 18.2 positive patients with recurrent or metastatic advanced solid tumors(including advanced gastric cancers and

90、non-gastric cancers)and have failed prior lines of systemic treatmentUS IND was cleared on June 1,2022Orphan Drug Designation was granted by FDA on November 22,2022The US clinical trial is actively recruiting at two sites as of October 20231 Zhang J,et al.Chin J Cancer Res.2020 Apr;32(2):263-70.2 Sa

91、hin U,et al.Clin Cancer Res.2008 Dec 1;14(23):7624-34For gastric cancer,esophageal cancer and pancreatic cancer27This presentation is for investor relations purposes only Not for product promotional purposesLB2102:Legend Armored CAR-T Targeting DLL-3MOA/SCIENTIFIC RATIONALETARGETDLL-3,a promising ta

92、rget with prevalent&homogeneous expression in SCLC(80%positive)and other neuroendocrine tumorsMinimal to no expression in normal tissuesSCLC has limited treatment options&high unmet needsTandem humanized binders with high affinity and specificityAn armor overcoming suppressive TME to promote CAR-T c

93、ell expansion,persistence and infiltrationFor SCLCPRECLINICAL&CLINICAL DEVELOPMENT STRATEGYWell-tolerated in vivo in s.c and pulmonary orthotopic xenograft modelsUS IND was cleared on November 21,2022Orphan Drug Designation was granted by FDA on June 21,2023The US clinical trial is actively recruiti

94、ng at three sites as of October 2023CARArmor28This presentation is for investor relations purposes only Not for product promotional purposesOur StrengthsWhy Legend continues to show growth and excellent performanceGlobal collaboration with Janssen for the development of cilta-cel with ongoing clinic

95、al trialsPromising Clinical DataDeep and durable anti-tumor responses observed in heavily pretreated patients with RRMM with cilta-cel*Fully Integrated PlatformEnd-to-end R&D and manufacturing capabilities with multiple core technologies and platformsStrong LeadershipExperienced team with expertise

96、in drug discovery,development and commercialization*A Biologics License Application seeking approval of cilta-cel has been approved by the U.S.FDA and commercialized under the brand name CARVYKTI.The product has also been approved by the Ministry of Health,Labour and Welfare in Japan and received conditional marketing authorization by the European Medicines Agency.Global Collaboration29THANK YOU

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