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Environmental Prerequisites to Invest Pharmaceutical Sector in Developing Countries
在发展中国家投资药品产业所需要的环境
Helen Yang 杨光
Director, International Business Development
国际业务发展总监
Sinovac Biotech Co. Ltd.
北京科兴生物制品有限公司
June 12, 2012
Environment Expected to Invest in Pharmaceutical Sector in
(less) Developing Countries
1 Sinovac Profile
Sinovac’s Plan to Work with Africa
2
3
Company Overview
Going International
Influenza Vaccine Practices in South Africa and Kenya
What do the manufacturers concern?
-Key Requirements for Pharmaceutical Sector
-Drivers and Determinants
Company Overview
Going International
1 Sinovac Profile
4
• Provide Chinese children with the best vaccines in the
world,
• Let children in the developing world being benefited from
vaccines at affordable price;
Our mission is to supply vaccines to
eliminate human diseases.
Sinovac Biotech Ltd. (NASDAQ GSM: SVA)
5
Supply Vaccine to Eliminate
Human Diseases
R&D
Manufacturing
Sales &
Marketing
Post-Sales
Services
H5N1
H1N1
6
Five Key Strategic Objectives
.....
.....
.....
New Version of
Chinese Pharmacopeia
• October 2010
• February 2011
• February 2011
New Version of China
GMP Standards
NRA of China pass WHO
Pre qualification
Develop new products
to serve unmet medical
needs
Expand production capacity
to meet growing demand from
China and other developing
markets
Maintain high quality to
comply with
international standards
Maximize domestic sales
and achieve registration in
overseas markets
Seek international
collaborations to leverage
competitive advantages
and share benefits with
partners
Develop more vaccines against more types of disease
Provide high quality products at affordable prices
Deliver products in China and around the globe
Path to “Go International”
Local Registration
& Distribution
Through Local
Partner
Local Partnership
for Joint
Investment
Local Investment
Why: Sufficient Capacity, Efficient Supply, Affordable Price for Developing
Countries?
Current Distributors & Target Markets
Mexico
Venezuela
Peru
Chile
Algeria
Egypt
Saudi
Uzbekistan
Mongolia
Nepal
India
Pakistan
ThailandVietnam
Philippines
Malaysia
Korea
Ukraine
Turkey
Israel
Registration Process x6Local Distribution x3 Target Markets in 2012 x15
Kenya
Brazil
Columbia
Argentina
Human Vaccines Animal Vaccine
Current Product Portfolio
1st inactivated Hepatitis A vaccine developed, produced,
and marketed by a Chinese manufacturer
Better safety profile than the counterpart
Primarily sold in China; start to sell into overseas market
About 30million doses sold in China since the beginning;
1st inactivated hepatitis A and B vaccine produced in China
The only supplier in China
1st locally produced flu vaccine without preservative;
First IVS (Influenza Vaccine Supply) task force member from
developing country
Primarily sold in China; start to sell into overseas market
First and only approved H5N1 vaccine in China
Only qualified H5N1 vaccine (against avian flu) for Chinese
government stockpiling program
1st company globally to receive production license for H1N1
vaccine
Inactivated animal rabies vaccine
Locally occurring virus strain, which improves the
protective effect
Replicate quality control system for human
vaccines to guarantee the quality of animal
vaccines
Competitively priced compared with similar
products imported
~80 million registered dogs in China
Healive
Bilive
Anflu
Panflu
Panflu.1
RabEnd
Deep Pipeline to Drive Future Growth
Human Vaccines
• EV71 Vaccine (hand, foot
and mouth disease)
• Pneumococcal Conjugate Vaccine
(PCV)
Clinical Trials
 Over 1.6 million cases reported in China with 506
fatalities in 2011.
 ~80M children (children aged 5 and under in China)
 Target Population:
 ~32M children (children aged 2 and under in China)
 Over 350 million people over age 50
• Mumps Vaccine
• Rubella Vaccine
• Long-term objective to launch MMR vaccine within 5
years
• In 2011, 26.3 million doses of MMR were approved
and released in China.
• Rotavirus Vaccine
• Pneumococcal Polysaccharides
Vaccine (PPV)
• Chickenpox Vaccine (Varicella) • 14.2 million doses supplied in China in 2011
•Potentially being included in public market
• Rabies Vaccine for Humans • In 2011, 11.55 million doses of rabies vaccines
were approved and released in China
P1 P2 P3
Pipeline Market Potential
Pre-
Clinical
File
IND
Clinical Trials Reg.
• 5.8 million doses of vaccines for rotavirus were
approved for sale in China in 2011
Manufacturing Facilities
State-of-the-Art-Facilities
Headquarter- Beijing Beijing
Dalian
Tangshan
Filling & Packaging Plant
Flu Plant
R & D Center
Dalian Site
Tangshan Site-Animal Vaccine
Changping site, Beijing
PUK Bio-city
In China, Sinovac possesses commercial production sites of total 160,000 m2
Environment Expected to Invest in Pharmaceutical Sector in
(less) Developing Countries
2
What do the manufacturers concern?
-Key Requirements for Pharmaceutical Sector
-Drivers and Determinants
What do the manufacturers concern? General preconditions for most
industrial investment
Political Environment Economic Environment
Social, Cultural and Natural Environment Technical Environment
Legal & Regulatory Environment
Political System
-Administration
-Legislation
-Justice
…
Major Parties
-…
-…
-…
Industrial Survey
GDP, GNI, CPI…
Development
Stage
Import & Export
…
Natural Environment
-Geography & Climate
-Energy
-Communication & Transportation
…
Social & Cultural Environment
-Races, language
-Demographics
Education
Colleges &
Institutes
Encouraging
Industries
International
cooperation
…
Special Local Laws
Revenue System
…
Major Laws for Investment
I.P. Laws
Foreign Currency Management
…
Political Stability Investment landscape in Sub-Saharan Africa
What do the manufacturers concern?
Key Requirements for Pharmaceutical Sector
Skilled human resources: pharmacists; graduates in pharmacy, chemistry, biochemistry...; technicians; marketing&sales.
Quality of scientific education…
Local Business management schools and graduates returning of foreign business schools…
Reliable power and clean water;
Special industrial zones…
Capable to encourage foreign investment into the local pharmaceutical industry;
Builds confidence to export to other countries.
Human Resources
Basic Infrastructure
Functioning National Drug Regulatory Authority
What do the manufacturers concern? (Con’t)
Drivers and Determinants
Market Size.
Long term plan in the country or in the area.
Flagship or pipeline products, or distribution network driven M&A, JV.
Take advantage of efficiencies and lower costs by consolidation.
Eg. Moving R&D activities to China and India.
Work in R&D with institutes or universities of developing countries.
Registration requirements, pricing.
Intellectual property.
Foreign investment incentive policy.
Market Access
Seeking Efficiency
Policies Facilitation & Incentive
Aside from economic motives, humanitarian concerns only.
Eg. HIV and AIDS local R&D or production.
Humanitarian and Moral Drive
Conclusion - Near-Term Solution
Understand
the Culture
Understand
the
regulations
Access to
the
resources
Gain market
access
……
Sinovac’s Plan to Work with Africa3
Influenza Vaccine Practices in South Africa and Kenya
Sinovac’s Plan to work with Africa - Case sharing
Countries
Flu vaccine
Consumption 2009
(thousand doses)
Immunization
Rate
South Africa 1,103 2.20%
Mauritius 52 4.00%
Kenya 20 0.05%
Cameroon 10 0.05%
Angola 10 0.05%
Namibia 9 0.40%
Burkina Faso 8 0.05%
Mali 8 0.05%
Zambia 7 0.05%
Botswana 6 0.28%
Benin 4 0.05%
Total 1,237
Step 1. Political Stability--South Africa & Kenya
Conclusion:
Possible to launch business.
Step 2. Environment Evaluation Checklist
Political; Economic; Social&& Cultural& Natural;
Technical; Laws& Regulatory.
Step 3. Flu Vaccine Market Research
Local production; Size; Pricing; Competitions;
Distribution…
Step 4. Launching Plan
FDI? M&A? JV? Distributor?
Suspending for WHO PQ?
Step1 Step2 Step3
Local Production:
A PPP company
is under
establishment to
manufacture flu
vaccine and
others.
Regulatory Gap:
1. EU format
dossier;
2. Local pre-
licencing
clinical trial.
OK
Step4
Suspending
South Africa
Step1 Step2 Step3
Market size is
relative small, but
foresee the future
development
and covering
other African
countries.
OKOK
Step4
Distributor
Kenya
Local
Production
*Provision of seasonal influenza vaccines in 157 countries (2004 – 2009), IFPMA.
Government
Organizations
Local
Distributors
NGOsInstitutions
Local
Manufacturers
Vision of our Partnership Intention with Africa
With “going international” as part our corporate strategy, Sinovac intents to collaborate with
various parties of African countries in order to bring high quality vaccine products to people living
there and help them improve health condition.
Thank You

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Sinovac

  • 1. Environmental Prerequisites to Invest Pharmaceutical Sector in Developing Countries 在发展中国家投资药品产业所需要的环境 Helen Yang 杨光 Director, International Business Development 国际业务发展总监 Sinovac Biotech Co. Ltd. 北京科兴生物制品有限公司 June 12, 2012
  • 2. Environment Expected to Invest in Pharmaceutical Sector in (less) Developing Countries 1 Sinovac Profile Sinovac’s Plan to Work with Africa 2 3 Company Overview Going International Influenza Vaccine Practices in South Africa and Kenya What do the manufacturers concern? -Key Requirements for Pharmaceutical Sector -Drivers and Determinants
  • 4. 4 • Provide Chinese children with the best vaccines in the world, • Let children in the developing world being benefited from vaccines at affordable price; Our mission is to supply vaccines to eliminate human diseases. Sinovac Biotech Ltd. (NASDAQ GSM: SVA)
  • 5. 5 Supply Vaccine to Eliminate Human Diseases R&D Manufacturing Sales & Marketing Post-Sales Services H5N1 H1N1
  • 6. 6 Five Key Strategic Objectives ..... ..... ..... New Version of Chinese Pharmacopeia • October 2010 • February 2011 • February 2011 New Version of China GMP Standards NRA of China pass WHO Pre qualification Develop new products to serve unmet medical needs Expand production capacity to meet growing demand from China and other developing markets Maintain high quality to comply with international standards Maximize domestic sales and achieve registration in overseas markets Seek international collaborations to leverage competitive advantages and share benefits with partners Develop more vaccines against more types of disease Provide high quality products at affordable prices Deliver products in China and around the globe
  • 7. Path to “Go International” Local Registration & Distribution Through Local Partner Local Partnership for Joint Investment Local Investment Why: Sufficient Capacity, Efficient Supply, Affordable Price for Developing Countries?
  • 8. Current Distributors & Target Markets Mexico Venezuela Peru Chile Algeria Egypt Saudi Uzbekistan Mongolia Nepal India Pakistan ThailandVietnam Philippines Malaysia Korea Ukraine Turkey Israel Registration Process x6Local Distribution x3 Target Markets in 2012 x15 Kenya Brazil Columbia Argentina
  • 9. Human Vaccines Animal Vaccine Current Product Portfolio 1st inactivated Hepatitis A vaccine developed, produced, and marketed by a Chinese manufacturer Better safety profile than the counterpart Primarily sold in China; start to sell into overseas market About 30million doses sold in China since the beginning; 1st inactivated hepatitis A and B vaccine produced in China The only supplier in China 1st locally produced flu vaccine without preservative; First IVS (Influenza Vaccine Supply) task force member from developing country Primarily sold in China; start to sell into overseas market First and only approved H5N1 vaccine in China Only qualified H5N1 vaccine (against avian flu) for Chinese government stockpiling program 1st company globally to receive production license for H1N1 vaccine Inactivated animal rabies vaccine Locally occurring virus strain, which improves the protective effect Replicate quality control system for human vaccines to guarantee the quality of animal vaccines Competitively priced compared with similar products imported ~80 million registered dogs in China Healive Bilive Anflu Panflu Panflu.1 RabEnd
  • 10. Deep Pipeline to Drive Future Growth Human Vaccines • EV71 Vaccine (hand, foot and mouth disease) • Pneumococcal Conjugate Vaccine (PCV) Clinical Trials  Over 1.6 million cases reported in China with 506 fatalities in 2011.  ~80M children (children aged 5 and under in China)  Target Population:  ~32M children (children aged 2 and under in China)  Over 350 million people over age 50 • Mumps Vaccine • Rubella Vaccine • Long-term objective to launch MMR vaccine within 5 years • In 2011, 26.3 million doses of MMR were approved and released in China. • Rotavirus Vaccine • Pneumococcal Polysaccharides Vaccine (PPV) • Chickenpox Vaccine (Varicella) • 14.2 million doses supplied in China in 2011 •Potentially being included in public market • Rabies Vaccine for Humans • In 2011, 11.55 million doses of rabies vaccines were approved and released in China P1 P2 P3 Pipeline Market Potential Pre- Clinical File IND Clinical Trials Reg. • 5.8 million doses of vaccines for rotavirus were approved for sale in China in 2011
  • 11. Manufacturing Facilities State-of-the-Art-Facilities Headquarter- Beijing Beijing Dalian Tangshan Filling & Packaging Plant Flu Plant R & D Center Dalian Site Tangshan Site-Animal Vaccine Changping site, Beijing PUK Bio-city In China, Sinovac possesses commercial production sites of total 160,000 m2
  • 12. Environment Expected to Invest in Pharmaceutical Sector in (less) Developing Countries 2 What do the manufacturers concern? -Key Requirements for Pharmaceutical Sector -Drivers and Determinants
  • 13. What do the manufacturers concern? General preconditions for most industrial investment Political Environment Economic Environment Social, Cultural and Natural Environment Technical Environment Legal & Regulatory Environment Political System -Administration -Legislation -Justice … Major Parties -… -… -… Industrial Survey GDP, GNI, CPI… Development Stage Import & Export … Natural Environment -Geography & Climate -Energy -Communication & Transportation … Social & Cultural Environment -Races, language -Demographics Education Colleges & Institutes Encouraging Industries International cooperation … Special Local Laws Revenue System … Major Laws for Investment I.P. Laws Foreign Currency Management … Political Stability Investment landscape in Sub-Saharan Africa
  • 14. What do the manufacturers concern? Key Requirements for Pharmaceutical Sector Skilled human resources: pharmacists; graduates in pharmacy, chemistry, biochemistry...; technicians; marketing&sales. Quality of scientific education… Local Business management schools and graduates returning of foreign business schools… Reliable power and clean water; Special industrial zones… Capable to encourage foreign investment into the local pharmaceutical industry; Builds confidence to export to other countries. Human Resources Basic Infrastructure Functioning National Drug Regulatory Authority
  • 15. What do the manufacturers concern? (Con’t) Drivers and Determinants Market Size. Long term plan in the country or in the area. Flagship or pipeline products, or distribution network driven M&A, JV. Take advantage of efficiencies and lower costs by consolidation. Eg. Moving R&D activities to China and India. Work in R&D with institutes or universities of developing countries. Registration requirements, pricing. Intellectual property. Foreign investment incentive policy. Market Access Seeking Efficiency Policies Facilitation & Incentive Aside from economic motives, humanitarian concerns only. Eg. HIV and AIDS local R&D or production. Humanitarian and Moral Drive
  • 16. Conclusion - Near-Term Solution Understand the Culture Understand the regulations Access to the resources Gain market access ……
  • 17. Sinovac’s Plan to Work with Africa3 Influenza Vaccine Practices in South Africa and Kenya
  • 18. Sinovac’s Plan to work with Africa - Case sharing Countries Flu vaccine Consumption 2009 (thousand doses) Immunization Rate South Africa 1,103 2.20% Mauritius 52 4.00% Kenya 20 0.05% Cameroon 10 0.05% Angola 10 0.05% Namibia 9 0.40% Burkina Faso 8 0.05% Mali 8 0.05% Zambia 7 0.05% Botswana 6 0.28% Benin 4 0.05% Total 1,237 Step 1. Political Stability--South Africa & Kenya Conclusion: Possible to launch business. Step 2. Environment Evaluation Checklist Political; Economic; Social&& Cultural& Natural; Technical; Laws& Regulatory. Step 3. Flu Vaccine Market Research Local production; Size; Pricing; Competitions; Distribution… Step 4. Launching Plan FDI? M&A? JV? Distributor? Suspending for WHO PQ? Step1 Step2 Step3 Local Production: A PPP company is under establishment to manufacture flu vaccine and others. Regulatory Gap: 1. EU format dossier; 2. Local pre- licencing clinical trial. OK Step4 Suspending South Africa Step1 Step2 Step3 Market size is relative small, but foresee the future development and covering other African countries. OKOK Step4 Distributor Kenya Local Production *Provision of seasonal influenza vaccines in 157 countries (2004 – 2009), IFPMA.
  • 19. Government Organizations Local Distributors NGOsInstitutions Local Manufacturers Vision of our Partnership Intention with Africa With “going international” as part our corporate strategy, Sinovac intents to collaborate with various parties of African countries in order to bring high quality vaccine products to people living there and help them improve health condition.