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 Countries1 Sinovac ProfileSinovac’s Plan to Work with Africa23Company OverviewGoing InternationalInfluenza Vaccine Practices in South Africa and KenyaWhat do the manufacturers concern?-Key Requirements for Pharmaceutical Sector-Drivers and Determinants
Company OverviewGoing International1 Sinovac Profile
4• Provide Chinese children with the best vaccines in theworld,• Let children in the developing world being benefited fromvaccines at affordable price;Our mission is to supply vaccines toeliminate human diseases.Sinovac Biotech Ltd. (NASDAQ GSM: SVA)
5Supply Vaccine to EliminateHuman DiseasesR&DManufacturingSales &MarketingPost-SalesServicesH5N1H1N1
6Five Key Strategic Objectives...............New Version ofChinese Pharmacopeia• October 2010• February 2011• February 2011New Version of ChinaGMP StandardsNRA of China pass WHOPre qualificationDevelop new productsto serve unmet medicalneedsExpand production capacityto meet growing demand fromChina and other developingmarketsMaintain high quality tocomply withinternational standardsMaximize domestic salesand achieve registration inoverseas marketsSeek internationalcollaborations to leveragecompetitive advantagesand share benefits withpartnersDevelop more vaccines against more types of diseaseProvide high quality products at affordable pricesDeliver products in China and around the globe
Path to “Go International”Local Registration& DistributionThrough LocalPartnerLocal Partnershipfor JointInvestmentLocal InvestmentWhy: Sufficient Capacity, Efficient Supply, Affordable Price for DevelopingCountries?
Current Distributors & Target MarketsMexicoVenezuelaPeruChileAlgeriaEgyptSaudiUzbekistanMongoliaNepalIndiaPakistanThailandVietnamPhilippinesMalaysiaKoreaUkraineTurkeyIsraelRegistration Process x6Local Distribution x3 Target Markets in 2012 x15KenyaBrazilColumbiaArgentina
Human Vaccines Animal VaccineCurrent Product Portfolio1st inactivated Hepatitis A vaccine developed, produced,and marketed by a Chinese manufacturerBetter safety profile than the counterpartPrimarily sold in China; start to sell into overseas marketAbout 30million doses sold in China since the beginning;1st inactivated hepatitis A and B vaccine produced in ChinaThe only supplier in China1st locally produced flu vaccine without preservative;First IVS (Influenza Vaccine Supply) task force member fromdeveloping countryPrimarily sold in China; start to sell into overseas marketFirst and only approved H5N1 vaccine in ChinaOnly qualified H5N1 vaccine (against avian flu) for Chinesegovernment stockpiling program1st company globally to receive production license for H1N1vaccineInactivated animal rabies vaccineLocally occurring virus strain, which improves theprotective effectReplicate quality control system for humanvaccines to guarantee the quality of animalvaccinesCompetitively priced compared with similarproducts imported~80 million registered dogs in ChinaHealiveBiliveAnfluPanfluPanflu.1RabEnd
Deep Pipeline to Drive Future GrowthHuman Vaccines• EV71 Vaccine (hand, footand mouth disease)• Pneumococcal Conjugate Vaccine(PCV)Clinical Trials Over 1.6 million cases reported in China with 506fatalities 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 5years• In 2011, 26.3 million doses of MMR were approvedand released in China.• Rotavirus Vaccine• Pneumococcal PolysaccharidesVaccine (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 vaccineswere approved and released in ChinaP1 P2 P3Pipeline Market PotentialPre-ClinicalFileINDClinical Trials Reg.• 5.8 million doses of vaccines for rotavirus wereapproved for sale in China in 2011
Manufacturing FacilitiesState-of-the-Art-FacilitiesHeadquarter- Beijing BeijingDalianTangshanFilling & Packaging PlantFlu PlantR & D CenterDalian SiteTangshan Site-Animal VaccineChangping site, BeijingPUK Bio-cityIn China, Sinovac possesses commercial production sites of total 160,000 m2
Environment Expected to Invest in Pharmaceutical Sector in(less) Developing Countries2What do the manufacturers concern?-Key Requirements for Pharmaceutical Sector-Drivers and Determinants
What do the manufacturers concern? General preconditions for mostindustrial investmentPolitical Environment Economic EnvironmentSocial, Cultural and Natural Environment Technical EnvironmentLegal & Regulatory EnvironmentPolitical System-Administration-Legislation-Justice…Major Parties-…-…-…Industrial SurveyGDP, GNI, CPI…DevelopmentStageImport & Export…Natural Environment-Geography & Climate-Energy-Communication & Transportation…Social & Cultural Environment-Races, language-DemographicsEducationColleges &InstitutesEncouragingIndustriesInternationalcooperation…Special Local LawsRevenue System…Major Laws for InvestmentI.P. LawsForeign Currency Management…Political Stability Investment landscape in Sub-Saharan Africa
What do the manufacturers concern?Key Requirements for Pharmaceutical SectorSkilled 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 ResourcesBasic InfrastructureFunctioning National Drug Regulatory Authority
What do the manufacturers concern? (Con’t)Drivers and DeterminantsMarket 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 AccessSeeking EfficiencyPolicies Facilitation & IncentiveAside from economic motives, humanitarian concerns only.Eg. HIV and AIDS local R&D or production.Humanitarian and Moral Drive
Sinovac’s Plan to Work with Africa3Influenza Vaccine Practices in South Africa and Kenya
Sinovac’s Plan to work with Africa - Case sharingCountriesFlu vaccineConsumption 2009(thousand doses)ImmunizationRateSouth 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 1,237Step 1. Political Stability--South Africa & KenyaConclusion:Possible to launch business.Step 2. Environment Evaluation ChecklistPolitical; Economic; Social&& Cultural& Natural;Technical; Laws& Regulatory.Step 3. Flu Vaccine Market ResearchLocal production; Size; Pricing; Competitions;Distribution…Step 4. Launching PlanFDI? M&A? JV? Distributor?Suspending for WHO PQ?Step1 Step2 Step3Local Production:A PPP companyis underestablishment tomanufacture fluvaccine andothers.Regulatory Gap:1. EU formatdossier;2. Local pre-licencingclinical trial.OKStep4SuspendingSouth AfricaStep1 Step2 Step3Market size isrelative small, butforesee the futuredevelopmentand coveringother Africancountries.OKOKStep4DistributorKenyaLocalProduction*Provision of seasonal influenza vaccines in 157 countries (2004 – 2009), IFPMA.
GovernmentOrganizationsLocalDistributorsNGOsInstitutionsLocalManufacturersVision of our Partnership Intention with AfricaWith “going international” as part our corporate strategy, Sinovac intents to collaborate withvarious parties of African countries in order to bring high quality vaccine products to people livingthere and help them improve health condition.