【行业研究报告】和黄医药-Exploit global market opportunities

类型: 港股公司研究

机构: 招银国际

发表时间: 2023-03-02 00:00:00

更新时间: 2023-03-02 16:11:04

increasingnewCRCpatientstreated(28kin2H22,14kin1H22,12kin2H21),
increasingnewCRCpatientstreated(28kin2H22,14kin1H22,12kin2H21),
thein-marketsalesoffruquintinibinFY22grewby32%YoYtoUS$93.5mn,
resultinginUS$69.9mnrevenuebookedbyHCM.Fruquintinibhasbecomea
marketleaderfor3LCRCinChinawitha44%patientsharein4Q22.InJan,
HCMout-licensedtheex-ChinarightsoffruquintinibtoTakeda,andiseligibleto
receiveUS$400mnupfrontpaymentanduptoUS$730mnmilestones
payments.TheMRCTFRESCO-2trialhasdemonstratedsuperiorefficacyand
safetyintreatinglate-lineCRCpatientsthanotherapprovedproducts(CMBI
reportlink).HCMtargetstocompletetheBLArollingsubmissionin1H23inthe
US,withEUandJapantofollow.Wearepositivetowardstheoverseas
approvalsforCRC.Meanwhile,fruquintinibshowedpositivePFSresultsofthe
Ph3FRUTIGAtrialin2LGC,whiletheOSco-primaryendpointwasnotmet.
HCMplanstofilethesBLAforfruquintinibin2LGCbasedontheFRUTIGAdata
inChinain1H23.Givenramucirumab,theonlyapprovedI/Odrugforthe2LGC
inChina,didnotachievesignificanceinOSimprovementeitherinitsRAINBOW-
Asiatrial(link).WethinkitislikelyfruquintinibcanbeapprovedinChinafor2L
GC.WelookforwardtothedatareleaseoftheFRUTIGAtrial.Wealsoexpect
thereadoutoffruquintinib+PD-1in2LEMCandRCCin1H23.
NRDLinclusiontofurtherdrivesalesgrowthofsavolitinib.Thein-market
salesofsavolitinibincreased159%YoYtoUS$41.2mninFY22,with
US$22.3mnrevenueattributabletoHCM.SinceMar2023,savolitinibwillbe
coveredbyNRDL,whichwillfurtherfacilitatesalesgrowth.HCMwillcontinue
theenrolmentofthePh2SAVANNAHstudy,andevaluatethepotentialofUS
acceleratedapprovalbasedonthistrial.WealsoexpectHCMtoreleasedata
ofsavolitinib’spotentialregistrationalPh2trialforGCin1H23.
Nextwaveofinnovativedrugcommercialization.ThepivotaltrialESLIM-01
ofsovleplenib(Syk)in2LITPwasfullyenrolledinDec2022,andHCMexpects
thedatareadoutandpotentialNDAin2H23.Foramdizalisib(PI3Kδ),thePh2b
trialin2LFLjustcompletedenrolmentinFeb,andHCMexpectsthereadout
andNDAin2H23aswell.
MaintainBUY.WelikeHCMgivenitsstrongproductsalesgrowthmomentum
inChinaandbigpotentialofcommercialapprovalsofkeyassetsinoverseas
regions.WerevisedourTPfromHK$36.06toHK$37.49basedonDCF
valuation(WACC:9.51%,terminalgrowthrate:2%).