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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.