Vaccine r&d and industrialization in china

Current Situation of Vaccine R&D and Industrialization in China

PERSONAL INFORMATION

photo

Dr. Zhang

Name: Yi Zhang Nationality: China Technical Title: ResearcherEducational Background:Postdoctor,The Chinese Academy of Sciences Working for: Yunnan Walvax Biotechnology Co.,Ltd.Position: DirectorMajor research direction:Functionality research of a new tumor suppress gene and family's other gene. Quality research of new biotech productsMajor working direction: Participated in amendment of the third appendix < Chinese Pharmacopoeia > and < Chinese biological products regulation >.in charge of biopharmaceutical pilot produce center of Kunming National biological industry base.Undertook Freeze Dried Meningococcal Group A, C Bivalent Polysaccharide Conjugate Vaccine abroad clinic research and popularize application.Taking charge of research center of Yunnan vaccine engineering technology.

国内疫苗产业化状况 42009-2011 年疫苗产品规模及竞争分析 Ⅴ

Ⅵ Analysis of Prospect of Vaccine Industry

CONTENT

国内疫苗研发情况Ⅳ

Introduction of Vaccine Enterprises in Domestic and Abroad

Situation of Vaccine Industrialization in Domestic and Abroad

ⅡⅢ

Introduction of 2010-2011 Global Infectious DiseasesⅠ

国内疫苗产业化状况 4Analysis of Major Vaccine Productions Scale and Competition in 2009-2011Ⅴ

Situation of Vaccine R&D in Domestic and Abroad

Introduction of 2010-2011 Global Infectious Diseases

According to WHO and Epidemic Report Web from 2010 to 2011 the distribution of epidemic in global different areas shows like the picture

Somalia,Uganda,Ethiopia, Morocco,Nigeria etc.

Germany,France,Rumania, Bulgaria etc.

Dominica,Paraguay, Polly Vigna etc.

cholerameasles,Escherichia coli,Influenza （ H5N1 ）yellow fever

Sinkiang,Gan Su, He Nan,Liao Ning

AIDS 、 Plague 、 Tick-bite disease

Introduction of Pathogens and Corresponding Vaccine of Major Epidemic

Cholera:acute diarrheal disease which mainly happens in summer and leads to diarrheal and dehydration even death. Endemic areas:Africa Therapeutics and Precautions: Vaccine,Complement water and electrolyte treat with antibiotics.

Vaccine R&D and Production: 1.WC-rBS researched by Chinese Academ

y of Military Medical Biological Engineering. 2.Institute of Biological Products of Lanzhou, China

Cholera

Yellow Fever:acute viral haemorrhagic disease caused by infected mosquito. Endemic Areas: Latin America,Africa Precautions: Vaccine Vaccine Production: Beijing Tiantan Biological Products Co.,Ltd.

Yellow Fever Virus


Bunia Virus ： Hemorrhagic fever with renal syndrome virus is a kind of Bunia Virus,which leads to sicken like influenza or Dengue disease,Hemorrhagic fever,meningitis.

Endemic Areas: China,Korea,Russia,Japan,east europe

Precaution:VaccineManufacturers of Vaccine of Hemorrha

gic fever with renal syndrome virus : 1.Chang Chun Chang Sheng Biotechnology Co.,Ltd.

2.Liao Ning Cheng Da Biotechnology Co.,Ltd. 3.Zhe Jiang Tian Yuan Bio-Pharmaceutical Co.,Ltd. 4.Institute of Biological Products of Chang chun,China Bunia Virus


Influenza ： caused by influenza virus, which leads to extensive epidemic of acute respiratory infection.

Endemic Areas:Global Precautions:Vaccine Vaccine Production: 1.GSK

2.sanofi pasteur 3.Novartis 4.CSL biotherapies 5.Hua Lan Biological Engineering Co.,Ltd.

6.Beijing Tiantan Biological Products Co.,Ltd. 7.Cheng du Kang Hua Biological Products Co.,Ltd. 8.Zhe Jiang Tian Yuan Bio-Pharmaceutical Co.,Ltd.etc. Influenza Virus




CONTENT



Introduction of Vaccine Enterprises in Domestic and AbroadⅡ

Ⅲ




Global Vaccine Market Situation in 2009

Developmental Situation of Global Vaccine Industry

GSK Sanofi Pasteur Merck Novartis Pfizer/Wyeth

In 2009,just the five enterprises have possessed 81.2% market share in global vaccine market,and they will successively go abroad to broaden market,while enter into chinese high-end vaccine market and possessed more than 50% market share in this field.Sanofi Pasteur

Novartis

GSK

MerckWyeth/Pfizer

81.2%

Developmental Situation of Global Vaccine Industry

Chinese Domestic Vaccine Manufacturers and Market Situation

Domestic Vaccine Enterprises

Encourage Development Factors

1.National Policy: In Feb.28th,2008.Ministry of Health issued <Expend National Immunization Planning Program>2.Demand stably increased.3.Reinforced public immune concept.4.In Mar.1st,2011.Chinese vaccine administration system has passed appraisal by WHO.

China National Biotech Group

Kunming Institute of Biology,Chinese Academy of Medical Sciences

Beijing Tiantan Biological Products Co.,Ltd,HuaLan Biotech Co.,Ltd etc.

Currently,chinese vaccine sale is about 5 billion yuan(calculated by factory price),and the capacity is about 1 billion dose.According to statistics from Chinese Medical Institute,the market growth rate is about 15%.Chinese vaccine market presents such characteristics that large quantity with small scale.

Chinese Listed Vaccine Eenterprises

Products ： recombinant HBV(Saccharomyces), MMR, freeze-dried inactive encephalitis B(Vero), DTaP, OPV, Measles and Rubella combined vaccine,Measles live vaccine,Rubella live vaccine, Influenza vaccine, Typhoid vaccine, yellow fever, Diphtheria and Tetanus combined vaccine(adsorbed), Group A Meningococcal Polysaccharide vaccine, H1N1 vaccineResearch Projects ： purified yellow fever vaccine,MMR-Varicella combined vaccine,chincough component vaccine,Rabies vaccine(2BS)

Major Capacity(Million copies) Rubella vaccine 9.94 MMR vaccine 0.88 Measles and Rubella combined vaccine 20.25 Measles vaccine 7.13 Diphtheria and Tetanus combined vaccine 3.90 Group A Meningococcal Polysaccharide vaccine 60.15 DTaP 7.76 HBV （ 10μg ） 2.81 HBV （ 5μg ） 26.91 HBV （ Vero ） 5.27 Influenza （ adult ） 0.69 Vi Polysaccharide Typhoid vaccine 0.81 Poliomyelitis vaccine 65.81 Yellow Fever live vaccine 0.06

Introduction ： Specialized in vaccine, blood preparations and diagnostic products research,manufacture and marketing,which stake controlled by China National Biotech Group Co.,Ltd.Market sale ： about 70% in vaccine marketCapacity: more than 200 million copies/year

Mainly products including human serum albumin,human Immunoglobulin,Influenza vaccine(split virion) etc.Introduction

Capacity Influenza vaccine(split virion) for adult:4.73 million copies/year

Products Influenza vaccine(split virion)

Tetanus vaccine, purified encephalitis B vaccine, Group A and C Meningococcal Polysaccharide vaccine, HBV(Saccharomyces),ACW135Y Meningococcal Polysaccharide vaccine

Research Projects


Introduction ： Subsidiary of listed Sinovac Co.,Ltd,also the only vaccine enterprise listed in America stock market.Standard:Conform to China Good Manufacturing Practice (GMP) ,and achieved FDA GMP standard.

Capacity ： HAV 30 million copies/year Influenza vaccine 20 million copies/yearResearch Projects ： freeze-dried ACW135Y Meningococcal Polysaccharide vaccine,Pneumococcal Vaccine Polyvalent-13,Vi Polysaccharide Typhoid vaccine,HPV-6,Rabies vaccine(human diploid cell)for human use,Varicella vaccine.

Products ： HAV,Influenza vaccine,Hepatitis A and B combined vaccine.

SINOVAC BIOTECH CO.,LTD


One of the largest scale manufacturers of influenza vaccine in china.Now is subsidiary of Novartis.The company possessed hi-tech viral and bacteria vaccine production plant.

ACW135Y Meningococcal Polysaccharide vaccine 5 million copies/year

Influenza vaccine(split virion),Haemorrhagic Fever Bivalent inactivated vaccine,Haemorrhagic Fever with Renal Syndrome Bivalent vaccine,Encephalitis B vaccine,Group A and C Meningococcal Polysaccharide vaccine

Vi Polysaccharide Typhoid vaccine, DTaP

Zhe Jiang Tian Yuan Bio-Pharmaceutical Co.,Ltd.etc.

Every production plant has passed GMP certification by SFDA


standard

capacityCapacity

Instruction

Products

Research Projects

Introduction ： One of hi-tech enterprises which specialized in vaccine manufacture,research and marketing.Now stock controlled by yun da science and technology.

Capacity ： HBV 30 million copies/year Products ： Rabies vaccine(Hamster Kidney Cell) for human use、 Recombinant HBV(Hansenula polymorpha)Research Projects ： Rabies vaccine(Vero Cell) for human use,combined vaccine based on HBV,HPV,Recombinant hepatitis E vaccine,therapeutic HBV.

Da Lian Hissen Bio-Pharm.Co.,Ltd

Standard ： Production plants have passed GMP certification by SFDA.


Mainly engaged in biological products research,manufacture and marketing.Now equity participation with SHANGHAI INDUSTRIAL and SJTU ANGLI.So far has became the most scale manufacturer of HBV.

HBV（ 10μg ） 19.10 million copies/yearHBV（ 5μg ） 29.34 million copies/year

Recombinant HBV

DTaP-Hib,Rotavirus vaccine

Introduction

Capacity

Products

Research Projects

Market share above 50%Sale

Shenzhen Kangtai Biological Products Co. Ltd.


Undertake several projects of

“863”Foundation

Hib 、 Group A,C Meningococcal Polysaccharide launched into mark

et

Company entered capital mark

et

2001 2002-2006

2008-2009 2010

Yun Nan WALVAX Biotech Co.,Ltd

Products ： Hib,Group A and C Meningococcal PolysaccharideResearch Projects:freeze-dried ACW135Y Meningococcal Polysaccharide vaccine,Vi Polysaccharide Typhoid vaccine,Pneumococcal Vaccine Polyvalent-13 ， HPV-6， Recombinant HBV,Rabies vaccine(human diploid cell) for human useProduction Technology ： bacterial polysaccharide combined vaccine technology which leading in domestic market. Standard:The products have achieved requirment of WHO and <European Pharmacopeia>


Major Vaccine Manufacturers in China

Manufacturers

Beijing,Changchun,Chengdu,Lanzhou, Shanghai,Wuhan Biological Products Institute, Beijing Tiantan Biological Products Co.,Ltd.

Market Share

In 2009, sold 620 million dose,be the most manufacturer in vaccine and blood products feild with possessed market share about 62%

Introducton for China National Biotec

h Group

Introduction ： CHBG is comprised by six National Biological Products Institute which affiliated Ministry of Health,now is the most powerful research and manufacture organization.Products ： Recombiant HBV, MMR,DTaP,OPV,Vi Polysaccharide Typhoid vaccine,Yellow Fever Live vaccine,Influenza vaccine,Leptospira vaccine,Group A,C Meningococcal Polysaccharide,Rotavirus vaccine,Rabies vaccine for human use,Haemorrhagic Fever with Renal Syndrome,Pneumococcal Vaccine Polyvalent-23 etc.Research Projects:MMRV,HPV,Haemorrhagic Fever vaccine,coli O157 combined vaccine,HEV,cholera vaccine,HCV,Rotavirus vaccine Polyvalent.Tick-borne Encephalitis vaccine etc.

Kunming Institute of Biology,Chinese Academy of Medic

al Sciences

Cooperated with WHO in reference research of enter

ovirus

Founded in 1958,engaged in science research and biological products research and manufacture

Products ： Freeze-dried HAV,OPV(Monkey Kidney),HAV inactive vaccine,enterovirus EV71 inactive vaccine(human diploid cell)

Research Projects ：OPV （ sabin strain),IPV-DTP,Mumps live vaccine(F gene),Influenza vaccine,Rotavirus inactive vaccine

Major Vaccine Manufacturers in China



CONTENT




Ⅲ




The First ： The vaccine that government provide citizen for free ,and citizen should inoculate conform to governmental regulations.The Second ： The vaccine that charged citizen with voluntary inoculation.

Class Current Scale Proportion Major products Leader

The First 1 billion 20%

HAV,HBV,Encephalitis B vaccine,MMR,Group A and C Meningococcal Polysacchar

ide

China National Bioteh Group possessed market

share about 90%

The Second 4 billion 80%

Varicella vaccine,Influenza vaccine,Hib,Tetanus vaccin

e,Rabies vaccine

Foreign Enterprises possessed

market share about50%

Classification of China Domestic Vaccine

Supply and Demand of China Domestic first class vaccine market Shows as below

Supply and Demand of China Domestic First Class Vaccine Market

Vaccine Name DoseNumber of years newborn （ m

illion ） Demand

(million dose/year)

Quantity of Release in 2009 （ m

illion dose ） Gap （ million dose ）

HBV 3 20 60 183.72 -123.72BCG 1 20 20 11.45 8.55

Poliomyelitis vaccine 4 20 80 107.45 -27.45DTP 4 20 80 13.63 66.37

Diphtheria and Tetanus 1 20 20 3.41 16.59Measles and Rubella 1 20 20 7.10 12.90

MMR 1 20 20 13.46 6.54Measles and Mumps 1 20 20 19.21 0.79

Measles 1 20 20 66.84 -46.84encephalitis B live vaccin

e 2 20 40 62.40 -22.40Group A Meningococcal P

olysaccharide 2 20 40 4.92 35.08Group A,C Meningococcal

Polysaccharide 2 20 40 21.83 18.17HAV Live vaccine 1 20 20 18.71 1.29

encephalitis B inactive vaccine 4 20 80 6.24 73.76

HAV inactive vaccine 2 20 40 13.93 26.07

First class vaccine market

Hepatitis vaccine

Poliomyelitis

DTP

MMR

Encephalitis B

Meningococcal

BCG

This is chinese first class vaccine quantity of release proportion in 2009(million dose),it shows although Hepatitis vaccine and Poliomyelitis vaccine have possessed greater market share,but according to the low price of first class vaccine,they make less benefits than the second class.And domestic vaccine manufacturers possessed the low price first class vaccine market.

Analysis of The First Class Vaccine Market

Hepatitis vaccine 39%

Poliomyelitis 20%

DTP 3%

MMR 19%

Encephalitis B 12%

Meningococcal 5%

BCG 2%



CONTENT

国内疫苗研发情况



Ⅲ



Ⅳ Situation of Vaccine R&D in Domestic and Abroad

The Process from R&D to Industrialization of Chinese Vaccine

Pre-clinical Research

Chinese vaccine enterprises set R&D,manufacture and marketing as a system,to guarantee safety and effectiveness of products any part has seriously controlled by national and industrial related legislation and quality control system.

Vaccine clinical test technology guideline,GCP

Administration approaches for drugs registration, Approval methods for new biological products,Administration approaches for import drugs registration

GSP,Vaccine distribution and inoculation regulations

Clinical Test

Vaccine Registration

Vaccine Sale

Vaccine Manufacture

Pre-clinical research guideline of Biological products for prevention,GLP

Pharmacopoeia, Administration approaches for drugs manufacture,GMP,Release system for biological products

Process of Vaccine R&D in China

Cycle of R&D about 6-10 year

1.Pre-clinical Research

Pre-clinical research phase usually ab

out 2-5 years

3.Apply for manufacture license

Apply for manufacture license phase usually about 2 year

s

2.Clinical Research

Clinical research phase usually about

2-3 years

Approval Process of Chinese Vaccine

SFDA Provincial Food and Drug Admi

nistration

Enterprise Quality Assurance Dep. （ Q

A ）

To assure vaccine quality,all of them supervise every manufacture process of manufacturers.Including each batch of products marketed or imported to compulsively verify and auditing.Failure can not marketed or imported. 。

Vaccine Quality

R&D of PCVPneumococcal Vaccine Polyvalent-7Pneumococcal Polysaccharide Vaccine Polyvalent-9Pneumococcal Vaccine Polyvalent-13Pneumococcal Polysaccharide Vaccine Polyvalent-23

9PCV Yunnan Walvax13PCV Beijing Minhai Biotech, Sinovac Biotech,23PCV Chengdu Biological Institute, Yunnan Walvax

Children under 2 years old.Currently,total target population is about 34 million.

7PCV Wyeth 13PCV Wyeth23PCV Sanofi Pasteur, Beijing Minhai Biotech,Merck

EligiblesEligibles

R&DR&DEnterpriseEnterprise

Manufa-Manufa-cturercturerClassClass PCV

HPV

R&D of HPV

A kind of cancer vaccine used for preventing cervical cancer and precancerous genital lesions caused by HPV-6,11,16,18. 70% cervical cancer caused by HPV16,18.There are about 0.24 million people died of the cancer all over the world.

HPV-16,18(saccharomyces) ： Shanghai runze Biotech Co.,Ltd.HPV-6,11,16,18 ： Merck

HPV-6,11,16,18(saccharomyces) ： MerckHPV-6,11(coli) ： Xiamen Innovex Biotech Co.,Ltd.

Introduction

Manufacture

Research Enterprise

Domestic R&D of Poliomyelitis Vaccine

2008

2007

2006

2002

2001

2000

Kunming Institute of Biology,Chinese Academy of Medical SciencesBeijing Tiantan Biological Products Co.,Ltd.

Poliomyelitis vaccine used for prevent acute infectious disease which caused by poliomyelitis virus.Due to it usually happen to infant,it also called infantile paralysis.Infection rate above 90% among 6 month to 5 years old children.

OPV(oral poliomyelitis vaccine)IPV(inactivated poliomyelitis vaccine)

Introduction

Class

Manufacturer and R&D Ent

erprise

Poliomyelitis Live Vaccine (Monkey Kidney Cell),Oral

EV71(Human enterovirus 71) can induce central nervous system diseases,like hand - foot and mouth disease ；

(HFMD)

Vaccine R&D including inactived,live, subunit,DNA, Epitope peptide,Virus-like particle

vaccine

Zhejiang Pukang Biotech and Sinovac Biotech produce EV71 and HAV comb

ined vaccine

EV71 vaccine possessed 1.94% of the total number of R&D and manufacture.And HFMD epidemic prevention is more serious in China,only in Mar.2009,there are total 115618 cases of HFMD in China,of which 773 cases of severe, 50 cases of death.

EV71

Domestic R&D of EV71

Manufacturers and R&D Enterprise ： Kunming Institute of Biology,Beijing Weigu Biotech,Zhejiang Pukang Biotech,Sinovac Bi

otech

Rotavirus Vaccine

The major phathogen which caused children under 2 years diarrhea even death is rotavirus.In China there are 10 million infants under 2 years suffering from gastroenteritis caused by rotavirus.Rotavirus is the main phathogen causes of severe diarrhea.

Xinkexian (Beijing) Biotech Co.,Ltd,Lanzhou Biological Products Institute.

Oral Live Vaccine, Recombinant Polyvalent Vaccine, Subunit Vaccine, Gene Vaccine

Introduction

Manufacturer Class

Domestic R&D of Rotavirus Vaccine

1.DPT/HibR&D Enterprises:Beijing MinHai Biotech Co.,Ltd,Yunnan Walvax Co.,Ltd.2.EV71/HAVR&D Enterprises:Sinovac Biotech Co.,Ltd.Manufacturer:Zhejiang Kangpu Biotech Co.,Ltd.3.DTaP/HBVManufacturer:Wuhan Biological Products Institute4.HAV/HBVR&D Enterprises:Changchun Biological Products InstituteManufacturer:Sinovac Biotech Co.,Ltd.

R&D and Manufacture ：

Advantages ： To inoculate combined vaccine ,expand the range of prevention in single dose to increase inoculation rate. Besides,benefit arrangement of immunization program from reducing vaccination equipment and labor costs.Patients and parents will easily accept inoculation and it will help promote implement expanded immunization program.Researching combined vaccine have became one of R&D direction.

Combined Vaccine

Domestic R&D of Combined Vaccine

R&D Prospect ： New age subunit or peptide vaccine R&D and use application rely on safety and effective adjuvant to enhance immunogenicity.But traditional aluminum adjuvant can not satisfy requirement of kinds of new-type vaccine more and more.Therefore, study of new adjuvants is becoming one of the hot-spot

Class ：1.Composite Adjuvant ISOM： used for Influenza vaccine,measles vaccine,HIV vaccine.2.Liposomes:used for HAV,HBV,Influenza vaccine,Rabies vaccine3.Cholera subunit(CT):used for Influenza vaccine4.Cytokines (interleukin IL-1/IL-2):used for Influenza vaccine,recombinant vaccine5.CpG:used for cancer vaccine, HBV Yunnan Walvax Biotech Co.,Ltd is developing CpG adjuvant used for HBV

New Adjuvant

Domestic R&D of New Adjuvant

HEV R&D Enterprise:

Xiamen INNOVAX Biotech, Institute of Lanzhou Biological Products, Kunming Institute of Biology

Helicobacter Pylori

R&D Enterprise:

Chongqin Kangwei Biotech(developing technology comes from the Third Military Medical University)

SARS R&D Enterprise:

Beijing Sinovac Biotech

H1N1 Influenza Vaccine

R&D Enterprise:

Tiantan Biotech, Institute of Shanghai,Changchun, Lanzhou Biological Products, Changchun ChangSheng Biotechnology, Hualan Biotech, Dalian Ya Lifeng Biotech, Beijing Sinovac Biotech,

HIV R&D Enterprise:

Changchun BCHT Biotech(DNA vaccine and recombinant vaccine combined vaccine)

Major Developing Vaccine in China

R&D Enterprise:Institute of Beijing Biological Products(Yi Ke), The Third Military Medical University combined with Chongqing Brewery (Therapeutic peptide vaccine), Shenzhen Kangtai Biotech (Protein vaccine)

Therapeutic HBV

According to statistics, until Jan.2001, four kind of therapeutic HBVs are under Ⅱ ， Ⅲ clinical trial .They are antigen-antibody combined therapeutic HBV, Synthetic peptide vaccine, high-dose HBV, plasmid DNA vaccine. Verified by the results of trial, therapeutic HBVs do have effects on hepatitis B patients, but it still needs a large number of samples to ensure the security and effectiveness of vaccine which can acchieve satisfied degree.

Major Developing Vaccine in China


CONTENT




Ⅲ


国内疫苗产业化状况 42009-2011 年疫苗产品规模及竞争分析 Ⅴ 国内疫苗产业化状况 4Analysis of Major Vaccine Productions Scal

e and Competition in 2009-2011Ⅴ


Pneumococcal Vaccine-23

Encephalitis B

H1N1 vaccine

Rabies vaccine

HBV

Hib

0 5 10 15 20 25 30

12

15

17

15

14

27Influenza vaccine

DTaP

15

9

Varicella live vaccine

ACYW135

Poliomyelitis vaccine

7

6

5

other 3

Registration Amount

Kinds of Vaccine Registration Amount in 2009-2011

Influenza Vaccine

2.Manufacturers:Hunlan Biotech,Chengdu Kanghua,Zhejiang

Tianyuan,Beijiang Tiantan,Changchun/Shanghai/Lanzhou/ Biological Institute,Changchun C

hangsheng etc.

Influenza Vaccine: In China,currently it is the largest amount vaccine in R&D and manufacture.

1.the reason of larger market

Seasonal Features

Antigen easily mutate

Industrialization of Domestic Influenza Vaccine

Hepatitis Vaccine ： HBV ， HAV ， HBV/HAVChina is high incidence area of hepatitis

Manufacturers ：Shanghai runze,Kunming Institute of Biology,Changchun Changsheng,Chongqing Zhifei,Sinovac.R&D Enterprises: Shenzhen Kangtai

HAVRecombinant HBV （ Saccharomyces ）Manufacturers ：Hualan Biotech,Beijing Tiantan,Shenzhen Kangtai,Hangzhou Taige,Yunnan Walvax,Dalian Hissen

Industrialization of Domestic Hepatitis Vaccine

27.27%

24.24%18.18%

Industrialization of Domestic Bacterial Polysaccharide Vaccine

24.24%

6.06%

Bacteri al Pol ysacchari de Vaccine

PCV23

Group A, C Meni ngococcal Pol ysacchari de Vi Pol ysacchari de Typhoi d PCV 7/ 9/ 13

ACW135Y

PCV23 27.27%

Group A,C Meningococcal Polysaccharide 24.24%

PCV7/9/13 24.24%

ACYW135 24.24%

Vi Polysaccharide Typhoid



CONTENT




Ⅲ




Analysis of Vaccine Industry Prospect

2006 2008 2012

Global Vaccine Market China Vaccine Market

（ Unit : billion dollar ）（ Unit : billion RMB ）

22.1

2006 2009 2012

34.011.6

123

5

Global vaccine market expected achieving 34 billion dollars in 2012,and this market will rapidly develop with faster speed than anti-tumor drugs in 5 years,advancing with 14% annual growth rate,undoubtedly it will become the fastest growth field among global pharmaceutical industry.

In China,the vaccine scale is about 5 billion RMB,and keeping annual growth rate at 15% which surpassed the global level of 14%.Chiese vaccine scale expected achieving 12 billion RMB in 2012.

<Good Manufacturing Practice(2010 revision) >(New edition GMP) officially implement on 1st Mar.2011.It will improve current manufacturers from R&D to marketing,and will mostly help chinese vaccine to export to EU.

Now there are 36 vaccine manufacturers in China.With automatic production management system and the capability of independent R&D and producion.China can be the great country of pharmaceutic with annual capacity of 1 billion (per person)

Chinese vaccine administration system has passed pre-appraisal by WHO on 1st Mar.2011,China will provide UN with low price,high quality,safety and effective vaccine.

2010<China Pharmacopeia> assured every step of drugs R&D,manufacture,marketing,application,management to seriously conform to national standard.It is the core of national drugs standard system.Moreover,it will promote international collaboration.

Analysis of Vaccine Industry Prospect

Recently Vaccine Collaboration and merge

Nation Partner 1 Partner 2 Date Type of collaboration Indications

Brazil Sanofi Pasteur Biotantan Institute 1999 Joint venture/technology transfer/R&D support to provide Brazil market with more vaccine Many

Brazil GSK Oswaldo Crux Foundation 1985 Joint venture/technology transfer/R&D support to provide Brazil market with more vaccine Many

China GSK Shenzhen Haiwang Biotech 2009 Joint venture,Influenza vaccine R&D in China Many

China Novartis Zhejiang Tianyuan 2009 Acquisition

China GSK Yunnan Walvax 2009 join venture to R&D children vaccine for China Many

China GSK 2007 Collaboration protocol,Anflu popularize and sale Influenza

India Sanofi Pasteur Sbanthn Biotech 2009 Acquisition

India Merck Wellcome Trust 2009 Joint venture to establish non-profits organization Many

Japan Novartis Takeda 2009 VaremHib commercialization Hib

Japan Sanofi Pasteur Daiichi-Sankyo 2008 AciHib sales protocol Hib

Mexico Sanofi Pasteur Binnex 2009 Provide influenza vaccine,manufacture and technology transfer Influwnza

Korea GSK Green Crosa 2007 Protocol of kinds of vaccine sale in Korea Many

Korea Novartis Green Crosa 2009 Joint venture to realize independently manufacture Many

Korea Merck SK chemistry 2007 Protocol of kinds of vaccine sale in Korea Many

Korea Sanofi Pasteur Korean vaccine 2007 Protocol of kinds of vaccine sale in Korea Many

Thank You!

Vaccine r&d and industrialization in china

Health & Medicine

Transcript of Vaccine r&d and industrialization in china