安维汀最新资料

安维汀最新资料２０１２罗氏全球罗氏全球弗里兹豪夫迈和妻子阿黛拉罗氏罗氏瑞士巴塞尔总部研究大楼罗氏全球一览•1896年成立于瑞士巴塞尔•业务遍及全球150个国家•拥有80,500名员工•2011年前三季度销售额：315亿瑞士法郎•专注于健康医疗事业制药领域领导者(#5)——引领全球抗肿瘤/病毒学领域体外诊断领域领导者(#1)•独特的创新模式•2010年，罗氏在研发上的投入位居全球第一**来源：Booz&Company罗氏制药在中国罗氏制药在中国•成立于1994年•全国约3000名员工(包括PDY/RRDCC/RP)截至2011年11月•致力于肿瘤学、病毒学、移植学等关键治疗领域•拥有15个创新处方药品•对中国的可持续发展承诺:-1994－2011年，罗氏中国17年率先在华建成完整的医药产业价值链；-2009年，罗氏制药亚太运营中心落户中国上海率先在华完成全功能亚太区域总部布局RankCorporationValueShareGrowthRateΔMSEV1PFIZERGROUP7,762,810,0748.6923.390.32103.792ASTRAZENECAGROUP6,629,481,4527.4216.33-0.1697.853SANOFIGROUP6,308,844,4197.0623.200.25103.634BHCGROUP5,937,297,7006.6420.950.11101.745ROCHEGROUP4,732,235,0545.3018.780.0099.916NOVARTISGROUP3,965,412,5074.4418.67-0.0199.827M.S.D.GROUP3,910,003,7074.3822.050.12102.668NOVONORDISKGROUP3,736,369,6334.1822.160.11102.759GLAXOSMITHKLGROUP3,477,075,1913.8916.48-0.0897.9810ELILILLYGROUP2,545,293,7272.8521.970.07102.5910大公司排名–按市场份额-2011年第三季度（全中国外资制药企业）罗氏肿瘤在中国RocheOncologyreplacedHengrui,No.1inChinaSource:IMSHospitalAudit12345678910RankMAT10-2011(RMBmn)2011Q3Growth(%)Company32.32312.40819.29536.08132.8125.081031.43414.32719.16612.21932.322,4712,2381,3021,1631,0189157846456246222011Q2Growth(%)27.2433.40922.70542.09127.4422.261026.56414.24611.4878.78827.24GRrankingin2011Q3GRrankingin2011Q2关于安维汀抗血管治疗的发展历史•Ideetal.AmJRoentgenol.1939;42:891;Folkmanetal.NewEnglJMed.1971;285:1182–6;Ferraraetal.BiochemBiophysResComm.1989;161:851;Isneretal.Lancet.1996;348:370–4;Prestaetal.CancerRes.1997;57:4593–9;Kimetal.Nature1993;362:841–4Leonardoda首先绘制了人体血管系统15001939Ideetal提出了肿瘤血管刺激学说1989Ferraraetal分离出了VEGF2004大型III期临床研究证实安维汀可以显著改善转移性结直肠癌患者的生存期201１安维汀在全球上市了六大适应症，有超过５００个临床研究正在进行中和超过1000000名患者安全使用安维汀并从治疗中获益1997人源化单克隆抗体贝伐珠单抗问世1971Folkman提出了肿瘤血管生成的学说和抗血管生成的概念’发现抗VEGF治疗可以有效抗击小鼠体内移植肿瘤1993发展假说的肿瘤血管刺激因子安维汀主要的适应症批准的历程2010中国上市了mCRC适应症EU,EuropeanUnion;US,UnitedStatesofAmerica;GBM,glioblastoma;mRC,metastaticcolorectalcancer;mNSCLC,metastaticnon-smallcelllungcancer;mRCC,metastaticrenalcellcarcinoma;mBC,metastaticbreastcancer;12200420062007mCRC1stlineUSmNSCLC1stlineUSmCRC1stlineEUmBC1stlineEUmRCCEU2005RelapsedGBMUS,Others20082009mRCCUSmCRC2ndlineUSmNSCLC1stlineJapanmBC1stlineHER-2–veUSmCRCcombinationwithanychemotherapy,1stor2ndlineEU2010mCRCChinamCRCrecurrentoradvancedJapanmNSCLC1stlineEUMOCEU2011安维汀:12个阳性结果的试验有效治疗6个实体肿瘤1,Hurwitz,etal.NEJM2004;2.Saltz,etal.JCO2008;3.Sandler,etal.NEJM20064.Reck,etal.JCO2009;5.Gray,etal.JCO2009;6.AvastinSmPC7.Escudier,etal.Lancet2007;8.Rini,etal.JCO2008,9.Friedmanetal.JClinOncol2009;10.BurgeretalASCO2010:11.Perrenetal.,ESMO2010mCRCmNSCLCmBCmRCCAVF2107g1OS:+4.7mtsHR=0.66p0.001NO16966PFS:HR=0.83p=0.0023E45993OS:+3.9mtsHR=0.79p=0.003E21005PFS:+5.3mtsHR=0.48p0.0001AVOREN7PFS:+4.8mtsHR=0.63p=0.0001AVAiL4PFS:HR=0.75p=0.003AVADO6PFS:HR=0.67p=0.0002CALGB902068PFS:HR=0.71p0.0001BRAIN96mtsPFS:50%vs.15%inhistoricalcontrolsrGBM13OCGOG21810PFS:+6.2mtsHR=0.64p0.0001ICON-711PFS:HR=0.79p=0.001•TrialsmissedprimaryendpointinGastric,Prostate,PancreaticandadjuvantColonCancerOCEANSPFS:HR=0.484p0.0001安维汀联合化疗较单化疗显著提高OS或PFS•Inseveralpivotaltrials,bevacizumabhasdemonstratedsignificantclinicalbenefit1.Hurwitz,etal.NEJM2004;2.Sandler,etal.NEJM2006;3.Gray,etal.JCO2009;4.Escudier,etal.Lancet200714*TheinitialprimaryendpointintheAVORENtrial4wasOS.SecondaryendpointsincludedPFSandsafety.However,basedontheapprovalofnewactivetherapiesduringtheconductofthetrial,whichcouldconfoundOSanalyses,itwasagreedwithregulatoryagenciesthatPFSwouldbecomethemainoutcomemeasureIFL=irinotecan/5-fluorouracil/leucovorin;CP=carboplatin/paclitaxel;Pac=paclitaxel;IFN=interferon.安维汀联合化疗较单用化疗明显提高有效率•Inpivotaltrials,bevacizumabconsistentlyincreasedORRby10to25%*incombinationwithchemotherapyvschemotherapyalone1–41.Hurwitz,etal.NEJM2004;2.Klencke,etal.ASCO2008(Abstractandposter);3.Sandler,etal.NEJM2006;4.Escudier,etal.Lancet200715IFL=irinotecan/5-fluorouracil/leucovorin;CP=carboplatin/paclitaxel;Pac=paclitaxel;IFN=interferon.*DatarefertotheabsoluteincreaseinORR.16安维汀是2011ASCO关注的焦点No.ofAbstracts14787737364665636323022221712109764331112011ASCO各个产品的文章情况17ASCO2011安维汀相关研究概况N=147(Excludes“publicationonly”abstractsandEducational/SpecialSessions)aAnalysisbasedonabstractspostedonasco.orgasofMay23,2011(excludes“publicationonly”abstractsandspecialsessions).“GI(non-CRC)”includesgastric,hepatocellular,andpancreaticcancers.安维汀上市后的应用情况19安维汀上市后全球业绩表现GrowthdespitedifficultenvironmentCHFbnGlobalsales+9%1LocalgrowthRegionalsalesUS0%Japan+51%WesternEurope+7%International+31%1,4742,6213,7225,1166,2226,77802,0004,0006,0008,000200520062007200820092010+9%Source:SPrINTSAP-BW.ExchangeRate:@A09CHF•Largestbrandwithsalesof6.77bnCHF•+556mCHFvs.2009•31%growthininternationalregion•FirstapprovalinChina(mCRC)•1millionpatientstreatedwithAvastinsincelaunch2010全球抗肿瘤药物销售情况70006000500040003000200010000百万美元65%51%50%45%31%20%11%12%18%28%29%39%43%51%7%USAFranceGermanyItalySpainAvastincetuximabchemoonlyIBTCountries1LmCRCpatientshareSource:Accordingtolocalsources,US:quarterlydataQ12011EU4:quarterlyorbi-annuallydataQ4-2010,exceptItaly:MATQ42010data安维汀在转移结肠