【行业研究报告】信达生物-Mazdutide (IBI362) to become the best GLP-1 drug for obesity in China

12May2023
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
InnoventBiologics(1801HK)
Mazdutide(IBI362)tobecomethebestGLP-1drug
forobesityinChina
Ph2studyofIBI362(9mg)forobesitymetprimaryendpoint.Innovent
reportedpositiveresultsofPh2studyofhigher-dose(9mg)IBI362(GLP-
reportedpositiveresultsofPh2studyofhigher-dose(9mg)IBI362(GLP-
1R/GCGR)forthetreatmentofsubjectswithmoderatetosevereobesity(link).
ThePh2studyenrolled80Chinesesubjectswithabaselinemeanweightof
96.9kgandmeanBMIof34.3kg/m
2
,forwhichpeoplemetabolicsurgeryisthe
currentmaintreatmentoption.After24weeksoftreatment,IBI362(9mg)
achieved15.4%(P<0.0001)or14.7kg(P<0.0001)placebo-adjustedweightloss,
whichwasmuchbetterthanotherweeklyadministratedGLP-1targetedpeers.In
cross-trialcomparisons,tirzepatideachieved9.0%,11.5%and12.0%placebo-
adjustedweightloss(or7.1kg,13.0kgand13.0kginweightloss)inthe5mg,
10mgand15mgtreatmentgroupsinitsPh3SURMOUNT-1trial(link)atweek24;
semaglutidedemonstrated8.0%weightlossversusplacebo(or7.7kg)initsPh3
STEP-1trial(link).The15.4%weightlossofIBI362(9mg)demonstrateditsBIC
potentialforobesity,inourview.Additionally,inthePh1study(link),IBI362(9mg)
realized9.9%placebo-adjustedweightlossafter12weeksoftreatmentinthe12
subjects(baselineBMIof30.1intheIBI362arm).SincethePh2trial,asa
separatestudy,enrolledsubjectswithhigherBMI(34.3onaverageatbaseline),
the15.4%weightlossat24weeksoftreatmentdemonstratedsustainedefficacy
ofthedrug,inourview.
FavourablesafetyprofileofIBI362withdetaileddatatobereleased.ThePh2
obesitystudyofIBI362(9mg)isstillinprogresswithdetailedsafetydatatobe
disclosed,whileIBI362(9mg)isoverallwell-tolerable.InthePh2study,thedrop-
outrateoftheIBI362groupwaslowerthantheplacebogroup,andtherewasno
subjectintheIBI362groupdiscontinuedduetoAE.However,incross-trial
comparison,inthePh3studiesoftirzepatide(15mg)andsemaglutide,6.2%and
7.0%ofsubjectsdiscontinuedduetoAE.Additionally,therewasnoSAEinthe
Ph2trialofIBI362(9mg),whiletheratesofSAEwere5.1%and9.8%for
tirzepatide(15mg)andsemaglutide.ThemostcommonAEsofIBI362(9mg)were
gastrointestinaldisorders,mostofwhichweremildormoderateandtransient.
Thestudywillextendtreatmentto48weeks,andthefulldataincludingefficacy
andsafetywillbedisclosedafterthecompletionofstudy.