【行业研究报告】科伦博泰生物-B-Intense data release to further validate the global potential of SKB264

27Mar2024
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
Kelun-Biotech(6990HK)
Intensedatareleasetofurthervalidatetheglobal
potentialofSKB264
Kelun-BiotechrecordedRMB1.54bnrevenueinFY23,primarilyfromlicensingand
collaborationagreementswithMSD.InMar2023,SKBreceivedaround
RMB1.21bnupfrontpaymentfromMSDforout-licensingcertainpre-clinicalADC
assets,aportionofwhichwasrecognizedinFY23.Additionally,Kelun-Biotech
receivedRMB215mnmilestonepaymentfromMSDrelatedtoSKB264in4Q23.
TheCompanyexpectstoreceiveoverUS$100mnpaymentsfromMSDinFY24.In
FY23,Kelun-BiotechspentRMB1.03bninR&DforitsChinatrials,+21.9%YoY.
ThenetlossshranktoRMB574mninFY23fromRMB616mninFY22.Asofend-
2023,theCompanyhadasufficientcashbalanceofRMB2.53bn.
SKB264tounlockcommercialvalueuponapprovalinChinain2H24.In
China,theNDAofSKB264,basedonPh3trialfor3L+TNBC,hasbeenunder
China,theNDAofSKB264,basedonPh3trialfor3L+TNBC,hasbeenunder
reviewsinceDec2023,withapprovalexpectedin2H24,markingthefirst
approvedindicationforSKB264.Kelun-BiotechhasrecentlystartedaPh3trial
ofSKB264for1LTNBCtreatment(NCT06279364).WeanticipatethePh3data
releaseofcompetingTROP2ADCsin1LTNBCin2H24,includingTrodelvy’s
ASCENT-03studyandDato-DXd’sTROPION-Breast02study.SinceSKB264
willalsoreleaseitsPh2datain1LTNBC,webelievethecrosstrialcomparison
willhelpustobetterunderstandSKB264’sglobalpotential.ForHR+/HER2-
BC,SKB264’sPh3trialin2L+patientsstartedinNov2023.TheCompanyplans
tostartapivotaltrialofSKB264+/-A167inHR+/HER2-BCwhoprogressed
endocrinetherapy+/-CDK4/6inhibitorandwithoutadditionalchemotherapy.
BothDato-DXdandTrodelvyhavefiledBLAinChinafor2L+HR+/HER2-BC
in1Q24.ForNSCLC,weexpecttheCompanytofileNDAfor3L+EGFRm
NSCLCin2H24,andtostartpivotaltrialofSKB264in1LEGFRmpatientsin
combowithTKI.Kelun-BiotechplanstostartPh3trialsofSKB264in1LEGFR-
wtNSCLCinChinain2024,indicatingtheCompany’sconfidenceinthissetting.
MSDexpeditestheglobaldevelopmentprocessofSKB264.MSDhas
vigorouslystarted/registeredsixglobalPh3trialsofSKB264,includingfourin
NSCLC,oneinBCandoneinendometrialcarcinoma.Withthepotentialtobe
combinedwithKeytrudatoextenditslifecycle,SKB264hasbecomea
prominentoncologyassetforMSD.WeexpectMSDtocommenceadditional
Ph3trialsofSKB264in2024.Moreimportantly,wethinktheupcomingrelease
ofSKB264’sPh2datain1LEGFRwild-typeNSCLCatASCOmeetinginJune
willfurthervalidateSKB264’spotentialinthisimportantarea.
Preparefordomesticcommercialization.TheCompanyisassemblinga
commercialteaminanticipationofupcomingapprovalsforSKB264,A166
(HER2ADC),A167(PD-L1),andA140(cetuximabbiosimilar),expectedtogrow
toapproximately500employeesbytheendof2024.Wethinkbreastcancer
andlungcancerwillbetheCompany’smajorfocusesatthebeginning.
MaintainBUY.WeeagerlyawaitthereadoutofSKB264from1)thePh2data
inpre-treatedNSCLCandthePh2datainGCatAACR,2)thePh2datain1L
EGFRwild-typeNSCLCatASCO,3)thePh2datain1LTNBCatASCO,and
4)thePh3in3L+TNBCatASCO.WereviseupourDCF-basedTPfrom
HK$189.25toHK$200.77(WACC:10.46%,terminalgrowthrate:3.0%).