中国生物制药报告

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1、BiopharmaceuticalIndustryMar.2009OCIInchinaandworldwideBriefs:nBiopharmaceuticalenjoyahighgrowthrateworldwidelynBiotechisessentialfordruginnovationnChinahasestablishedfavorableenvironmentforbiopharmafirmsnWithasolidandrapidprogressChinasbiofirmshavepreparedformakingblockbusters1IndexnGlobalbiopharma

2、ceuticalstatus:MarketcapacityandgrowthInnovations,developmentcycleM&AdealsnChinabiopharmaceuticalconditions:StructureMarketcapacityandgrowthDrivingforces&environmentAdvancementWeaknessandopportunitiesnAppendix2BiotechgrowthismuchhigherthantraditionalpharmaceuticalsRevenue:billionUSD%GROWTHGlobalBiot

3、echSalesandGrowth(US$)Source: IMS Health, MIDAS, MAT Dec 2007GlobalBiotechMarketReached$75Bnin20073NumberofNMEs*firstlaunchedworldwide1990-2006Source: CMR internationalNMEsTotalBiologicalNMEisCrucialforDrugInnovations*new molecular entities (NMEs)4BiotechnologyapproachTargetdiscoveryandearlyvalidati

4、onLeaddiscoveryLeadoptimizationTransitiontodevelopmentDevelopment=3- -5yearsindiscovery3yearsindevelopmentPharmacologyBiologyChemistryTraditionalapproachDevelopmentTargetdiscoveryTargetvalidationLeaddiscovery LeadoptimizationTransitiontodevelopment12years13years0.51year24years12years=612yearsindisco

5、very3- -4yearsindevelopmentnBiopharmaceuticalnTraditionalpharmaceuticalBiotechnologyReducesDrugDiscoveryCircleTime5AutoimmuneDisordersBloodDisordersCancer/RelatedConditionsCardiovascularDiseaseDiabetes/RelatedConditionsDigestiveDisordersEyeConditionsGeneticDisordersGrowthDisordersHIV/AIDSinfection/R

6、elatedConditionsInfectiousDiseasesNeurologicDisordersRespiratoryDisordersSkinDisordersTransplantationOtherBiotechnologyMedicinesTrendsInDevelopment(USA)*Some medicine are listed in more than one categoryByTherapeuticCategory*ByProductCategory*Total633biopharmaceuticalsunderclinicaltrailorwaitforFDAa

7、pprovalinyear2008Sources: PhRMA 20096BiotechDominates2008Pharma M&ADealmakingnTotal150DealsAnnouncedworthUSD93.7Billionworldwidein20087BiopharmaceuticalIndustryinChina8ChinasPharmaceuticalIndustrySource: Datamonitor(%share,byvalue)ShareofbiopharmaceuticalinAsiaPacific20079ChinaBiopharmaMarketValue20

8、03-2007Source: DatamonitorRevenue:millionUSDCAGR:18.2%ThemarketofChinasbiopharmaceuticalindustryisgraduallyexpandingduotoChinasrapideconomicgrowth,peopleshigherincome,increasingunderstandinganddemandofbiopharmaceutical.Growth%10ChinaBiotechIndustryin200811ChinaBiopharmaMarketValueForecast:2007-2012C

9、AGR:24.7%nanticipatedCAGRof24.7%forthefive-yearperiod2007-2012Source:DatamonitorRevenue:millionUSDGrowth%12DrivingforcesforChinesebiopharmaindustrynBigandprofitablemarketMorethan400biogenericmanufacturersOver300biopharmaceuticalinnovationfirmsChinesebiotherapeuticsenjoyagrowthrateof30%withhighmargin

10、Exported$478millionperyearatagrowthrateof54%nGovernmentencouragesbiologicinnovatorproductsBiopharmaceuticshasbeenincludedinPrioritylistforNationalEconomicDevelopmentChinas“863”andotherprogramfundingpromisingR&DprojectsBuildbiologicalhigh-techparkIPrightsprotectionhasbeenstrengthenednCapitalinfusionT

11、heindustryiswitnessingasurgeofmergers,acquisitionsandpartnershipsbetweendomesticandmultinationalbigpharmasandsmallbiopharmas.13AdvancementofChinesebiotechfirmsTheearliesttraditionalVaccineprovider(CNBG)1919In1989Chinamarketeditsfirstgeneticallyengineereddrug:recombinanthumaninterferonalpha1bThefirst

12、tocompleteclinicaltrailforavaccineforSARsandavainflu.Commercializedthefirstgenetherapyproduct:rh-AdenoP53in2004Hasdeveloped30biotechdrugs,morethan150biopharmaceuticalsinpipelineinclude35innovativeproductsatclinicaltrailstageLaunchedtheworldsfirstrh-Endosatin(Endu)fortreatmentofnon-small-celllungcanc

13、erOver40new“Class1”biopharmaceuticalsareexpectedtocompleteclinicaltrailsnTraditionalvaccine&bloodproducts:nFollow-ongenericsnR&Doriented:nDomesticBlockbuster:nInternationalBlockbusters?1415CompanyNamePipelineproductsTianjinFusogenPharmaSifuvirtide,Fusolin(HBVinhibitor),Fusopin(HCVinhibitor)SinovacBi

14、otech.Ltd.SARSVaccine,PandemicInfluenzaVaccine(Human-usedAvianFluVaccine)ShanghaiSunwayBiotechH102,H103BeijingBiotechPharmarEGF-P64k/Montvaccine,HumanizedAnti-CD6MonoclonalAntibodyBeijingSLPharmarhParathyroidHormoneforInjectionWuhanInstituteofBiologicalProductsMonoclonalantibodyagainsthemorrhagicfev

15、erforinjectionXiamenPKUBiowayBiotechHWAP-1,Dx-HemoglobinGuangzhouDoublleBioproduct,Inc.RecombinanthumanendostatinadenovirusinjectionChangchunBCHTPharmaAIDSvaccineAnhuiGlodenSunBiochemTumorvaccineSuzhoulandingBiopharmaRecombinanthumanpro-urokinaseforinjectionSampleofinnovativeproductsinChinaBiofirmsP

16、ipeline16nSize:nFinancing:nR&D:nProduction:nManagementandWeaknessofChinesebiotfirmsChinesebiotechfirmsneedtoovercomemanyweaknesses:Ingeneral,ChinesebiotechfirmsaresmallMostcompaniesdonthavesufficientfundstofosterintensiveR&Dandfacilityupgrades90%ofthesefirmsfocusonthedevelopmentandproductionoffollow

17、-onbiologicsSofar,noChinesebiopharmahasmanagedtoobtainWesternGMPcertificationsorWHOprequalificationManycompaniesdonothavemanagerswithinternationalmanagerialormarketingexperience.Marketing:17ChinabiofirmsCollaborationsandPartnershipsn2008年有限公司与赛富亚洲投资基金等共同向翰宇首期投入深圳翰宇药业深圳翰宇药业1500万美元从事多肽药物的研究与开发深圳翰宇正与Te

18、va、Hospira、Apotex、Biocon、Chemo、DKSH等知名药企展开合作n2006年南京先声南京先声出资2亿购买天津麦德津80%的股权拥有了抗肿瘤I类生物药“恩度”的专利权“恩度”2006年上市,07年销售额超过2个亿,08年估计6个亿(”恩度” 2005年拿到生产许可证,南京先声购买天津麦德津是在2006年接触到谈判仅用了半年多,竞标企业估计50多个,包括淡马锡)n2007年绿叶制药绿叶制药9940万元收购维信北京大学生物科技公司43%股权n2008年GSK出资3133万美元与海王英特龙海王英特龙成立合资公司从事创新疫苗的开发18Appendix:nMajorbiogener

19、icsinChina(TableAB)nToptenbiofirmsnToptenbiotherapeuticareasnToptenbio-medicinesnSampleofnewlyapprovedinnovativebio-medicineinyear200719BiogenericsIndicationsManufacturer(s)IFN-1bHepatitisB,hepatitisCShenzhenKexingShanghaiInstituteofBiologicalProductsBeijingTri-primeIFN-1b(eyedrop)ViralkeratitisChan

20、gchunInstituteofBiologicalProductsIFN-1aHepatitisB,hepatitisCChangchunInstituteofBiologicalProductsChangShengGenePharmaSunshinePharmaSundiroPharmaLiaoningSatelliteShanghaiWanxingIFN-2a(Suppository)GynecologicaldiseasesWhhanTianaoChangchunChangshengIFN-2bHepatitisB,hepatitisCAnkeHanshengHuaxinDingliY

21、uanceHualidaNeptunusInterlongReaharChangchunInstituteofBiologicalProductsIFN-2b(gel)HerpesHefeiZhaofengIFNRheumatoidShanghaiInstituteofBiologicalProductsShanghaiCloneLivzonPharmaInterleukin-2(IL-2)AdjunctivetherapyforcancerFour-ringsHuaxinChangchunInstituteofBiologicalProductsSunshinePharmaChangshen

22、gGene-ScienceRuideJinsiliKangliBiogenericsIndicationsManufacturer(s)125IL-2AdjunctivetherapyforcancerBeijingSLPharma125SerIL-2AdjunctivetherapyforcancerShandongQuangangLiaoningSatelliteG-CSFLeukopeniaHangzhouJiuyuanGeneEng.BeijingSLChangchunGeneScienceSuzhouZhongkaiShanghaiSunwayBeihaiFangzhouAmoyto

23、pShangdongKexingXinpengGeneLeukLiluChengduRongshengReaharNorthChinaPharmaGM-CSFLeukopeniaXiamenAmoytopNorthChinaPharmaBeijingMedicalIniv.PharmaReaharHainanHuakangGene-ScienceShanghaiHuaxinLiaoningSatelliteErythropoietin(EPO)RenalanemiaSunshinePharmaHuaxinShandongKexingShanghaiCloneChengduDiaoShangdo

24、ngAhuaFour-ringsBiologicalsNorthChinaPharmaHepatitisBvaccine(yeast)PreventionofhepatitisBShenzhenKangtaiBeijingInstituteofBiologicalProductsTableA.MajorbiogenericsinChinaTableB.MajorbiogenericsinChina20全球十大生物制药企业全球十大生物制药企业前十企业前十企业2007 2007 市场规市场规模(亿美元)模(亿美元)市场分额市场分额(%)增长率增长率(%)复合年均增长复合年均增长率(率(%,02-0

25、6年)年)全球生物技术市场全球生物技术市场751.210012.518.81安进公司(Amgen)159.6421.3-0.5272罗氏/基因技术(Roche/Genentech)154.6920.620.433.53强生公司(Johnson&Johnson)62.858.4-3.434诺和诺德公司(NovoNordisk)58.97.813.717.65礼来公司(Lilly)39.315.27.14.76赛诺菲-安万特公司(Sanofi-Aventis)32.014.333.337.77雅培公司(Abbott)31.454.239.2119.18德国默克公司(MerckKGaA)27.343

26、.613.517.99先灵葆雅公司(ScheringPlough)25.773.45.81.410惠氏公司(Wyeth)22.5431838.4前十合计前十合计614.5181.810.520.3http:/ (% %)增长率增长率(% %)复合年均增长率复合年均增长率(% %,02-0602-06年)年)全球生物医药市场全球生物医药市场751.210012.518.81促红细胞生成素(EPO)128.7217.1-911.92抗肿瘤药(Anticancer)113.6515.124.245.93抗糖尿病药(Diabetes)102.3113.614.615.44自身免疫药(Auto-immu

27、ne)83.5711.124.5595干扰素(Interferon)66.798.92.39.86ImmunostimAgExIntfron60.058517.37免疫抑制剂(Immuedepression)45.2619.621.78生长激素(Somatotrophin)26.273.5129.79血液凝结剂(Coagulation)24.333.29.617.410疫苗(Vaccine)20.992.8172.42.8前十合计前十合计671.8989.411.419.2http:/ 2007 销售收销售收入入(亿美元)(亿美元)市场分额市场分额(%)增长率增长率(%)复合年均增长率复合年均

28、增长率(%,02-06年)年)全球生物医药市场全球生物医药市场751.210012.518.81Enbrel(AMG/WYE/TAK)52.9715.547.42Aranesp(AMG)44.155.9-12.988.13Remicade(J&J/S-P)42.25.615.622.34Mabthera/Rituxan(ROC)37.144.913.225.45Neulasta(AMG)35.564.7864.36Herceptin(ROC)32.554.324.145.97Erypo/Procrit(J&J)32.914.4-12.4-38Epogen(AMG)29.824-5.22.69Avastin(ROC)28.473.840.9-10Humira(ABT)27.93.740.81,021.80前十合计前十合计363.5948.48.928.1http:/

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