【行业研究报告】瑞科生物-B-Clinical development of core pipeline products continues

30May2023
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
Recbio(2179HK)
Clinicaldevelopmentofcorepipelineproducts
continues
9-ValentHPVVaccine,REC603:ThePhIIItrialofREC603infemales
aged9-45,whichrecruitedatotalof16,050subjects,isinprocess.Recbio
aged9-45,whichrecruitedatotalof16,050subjects,isinprocess.Recbio
hascompletedthreedosesvaccinationofimmune-bridgingtrialinyounger
agegroupsandtheimmunogenicitycomparativetrialwithGardasil®9.The
Companynowfollowsuponthesubjectsofprimaryefficacytrial.Currently,
thereisone9-valentHPVvaccine,Gardasil®9,approvedinChinawhichis
theglobaltop3best-sellingvaccinesin2022,accordingtotheF&S.Five
domestic9-valentHPVvaccinesareunderPhIIIclinicaltrials.Weexpect
RecbiotosubmitBLAapplicationforREC603in2025Eandtobecomeone
ofthefirstcommercializeddomestic9-ValentHPVvaccinesinChina.
ShinglesVaccine,REC610:RecbioisconductingthePhItrialofREC610
inthePhilippinestoevaluatethesafetyandimmunogenicityofREC610vs.
GSKShingrix®inhealthyadultsubjectsaged40andabove.Thefirstbatch
ofsubjectenrollmentwascompletedinFeb2023andweexpectclinical
datareadoutin2H23E.Moreover,theCompanyplanstoinitiatePhIand
PhIIItrialsinChinain2H23Eand2024E,respectively,andaimstosubmit
BLAapplicationforREC610in2025E.Currently,twoshinglesvaccines
havebeenapprovedinChinaincludingonerecombinantvaccine,Shingrix®
fromGSK,whichistheglobaltop5best-sellingvaccinesin2022according
totheF&S,andonedomesticlive-attenuatedvaccinefromBCHTBiotech
approvedinJan2023.Threeotherrecombinantvaccinecandidatesare
underclinicaldevelopmentinChina.
COVIDvaccine,ReCOV:RecbiopresentedpositivedatafromthePhaseII
clinicalstudies(Announcement;CMBIreport)andcompletedtheenrollment
ofsubjectsforinternationalmulti-centerPhIIIclinicaltrialsinNov2022.The
CompanyhassubmittedthemarketingapplicationtothePRCregulatory
authoritiesonarollingbasisinDec2022andobtainedEUAforReCOVin
MongoliainMar2023.WeexpectReCOVtobeapprovedin2023EinChina
andtocontributerevenuefrom2024E.
MaintainBUY.InMay2023,theCompanyhasbeenselectedasa
constituentoftheMSCIChinaSmallCapIndex.Recbioreported
RMB722.7mnnetattributablelossfor2022,vsRMB657.6mnnet
attributablelossin2021.R&Dexpenseincreasedby51.5%YoYto
RMB716.4mnin2022,mainlyduetoclinicaltrialexpensesrelatedtothe
expansionofscopeofReCOVclinicaltrialsandPhIIItrialofREC603.Given
thedecliningdemandforCOVIDvaccinesandintensifyingcompetition
amongdomesticCOVIDvaccines,weloweredourestimatesonReCOV.
WerevisedourTPfromHK$38.86toHK$20.96(WACC:10.6%,terminal
growthrate:2.5%).