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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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