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1、STRONG INNOVATION&COMMERCIALIZATION BUILDING VALUE&SUSTAINABILITYCORPORATE PRESENTATIONJanuary 2023Nasdaq/AIM:HCM|HKEX:131GET PDFThe performance and results of operations of the HUTCHMED Group contained within this presentation are historical in nature,and past performance is no guarantee of future
2、results.This presentation contains forward-looking statements within the meaning of the“safe harbor”provisions of the U.S.Private Securities Litigation Reform Act of 1995.These forward-looking statements can be identified by words like“will,”“expects,”“anticipates,”“future,”“intends,”“plans,”“believ
3、es,”“estimates,”“pipeline,”“could,”“potential,”“first-in-class,”“best-in-class,”“designed to,”“objective,”“guidance,”“pursue,”or similar terms,or by express or implied discussions regarding potential drug candidates,potential indications for drug candidates or by discussions of strategy,plans,expect
4、ations or intentions.You should not place undue reliance on these statements.Such forward-looking statements are based on the current beliefs and expectations of management regarding future events,and are subject to significant known and unknown risks and uncertainties.Should one or more of these ri
5、sks or uncertainties materialize,or should underlying assumptions prove incorrect,actual results may vary materially from those set forth in the forward-looking statements.There can be no guarantee that any of our drug candidates will be approved for sale in any market,that any approvals which are o
6、btained will be obtained at any particular time,or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners(collectively,“HUTCHMEDS Products”)will achieve any particular revenue or net income levels.In particular,managements expectations could be
7、affected by,among other things:unexpected regulatory actions or delays or government regulation generally,including,among others,the risk that HUTCHMEDs ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated there
8、under;the uncertainties inherent in research and development,including the inability to meet our key study assumptions regarding enrollment rates,timing and availability of subjects meeting a studys inclusion and exclusion criteria and funding requirements,changes to clinical protocols,unexpected ad
9、verse events or safety,quality or manufacturing issues;the inability of a drug candidate to meet the primary or secondary endpoint of a study;the impact of the COVID-19 pandemic or other health crises in China or globally;the inability of a drug candidate to obtain regulatory approval in different j
10、urisdictions or the utilization,market acceptance and commercial success of HUTCHMEDS Products after obtaining regulatory approval;competing drugs and product candidates that may be superior to,or more cost effective than,HUTCHMEDS Products and drug candidates;the impact of studies(whether conducted
11、 by HUTCHMED or others and whether mandated or voluntary)or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMEDS Products and candidates in development;the costs of developing,producing and selling HUTCHMED Products;the ability o
12、f HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance;global trends toward health care cost containment,including ongoing pricing pressures;uncertainties regarding actual or potential legal proceedings,including,among
13、others,actual or potential product liability litigation,litigation and investigations regarding sales and marketing practices,intellectual property disputes,and government investigations generally;and general economic and industry conditions,including uncertainties regarding the effects of the persi
14、stently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates.For further discussion of these and other risks,see HUTCHMEDs filings with the U.S.Securities and Exchange Commission,on AIM and with The Stock Exchange of Hong Kong Limited.HUT
15、CHMED is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information,future events or otherwise.This presentation is intended for investors only.Information concerning pharmaceuticals(inc
16、luding compounds under development)contained within this material is not intended as advertising or medical advice.Some of the clinical data in this presentation relating to HUTCHMEDs products or its investigational drug candidates is from pre-clinical studies or early phase,single-arm clinical tria
17、ls.When such data or data from later stage trials are presented in relation to other investigational or marketed drug products,the presentation and discussion are not based on head-to-head trials between HUTCHMEDs investigational drug candidates and other products unless specified in the trial proto
18、col.HUTCHMED is still conducting pre-clinical studies and clinical trials and,as additional patients are enrolled and evaluated,data on HUTCHMEDs investigational drug candidates may change.In addition,this presentation contains statistical data,third-party clinical data and estimates that HUTCHMED o
19、btained from industry publications and reports generated by third-party market research firms,including Frost&Sullivan,IQVIA,independent market research firms,clinical data of competitors,and other publicly available data.All patient population,market size and market share estimates are based on Fro
20、st&Sullivan or QuintilesIMS/IQVIA research,unless otherwise noted.Although HUTCHMED believes that the publications,reports,surveys and third-party clinical data are reliable,HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data.You are cautio
21、ned not to give undue weight to this data.Such data involves risks and uncertainties and are subject to change based on various factors,including those discussed above.Nothing in this presentation or in any accompanying management discussion of this presentation constitutes,nor is it intended to con
22、stitute or form any part of:(i)an invitation or inducement to engage in any investment activity,whether in the United States,the United Kingdom,Hong Kong or in any other jurisdiction;(ii)any recommendation or advice in respect of any securities of HUTCHMED;or(iii)any offer or an invitation to induce
23、 an offer by any person for the sale,purchase or subscription of any securities of HUTCHMED.No representation or warranty,express or implied,is made as to,and no reliance should be placed on,the fairness,accuracy,completeness or correctness of the information,or opinions contained herein.Neither HUT
24、CHMED,nor any of HUTCHMEDs advisors or representatives shall have any responsibility or liability whatsoever(for negligence or otherwise)for any loss howsoever arising from any use of this presentation or its contents or otherwise arising in connection with this presentation.The information set out
25、herein may be subject to updating,completion,revision,verification and amendment and such information may change materially.All references to“HUTCHMED”as used throughout this presentation refer to HUTCHMED(China)Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or
26、indicated by context.This presentation should be read in conjunction with HUTCHMEDs results for the six months ended June 30,2022 and HUTCHMEDs other SEC filings and announcements published in accordance with the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited co
27、pies of which are available on HUTCHMEDs website(www.hutch-).Use of Non-GAAP Financial Measures-This presentation includes certain non-GAAP financial measures.Please see the appendix slides titled“Non-GAAP Financial Measures and Reconciliation”for further information relevant to the interpretation o
28、f these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.The performance and results of operations of the HUTCHMED Group contained within this presentation are historical in nature,and past performance is no guarantee of future results.Safe harb
29、or statement&disclaimer2Fully integrated R&D and commercialization platform1 13 cancer drug candidates advanced from in-house discovery into clinical developmentA global science-focused biopharmaClinical development®ulatory operations in all major markets China,U.S.,EU&Japan clinical infrastructu
30、re First 3 novel oncology drugs approvedGlobal novel drug discovery&manufacturingoperations20+years novel drug discovery 13 innovative NMEs1for oncology discovered in-houseNew flagship factory expected to come online in 2023/4 to expand capacity by 5xCommercial teams in China Oncology commercial tea
31、m covering 3,000 oncology hospitals in China Commercial partnering outside of China3Mostly discovered in-housePRODUCTMOAINDICATIONSPARTNERCHINA1GLOBAL1FruquintinibVEGFR 1/2/3Colorectal,gastric,EMC(multiple I/O&TKI combos)(China)3Marketed(Colorectal);Pending NMPA discussion(Gastric)Ph.IIreg-intent on
32、going(EMC)Filing in U.S.,E.U.,Japan based on positive MRCT(Colorectal)SurufatinibVEGFR 1/2/3,FGFR1&CSF-1RNET,NEC(multiple I/O combos)None5Marketed(NET)Marketed(pNET)Ph.III(NEC)Ph.III ready US,EUPMDA consultation for JNDA filingSavolitinibMETNSCLC,kidney,gastric,colorectal2(multiple I/O&TKI combos)(W
33、orldwide)4Marketed(NSCLC mono)Ph.III(NSCLC combo)Ph.IIreg-intent(Gastric)Ph.II/III global(multiple NSCLC)Ph.IIIglobal(PRCC)AmdizalisibPI3KB-cell malignancies indolent NHLNone5Ph.IIreg-intent(FL&MZL)Ph.IISovleplenibSykITP,B-cell malignanciesNone5Ph.III(ITP)TBD TBD(NHL)Ph.IITazemetostatEZH2Solid tumor
34、s,hematological malignancies(ex-China)6Marketed(ES&FL,Hainan)Bridging(3L FL)Marketed by Ipsen7Global Ph.Ib/III(2L FL combo)HMPL-453FGFR 1/2/3CholangiocarcinomaNonePh.II reg-intent study in preparation-HMPL-306IDH 1/2Hematological malignancies,solid tumorsNone5Ph.IPh.IHMPL-295ERK(MAPK pathway)Solid t
35、umorsNonePh.I-HMPL-7603G BTKHematological malignanciesNone5Ph.IPh.IHMPL-653CSF-1RSolid tumorsNonePh.I-HMPL-A83CD47mAb solid tumors,hematological malignanciesNonePh.I-1 Represents the most advanced clinical trial stage and indication;2 Investigator initiated trials(IITs);3 HCM has WW rights ex-China;
36、Subject to meeting pre-agreed sales targets,Lilly will pay HUTCHMED an estimated total of 70%-80%of ELUNATE sales in the form of royalties,manufacturing costs and service payments;4 AZ has WW rights:China(30%royalty),ex-China(9-18%tiered royalty);5 Open to partnering outside of Greater China;6 HCM h
37、as commercial&development rights in Greater China;7 Tazemetostat was developed by and is marketed in the U.S.by Epizyme,Inc.,which was acquired by Ipsen SA in August 2022.HUTCHMEDs deep&broad portfolio42022 Summary 3 launched products oncology revenues+113%to$91.1m through H1 2022 Well-established i
38、nfrastructure positioned for future growth 15+reg.studies on 6 assets potential readout/file in 2023-2025 5 additional NMEs in earlier stage development Fruquintinib US/EU/JP registrations pending,supported by positive MRCT presented at ESMO Savolitinib multiple global Ph III studies ongoing Strateg
39、ic focus removes need for near term financing Cash balance of$826m(June 30,2022)2 NMEs with reg.enabling studies outside of solid tumors(amdizalisib and sovleplenib)Focus on late-stage programs12354Commercial results China oncologyBroad development program Late-stage global assets Strength&experienc
40、e in managing challengesNext wave5August 2022 oncology consolidated revenues guidance:$160-$190 million1 Total sales to third parties provided by Lilly(ELUNATE),AstraZeneca(ORPATHYS)and HUTCHMED(SULANDA and TAZVERIK);2For ELUNATE and ORPATHYS,represents manufacturing fees,commercial service fees and
41、 royalties paid by Lilly and AstraZeneca,respectively,to HUTCHMED,and sales to other third parties invoiced by HUTCHMED;for SULANDA and TAZVERIK,represents the Companys sales of the product to third parties.Continuing growth of Oncology revenuesSavolitinib TabletsUS$mFY 2021%ChangeH1 2021H1 2022%Cha
42、nge(Unaudited)(Unaudited)In-market Sales1ELUNATEELUNATE$71.0+111%$40.1$50.4+26%SULANDASULANDA$11.6-$8.0$13.6+69%ORPATHYSORPATHYS$15.9-$23.3-TAZVERIKTAZVERIK-$0.1-Total$98.5+192%$48.1$87.4+82%Consolidated RevenuesProduct SalesProduct Sales22$76.4+282%$37.8$63.5+68%Other R&D Service incomeOther R&D Se
43、rvice income$18.2+77%$5.1$12.6+149%Milestone paymentMilestone payment$25.0-$15.0-Total$119.6+296%$42.9$91.1+113%61Over 50,000 patients treated to dateELUNATE market leader in 3L CRCIn-market sales(US$millions)1 IQVIA audit data in proprietary post-launch research panel of mainly Class 3 hospitals in
44、 Top 30 cities in ChinaContinued progress in H1 2022 14,000 est.new patients treated,up 40%versus H1 2021 RMB1bn in cumulative in-market sales since launch 3 years agoStrong competitive position 2022 NRDL renewal Patient share market leader in 3L CRC(IQVIA1)despitelater launchQ4Q4-1818Q4Q4-1919Q4Q4-
45、2020Q4Q4-2121Q2Q2-2222ELUNATE2%25%33%39%43%43%STIVARGA29%32%35%34%33%43%021H1 2021H12022HUTCHMED assumed all on-the-ground commercial activities from Q4 2020+91%NRDL inclusion+111%HUTCHMED Sales team17.633.771.040.1+26%50.4NRDL inclusion allowing wider patient access from Jan 2022SULANDA
46、China momentum buildingIn-market sales(US$millions)11.68.013.62 2021021H1 H1 20212021H1H120222022Impact of NRDL inclusion 34,000 new patients/yr.with adv.NETs NRDL inclusion Jan 2022 with 52%reduction versus 2021 list price Patient self-pay price reduced 80%2022 access&awareness rapidly growing 43,0
47、00 HCPs in H1 2022 educational events 7,500 est.new patients treated 280%more new patients treated in H1 2022 vs.H1 2021+69%NRDLinclusion280%more new patients treated18AZ a strong China commercial partner Top lung cancer franchise synergies Patient access program introduced in late 2021 MET diagnost
48、ic testing is now recommended as SOC for late-stage NSCLC Preparing for NRDL inclusion for 20231styear in-market sales(US$millions)1 New treatment guidelines with National Health Commission(NHC),Chinese Society of Clinical Oncology(CSCO),Chinese Anti-Cancer Association(CACA),China Medical Associatio
49、n(CMA),Chinese Thoracic Oncology Group(CTONG).Estimated 120,000 annual incidence of MET-driven patients in China across all indicationsORPATHYS First-in-class MET inhibitorH2 2021H2 2021H1 2022H1 2022A unique treatment for Chinese patients 13,000 new pts/yr with MET Ex14 NSCLC The only approved MET
50、ex14 therapy The only selective MET TKI availableFirst anniversary of launch 4,000+new pts treated 12 mths after launch Inclusion in 5 new treatment guidelines NHC,CSCO,CACA,CMA,CTONG 115.923.3+46%19China sales benefitting from robust commercial infrastructureCommercial coverageRobust on-the-ground
51、activitiesJune 30,2022 vs.Sept 30,2020Commercial organization at optimal scale,with capacity to grow sales further 30,000 oncology physicians covered 800-person oncology commercial team 500+more hospitals covered versus 2021,especially in tier 2&tier 3 cities Strong core of regional managers and ter
52、ritory managers across China NRDL inclusions&renewals at reasonable pricing Many more and highly effective digital promotion events to mitigate the COVID challenges,e.g.3,800 ELUNATE events(+100%vs.H121)43,000 SULANDA HCPs covered(+180%vs.H121)+96%+148%+197%CitiesCoveredHospitalsCoveredHospitalPharm
53、acyListings3,000550325optimal scale,11015+trials for six drug candidates supporting potential near-term NDA filings DrugStudyTarget DiseaseRegionDesign(N,arms,1endpoint)StatusEst.(s)NDA filing if positiveFRUQFRESCO-23L+colorectal cancerGlobal690,treatment vs.BSC,OSUS,EU,JP filings to complete in 202
54、3US,EU,JP filings to complete in 2023Started Dec 22FRUQFRUTIGA2L GC,combo with chemoChina700,combo vs.chemo,OS&PFSTo file To file sNDAsNDA in Chinain ChinaH1 2023SAVO*ConfirmatoryNSCLC,MET Exon 14 alteration China160,1 arm,ORRFPI 2022FPI 2022H2 2023SOVLEESLIM-012L immune thrombocytopeniaChina180,2 a
55、rms(placebo),DRRLPI Dec 22LPI Dec 22H2 2023AMDIZ3L FL3L follicular lymphomaChina100,1 arm,ORRFPI Apr 21FPI Apr 21H2 2023FRUQ2L EMC2L EMC,combo with PD-1China130,1 arm,ORRFPI Oct 21FPI Oct 212024AMDIZAMDIZ2L MZL2L marginal zone lymphomaChina80,1 arm,ORRFPI Apr 21FPI Apr 212024TAZBridging3L follicular
56、 lymphomaChina40,2 arms(EZH2+or wt),ORRFPI Jul 22FPI Jul 222024SAVO*GASTRIC2L GC,MET amplified China75,1 arm,ORRFPI Jul 21 FPI Jul 21 2024SAVO*SACHI2L EGFR TKI refractory NSCLC,MET+China250,combo vs.chemo,PFSFPI Nov 21FPI Nov 212024SAVO*SAVANNAH2/3L Tagrisso refractory NSCLC,MET+GlobalNew cohort for
57、 pot.AAFPI 2022FPI 20222024SURUSURTORI-012L NEC,combo with PD-1China190,combo vs.chemo,OSFPI Sep 21FPI Sep 212024FRUQ2L RCC2L RCC,combo with PD-1China260,2 arms,PFSFPI Oct 22FPI Oct 222025SOVLEwAIHA2L wAIHAChina110,2 arms(placebo),Hb responseFPI Sep 22FPI Sep 222025SAVO*SANOVO1L EGFRm+NSCLC,MET+Chin
58、a320,combo vs.Tagrisso,PFSFPI Sep 21FPI Sep 212025SAVO*SAMETAMET driven PRCC,combo with PD-L1Global200,3 arms combo vs.monos,PFSFPI Oct 21FPI Oct 212025SAVO*SAFFRON2/3L Tagrisso refractory NSCLC,MET+Global320,combo vs.chemo,PFSFPI 2022FPI 20222025wAIHA=warm antibody autoimmune hemolytic anemia.In co
59、llaboration with Epizyme.*In collaboration with AstraZenecaHUTCHMED registration/potential registration studies2117 registrational studies 3 global&4 in ChinaMET Exon14 skipping NSCLC NDA conditional approval in June 2021 Confirmatory Phase III study FPI September 20212L EGFR TKI refractory NSCLC w/
60、MET amplification Savolitinib+TAGRISSO Phase III registration study FPI in November 2021 SACHI Study1L EGFRm+NSCLC w/MET overexpression Savolitinib+TAGRISSO Phase III registration study FPI in September 2021 SANOVO StudyGastric cancer w/MET amplification Single arm study with potential for registrat
61、ion FPI in July 2021MET-driven Papillary Renal Cell Carcinoma(PRCC)Savolitinib+IMFINZI vs.SUTENT monotherapy vs.IMFINZI monotherapy Phase III registration study FPI in October 2021 SAMETA Study2/3L TAGRISSO refractory NSCLC w/MET aberration SAVANNAH study continue evaluation for potential accelerate
62、d approval;first data presentation at WCLC2/3L TAGRISSO refractory NSCLC w/MET aberration Savolitinib+TAGRISSO Phase III registration study$15 million milestone from AstraZeneca SAFFRON Study initiate in 2022CHINA led by HUTCHMEDGLOBAL led by AstraZenecaSavolitinib major late-stage expansion12345677
63、 registrational studies312SAFFRON MRCT open for recruitment(NCT05261399)TAGRISSO combo rationale now even stronger in SAFFRON Phase III NSCLC populationNovel biomarker and patient enrichment strategy driven by SAVANNAHWCLC 2022 Abstract#EP08.02-140.Savolitinib EGFRm+NSCLC w/MET aberrationN=185*MET-h
64、ighMET-low300mg QDIHC90+and/or FISH10+IHC5090 and/or FISH 5-10 Prevalence among patients screened34%34%28%Prior Chemo20%No prior chemo subset18%No prior chemo subsetNumber of patientsn=108n=87n=77n=63mDoR,95%CI9.3 mo.7.610.69.6 mo.7.614.96.9 mo.4.116.97.3 mo.4.1NCmPFS,95%CI7.1 mo.5.38.07.2 mo.4.79.2
65、2.8 mo.2.64.32.8 mo.1.84.2 Locally advanced or metastatic NSCLC Progression on 1L/2L TAGRISSO(osimertinib)therapy,no prior chemo EGFRm and MET-highSavolitinib 300 mg BID+Osimertinib 80 mg QDPlatinum-based doublet chemotherapy N=3241:1WCLC2022ORR,95%CI49%395952%41639%41810%42052%34%*Evaluable for eff
66、icacy defined as dosed patients with measurable disease at baseline who had 2 on-treatment RECIST scans.Excludes eight patients with invalid or missing test results for IHC90+and/or FISH10+status,these patients were excluded from the subgroup analyses based on MET levels.rationale now even stronger3
67、13SAMETA global Phase III trial in combination with IMFINZI(durvalumab)SOUND exploratory study in EGFR-wildtype NSCLCSavolitinib+IMFINZI combinationsHighly correlated to MET-driven alterations/amplificationsSAMETAFPI in October 2021 11 countries/global1 ASCO 2021 Surez C et al.J Clin Oncol 39,2021(s
68、uppl 15;abstr 4511).CALYPSO MET-driven=MET DNA alterations (central analysis:chromosome 7 gain/MET or HGF amplification,kinase domainmutations).2 Lu et al.Annals of Oncology(2022)33(suppl_2):S27-S70.3 Papaccio et al Int J Molec Sciences,2018;19(3595).4 Felipet al.J of Thoracic Onc,DOI:10.1016/j.jtho
69、.2021.01.1060.Allpatients(n=41)MET-driven(n=14)ORR29%57%mPFS4.9 mo.2.5-10.010.5 mo.2.9-15.7mOS14.1 mo.7.3-30.727.4 mo.7.3-NRPFS 12 mo.29.6%16.1-44.346.2%19.2-69.6OS 12 mo.54.3%37.5-68.464.3%34.3-83.357%IMFINZI(PD-L1i)combo activity 1seen in CALYPSOsunitinibsunitinibN=50durvalumabdurvalumabN=50savosa
70、vo+durvalumab+durvalumabN=100Crossover to savolitinib+durvalumab after PD by IRCUntil objective radiological PD assessed by IR,unacceptable toxicity,consent is withdrawn or other discontinuation criterionPivotal Phase III study in MET-driven PRCCsavolitinib+durvalumabUntil objective radiological PD
71、assessed by IR,unacceptable toxicity,consent is withdrawn or other discontinuation criterionMET exon 14 MET exon 14 skipping mutationskipping mutationMET MET amplification amplification MET MET overexpressionoverexpression MET inhibitors benefiting EGFR/ALK/ROS1 wild-type NSCLC pts,including savolit
72、inib in China2 Evidence of MET correlations w/PDMET correlations w/PD-L1 expressionL1 expression,neutrophil migration,other related immune systems3 METiMETi+PD+PD-1i 1i has shown promising efficacy in NSCLCpromising efficacy in NSCLC4 Promising CALYPSO results show efficacy&tolerabilityefficacy&tole
73、rability of savolitinib+durvalumab combo3SOUNDExploratory study in China in EGFR/ALK/ROS1wt NSCLC14Unmet medical need Limited use of approved 3L treatments Regorafenib(approved Q3 2012)TAS-102(approved Q3 2015)Chemotherapy,anti-VEGF&anti-EGFR agents used across all lines Newer treatment options focu
74、s on discrete actionable mutations 10%of patients have BRAF mutation 1 15%of patients have MSI-H or dMMRdisease 2Colorectal cancer a significant burdenbut there are still limited treatment options for most patientsNote:Epidemiology data are sourced from SEER,for the U.S.1 DHaene N,et al.Clinical app
75、lication of targeted next-generation sequencing for colorectal cancer patients:a multicentric Belgian experience.Oncotarget.2018;9(29):20761-20768.Published 2018 Apr 17.doi:10.18632/oncotarget.250992 Andr T,et al.Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer.N Engl J Me
76、d.2020;383(23):2207-2218.doi:10.1056/NEJMoa2017699Second most common metastatic cancer diagnosisPatients diagnosed with metastatic disease have low 5-year relative survival rate33 32 28 19 17 12 6 4 4 LungColorectalPancreaticBreastProstateNHLBladderKidneyEndometrialMelanomaEst.US cases in 2022 (000)
77、55%36%24%18%14%0%50%100%AliveTime since diagnosisLungCRCPancreaticBreastProstate130315Initiated US rolling NDA submission;plan to complete filings in the U.S.,Europe and Japan in 20231ESMO 2022,LAB25.Dasari NA,Lonardi S et al.LBA25-FRESCO-2:A global phase III multiregional clinical trial(MRCT)evalua
78、ting the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer.12 Sep 2022,Proffered Paper session 2:GI,lower digestive Session.Annals of Oncology(2022)33(suppl_7):S808-S869.10.1016/annonc/annonc1089;2 Li J,et al.Effect of Fruquintinib vs Placebo on Overall Sur
79、vival in Patients With Previously Treated Metastatic Colorectal Cancer:The FRESCO Randomized Clinical Trial.JAMA.2018;319(24):2486-2496.doi:10.1001/jama.2018.7855.Fruquintinib FRESCO-2 positive;data at ESMO3FRESCO-2 MRCT started after regulatory consultation in U.S.,Europe&JapanU.S.Fast Track Design
80、ation for 3L mCRC&potential for rolling submissionPrimary endpoint is overall survival691 patients150 sites14 countriesRecruited in 15 monthsFruquintinib Basis for global filings Aggregation of China,U.S.&global studiesFRESCO-2Global Ph III(N=691)Late-stage CRC FRESCO China Ph III(N=416)3L CRC U.S.P
81、h Ib(N=116)3L/3L+CRC(81)Other tumorsConsistency of effect across late-stage settings enriches the continuum of care Spain26%Italy16%Hungary10%France9%Other European countries10%Japan8%Australia3%U.S.18%ESMO2022FRESCO-2 1FRESCO 22Fruq(n=461)Placebo(n=230)Fruq(n=278)Placebo(n=138)Prior TxVEGFi97%96%30
82、%30%EGFRi as%of RASwt100%100%25%25%TAS-10252%53%0%0%Regorafenib9%8%0%0%Both TAS-102®o39%40%0%0%mOS,mo.7.44.8 9.36.6 95%CI6.7-8.24.0-5.88.2-10.55.9-8.1HR(95%CI,p-value)0.66(0.55-0.80,p0.001)0.65(0.51-0.83,p0.001)mPFS,mo.3.71.83.71.895%CI3.5-3.81.8-1.93.7-4.61.8-1.8HR(95%CI,p-value)0.32(0.27-0.39,p
83、0.001)0.26(0.210.21-0.34,p0.001)0.34,p0.001)DCR55.5%16.1%62.2%12.3%DCO:June 24,2022DCO:January 17,2017+2.6+2.7+1.9+1.916“FRESCO-2 results are consistent with those of FRESCO and support a new global oral treatment option for patients with refractory mCRC,which enriches the continuum of care for thes
84、e patients.”ESMO 2022 1ITT Population.1 ESMO 2022,LBA25.Dasari NA,et al.LBA25-FRESCO-2:A global phase III multiregional clinical trial(MRCT)evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer.12 Sep 2022,Proffered Paper session 2:GI,lower diges
85、tive Session.Annals of Oncology(2022)33(suppl_7):S808-S869.10.1016/annonc/annonc1089.FRESCO-2 met OS 1 Endpoint&PFS 2 EndpointProbability of Overall Survival(%)Time since randomization(months)0 11 12 13 14 15 16 17 18 191.00.80.60.40.20Fruquintinib+BSCFruquintinib+BSCPlacebo+BSCPlacebo+BS
86、CProbability of Progression-free Survival(%)Time since randomization(months)1.00.80.60.40.200 11 12 13 14 15 16 17 18 19OVERALL SURVIVALFruquintinibFruquintinibPlaceboPlaceboEvents/Patients(%)317/461(68.8%)173/230(75.2%)Median(mo)(95%CI)7.4(6.7,8.2)4.8(4.0,5.8)mOS difference+2.6 monthsStr
87、atified HR(95%CI)0.662(0.549,0.800)p0.001PROGRESSION-FREE SURVIVALFruquintinibFruquintinibPlaceboPlaceboEvents/Patients(%)392/461(85.0%)213/230(92.6%)Median(mo)(95%CI)3.7(3.5,3.8)1.8(1.8,1.9)mPFS difference+1.9 monthsStratified HR(95%CI)0.321(0.267,0.386)p0.001317Median follow up:Fruquintinib:11.3 m
88、oPlacebo:11.2 moPositive FRESCO-2 OS&PFS consistent across all subgroupsOverall Survival by subgroupsProgression Free Survival by subgroupsESMO 2022,LBA 253FruqFruq n/Nn/N PboPbo n/Nn/NHR(95%CI)HR(95%CI)ITT PopulationITT Population317/461173/2300.662(0.549,0.800)Age 65 years=65 years=65 years146/214
89、84/1110.648(0.494,0.851)SexFemaleFemale149/21661/900.828(0.609,1.125)MaleMale168/245112/1400.584(0.456,0.749)ECOG PS0 0121/19667/1020.775(0.573,1.050)1 1196/265106/1280.571(0.449,0.728)RaceCaucasianCaucasian260/367145/1920.696(0.567,0.854)AsianAsian24/4314/180.377(0.171,0.833)African AmericanAfrican
90、 American7/135/70.550(0.135,2.231)OtherOther26/389/131.199(0.478,3.008)RegionN.AmericaN.America50/8229/420.620(0.387,0.995)EuropeEurope237/329130/1660.688(0.554,0.855)Asia PacificAsia Pacific30/5014/220.631(0.321,1.241)Duration of Metastatic Disease 18 months 18 months30/378/130.605(0.260,1.406)18 m
91、onths 18 months287/424165/2170.642 0.529,0.779)Primary Tumor Siteat 1stDiagnosisColonColon195/279109/1370.672(0.528,0.855)RectumRectum99/14349/700.633(0.446,0.900)Colon&RectumColon&Rectum23/3915/230.686(0.339,1.388)RAS StatusWTWT119/17062/850.667(0.489,0.909)MutantMutant198/291111/1450.683(0.539,0.8
92、65)#of Prior Tx Lines in Metastatic Disease 3 lines 3 lines80/12545/640.714(0.488,1.043)3 lines3 lines237/336128/1660.645(0.519,0.802)Prior VEGFiYesYes306/445167/2210.683(0.565,0.827)NoNo11/166/90.193(0.024,1.557)Prior EGFRiYesYes127/18064/880.689(0.507,0.936)NoNo190/281109/1420.666(0.524,0.846)Prio
93、r TAS-102 orRegorafenibTASTAS-102102165/24088/1210.723(0.557,0.938)RegorafenibRegorafenib25/4012/180.772(0.379,1.573)BothBoth127/18173/910.600(0.447,0.805)Liver MetastasesYesYes255/339132/1560.576(0.465,0.713)NoNo62/12241/740.771(0.513,1.158)FruqFruq n/Nn/N PboPbo n/Nn/NHR(95%CI)HR(95%CI)ITT Populat
94、ionITT Population392/461213/2300.321(0.267,0.386)Age 65 years=65 years=65 years178/214102/1110.314(0.241,0.410)SexFemaleFemale190/21681/900.351(0.263,0.468)MaleMale202/245132/1400.302(0.237,0.385)ECOG PS0 0169/19690/1020.264(0.197,0.354)1 1223/265123/1280.351(0.277,0.446)RaceCaucasianCaucasian312/36
95、7176/1920.313(0.255,0.383)AsianAsian37/4317/180.286(0.140,0.584)African AmericanAfrican American9/137/70.081(0.014,0.468)OtherOther34/3813/130.525(0.248,1.110)RegionN.AmericaN.America64/8236/420.261(0.163,0.417)EuropeEurope283/329158/1660.324(0.261,0.401)Asia PacificAsia Pacific45/5019/220.271(0.144
96、,0.509)Duration of Metastatic Disease 18 months 18 months35/3711/130.361(0.166,0.787)18 months 18 months357/424202/2170.300(0.249,0.363)Primary Tumor Siteat 1stDiagnosisColonColon241/279127/1370.294(0.231,0.375)RectumRectum118/14364/700.315(0.225,0.441)Colon&RectumColon&Rectum33/3922/230.386(0.202,0
97、.739)RAS StatusWTWT145/17076/850.333(0.245,0.454)MutantMutant247/291137/1450.318(0.254,0.399)#of Prior Tx Lines in Metastatic Disease 3 lines 3 lines108/12557/640.280(0.192,0.409)3 lines3 lines284/336156/1660.334(0.270,0.412)Prior VEGFiYesYes377/445206/2210.335(0.278,0.402)NoNo15/167/90.020(0.001,0.
98、385)Prior EGFRiYesYes154/18079/880.325(0.239,0.440)NoNo238/281134/1420.310(0.247,0.391)Prior TAS-102 orRegorafenibTASTAS-102102210/240111/1210.367(0.287,0.470)RegorafenibRegorafenib29/4016/180.292(0.139,0.611)BothBoth153/18186/910.285(0.212,0.382)Liver MetastasesYesYes297/339149/1560.291(0.234,0.362
99、)NoNo95/12264/740.334(0.235,0.476)0.11.010.00.11.010.018Favors FruquintinibFavors PlaceboFavors FruquintinibFavors PlaceboFRESCO-2 results have potential to change clinical practice worldwideNote:Illustrative comparison only.No head-to-head studies have been conducted.Study parameters differ.1 ESMO
100、2022,LBA25;2 Grothey A,et al.Regorafenib monotherapy for previously treated metastatic colorectal cancer(CORRECT):an international,multicentre,randomised,placebo-controlled,phase 3 trial.Lancet.2013;381(9863):303-312.doi:10.1016/S0140-6736(12)61900-X;3 Mayer RJ,et al.Randomized trial of TAS-102 for
101、refractory metastatic colorectal cancer.N EnglJ Med.2015;372(20):1909-1919.doi:10.1056/NEJMoa1414325.Fruquintinib has a highly competitive profile193FRESCO-2CORRECTCORRECTRECOURSERECOURSE4.87.4FruquintinibPlaceboMedian Overall Survival5.37.1TAS-102Placebo5.06.4RegorafenibPlacebo+2.6 mo.HR=0.66+1.4 m
102、o.HR=0.77+1.8 mo.HR=0.68 mOS1.83.7FruquintinibPlaceboMedian Progression Free Survival1.72.0TAS-102Placebo1.71.9RegorafenibPlacebo+1.9 mo.HR=0.32+0.2 mo.HR=0.49+0.3 mo.HR=0.48 mPFSTolerabilityFRESCO-2 1CORRECT 2RECOURSE 3FruquintinibPlaceboRegorafenibPlaceboTAS-102PlaceboDiscontinuation due to AE20%2
103、1%17%12%4%2%TEAE Grade 363%50%54%14%69%52%Major TEAE Grade 3Hypertension14%1%7%1%n/an/aHand-foot syndrome 6%0%17%1%n/an/aAsthenia/fatigue 8%4%15%9%7%9%Other AEs of noten/aBlackbox warning on hepatoxicityBlackbox warning on hepatoxicityMonitor liver function prior to and Monitor liver function prior
104、to and during treatmentduring treatmentSevere myelosuppressionSevere myelosuppressionObtain complete blood counts prior Obtain complete blood counts prior to and on day 15 of each cycleto and on day 15 of each cycleFruquintinib is well tolerated with a safety profile consistent with the previously e
105、stablished monotherapyprofile16.1%55.5%FruquintinibPlaceboDisease Control Rate16.3%44.0%TAS-102Placebo14.9%41.0%RegorafenibPlacebo+39.4%+26.1%+27.7%DCRThe fifth most commonly diagnosed cancer worldwideGlobocan 2020China,Japan,and Korea account for 60%of newly diagnosed cases in the worldGastric canc
106、er:a common cancer that disproportionately affects Asia 202,261,4192,206,7711,931,5901,414,2591,089,103905,677Annual incidence globallyEurope12%US2%RoW10%China44%Japan13%Korea3%Other Asia16%Asia76%Annual incidence of gastric cancer by geography4sNDA filing in H1 2023Dual primary endpoints:Progressio
107、n free survivalProgression free survival:clinically and statistically sign.improvementOverall survivalOverall survival:improvement not statistically significant per the pre-specified statistical plan Secondary endpoints:ORR DCR DoRSafety profile consistent with previously reported studiesFRUTIGAChem
108、o combo in 2L gastric cancerSupportive Phase II resultsSource:Xu RH,Zhang DS et al.A Phase I/II trial of fruquintinib in combination with paclitaxel for second-line treatment in patients with advanced gastric cancer.Journal of Clinical Oncology 2017 35:4_suppl,128-128.DOI:10.1200/JCO.2017.35.4_suppl
109、.128FRUTIGA:combo with paclitaxel in 2L gastric cancer21File sNDA with NMPA in H1 2023Eligible patients Gastroesophageal junction or gastric cancer Progressed after 1stline chemo w/fluoropyrimidine&platinumPlacebo+PaclitaxelN=350Fruquintinib+PaclitaxelN=350ORR of 36%ORR of 36%(10/28)&(10/28)&DCR of
110、68%DCR of 68%in efficacy evaluable pts.in efficacy evaluable pts.Fruquintinib 4mg:Fruquintinib 4mg:16 wk.PFS of 50%16 wk.PFS of 50%&7 mo.OS of 50%.&7 mo.OS of 50%.Drug related grade 3 or 4 AEs(NCI-CTCAE v 4.0)termDose Expansion Stage(N=19)Fruquintinib 4 mg+paclitaxel 80 mg/mNeutropenia11(57.9%)Leuko
111、penia4(21.0%)Hypertension2(10.6%)PLT decreased,Anemia,HFSR,Mucositis oral,Hepatic disorder,Upper gastrointestinal hemorrhage1(5.3%)eachAE profile inAE profile in-line with expectationsline with expectationsWaterfall Plots of Best Response2040020406080302mg(n=3)3mg(n=3)4mg dose finding stage(n=8)4mg
112、dose expansion stage(n=19)Progressive Disease(PD)Non-Evaluable(NE)4SYK inhibitor fostamatinib delivers 44%response and 25%durable response:requires a better moleculeAgentResponse(1x PLT 50109/L)Durable response Responseafter discontinuationTPO-RA treatment increases platelet productionNPLATE (romipl
113、ostim)279-88%(24 weeks)38-61%(6/8 visits in weeks 16-24)14%sustained response 6 months after discont.PROMACTA(eltrombopag)59-70%(6 weeks)360%(6/8 visits in weeks 18-26)450%of pts maintained responseTreatments to decrease platelet destructionRITUXAN(rituximab)67%(4 weeks)Median response duration 27-3
114、6 monthsTAVALISSE(fostamatinib)544%(12 weeks)24-26%(4/6 visits in weeks 14-24)n/aTreatments for chronic ITP 11 Provan D,Arnold DM,Bussel JB,et al.Updated international consensus report on the investigation and management of primary immune thrombocytopenia.Blood Adv.2019;3(22):3780-3817.doi:10.1182/b
115、loodadvances.2019000812;2 Study 1&2 from USPI;3 Study 773A and B from US PI;4 RAISE study from US PI;5 US PI;6 Neunert C,Terrell DR,Arnold DM,et al.American Society of Hematology 2019 guidelines for immune thrombocytopenia published correction appears in Blood Adv.2020 Jan 28;4(2):252.Blood Adv.2019
116、;3(23):3829-3866.doi:10.1182/bloodadvances.2019000966.Treatment landscape for chronic ITP22ASH 2019 guidelines for 2L treatment 6:shared decision making with patientsPatient Patient preferencepreferenceDurable Durable responseresponseAvoidanceAvoidance of longof long-term medicationterm medicationAv
117、oidance of Avoidance of surgerysurgeryTPOTPO-RARARituximabRituximabSplenectomySplenectomySYK is a validated target for ITPSyk targets both B cells¯ophagesFostamatinib approved in the U.S.International consensus report considers evidence for fostamatinib use to be robust 1ASH guideline considers
118、evidence for fostamatinib use in 2L patients insufficient 2Sovleplenib Phase III Enrolled in Dec 2022China Phase Ib complete encouraging efficacy and good safety presented at ASH 20214Results from China Phase Ibin several NHL subtypes Encouraging single agent activity in indolent NHL Manageable safe
119、ty profileAmdizalisibHeme-onc assets progressing towards readout in 2023Efficacy evaluablepopulation(n=76):CR:12%ORR:54%CBR:76%CR:0%ORR:24%CBR:48%CR:13%ORR:75%CBR:88%Mantle cell lymphoma(MCL)Diffuse large B-cell lymphoma(DLBCL)CLL/SLLORR:100%Marginal zone lymphoma(MZL)CR:36%ORR:82%CBR:91%Follicular
120、lymphoma(FL)Breakthrough Therapy Designation in ChinaCR:0%ORR:50%CBR:100%As of June 15,2021.ESMO 2021:Cao J,et al.#833O-A phase Ib study result of HMPL-689,a PI3K inhibitor,in Chinese patients with relapsed/refractory lymphoma.Annals of Oncology(2021)32(suppl_5):S773-S785.doi:10.1016/annonc/annonc67
121、6.4China registration studies supported by differentiated proof-of-concept data23SovleplenibResults from China Phase I/II in R/R primary ITP Oral,fast onset of efficacy ORR 80%,Durable ORR 40%Robust efficacy in heavily pre-treated patients Similar efficacy with or without prior TPO/TPO-RA therapies
122、Sovleplenib300 mg,once dailyDouble-blinded Pts8+16 wksCross-over Pts16 wksTotal ORR:n(%)75.0%(12/16)100.0%(4/4)80.0%16/20)Durable ORR:n(%)31.3%(5/16)75.0%(3/4)40.0%(8/20)ASH2021ESLIM-01 pivotal Phase III studyrecruitment completed Dec 2022Breakthrough Therapy Designation in ChinaAs of June 15,2021.A
123、SH 2021#16.Yang H,Zhou Y,Hu JY,et al.Safety,Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Adult Patients with Primary Immune Thrombocytopenia:A Randomized,Double-Blind and Placebo-Controlled Phase 1b Study.Blood 2021;138(Supplement 1):16.doi:https:/doi.org/10.1182/blood- FL Pha
124、se IIb recruitment to complete in early 2023Bridging study for rapid registration and indication expansion through combinationsEncouraging combo activity with R Current statusTazemetostat:China development strategyMonotherapy bridging study in 3L+R/R follicular lymphoma FPI in July 2022SYMPHONY-1 st
125、udy combo w/R global Phase III in 2L follicular lymphoma FPI September 2022Hainan Health Tourism Policy U.S.FDA approved oncology drugs channel in Hainan ProvinceCombo study with amdizalisib(PI3Ki)IND cleared in China;FPI expected H1 2023Preliminary efficacyMedian duration of tazemetostat treatment
126、was 32 weeks38/44 were efficacy evaluable*Safety consistent with previously reported safety information for this combinationBest Overall Response Best Overall Response a a(%)(%)TAZ+R(n=38)TAZ+R(n=38)b bObjective response rate95%Complete response c50%Partial response45%Stable disease5%Progressive dis
127、ease0a Overall,there were 31 PET-CTbased responses and 7 CT-based responses.b 6 patients were not included in the initial efficacy assessments.C For complete response,18 were PET-CTbased responses and 1 was a CT-based response.CT,computed tomography;PET,positron emission tomography;R2,lenalidomide+r
128、ituximab;TAZ,tazemetostat.DCO:January 2022ASCO2022Revlimid+Rituximab(R2)is a registered trademark of Celgene Corporation,a Bristol Myers Squibb company.ASCO 2022 poster 7572424Well-financed position continue delivering on our strategic objectives1 Bank borrowings of$0.4m under non-current liabilitie
129、s as of Jun 30,2022(Dec 31,2021:$26.9m under current liabilities);2 Short-term investments:deposits over 3 months.Condensed Consol.Balance SheetsJun 30,Jun 30,Dec 31,Dec 31,(in US$millions)2022202220212021(Unaudited)AssetsAssetsCash,cash equivalents&short-term investments826.21,011.7Accounts receiva
130、ble77.183.6Other current assets118.9116.8Property,plant and equipment44.141.3Investments in equity investees83.076.5Other non-current assets45.042.8Total assetsTotal assets1,194.31,194.31,372.71,372.7Liabilities and shareholders equityLiabilities and shareholders equityAccounts payable51.041.2Other
131、payables,accruals and advance receipts233.6210.9Bank borrowings 10.426.9Other liabilities57.554.2Total liabilitiesTotal liabilities342.5342.5333.2333.2Companys shareholders equityCompanys shareholders equity799.7799.7986.9986.9Non-controlling interests52.152.6Total liabilities and shareholders equit
132、yTotal liabilities and shareholders equity1,194.31,194.31,372.71,372.7As of Jun 30,2022As of Jun 30,2022Cash Resources:$826m cash/cash eq./ST inv.2Including short-term investment of$359m$359m$178m unutilized banking facilities from Bank of China,HSBC and Deutsche Bank$113m$113m unutilized fixed asse
133、t loan facility Others:$58m additional cash at SHPL JV525(in US$millions,except share and per share data)6 months ended6 months endedJun 30,Jun 30,Year endedYear endedDec 31,Dec 31,202220222022021 120212021(Unaudited)Revenues:Revenues:Oncology/Immunology Marketed Products63.537.876.4 Oncology/Immuno
134、logy R&D27.65.143.2 Oncology/Immunology consolidated revenues91.142.9119.6 Other Ventures110.9114.5236.5 Total revenuesTotal revenues202.0202.0157.4157.4356.1 356.1 Operating expenses:Operating expenses:Costs of revenues(137.3)(123.2)(258.2)R&D expenses(181.7)(123.1)(299.1)Selling&general admin.expe
135、nses(79.8)(54.8)(127.1)Total operating expensesTotal operating expenses(398.8)(398.8)(301.1)(301.1)(684.4)(684.4)(196.8)(196.8)(143.7)(143.7)(328.3)(328.3)Gain on divestment of an equity investee-121.3 Other(expense)/income(3.8)3.3(8.7)Loss before income taxes&equity in earnings of equity investeesL
136、oss before income taxes&equity in earnings of equity investees(200.6)(200.6)(140.4)(140.4)(215.7)(215.7)Income tax benefit/(expense)4.2(1.9)(11.9)Equity in earnings of equity investees,net of tax33.528.744.7 Equity in earnings of divested equity investee,net of tax-14.315.9Net lossNet loss(162.9)(16
137、2.9)(99.3)(99.3)(167.0)(167.0)Less:Net income attrib.to non-controlling interests0.0(3.1)(27.6)Net loss attrib.to HUTCHMEDNet loss attrib.to HUTCHMED(162.9)(162.9)(102.4)(102.4)(194.6)(194.6)Losses/share attrib.to HUTCHMED basic&diluted(US$per share)(0.19)(0.14)(0.25)Losses/ADS attrib.to HUTCHMED ba
138、sic&diluted(US$per ADS)(0.96)(0.70)(1.23)Oncology sales growth&Other Ventures income help offset R&D investmentCondensed Consol.Statements of OperationsSix-month revenues up 28%to$202.0m Oncology revenues doubled to$91.1m(H121:$42.9m),on track with guidance$15.0m development milestone from AZ(for th
139、e initiation of start-up activities of SAFFRON study)R&D spending supporting 13 registration enabling programs R&D expenses up 48%to$181.7mChina R&D expenses up 54%to$98.1m(H121:$63.8m)U.S.&EU R&D expenses up 41%to$83.6m(H121:$59.3m)Equity investees income partially offsetting R&D investment Net inc
140、ome attributable to HUTCHMED from equity investees up17%to$33.5m(H121:$28.7m)526-2 2 1 4 7 7 8 11 15 17 22 29 35 34 36 47 30 35-3 3 5 5 6 7 7 7 8 8 8 8 6 8 37 96 11-40 3 0304050607080951H121H122Base operationsHBYSOne-time gains736+19%+19%542413965135Value of our non-
141、core assets continue to increase1 NI=Net income/(loss);20032006 incl.discontinued operation;Based on aggregate Non-GAAP NI of consolidated subsidiaries&non-consolidated joint ventures of Other Ventures,please see appendix“Non-GAAP Financial Measures and Reconciliation”;2 Total NI consists of aggrega
142、te net profit from HBYS operation of$269m and one-time gain of$193m.NI attributable to HUTCHMED represents the aggregate share of net profit from HBYS operation of$106m and one-time gain of$117m;3 One-time gains represent our share of one-off property gains from SHPL,includes the land compensation o
143、f$40.4m in 2016,and R&D related subsidies of$2.5m in 2017;4 Represent our share of HBYS net profit from operation of$7.7m and one-time gains from land compensation of$28.8m in 2020.The Group divested its entire interest in HBYS in Sep 2021 and thus the Groups share of HBYS net profit from operation
144、only covered the period from Jan 1st-Sep 28th for 2021 which is$7.1m,plus further land compensation of$5.6m in 2021.The Group also recognized a gain on HBYS divestmentof$82.9m in 2021;5 Excluded HBYS NI attributable to HUTCHMED of$11.5m in H1 2021;6 Included HBYS land compensation of$5.6m in H1 2021
145、Substantial value in our Other Ventures-6-4-17040(US$millions)Other VenturesCumulative2007-2021 CAGRNI1NI attrib.to HUTCHMEDConsol.Subsidiaries&SHPL672339+31%HBYS22462223Total1,34562Net income attrib.to HUTCHMED since inceptionNet Income(NI)attributable to HUTCHMEDNet Income(NI)attributab
146、le to HUTCHMED41527StrategicPartnershipsPipeline Synergy CollaborationsBandwidth PartnershipsPartnership focusScientific/medical partnership strategyOur BD strategy is focused on three key activities1 Led by Epizyme;2 Led by AstraZenecaORPATHYS world-wide Launched in China 7 registration studies in
147、NSCLC,PRCC&gastric cancerELUNATE ChinaEpigenetics Ipsen:tazemetostattazemetostatI/O Combos Junshi:Suru+toripalimabtoripalimab Innovent:Fruq+sintilimabsintilimab BeiGene:Suru/Fruq+tislelizumab tislelizumab Immunology 4 preclinical candidates for immunological diseases Funded by Inmagene HUTCHMED righ
148、t to co-commercialize in China Commercialize fruquintinib in U.S.,Europe,Japan&RoW Broaden development outside of China Leverage China commercial successJunshiBiosciences28Global vision unchanged:bringing our innovative medicines to patients worldwide10+NDAsubmissions in plan,in China&globallyContin
149、ue our strong China commercialmomentumHUTCHMED 2023-25Bring near-term valueBuild a long-term sustainable businessRapidly growing China salesDeliver the next wave of new product registrations Fruquintinib global(with positive FRESCO-2)Sovleplenib,amdizalisib&tazemetostat in ChinaPath to profitability
150、Remain agilePrioritize late-stage programs,registration studies®ulatory approvalsCommercial partnering internationally to expedite access to our medicines globallyBuild on our strengthsStrategic focus29www.hutch-Thank you 2022 HUTCHMED.APPENDIXExecutive Management CommitteeDr.Weiguo SuChief Execu
151、tive Officer&Chief Scientific OfficerMr.Johnny ChengChief Financial OfficerDr.Michael ShiHead of R&D and Chief Medical OfficerDr.Karen AtkinChief Operating OfficerDr.Zhenping WuPharmaceuticalSciencesWorld-class team with track record of success in HUTCHMED&multinational pharma xx/xxxx Years in indus
152、try/at HUTCHMED;Company logos denote prior experience.HUTCHMEDs deep leadership team32Dr.Junjie Zhou General Manager,SHPLMr.Hong ChenChief Commercial Officer,ChinaMs.YilingCuiGovernment AffairsDr.May WangBusiness Dev.&StrategicAlliancesMr.Mark LeeCorporate Finance&DevelopmentMr.Charles NixonGeneral
153、CounselMs.Selina ZhangHuman ResourcesHENG RUI PHARMACEUTICALSDr.Thomas FuQualityIFRSIFRSUS GAAPUS GAAPH121H121-H122H122Total since Total since inceptioninception(US$millions)03030404050506060707080809092581H121H121H122H122GrowthGrowthNet(loss)/Income(NonNe
154、t(loss)/Income(Non-GAAP)GAAP)include oneinclude one-time gainstime gains(10.7)(10.7)(3.6)(3.6)2.2 2.2 6.7 6.7 11.2 11.2 14.7 14.7 21.5 21.5 27.9 27.9 30.1 30.1 33.1 33.1 39.7 39.7 48.8 48.8 54.1 54.1 144.1144.182.3 82.3 83.6 83.6 84.9 84.9 162.2 162.2 231.2231.27787.3 87.3 69.4 69.4-21%21%1,133.41,1
155、33.4Net(loss)/Income(NonNet(loss)/Income(Non-GAAP)GAAP)exclude oneexclude one-time gainstime gains(10.7)(10.7)(3.6)(3.6)2.2 2.2 6.7 6.7 11.2 11.2 14.7 14.7 21.5 21.5 27.9 27.9 30.1 30.1 33.1 33.1 39.7 39.7 48.8 48.8 54.1 54.1 63.363.33377.377.34483.6 83.6 84.9 84.9 90.290.255110.3110.3676758.858.888
156、69.4 69.4 18%18%854.7854.7Consolidated subsidiariesConsolidated subsidiaries(10.3)(4.9)(2.9)(2.4)0.2 0.0 0.8 1.0(0.4)(1.1)0.1 1.6 1.4 3.15.96.93.83.93.11.52.353%12.1NonNon-consolidated joint venture consolidated joint venture-SHPLSHPL(0.4)1.3 1.9 1.3 1.9 2.8 6.0 11.9 14.2 17.7 22.6 26.4 31.3 39.8350
157、.6459.8 61.3 67.0 89.4 57.3 67.1 17%573.9NonNon-consolidated joint venture consolidated joint venture-HBYSHBYS-3.2 7.8 9.1 11.9 14.7 15.0 16.3 16.5 17.0 20.8 21.4 20.420.816.919.819.3517.867-8-268.7-Net(loss)/income attrib.to HUTCHMED Net(loss)/income attrib.to HUTCHMED include oneinclude one-time g
158、ainstime gains(5.7)(5.7)(3.7)(3.7)(0.5)(0.5)1.2 1.2 4.54.5225.95.9229.39.32212.612.62213.613.62214.614.62218.218.22222.822.82225.225.22270.370.340.0 40.0 41.4 41.4 41.5 41.5 72.872.8142.9142.97741.3 41.3 35.4 35.4-14%14%562.3562.3Net(loss)/income attrib.to HUTCHMED Net(loss)/income attrib.to HUTCHME
159、D exclude oneexclude one-time gainstime gains(5.7)(5.7)(3.7)(3.7)(0.5)(0.5)1.2 1.2 4.54.5225.95.9229.39.32212.612.62213.613.62214.614.62218.218.22222.822.82225.225.22229.929.93337.537.54441.4 41.4 41.5 41.5 44.044.05554.454.4676729.829.88835.4 35.4 19%19%402.1402.1Consolidated subsidiariesConsolidat
160、ed subsidiaries(5.5)(4.3)(2.7)(2.4)0.2 0.00.8 1.0 0.0(0.7)0.2 1.3 1.0 1.8 3.9 4.8 2.9 2.8 2.6 1.21.857%9.5NonNon-consolidated joint venture consolidated joint venture SHPLSHPL(0.2)0.6 1.0 0.7 0.9 1.4 3.0 5.9 7.1 8.8 11.2 13.2 15.6 19.9325.3429.9 30.7 33.5 44.7 28.6 33.617%286.8NonNon-consolidated jo
161、int venture consolidated joint venture HBYSHBYS-1.2 2.9 3.4 4.5 5.5 5.7 6.5 6.5 6.8 8.3 8.6 8.2 8.3 6.7 7.9 7.757.167-8-105.8Other Ventures-Reconciliation of Non-GAAP Net(Loss)/Income 1Consolidated Subsidiaries:includes Hutchison Sinopharm and othersNon-consolidated joint ventures:includes SHPL and
162、HBYS71 20032006 incl.disco.operation;2 Excluded discontinued operations results in respective years;3 Excluded the land compensation in SHPL of$80.8 million from net income and$40.4 million from net income attributable to HUTCHMED for 2016;4 Excluded SHPLs R&D related subsidies of$5.0 million from n
163、et income and$2.5 million from net income attributable to HUTCHMED for 2017;5 Excluded the land compensation in HBYS of$72.0 million from net income and$28.8 million from net income attributable toHUTCHMED for 2020;6 Excluded the gain on divestment of HBYS of$106.9 million from net income and$82.9 m
164、illion from net income attributable to HUTCHMED;and excluded the land compensation in HBYS of$14.0 million from net income and$5.6 million from net income attributable to HUTCHMED for 2021;7The Group divested its entire interest in HBYS in Sep 2021 and thus the Groups share of HBYS net profit only c
165、overed the period from Jan 1st-Sep 28thfor 2021;8 Excluded net income from HBYS of$28.5 million(of which$14.0 million land compensation)and net income attributable to HUTCHMED from HBYS of$11.5 million(of which$5.6 million land compensation)for H1 2021.Non-GAAP Financial Measures&Reconciliation Excl
166、ude one-time gainsInclude one-time gains33ADS=American depositary share.AIHA=autoimmune hemolytic anemia.ALK=anaplastic lymphoma kinase.ALL=acute Lymphoblastic LeukemiaAML=acute myeloid leukemia.ASCO=American Society of Clinical Oncology.ASCO GI=ASCO(American Society of Clinical Oncology)Gastrointes
167、tinal Cancers SymposiumASH=American Society of HematologybsAb=bi-specific antibodyBID=twice daily.BRAF=B-Raf.BSC=best supportive care.BTK=brutons tyrosine kinase.CBCL=cutaneous B-cell lymphoma.CI=confidence interval.CLL/SLL=chronic lymphocytic leukemia and small lymphocytic lymphomaCRC=colorectal ca
168、ncer.CRL=complete response letter.CSF-1R=colony-stimulating factor 1 receptor.DCO=data cutoffDDI=drug-drug interactions.Deutsche Bank AG=Deutsche Bank AG,Hong Kong Branch.DLBCL=diffuse large B-cell lymphomadMMR=deficient mismatchDoR=duration of response.DRR=durable response rate.epNET=extra-pancreat
169、ic neuroendocrine tumor.EGFR=epidermal growth factor receptor.EGFRm+=epidermal growth factor receptor mutated.EMA=European Medicines Agency.EMC=endometrial cancer.Epizyme=EpizymeInc.ERK=extracellular signal-regulated kinase.ES=epithelioid sarcoma.EU=European Union.EZH2=enhancer of zeste homolog 2.FI
170、SH=fluorescence in situ hybridization.FISH5+=MET amplification as detected by FISH with MET copy number 5 and/or MET:CEP signal ratio 2.FISH10+=MET amplification as detected by FISH with MET copy number 10.FDA=Food and Drug Administration.FGFR=fibroblast growth factor receptor.FL=follicular lymphoma
171、.FPI=first patient in.GAAP=Generally Accepted Accounting Principles.GC=gastric cancer.GI=gastrointestinal.HBYS=Hutchison Whampoa Guangzhou BaiyunshanChinese Medicine Company Limited.HKEX=The Main Board of The Stock Exchange of Hong Kong Limited.HL=Hodgkins lymphoma.HSBC=The Hongkong and Shanghai Ban
172、king Corporation Limited.Hutchison Sinopharm=Hutchison Whampoa Sinopharm Pharmaceuticals(Shanghai)Company Limited.IDH=Isocitrate dehydrogenase.In-market sales=total sales to third parties provided by Eli Lilly(ELUNATE),AstraZeneca(ORPATHYS)and HUTCHMED(SULANDAand TAZVERIK).HCPs=healthcare profession
173、alsIHC=immunohistochemistry.IHC50+=MET overexpression as detected by IHC with 3+in 50%tumor cells.IHC90+=MET overexpression as detected by IHC with 3+in 90%tumor cells.iNHL=indolent Non-Hodgkins Lymphoma.I/O=Immuno-oncology.IND=Investigational New Drug(application).IR=independent review.IRC=independ
174、ent review committee.ITP=Immune thrombocytopenia purpura.Lilly=Eli Lilly and Company.MAA=Marketing Authorization Application.MAPK pathway=RAS-RAF-MEK-ERK signaling cascade.Mab=monoclonal antibody.MCL=mantle cell lymphoma.MDS/MPN=myelodysplastic/myeloproliferative neoplasmsMET=mesenchymal epithelial
175、transition factor.MRCT=multi-regional clinical trial.MSI-H=high levels of microsatellite instability.MSS=microsatellite stable.MZL=marginal zone lymphoma.na=not available.NDA=New Drug Application.NEC=neuroendocrine carcinoma.NETs=neuroendocrine tumors.NHL=Non-Hodgkins Lymphoma.NR=not reached.NRDL=Na
176、tional Reimbursement Drug List.NSCLC=non-small cell lung cancer.ORR=objective response rate.OS=overall survival.QD=once daily.PD=progressive disease.PD-L1=programmed cell death ligand 1.PFS=progression-free survival.PI3K=phosphoinositide 3-kinase delta.PJP=pneumocystis jiroveciipneumonia.PMDA=Pharma
177、ceuticals and Medical Devices Agency.pNET=pancreatic neuroendocrine tumor.PRCC=papillary renal cell carcinoma.PTCL=peripheral T-cell lymphomas.R&D=research and development.ROS-1=c-rosoncogene 1.SHPL=Shanghai Hutchison Pharmaceuticals Limited.SOC=standard of care.Syk=spleen tyrosine kinase.TNBC=tripl
178、e negative breast cancer.TGCT=tenosynovial giant cell tumor.TKI=tyrosine kinase inhibitor.TPO-RA=thrombopoietin receptor agonists.Tx=treatment.VEGF=vascular endothelial growth factor.VEGFR=vascular endothelial growth factor receptor.WM/LPL=Waldenstrm macroglobulinemia and lymphoplasmacytic lymphoma.WT=wild-type.WCLC=IASLC World Conference on Lung Cancer.Abbreviations34