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Diabetes
&
Onglyza
Franchise
introductionJuly20152Diabetes
Market
OverviewDM
portfolio
strategySource:.Prevalence
and
Control
of
Diabetes
in
Chinese
Adults.
Yu
Xu,
etc.
JAMA.
2013
Sep
4;310(9):948-59;
IMS
LN
Ji
et
al.
BMC
Public
Health
2013,
13:602IMS:
T2DM
patient
flow
forecast2014China
has
the
largest
diabetes
populationand
treatedpatients
will
increase
to
33M
in
next
5years11.924.465.111310.90
50
100
150RussiaBrazilUSAChinaMillions
Country
diabetes
population
Treated
patients
will
increase
14M
in
5
years
Diagnosis
rate:
40%Treated
rate:
85%1922242730334030201002014201520162017
2018
2019Diagnosis
rate:
48%Treated
rate:
92%Treated
patients(M)14MInsulin
is
widely
used,
NIAD
market
is
dominated
by
oldclasses4SOURCE:
IMS
CHPA2014,3B
study,
Ji
Linong1/3
patientsuse
insulinwith
50%
value
China
NIAD
market
share191318215CAGR2008-141Percent
510353025201540ValuePercent45SUGLINIDEMETGLITAZONEDPP-IV
IGLP-1
AAGI02008
09
10
11
12 13
20141NIAD65%Insulin35%Insulin1.3
BNIAD1.25
BDPP-4
and
GLP-1
will
take
value
share
from
AGI
and
SUafter
2016
due
to
RDL*Data
Source:
IMS
CHPA
20142.4%3%5%14%18%1.5%2%9%6%8%9%4%0.2%0.8%1.8%3.7%0.0%5.0%10.0%15.0%20.0%25.0%30.0%35.0%45.0%40.0%201420152016201720182019DPPIVGLP-1AGI
SUTZDSGLT-2METothersGLP-1SGLT-2DPP-4More
new
players
will
enter
into
market
and
intensify
the
competition
onNIAD
market6
|2014in
marketproducts2015201620172018201920202021202220232024Saxa/DapaVictozaSemaglutideNovo
NordiskDulaglutideTrulicityEli
lilyCanagliflozinInvokanaJanssenEmpaJardianceEli
lilyNRDL/PRDLNRDL/PRDLNRDL/PRDLAlbiglutideTanzeumGSKJiangsuhaosenweekly3
Local
genericdailyCompetitor
productAZ
productLocal
DPP4i:Retagliptin(Heng
rui
)10+
DPP4
generic2+
Generic
DPP4i
FDCSanofiBITakedaNovartis7New
class
agents
offer
great
additionalbenefits
totreat
diabetesAZproductIn
marketbest
sellerGlucosecontrolCV
risksafetyLowhypoglycemiariskB-cellprotectionLoseweightReducebloodpressureDPP4OnglyzaGLP-1ByettaSGLT-2ForxigaOn-goingAGIGLUCOBAYSUNOVONORMAMARYL××××MetGLUCOPHAGE**Valueshare(%)*Data
Source:
IMS
CHPA
2014**
Value
share
:
IMS
CHPA
2015April2RankKey
Companies
&
top
Brands2014
Sales
in
M
USD1NOVONORDISKGROUP8917.7%NOVOMIX
30NOVOLIN
30RNOVONORMNKTNKTN-N2652151442BHC
GROUP3285%GLUCOBAYBY63193SANOFI
GROUP29518%LANTUSAMARYLAVSAVS213814ELI
LILLY
GROUP1768.8%HUMALOG
25
ELUHUMULIN
70/30
LLYHUMALOG
MIX
50
ELU605821512214%12218B.MYERS
SQUIBB
GRPGLUCOPHAGE
SSBASTRAZENECA
GROUP16.787%ONGLYZABYETTA8.78.0AZ
is
relatively
small betesmarketbut
are
competitive
in
DPP4
and
GLP-1
ClassRank
inclass:50%45%40%35%30%25%20%15%10%5%0%29%246%ONGLYZABYETTA9Diabetes
Market
OverviewDM
portfolio
strategy
&
focus
in2016Framing
the
China
diabetesstrategye
the
segment
leader
in
DPP4,GLP-1
and
SGLT2
class
in
2016
andize
pre-RDLsuccess
of
Dapafranchise3Lead
in
OADwithSaxa
/
Dapa
FDC4Establish
Saxa
asthe
foundationofChina’s
diabetesportfolio2-to-marketAccess
and
affordabilityLocal
data
generationPatient
strategy5Accelerate
Byettatoizeexenatide
franchise111DM
has
rich
portfolio
to
satisfy
individualized
patients
needsHbA1cSaxaExenatideDapaOnglyzaKombiglyzeForxiga
(overweight&obesity)Byetta7%7.5%9%NIADInsulinAllthreeproducts
plan
addoninsulin
indication
in
the
futureOAD
Failure11%Delay
insulin
use2013
AACE
&
CDS
guideline:Comprehensive
managementReduce
blood
glucoseReduce
blood
glucoseCV
risk
safetyB-cell
protectionLose
weightPast:
Pure
glucose
managementFuture:
comprehensive
managementAZ
Portfolio
launch
overviewSource:1A2Z
teamysisIDL
approvalAdd-onto
met/OADsPRDLPRDLNRDLNRDLCombo
w/MetSDTDCPAIAdd-on
to
insulinInitialtreatment2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
202LO3E
2024NRDL
PRDL13
|DM
has
achieved
strong
performance
since
2012
andwill
reach
39.6
M
sales
in2015-45.040.035.030.025.020.015.010.05.0201220142015Onglyza2013ByettaKombiglyzeForxigaCAGR
161%2.2M14.7M26.5M39.6MCS:$MnNew
product
launches
from
2016-2022
will
ensuresustainable
growth
of
DM
franchise20172018
20192020Kombiglyze
is
expected
to
get
IDL
approval
in
Q4,
2015Forxiga
base
case
is
to
get
IDL
in
Q2
2016Bydureon
SDT
is
expected
to
get
IDL
approval
May
2017
and
DCP
is
Sep
2018.2015PRDL2016NRDL20212022Bydureon
AINote:IDL-ApprovaltimeBydureon
DCP50045040035030025020015010050020142019ONGLYZA2015
2016KOMBIGLYZEBYETTA2017FORXIGA2018BYDUREONDM
will
achieve
433M
commercial
sales
in
2019Saxa
is
foundation
and
new
launches
also
contribute1526.5M40M66M173M287M433MCAGR
75%16澤OnglyzaKombiglyze格格?
(沙格列汀二甲雙胍緩釋片復(fù)方制劑)全球第一個(gè)上市的一天一次DPP4i與緩釋二甲雙胍復(fù)方制劑中國唯一一個(gè)一天一次的DPP4抑制劑的復(fù)方制劑外殼保護(hù)層(藍(lán)色)中間層(綠色):沙格列汀二甲雙胍緩釋微粒體獨(dú)有技術(shù)的結(jié)構(gòu)(化合物與制劑2項(xiàng)專利)規(guī)格:沙格列汀5mg和緩釋鹽酸二甲雙胍1000mg沙格列汀2.5mg和緩釋鹽酸二甲雙胍1000mgKXR’s
truly
once-daily
usage
with
strong
efficacy
makes
itsoutstanding
out
of
competitionBrandCombination/DosageUsageChina
IDLapproval
timeApproval
indicationRetail
PriceRMB/daySaxa5mg+Met
XR500mg11.94(5/1000)Saxa5mg+Met
XR1000mgOncedaily2015-10Initial
use*7.65x2Saxa2.5mg+Met
XR1000mgBest
caseDisplace
Met+
Saxa(2.5/1000,
2pills/day)( tomarket)Sita50mg+Met
500mSita50mg+Met
850mice
daily2012-08MetfailureDisplace
Met+Sita11Vita50mg+Met
500mVita50mg+Met
850mice
daily2014-12NANALIna2.5mg+Met
500mgLIna2.5mg+Met
1000mice
daily2015-12NANAAlog12.5mg+Met
500mgAlog12.5mg+Met
1000mice
daily2017-10NANA18KXR*
Subject
to
IDL
approvalof
KXRGood
efficacyIncrease
on rate
by
higher
adherenceHigh
cost
effective
solutionHave
good
experience
with
ARB
FDCSource:
China
FDC
Research
2015HbA1c,
haemoglobin
A1c19FDC
InsightCombo
usage
is
popular
in
T2DMclinical
practice
for
good
efficacyNa?ve
patients
:over
50%Revisit
patients
:over
90%>7.5Anti-diabetic
FDC
is
well
accepted
by
mostphysicians
for
its
simplicityComplementary
incontrollingbloodglucose:MET
for
FPGandDPP-4ifor
PPGGood
efficacy High
safetyLow
hypoglycemiariskforbothMET
good
for
reducingweight“MET+DPP-4”
is
the
“BESTcombination”Kombiglyze
XR
is
attractive
for
its
goodconvenience
and
low
GI
side
effectMost
of
physicians
like
FDC
for
its
simplicity
and
Kombiglyze
XR
isconsidered
attractive澤?/
格?可以方便解決大部分降糖需求血糖A1C<7.5血糖A1C>=7.5血糖A1C>9單藥2種口服藥聯(lián)用3種口服藥聯(lián)用口服藥+胰島素或胰島素現(xiàn)在未來胰島素有了澤?/格?
,降糖從此就是這樣簡單!過去現(xiàn)在/未來In
global
NIAD
market,
DPP4i
class
is
the
leader
with
50%
market
shareand
three
DPP4i
brands
are
on
TOP10
list
of
diabetes
brand
in
2014Global
Onglyza
Franchise
Monthly
Performance
Report,Oct
2014Data
source:
AnnualReports2.073.932.141.2250.0%40.0%30.0%20.0%10.0%0.0%60.0%Oct
2012Nov
2012Dec
2012Jan
2013Feb
2013Mar
2013Apr
2013May
2013Jun
2013Jul
2013Aug
2013Sep
2013Oct
2013Nov
2013Dec
2013Jan
2014Feb
2014Mar
2014Apr
2014May
2014Jun
2014Jul
2014Aug
2014Sep
2014Oct
2014NIAD
Market
Share
by
Class
(USD)All
OthersGlinideMetformin(Biguanides)TZD(Glitazones)AGIs(Alpha-glucosidase
inhibitors)DPP4-InhibitorsGLP-1SU(Sulphonylureas)
SGLT2DPP4i:50%
MSGlobal
NIADMarket
Share10.82
B
USDRevenue2014Ranking
on
TOP
102014Revenue2(B
USD)2671022Global
NIADMarket
CAGR
(2010-2014)
(%)
YoY(15
Mar
vs
14
Mar
GR)
(%)In
China,
DPP4i
class
still
outpaced
NIAD
market
despite
decreasing
GRfrom
2014
which
is
limited
by
market
access
restrictions
&
the
limitedself-paid
market22.416.017.810.011.986.12.115.413.49.420.3-
1
.
0178.19.5-
0
.
151.9NIAD
marketTZDMETSUGlinidesAGIGLP-1DPP42010
201123IMS
CHPA,
2010
–
2015
MarM
USDCAGR
(2010-2014)GLP-1
86.1%Glinide
11.9%AGI
17.8%-1.0%20.3%13.4%81520.4%13.0%8.4%38.5%0.3%
0.5%39.6%2.4%
1.5%20131,10770820.6%12.5%11.8%36.6%18.2%0.2%
0.1%
18.9%17.4%20141,25719.3%14.7%6.4%19.5%14.2%6.6%39.9%0.9%
1.0%
17.0%1.7%
1.2%
16.1%201297220.3%13.4%7.2%39.8%DPP4i
178.1%SUMETTZDCAGR
of
NIAD
Market
(2010-2014):
15.4%China
NIAD
MarketProprietary
andAstraZeneca–
for
internal
use
onlyTop
selling
diabetic
products
in
China9865821221443190100200300400BYETTAONGLYZADIAMICRON
TSVAMARYL
AVSGLUCOPHAGE
SSBNOVONORM
N-NGLUCOBAY
BY6NIAD
market
top
brands2132162880100200300400LANTUSNOVOLIN
30RNOVOMIX
30Insulin
market
top
brandsCurrently,
FDC
only
accounts
for
less
than
1%
DPPi
market
share
inChina
vs
over
30%
share
in
main
markets
such
as
US
and
EUSpain
Germany
France53%47%55%45%71%29%US29%70%FDCFF0,3%99,7%0,0%100,0%2012
2013
20140,0%100,0%FDCFFPDOT
Distribution PDOT
DistributionData
source:
Global
Onglyza
Franchise
Monthly
Performance
Report,
Oct
2014,
Xiehe
prescription
reportUS
EUChina25FDC
Global
/China4034
36
37
3730
32
3326
27
2821
2219
18500,001,000,001,500,002,000,0002,500,0003,000,00001020304014Q414Q314Q214Q113Q413Q313Q213Q112Q412Q312Q212Q111Q411Q311Q211Q110Q410Q310Q210Q1FDC%
(ARB
market)FDC
tyDPP4iARBChinaInARBmarket(endocrinology),FDC
reached
40%
sharein
Q4
2014
in
China@EndocrinologyDepartmentFDC
launch
will
strengthen
total
franchise
bycapturingmore
patientsKXR
launch
will
not
hurt
Onglyzabusiness
as
the
cannibalization
fromOnglyza
is
lessthan
10%BrazilColumbiaKXROnglyzaKXROnglyzaKXR
shows
strong
growth
uptakein
other
markets26FDCGlobal4
key
elements
in
right
place,
making
Exforge(倍博特)a
remarkablysuccessful
FDC
launchChina
FDC
Research2015IMS
dataClear
Strategy(Exforge
as
No.1
priority)One
KOL
consensusOne
FDC
clinical
trialFastest
hospital
listing(288
formal
listings
within
9months)ARBFDCExforgeARB
FDC
drives
theARB
total
marketgrowth123427Exforge
Experience293667241214Januvia422Onglyza313Galvus9611Tradjenta91Nesina48Janumet43Non-top
600Listed
intop
600
hospitalsOnglyza
key
challenge:
listing
hospitals
are
behind
Januvia28Data
source:AIA
data,
RDPACTop
600
formal
Listingperformance
since
launch20112334%46%50%45%40%35%30%25%20%15%10%5%0%050100150200250NationalTenderedOnce
listed,
Onglyza
has
the
ability
to
outperform
Januvia
within
ashort
time
period4540353025201510502015
Feb2015
Jan2014
Dec2014
Nov2014
Oct2014
Sept7060504030201002014
Oct 2014
Nov 2014
Dec 2015
JanComment:From
externaldata,
Onglyza
MS
wouldcatch
upJanuvia
withina
short
time
after
listing
successAlso,
Onglyza
has
the
abilityto
outperformJanuvia
in
listed
hospi
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