1、1Building a Global Biopharma LeaderJP Morgan 42nd Annual Healthcare ConferenceJanuary 8,20242Forward-Looking StatementsThis presentation contains forward-looking statements relating to our strategy and plans;potential of and expectations for our business and pipeline programs;our goals and expectati

2、ons under our growth strategy(including our expectations regarding our commercial-stage products,clinical-stage global-right products,revenue growth/CAGR,operating margins,and cash flow);the peak sales potential of our programs;capital allocation and investment strategy;clinical development programs

3、 and related clinical trials;clinical trial data,data readouts,and presentations;risks and uncertainties associated with drug development and commercialization;regulatory discussions,submissions,filings,and approvals and the timing thereof;the potential benefits,safety,and efficacy of our products a

4、nd product candidates and those of our collaboration partners;the expected benefits and potential of investments,collaborations,and business development activities;our future financial and operating results;and financial guidance.All statements,other than statements of historical fact,included in th

5、is presentation are forward-looking statements,and can be identified by words such as“aim,”“anticipate,”“believe,”“could,”“estimate,”“expect,”“forecast,”“goal,”“intend,”“may,”“plan,”“possible,”“potential,”“will,”“would,”and other similar expressions.Such statements constitute forward-looking stateme

6、nts within the meaning of the Private Securities Litigation Reform Act of 1995.Forward-looking statements are not guarantees or assurances of future performance.Forward-looking statements are based on our expectations and assumptions as of the date of this presentation and are subject to inherent un

7、certainties,risks,and changes in circumstances that may differ materially from those contemplated by the forward-looking statements.Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,including but not limited to(1)our

8、 ability to successfully commercialize and generate revenue from our approved products,(2)our ability to obtain funding for our operations and business initiatives,(3)the results of clinical and pre-clinical development of our product candidates,(4)the content and timing of decisions made by the rel

9、evant regulatory authorities regarding regulatory approvals of our product candidates,(5)risks related to doing business in China,and(6)other factors discussed in our most recent annual and quarterly reports and other reports we have filed with the U.S.Securities and Exchange Commission(SEC).We anti

10、cipate that subsequent events and developments will cause our expectations and assumptions to change,and we undertake no obligation to update or revise any forward-looking statements,whether as a result of new information,future events or otherwise,except as may be required by law.These forward-look

11、ing statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.Our SEC filings can be found on our website at and on the SECs website at http:/www.sec.gov.This presentation does not constitute an offer to sell or the solicitation of an o

12、ffer to buy any securities of Zai Lab Limited.3Expanding our innovative global drug pipelineStrong commercial infrastructure&execution in China with high synergy Key Market TrendsOur Vision Leveraging Our Strength in China and Scientific Expertise to Become A Global Biopharma LeaderHuge market poten

13、tial with significant unmet needsLarge patient pool with an aging population in ChinaPricing reflects clinical value of innovative drugs in NRDL“Price driven”to“Clinical value-oriented”Policies fostering innovative drug developmentAccelerating regulatory pathwayChina as a rising center of innovation

14、 for global marketIncreasing sourcing of innovation from ChinaPipeline of late-stage potential FIC/BIC assetsGlobal leaders with decades of R&D experience to identify and develop innovative drugsAbbreviations:first-in-class(FIC),best-in-class(BIC),national reimbursement drug list(NRDL).4Significant

15、Achievements in 2023Abbreviations:New Drug Application(NDA),sulbactam-durlobactam(SUL-DUR),Tumor Treating Fields(TTFields),acinetobacter baumannii-calcoaceticus complex(ABC),subcutaneous(SC),non-small cell lung cancer(NSCLC),chronic inflammatory demyelinating polyradiculoneuropathy(CIDP),cervical ca

16、ncer(CC),antibodydrug conjugate(ADC),ovarian cancer(OC),generalized myasthenia gravis(gMG),supplemental insurance plan(SIP),national reimbursement drug list(NRDL).Notes:(1)Based on IQVIA data and Company analysis,September 2023;(2)hospital-acquired and ventilator-associated bacterial pneumonia cause

17、d by Acinetobacter baumannii-calcoaceticus complex.COMMERCIAL EXCELLENCELeading PARPi in OC in China140+%volume sold supported by SIPApproval,launch and NRDL listing Strong pre-NRDL launch w/top hospitalsNRDL listingNRDL listing w/oral form added in 24PIPELINE/PRODUCT PROGRESS Three NDA acceptances

18、SC efgartigimod(gMG)SUL-DUR(ABC)2 Repotrectinib(ROS1+NSCLC)Positive pivotal data readouts SC efgartigimod(CIDP)KarXT(schizophrenia)TTFields(2L NSCLC)TIVDAK(2L+CC)Global pipeline ZL-1310(DLL3 ADC)Ph 1 initiated ZL-1218(CCR8)Ph 1 initiated ZL-1102(IL-17)Ph 2 initiating5Expect Substantial Growth Over t

19、he Next Five Years50%CAGR2023-2028 Expected Revenue Growth20232028ABCgMG*,CIDP,BP,TEDB E F O R E 2 0 2 3 ZEJULA,OPTUNE,QINLOCK,NUZYRAAbbreviations:generalized myasthenia gravis(gMG),chronic inflammatory demyelinating polyneuropathy(CIDP),bullous pemphigoid(BP),thyroid eye disease(TED),acinetobacter

20、baumannii-calcoaceticus complex(ABC),non-small cell lung cancer(NSCLC),brain metastases from NSCLC(NSCLC BM),pancreatic cancer(PC),mesothelioma(MPM),fibroblast growth factor receptor 2(FGFR2b),gastric cancer(GC),gastroesophageal junction cancer(GEJ),Alzheimers disease psychosis(ADP),neurotrophic tro

21、pomyosin receptor kinase(NTRK),colorectal cancer(CRC).Note:The trademarks and registered trademarks within are the property of their respective owners.Timeline is not drawn to scale.*Efgartigimods first indication,gMG,launched in China in September 2023 with IV formulation.2023 2028NEW LAUNCHES WITH

22、 BLOCKBUSTERPOTENTIALO T H E R N E A R-T E R M D R U G L A U N C H E S KRAS G12C NSCLC,CRCROS1 NSCLC,NTRK solid tumorsCervical cancerBemarituzumab FGFR2b GC/GEJKarXT Schizophrenia,ADPTTFieldsNSCLC,NSCLC BM,PC,MPM6Overall Support for the IndustryRecent Policy Updates in China Continue to be Supportiv

23、e of InnovationAbbreviations:National Medical Products Administration(NMPA),Center for Drug Evaluation(CDE),National Healthcare Security Administration(NHSA),Marketing Authorization Application(MAA).Sources:NHSA,NMPA,“China biopharma stepping on the global stage”issued on November 16,2021,McKinsey&C

24、ompany.“Price Driven”to“Patient-centric”&“Clinical Value-oriented”NMPA Fostering Innovative Drug DevelopmentNHSA Providing Better Support for Innovative DrugsBiotech designated as one of the pillar industries in China14th Five Year Plan targets 10%annual growth in R&D expenditure for pharmaceutical

25、industryGuiding principles for clinical value-oriented development of oncology drugsCDE guideline to accelerate review for innovative drugs MAA“Simplified renewal rules leading to milder price cuts and more clarity on pathways in 2023Policies leaning towards innovative drugs inclusion7 7Paving the W

26、ay for Long-term GrowthBuild Global PipelineGrow portfolio through internal discovery efforts and BD1Accelerate Topline GrowthTop-tier growth profile in biopharma23 Strong R&D and commercial execution 7 new launches in next 3 years 15 commercial products by 2028 Maximize potential with new indicatio

27、ns Increase productivity and leverage across the organization Continue R&D prioritization Cash resources1 expected to take us through profitabilityAchieve ProfitabilityTarget corporate profitability by end of 2025 Targeted approach in certain TAs and modalities Continue to strengthen global&China po

28、rtfolio through BD At least one global IND per yearAbbreviations:investigational new drug(IND),therapeutic area(TA),business development(BD).Note:(1)Cash and cash equivalents,short-term investments and restricted cash totaled$822.2 million as of September 30,2023.8Driving Topline Growth Through Stro

29、ng Commercial ExecutionZEJULA share in PARPi China vs.EU and US1#1 share in PARPi OC hospital sales in China1Leveraging NRDLUSCNEU42%28%21%and supplemental insurancePipeline-in-a-product1Significant Potential for VVVGARTDemonstrated Proven Commercial CapabilitiesReimbursed in supplemental insurance

30、plans only after Keytruda,and No.1 for Shanghai and Beijing2Huge Unmet Need in ChinaNRDL Price Reflects High Clinical ValueCovered by NRDL($800/vial)Notes:The trademarks and registered trademarks within are the property of their respective owners.(1)Based on Zai Lab and GSK financial reports.IQVIA d

31、ata and analysis,September 2023.Quarterly sales based on IQVIA hospital audit(=100 beds).Quarterly Zejula sales booked by Zai Lab as%of quarterly Zejula sales booked by GlaxoSmithKline.“Share in China”refers to hospital sales in China across all indications per IQVIA analysis,September 2023;“shares

32、in EU and the U.S.”refers to the percentage of Zejula sales over the total sales of Zejula and Lynparza in EU and the U.S.,respectively,as disclosed in the financials of AstraZeneca and GlaxoSmithKline;(2)Based on 3Q 2023 data,Meditrust Health disclosure.9VYVGART Initial Progress Encouraging;Laying

33、Foundation for Strong Growth20231st Dispatched&1st PrescriptionChina NDA ApprovedJun30Sep5Jan12024NRDL IncludedAccelerated Access to HCPs and PatientsExpect to Quickly Expand CoverageNRDL inclusionPrice effective Jan 1st,2024Strong outreach to top targets100%of top 200 target hospitals reached in-pe

34、rson by salesforce1Positive KOL experience90 of the top 100 physicians have already prescribed VYVGART11Broad coverageExpand outreach to 1,000 hospitals in 2024Accounting for 80%of total patient volumeEfficient commercial modelDedicated sales representatives 150 post-NRDLLeveraging established comme

35、rcial infrastructureSignificant overlap of physicians treating gMG and CIDPDebut Exposure at National Conference of NeurologySep8-9Note:(1)as of December 31,2023.108 Late-Stage FIC/BIC Assets to Support Near to Mid-term Growth1Abbreviations:First-in-class(FIC),best-in-class(BIC),treatment(TX),proof

36、of concept(POC),chronic inflammatory demyelinating polyneuropathy(CIDP),non-small cell lung cancer(NSCLC),cervical cancer(CC),head and neck squamous cell carcinoma(HNSCC),neurotrophic tropomyosin receptor kinase(NTRK),recurrent or metastatic(r/m),antibodydrug conjugate(ADC),standard of care(SoC),gas

37、tric cancer(GC),colorectal cancer(CRC),pancreatic cancer(PC),brain metastases(brain-met),hospital-acquired bacterial pneumonia(HABP),ventilator-associated bacterial pneumonia(VABP),acinetobacter baumannii-calcoaceticus complex(ABC),Alzheimers disease psychosis(ADP).Source:China patient numbers are f

38、rom Zai Lab market research.Notes:*Prevalence.Prevalence/incidence in China does not consider diagnosis/treatment rate,urban rate,lines of therapy,etc.The trademarks and registered trademarks within are the property of their respective owners.(1)including KRAS G12C-mutated NSCLC,CRC and pancreatic c

39、ancer;(2)hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex;rights including Asia Pacific region.IndicationFIC/BICKey DifferentiationCIDP50K*Lack of innovative treatment options that are effective,well-tolerated,and convenientROS1+

40、NSCLC22K Opportunity to roughly double the ROS1 market based on longer duration of response,higher response rate and better safety profile2L+CC110KFirst and only US-approved ADC for r/m cervical cancer2L+HNSCC71KBroad clinical program including POC in 1L r/m CC and 2L+HNSCC2L+NSCLC43K1Preferred 2L+S

41、oC for patients with KRASG12C1L NSCLCEarly efficacy in combination with I/O substantially exceeding SoC2L+CRCPotential first-to-market KRAS inhibitor in CRC in ChinaBemarituzumabFGFR2b+GC126KNo targeted therapies approved for patients with FGFR2b+GCTTFields2L NSCLC740KNovel,non-invasive treatment op

42、tion without added systemic toxicity1L PC125K1L NSCLC brain-met13KABC2330K2First FDA approved pathogen-targeted therapy to treat ABC,the#1 WHO priority pathogen,in HABP&VABPKarXTSchizophrenia8mn*Novel MOA with differentiated efficacy and safety profileADP4mn*No currently approved treatments for ADPL

43、imited/No TxIncidence/Prevalence11Strong revenue growth50%CAGR for 2023-2028New product launches and maximize potential with new indicationsRevenuesCOGSIncreased productivity with synergiesLeveraging existing infrastructure to support new launchesCost initiatives in placeSG&ACapital efficient spendi

44、ngContinued portfolio prioritizationR&DPath to Profitability Through Top-Line Growth and Operational Efficiencies2Significant room for improvementIncrease in scalePotential for more local manufacturingAbbreviations:compound annual growth rate(CAGR),cost of goods sold(COGS),research and development e

45、xpenses(R&D),selling,general and administrative expenses(SG&A).12Therapeutic-Area-Focused Organization Drives Leadership and LeverageMarketed/Late-Stage ProductsShared FunctionPipelineTA-driven Sales Force2TA-driven MarketingTA-driven Medical AffairsGovernment Affairs,Market Access and DistributionC

46、ommercial Strategy ExcellenceOncology Shared Sales(Emerging Market)2NSAiID Shared Sales(Emerging Market)22(gMG)AdagrasibBemarituzumabEfgartigimod(CIDP)ZipalertinibAdagrasibKarXT(ADP)Repotrectinib1GI CANCERNEUROLOGYLUNG CANCERWOMENS CANCERAbbreviations:Therapeutic area(TA),neuroscience,autoimmune and

47、 infectious diseases(NSAiID),chronic inflammatory demyelinating polyradiculoneuropathy(CIDP),generalized myasthenia gravis(gMG),Alzheimers disease psychosis(ADP).Notes:The trademarks and registered trademarks within are the property of their respective owners.(1)NTRK+breast cancer;(2)core market(top

48、 hospitals in large cities)will be covered by TA-driven sales force;the remaining hospitals are emerging market covered by shared sales team.TTFieldsTTFieldsUnlock Synergies with Additional Pipeline Assets to Launch13Aiming to Generate at Least One Global IND per YearOncogenic Driver MutationsDNA Da

49、mage Repair&Synthetic LethalityTAA/TME targeted ADC/bispecificVHH AntibodyOncologyImmunology3 Building a Global Pipeline through Internal Discovery Efforts andFocused Discovery EffortsZL-1310(DLL3 ADC)A next generation ADC platform Topoisomerase 1 inhibitor payload with high potency,high clearance a

50、nd better permeabilityPhase 1ZL-1218(CCR8)A novel antibody targeting CCR8 receptors that are selectively expressed on Tregs in solid tumors Demonstrated an encouraging pre-clinical profilePhase 1ZL-1102(IL-17 Humabody)High affinity human VH fragment antibody targeting IL-17A First-ever to demonstrat

51、e penetration of protein biologic through psoriatic skin resulting in clinical response1Entering Phase 2Abbreviations:Variable domain of heavy chain of heavy chain antibody(VHH),tumor-associated antigen(TAA),regulatory T cells(Tregs),tumor microenvironment(TME),antibodydrug conjugate(ADC),investigat

52、ion new drug(IND).Note:(1)Topical application of a novel anti-interleukin-17A antibody fragment penetrates psoriatic skin:Results of a randomized,double-blind,placebo-controlled Phase Ib study,2023.14Continuing To Expand our Pipeline Globally and Regionally with Our Proven BD ExpertiseOutstanding BD

53、 track record driven by deep scientific rigor and strong market insight AssetOriginal partnerM&A by.BemarituzumabZipalertinibAll demonstrated positive study resultsMany assets were in-licensed at early clinical stageOngoing strategy:Continue to identify regional opportunity with FIC/BIC potentialOpp

54、ortunistic to strategic partnership to create share-holder value3Leverage strong capability to identify and develop global assetsAbbreviations:first-in-class(FIC),best-in-class(BIC).Note:The trademarks and registered trademarks within are the property of their respective owners.15Clinical Data and R

55、egulatory ActionsClinical DevelopmentCommercial Execution VYVGART ramp-up in gMG post-NRDL Maintain ZEJULA leadership position in ovarian cancer Continue to grow supplemental coverage support for OptuneKey 2024 Priorities,Milestones and Catalysts Bemarituzumab in two Ph3 trials KarXT bridging confir

56、matory study in China ZL-1102(IL-17 Humabody)moving into full globalPh2 development Enroll patients in global Ph1 study for ZL-1310(DLL3)Abbreviations:National reimbursement drug list(NRDL),non-small cell lung cancer(NSCLC),colorectal cancer(CRC),brain metastases from NSCLC(NSCLC BM),acinetobacter b

57、aumannii-calcoaceticus complex(ABC),chronic inflammatory demyelinating polyradiculoneuropathy(CIDP),generalized myasthenia gravis(gMG),malignant pleural mesothelioma(MPM),cervical cancer(CC).Note:(1)Subject to satisfaction of customary closing conditions;anticipated closing by 1H 2024.The data reado

58、uts are referring to Phase 2 KRYSTAL-17 study for 1L NSCLC(TPS50%),Phase 3 KRYSTAL-12 study for 2L+NSCLC and Phase 3 KRYSTAL-10 study for 2L CRC.Planned China submissions SC efgartigimod(CIDP)Adagrasib(2L+NSCLC)TIVDAK(2L+CC)TTFields(NSCLC)Potential China approvals SUL-DUR(ABC)SC efgartigimod(gMG)Rep

59、otrectinib(ROS1 NSCLC)TTFields(MPM)Key clinical data TTFields in 1L NSCLC BM and 1L pancreatic cancer Adagrasib in 1L NSCLC,2L+NSCLC and 2L CRC116Our Ambition:Leveraging our strength in China and scientific expertise to become a global biopharma leaderDelivering an Exciting 2024 and BeyondPatient Centric&Clinical Value OrientedAccelerate Topline GrowthAchieve ProfitabilityBuild Global Pipeline