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Engineering Conferences International ECI Digital Archives Vaccine Technology IV Proceedings Spring 5-21-2012 Expectation of China's contribution to world vaccine development and supplies: Status, strategy and international approach Li Shi Shanghai Zerun Biotechnology Follow this and additional works at: hp://dc.engconfintl.org/vaccine_iv Part of the Biomedical Engineering and Bioengineering Commons is Conference Proceeding is brought to you for free and open access by the Proceedings at ECI Digital Archives. It has been accepted for inclusion in Vaccine Technology IV by an authorized administrator of ECI Digital Archives. For more information, please contact [email protected]. Recommended Citation Li Shi, "Expectation of China's contribution to world vaccine development and supplies: Status, strategy and international approach" in "Vaccine Technology IV", B. Buckland, University College London, UK; J. Aunins, Janis Biologics, LLC; P. Alves , ITQB/IBET; K. Jansen, Wyeth Vaccine Research Eds, ECI Symposium Series, (2013). hp://dc.engconfintl.org/vaccine_iv/13

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Page 1: Expectation of China's contribution to world vaccine

Engineering Conferences InternationalECI Digital Archives

Vaccine Technology IV Proceedings

Spring 5-21-2012

Expectation of China's contribution to worldvaccine development and supplies: Status, strategyand international approachLi ShiShanghai Zerun Biotechnology

Follow this and additional works at: http://dc.engconfintl.org/vaccine_iv

Part of the Biomedical Engineering and Bioengineering Commons

This Conference Proceeding is brought to you for free and open access by the Proceedings at ECI Digital Archives. It has been accepted for inclusion inVaccine Technology IV by an authorized administrator of ECI Digital Archives. For more information, please contact [email protected].

Recommended CitationLi Shi, "Expectation of China's contribution to world vaccine development and supplies: Status, strategy and international approach" in"Vaccine Technology IV", B. Buckland, University College London, UK; J. Aunins, Janis Biologics, LLC; P. Alves , ITQB/IBET; K.Jansen, Wyeth Vaccine Research Eds, ECI Symposium Series, (2013). http://dc.engconfintl.org/vaccine_iv/13

Page 2: Expectation of China's contribution to world vaccine

Expectation for China‘s Contribution to Expectation for China‘s Contribution to

World Vaccine Development and Supplies: World Vaccine Development and Supplies:

Status, Strategy and International ApproachStatus, Strategy and International Approach

ECI Vaccine Technology IV

1

ECI Vaccine Technology IVMay 20-25, 2012, Albufeira, Portugal

Li Shi, Ph.D.Li Shi, Ph.D.

Shanghai Zerun Biotechnology Co., Ltd.Shanghai Zerun Biotechnology Co., Ltd.

A Member of Wison GroupA Member of Wison Group

Page 3: Expectation of China's contribution to world vaccine

Presentation OutlinePresentation Outline

• World’s expectation for China vaccine market

• China’s readiness for contributing to world market with low-cost life saving vaccine supplies

• Bridging world-China vaccines markets

2

• Bridging world-China vaccines markets

Page 4: Expectation of China's contribution to world vaccine

Presentation OutlinePresentation Outline

• World’s expectation for China vaccine market

• China’s readiness for contributing to world market with low-cost life saving vaccine supplies

• Bridging world-China vaccines markets

3

• Bridging world-China vaccines markets

Page 5: Expectation of China's contribution to world vaccine

4

Page 6: Expectation of China's contribution to world vaccine

USA

EU

US / EU play key roles in vaccines innovation, US / EU play key roles in vaccines innovation,

development, production, and supplydevelopment, production, and supply

5

Page 7: Expectation of China's contribution to world vaccine

World Vaccine Market Shares

2.5

3.0

3.5

4.0

4.5

Sale ($ bn)

Pediatric

Adult

US and EU dominate World Vaccine MarketUS and EU dominate World Vaccine Market

6http://www.healthcarefinancenews.com/news/global-vaccine-market-now-exceeds-20b

0.0

0.5

1.0

1.5

2.0

2.5

US EU JP China S.Am Ind N.Am ROW

Countries

Sale ($ bn)

Page 8: Expectation of China's contribution to world vaccine

USA

EU

USA

EUASIAASIA

Vaccine Business Operation Locations Vaccine Business Operation Locations

now and futurenow and future

7

ASIAASIA

At present In future

Page 9: Expectation of China's contribution to world vaccine

Major Revenue Locations Major Revenue Locations

Now and FutureNow and FutureUSA

EU

USAASIA

8

EUASIA

At present In future

Page 10: Expectation of China's contribution to world vaccine

India

China

9

Page 11: Expectation of China's contribution to world vaccine

Historical Path of China Immunization ProgramsHistorical Path of China Immunization Programs

• In 1930s: Basically no immunization activities. Smallpox, diphtheria, pertussis, measles and polio infectious diseases caused annual incidence of more than 10 million.

• 1950s to 1980s: Vaccination with smallpox, BCG, diphtheria, polio, measles, PDT and tetanus vaccines resulted in significantly decrease in incidence rate.

10

• In 1980s: Started the implementation of national immunization program, and involved in WHO EPI. The vaccination rate of BCG, polio, measles and DPT vaccines for infant reached 85%.

• In 1990s: Achieved the eradication of polio and neonatal tetanus, and implemented comprehensive child immunization services.

• 2008: Hepatitis A, meningitis, encephalitis B and MMR etc vaccination had been included into national immunization programs (EPI). Up 2010, the programs cover 14 kinds of vaccines that prevent up to 15 different infectious diseases.

Page 12: Expectation of China's contribution to world vaccine

China Vaccination Rate (97.4~99.4%)China Vaccination Rate (97.4~99.4%)

1 year old children data from 2000 to 20081 year old children data from 2000 to 2008

Vaccination rate (%) of 1 year old children in China from 2000 to 20008

11Source: China SFDA

Page 13: Expectation of China's contribution to world vaccine

Current Landscape of Vaccines Market and Current Landscape of Vaccines Market and

Supplies in ChinaSupplies in China

• China is currently the biggest vaccine producer and consumer1,2

– 43 vaccine supply companies1

– ~1,000 mm doses of 49 vaccines delivered every year3

– 1.341 billion people4(up to 2011)

– ~201,5 million babies born every year20% of total world

vaccines supplies

12

• China's vaccine sector is growing fast

– ~20 (156-257) percent growth annually

– ~ $1.2-1.4 billion market size up to 20126,7,8

Sources:1. Vaccine Development in China, BioPharm International, YB Zhou, 20072. China Vaccine Industry Report, 2008-2009, ResearchInChina, 20093. Public Markets for Vaccines, Bill Gates Foundation, 20104. Xinhua Beijing, 20115. National Population and Family Planning Commission, Jiang Fan, 20076. Vaccine Manufacturing Quality Control System and Risk Management Workshop, SFDA, 20107. China's Vaccine Sector. Report from Zero2IPO, a Chinese venture-capital firm 20108. business.ezinemark.com 2011

vaccines supplies

Page 14: Expectation of China's contribution to world vaccine

20002000--2010 China Population Growth 2010 China Population Growth A Sustain Growth of Vaccines MarketA Sustain Growth of Vaccines Market

Growth rate

Mill

ion o

f P

eople

20% of World Population

13

Mill

ion o

f P

eople

Source: China vaccine market analysis report 2011 (version in Chinese)

~20 mm new born babies every year~20 mm new born babies every year

Page 15: Expectation of China's contribution to world vaccine

China Pharmaceutical and Vaccine MarketsChina Pharmaceutical and Vaccine Markets

14

Page 16: Expectation of China's contribution to world vaccine

Public market adoption (EPI) in China is Public market adoption (EPI) in China is

expected to grow at expected to grow at 4x 4x the rate of that in Indiathe rate of that in India

15

1.2009 Tender information, Hainan, Shanxi and Hunan Province for existing vaccines; 2/3 current PAHO pricing assumed for new vaccines2.2009 UNICEF pricing for existing vaccines; Penta, Rota, and PCV based off of GAVI investment caseSource: EPI adoption timing based of off in market interviews

Bill Gates Foundation 2010 Report on Key Public Markets for Vaccines

Page 17: Expectation of China's contribution to world vaccine

Presentation OutlinePresentation Outline

• World’s expectation for China vaccine market

• China’s readiness for contributing to world market with low-cost life saving vaccine supplies

• Bridging world-China vaccines markets

16

• Bridging world-China vaccines markets

Page 18: Expectation of China's contribution to world vaccine

““““““““China’s vaccine industry is wellChina’s vaccine industry is well--developed”developed”

Provide mainlyCategory 1 vaccines

(EPI: paid by government)

Provide mainlyCategory 2 vaccines

(Non-EPI: paid by individual)

Private/Public Companies MNC CompaniesState – Owned Companies

17Bill Gates Foundation 2010 Report on Key Public Markets for Vaccines

Page 19: Expectation of China's contribution to world vaccine

Vaccine Supplies in ChinaCategory 1 vaccines

EPI (paid by Government)Category 2 vaccines

(paid by individual)

Total shared doses (%) 80% 20%

Total shared revenue (%) 40% 60%

Sale growth rate 15% 28%

Profit margin Small (fixed, low price) Large (high price)

China Vaccine Supplies StatusChina Vaccine Supplies Status

18

# of diseases covered 15 rest diseases

# of vaccine kinds 14 rest vaccines

Total supplies needed large and stable varies

Dominated EnterprisesChina National Biotech Group

(CNBG)’s 6 companies

5 MNCs and 30+ local

companies

In fact, the compulsory and free EPI vaccines are dominant in inoculation vaccines in China on account of relatively low economic level and comparatively lower awareness of epidemic precaution. Taking human vaccine market for example, the release of EPI human vaccines reached 648.4261 million person doses in 2009, accounting for 80.4% of the total; while the extra EPI vaccine was only 158.512 million person doses, with a share of 19.6%. Yet, the sum of EPI vaccine only occupied

38.9% of the total being restricted by governmental procurement price, while the extra EPI vaccine covered 61.1%.

Source: Annals, ResearchInChina

Page 20: Expectation of China's contribution to world vaccine

Europe and China Vaccines SuppliersEurope and China Vaccines Suppliers

19

ChinaChinaChinaChina 43+43+43+43+ ????Eur Vaccine Mfg: Vaccines: a Strategic Industry for Europe, Hock 2007;China Today, Vaccine Development in China, Zhou 2007

Page 21: Expectation of China's contribution to world vaccine

The vast majority of vaccine doses are The vast majority of vaccine doses are

manufactured in Europemanufactured in Europe

China production: ~1,000,000,000 doses(~20% but almost no export)

20

20 companies20 companies

> 40 companies

Page 22: Expectation of China's contribution to world vaccine

Bill Gates Foundation 2010 Report on Key Public Bill Gates Foundation 2010 Report on Key Public

Markets for Vaccines:Markets for Vaccines:

Key Countries

1.India – emerging domestic market, strong export capability

2.China – strong domestic market, limited role in exporting vaccines

3.Brazil – strong domestic market, limited role in exporting vaccines

21

3.Brazil – strong domestic market, limited role in exporting vaccines

Purchasing Channels (WHO prequalification required)

1.GAVI – income based inclusion of poorest countries, UNICEF

procurement.

2.PAHO – regional purchasing through revolving fund

Page 23: Expectation of China's contribution to world vaccine

It may take some timeIt may take some time

“China's vaccine makers are gearing up over the next few years to push exports, which should lower costs of life saving immunizations for the world's poor, and provide major new competition for the big Western companies.”

22

“However, it may take some time before some parts of the world are ready to embrace Chinese vaccine products when safety is as sensitive an issue as it is with vaccines — especially given the food, drug and other scandals the country has seen.”

“The world should get ready for a new Made in China product — vaccines”.The Associated Press, 29 Nov 2011 by GILLIAN WONG

Page 24: Expectation of China's contribution to world vaccine

Chinese vaccines industry entering world marketChinese vaccines industry entering world market

23

It may take time to achieve the goal with full confidence

Page 25: Expectation of China's contribution to world vaccine

China's Long March to Innovation SuccessChina's Long March to Innovation Success

• “China’s journey from a seriously poor, autarkic, economy to the ‘shop floor of the world’, took a bit more than two decades.”

24

decades.”

• “Today, less than a decade later, it appears poised to evolve into becoming a leading global innovator; but can China actually make this next great leap forward? ”

Bill Fischer, Forbes, “Ideas, Innovation, Globalization, & China” 7/2011

Page 26: Expectation of China's contribution to world vaccine

China Economy Growth in Next Two DecadesChina Economy Growth in Next Two Decades

50505050

60606060

70707070

80808080

Economy ($ Trillion)

Economy ($ Trillion)

Economy ($ Trillion)

Economy ($ Trillion)

$73.5 Trillion

25

0000

10101010

20202020

30303030

40404040

50505050

1990199019901990 2000200020002000 2010201020102010 2020E2020E2020E2020E 2030E2030E2030E2030E

Economy ($ Trillion)

Economy ($ Trillion)

Economy ($ Trillion)

Economy ($ Trillion)

USAUSAUSAUSA

JapanJapanJapanJapan

ChinaChinaChinaChina

$38.2 Trillion

$8.4 Trillion

Source: IMF, Xinhua, Standard Charter & Time

Page 27: Expectation of China's contribution to world vaccine

Cars18 mmTOP 1Internet Users Rail road

10 years after joining WTOChina Economic GrowthChina Economic Growth

26www.bioway-pku.com 26

TOP 1Internet Users 420 mmTOP 1

Air flight passengers290 mmTOP 2

Rail road18358 kmTOP 1

Cell phone users860 mmTOP 1

High way74000km TOP 2

World Top 1 or 2

Page 28: Expectation of China's contribution to world vaccine

� “China medicine market today is about $8 billion (2005) and projected to grow to $24 billion by 2010”

� “China is No. 10 worldwide now, already quite something, and could

China’s Economic Growth in Western’s Eyes in 2005China’s Economic Growth in Western’s Eyes in 2005

27

already quite something, and could be the 3rd one.”

� “It grows currently at 20%, faster than the average market growth.”

� “….. is good in chemistry and so forth, but I believe this place (China) probably has more potential.”

Daniel Vasella, Chairman and CEO, Novartis 2005

Page 29: Expectation of China's contribution to world vaccine

China will soon become the second world China will soon become the second world

largest medicine marketlargest medicine market

350

400

450

500

$ Billion

World Medicine Market Scale

2011

2015

28

0

50

100

150

200

250

300

USA China EU Japan

$ Billion

Source: China pharmaceutical market analysis report 2010

Page 30: Expectation of China's contribution to world vaccine

World Pharmaceutical Market by 2020World Pharmaceutical Market by 2020

20072007 20092009 20112011 20202020

1. US 1. US 1. US 1. China

2. Japan 2. Japan 2. China 2. US

3. France 3. France 3. Japan 3. Japan

4. Germany 4. Germany 4. Germany 4. Germany

29

4. Germany 4. Germany 4. Germany 4. Germany

5. UK 5. China 5. France 5. France

6. Italy 6. Italy 6. Italy 6. Italy

7. Spain 7. Spain 7. Spain 7. Spain

8. Canada 8. UK 8. Brazil 8. Brazil

9. China 9. Brazil 9. US 9. US

10. Brazil 10. Canada 10 Canada 10 Canada

Source: IMS Health & ChinaBio 2011

Page 31: Expectation of China's contribution to world vaccine

800

1000

1200

$ Billion

World and China Pharma Market GrowthWorld and China Pharma Market Growth

World

30

0

200

400

600

2004 2009 2010 2011 2013E 2014E 2019E

$ Billion

Data Source: IMS, bioway-pku, and some media reports

China

~$110 billion(>20% growth)

Page 32: Expectation of China's contribution to world vaccine

China is leading the expansion of higher educationChina is leading the expansion of higher education

Nature 472, 276-279 (2011)

31

SOURCE: OECD/CHINESE MINISTRY OF EDUCATION

Page 33: Expectation of China's contribution to world vaccine

Nature 472, 276-279 (2011)

Germen

USA

China

320 10000 20000 30000 40000 50000 60000

India

Japan

UK

Number of Ph.D. Awarded

Page 34: Expectation of China's contribution to world vaccine

Chinese Oversea Returnees Changing the Way Chinese Oversea Returnees Changing the Way

Business is Done in ChinaBusiness is Done in China

138000

108300

69300

100000

120000

140000

160000

Number of Oversea Returnee

33

69300

42400

40000

35000

0

20000

40000

60000

80000

2005 2006 2007 2008 2009 2010

Number of Oversea Returnee

Source: ChinaBio 2011

A total of 430,000 oversea returnees in last 5 years including 150,000 in life science

Page 35: Expectation of China's contribution to world vaccine

China Lead in Global Life Sciences Supply ChainChina Lead in Global Life Sciences Supply Chain

70% of the surveyed companies ww have suppliers in China

34

Wynn Bailey, Contract Pharma Jan-Feb 2011

Page 36: Expectation of China's contribution to world vaccine

Research Records in a Highly Critical FieldResearch Records in a Highly Critical Field

ChinaUnited States

JapanGermany

FranceSouth Korea

EnglandRussia

Number of publications

in the highly critical field

35

0 500 1000 1500 2000 2500 3000 3500 4000

RussiaItaly

IndiaTaiwan

SpainCanada

SwitzerlandNetherlands

PolandSigaporeSweden

AustraliaBrazil

Number of Publications

RN Kostoff, The Scientist, 18(18) 2004

in the highly critical field

of nanotechnology for

top 20 countries during

Jan-Sept 2004

Page 37: Expectation of China's contribution to world vaccine

From the point of view of Intellectual PropertiesFrom the point of view of Intellectual PropertiesN

um

ber

of

Pate

nts

36

China

Num

ber

of

Pate

nts

Page 38: Expectation of China's contribution to world vaccine

Over 49 Vaccines on China marketOver 49 Vaccines on China market(in-complete list)

• Tick- borne Encephalitis• Yellow fever• JE(inactivated)• JE(attenuated,live)• Haemorrhagic fever• Rabies• rHBV

• BCG

• Vi Polysaccharide typhoid

• Tetanus Vaccine,Adsorbed

• Diphtheria Vaccine,Adsorbed

• DT

• DTaP

Viral vaccines Bacterial vaccines

37

• rHBV• HAV(live)• HAV(inactivated)• HAV+HBV• Rotavirus• Influenza vaccine(whole virion)• Split-virus flu vaccine• OPV• Varicella• Measles• Rubella• Mumps• Measles+Mumps• Measles+ Rubella• MMR

• DTaP

• DTwP

• Brucellosis, Percutaneous Scarification

• Plague,Percutaneous Scarification

• Anthrax,Percutaneous Scarification

• Meningococcal Polysaccharide A

• Meningococcal Polysaccharide A+C

• Meningococcal Polysaccharide A+C+Y+W

• Leptospira Vaccine

• Hib

• Pneumonia (23)

Page 39: Expectation of China's contribution to world vaccine

New VaccinesTherapeutic HB

Structure of China Vaccine TechnologiesStructure of China Vaccine TechnologiesAccumulated with 60 years of vaccine experienceAccumulated with 60 years of vaccine experience

38

Main Traditional Vaccines

Hepatitis B, JE, Rabies, Flu, Acellular Pertussis vaccines

Improved Vaccines

Men AC Conjugate, CombinationHIB Conjugate, MenACW135Y vaccines

Therapeutic HBNasal spray & Human-bird flu

Recombinant fluPurified DPaT vaccines

Page 40: Expectation of China's contribution to world vaccine

Traditional Vaccine Products Dominated China Traditional Vaccine Products Dominated China

Vaccine SuppliesVaccine Supplies

Innovated VaccinesInnovated VaccinesInnovated VaccinesInnovated VaccinesInnovated VaccinesInnovated VaccinesInnovated VaccinesInnovated Vaccines

Young in

39

Traditional VaccinesTraditional VaccinesTraditional VaccinesTraditional VaccinesTraditional VaccinesTraditional VaccinesTraditional VaccinesTraditional Vaccines Young in discovery research

Good in development

Page 41: Expectation of China's contribution to world vaccine

Vaccine Market Growth Driven by InnovationVaccine Market Growth Driven by Innovation

Traditional vaccine’s growth: ~ 11% per year

$23.8 bn

Novel vaccine’s growth: ~ 58% per year

40

$23.8 bn

Page 42: Expectation of China's contribution to world vaccine

HAVTyphoidMenAC

DPTHib

PolioRabiesHBV

TetanusJE

MenACMenAFlu

Vaccin

es

218 Vaccine Clinical Trials Approved by SFDA

(2004 – 2012)

410 5 10 15 20 25 30

HEVMalariaPneum

MRMumpsSARS

CholeraFHMD

MeaslesHIVVHFHPV

Pa-FluRota

VaricellaHAV

Vaccin

es

A total of 28 different types of vaccines

# of Clinical TrialsSource of Data: China SFDA web

Page 43: Expectation of China's contribution to world vaccine

218 Vaccine Clinical Trials Approved by SFDA

(2004 – 2012)

40

50

60

out o

f total

appro

val 115 (53%)

42

0

10

20

30

40

补充申请 进口 新药 已有国家标准

%% %%ou

t of to

tal ap

prova

l

Existing Products

Imported Products

NewProducts

Additionally Required Trials

Source of Data: China SFDA web

Page 44: Expectation of China's contribution to world vaccine

• HIV Phase II

• H1N1 Flu approved

• HEV approved

• H. Pylori Phase III

Examples of novel and bioExamples of novel and bio--similar similar

vaccines under development in Chinavaccines under development in China

• HPV Phase I, II

• Pneum C. Phase I

• IPV Phase II

• Rota Virus

(in-complete list)

43

• H. Pylori Phase III

• EV71 Phase ⅠI, III

• Cancer vaccines

• Others

• Rota Virus

• Others

Source of Data: China SFDA web

Page 45: Expectation of China's contribution to world vaccine

2011 publications: 2011 publications: “China prepares to enter world vaccine “China prepares to enter world vaccine

marketmarket::::::::lower costs, increased competition expected”lower costs, increased competition expected”

“The world should get ready for a new Made in China product — vaccines”.The Associated Press, 29 Nov 2011 by GILLIAN WONG

“Could your vaccines soon be ‘Made in China’ ?”The Associated Press, 29 Nov,2011 by Liz Klimas

“Rapid growth of the global vaccine market has great potential in China market for vaccines” Tweet, 1 Jan, 2011 by Gaga

44

Related publishers’ web sites:www.timeslive.co.zawww.azcentral.comwww.usatoday.comwww.boston.comnews.yahoo.com/chinahttp://vaccine.ezinemark.com

Tweet, 1 Jan, 2011 by Gaga

Page 46: Expectation of China's contribution to world vaccine

New Progresses of SFDA and WHO in ChinaNew Progresses of SFDA and WHO in China

• Concluded the qualification of SFDA quality monitoring system for vaccines on March 1, 2011

45

• Started “New GMP” (2010V) Implementation to meet international quality standard on March 1, 2011, with a deadline of Dec 31, 2013State Food and Drug Administration

Page 47: Expectation of China's contribution to world vaccine

NRA FunctionIndica tor

Estima te d

Indica tor

impleme nte d

%Sub-

indica tors

A. Na tiona l Re gula tory Syste m 7 7 95.45%

Function 1: Ma rke ting Authoriza tion and Licensing 9 9 96.30%

China 13 - 17 Dec 2010

WHO Assessment on SFDA Quality Monitoring WHO Assessment on SFDA Quality Monitoring

Systems through 52 indicatorsSystems through 52 indicators

46

Function 1: Ma rke ting Authoriza tion and Licensing

a ctivitie s9 9 96.30%

Function 2: Post-ma rke ting a ctivities including surve illance

of Adve rse Eve nts Following Immuniza tion (AEFI)8 8 96.00%

Function 3: NRA Lot re le ase 6 6 100.00%

Function 4: Labora tory a ccess 10 10 100.00%

Function 5: Regula tory inspe ctions 6 5 89.58%

Function 6: Regula tory ove rsight of clinica l tria ls 6 6 95.00%

Total of 52 indicatorsSource: SFDA public presentation 2011

Page 48: Expectation of China's contribution to world vaccine

47

Page 49: Expectation of China's contribution to world vaccine

Status of Implementation of New GMP quality Status of Implementation of New GMP quality

system in Chinasystem in China

� 4900 Pharma and Biopharma/Biotech Companies making 19336 medicine products

� 517 (11%) have passed new GMP required qualification inspections

� 43 vaccine companies making 172 vaccine products

48

� 8 (19%) have passed new GMP required qualification inspections� Changchun Institute of Biological Products Co., Ltd.

� Shenzhen Sanofi Pasteour Biologcal Products Co., Ltd.

� Chengdu Institute of Biological Products Co., Ltd.

� Hualan Biotechnology Company

� Wuhan Institute of Biological

� Shenzhen Kangtai Biological Products Co., Ltd.

� Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. (a Novartis company)

� Beijing Xiangrui Biologcal Products Co., Ltd.

� Zhejiang Pukang Biotechnology Co.,Ltd.

� All remaining companies have to pass new GMP inspections and receive SFDA certificate by the end of 2013.

Page 50: Expectation of China's contribution to world vaccine

Presentation OutlinePresentation Outline

• World’s expectation for China vaccine market

• China’s readiness for contributing to world market with low-cost life saving vaccine supplies

• Bridging world-China vaccines markets

49

• Bridging world-China vaccines markets

Page 51: Expectation of China's contribution to world vaccine

1. New GMP

2. WHO PQ

3. MNC’s competitions

China Vaccine Industry Faces New Changes & ChallengesChina Vaccine Industry Faces New Changes & Challenges

50

Page 52: Expectation of China's contribution to world vaccine

China Vaccine Manufcaturing Remains China Vaccine Manufcaturing Remains

Extra CapacityExtra Capacity

Capacity Yield

51

Men A and C Hib Rabies Hepatitis A

Source: China vaccine market analysis report 2011 (version in Chinese)

Page 53: Expectation of China's contribution to world vaccine

R&D and Manufacturing

Technologies

China vaccine Companies

China Vaccine Companies in World Vaccine Supply ChainChina Vaccine Companies in World Vaccine Supply Chain

At present

52

Manufacturing Batch Scale

R&D and Manufacturing

Technologies

Companies

World dominated vaccine suppliers

Page 54: Expectation of China's contribution to world vaccine

R&D and Manufacturing

Technologies

China vaccine Companies

China Vaccine Companies in World Vaccine Supply ChainChina Vaccine Companies in World Vaccine Supply Chain

In future

53

Manufacturing Batch Scale

R&D and Manufacturing

Technologies

Companies

World dominated vaccine suppliers

Page 55: Expectation of China's contribution to world vaccine

Consolidation Results in Complementary Consolidation Results in Complementary

Strength EnhancementStrength Enhancement

Capability of taking current market (currently product on market)

Government Relationship(Capability of influencing on

SFDA approval speed)

Capability of taking future market (R&D innovation and novel product pipeline) Future Leader of Future Leader of

54

SFDA approval speed)

Strong marketing and Sale Force

(Capability of market penetration)

Capability of effective international collaboration, exchange, & communication

novel product pipeline) Future Leader of Future Leader of Chinese Vaccine Chinese Vaccine Industry & MarketIndustry & Market

Page 56: Expectation of China's contribution to world vaccine

“Vaccine Market Access in China “Vaccine Market Access in China –– M&A Paves M&A Paves

the Way for Foreign Companies”the Way for Foreign Companies”

• “China is the largest vaccine consumer in the world. It is a closed market with a strong local vaccine industry, access to which is challenging for Western players.”

• “In order to penetrate the China market, partnerships with local vaccine companies are crucial for Western vaccine manufacturers.”

55

vaccine manufacturers.”

• “ New GMP implementation will further increase M&A opportunities for multinationals.”

Source: Corporate License, 7 November 2011, Datamonitor

Page 57: Expectation of China's contribution to world vaccine

Sanofi-Pastuer

GSK

Others

Merck-G

SFDA Approved 34 Vaccine Clinical Trials SFDA Approved 34 Vaccine Clinical Trials

from MNCs during 2004 from MNCs during 2004 –– 20122012

26

24

18

9

% out of total foreign vaccines

56

Merck

Chiron

Crucell

LG

Solvay

6

6

6

3

3

GSKGSK, SanofiSanofi--PasteurPasteur, and NovartisNovartis have already acquired or set up local vaccine production companies in China.SanofiSanofi--PasteurPasteur, and Novartis Novartis have started vaccine R&D centers in China as well.

Source: China SFDA

Page 58: Expectation of China's contribution to world vaccine

““““““““In China, Speeding Toward the Future”In China, Speeding Toward the Future”

“ Historically, most important vaccines have originated in Europe and the United States. Now, countries like Brazil, India and China are providing lower-cost versions of some of them. …… because countries like China have experience in making low-cost vaccines, they could be better at designing new ones in ways that make them low in cost from the very beginning.”

57

the very beginning.”

“………. I was impressed at how quickly the (Chinese vaccine) industry is moving ahead. They really understand low-cost manufacturing, and they're getting their quality up to world standards. Over the next five to ten years, they have the potential to create many breakthrough vaccines, as well as to help get current vaccines to the world’s poorest people, ……... “

Bill Gates Travel Note, 2010Bill Gates Travel Note, 2010Bill Gates Travel Note, 2010Bill Gates Travel Note, 2010

Page 59: Expectation of China's contribution to world vaccine

Building the BridgeBuilding the Bridge

ChinaChina World MarketWorld Market

Innovation, Quality,Innovation, Quality,

WHO and CollaborationWHO and Collaboration

58

Thank You !Thank You !

[email protected]