美國歐盟中國生物技術(shù)藥物比較表

1、美國、歐盟和中國生物技術(shù)藥物的比較表1 至2004年2月美國FDA批準(zhǔn)的生物技術(shù)藥物產(chǎn)品商品名公司首次批準(zhǔn)時(shí)間適應(yīng)證大腸桿菌表達(dá)得產(chǎn)品（produced by E coli.）多肽（Polypeptides）:Teriparatide，甲狀旁腺激素1-34FORTEOEli Lilly2002.11骨質(zhì)疏松Nesiritide，利尿鈉肽，hBNPNatrecorScios2001.8充血性心力衰竭激素（Hormones）:human somatropin人生長激素BioTropinGenoTropinHumatropeNorditropinNutropin DepotNutropin AQPr

2、otropinSOMAVERT(PEG化)Biotech GeneralPharmaciaEli LillyNovo NordiskGenentechGenentechGenentechNektar/ Pfizer1995.51995.81996.81995.51999.121993.111985.102003.3矮小癥肢端肥大癥human insulin，胰島素HumulinEli Lilly1982.10糖尿病insulin lispro，胰島素突變體HumalogHumalog Mix75/25Eli LillyEli Lilly1996.61996.6糖尿病糖尿病insulin gla

3、rgine，胰島素突變體LantusAventis2000.4糖尿病酶（Enzymes）:Reteplase，t-PA突變體RetavaseCentocor1996.10急性心梗細(xì)胞因子（Cytokines）:rhG-CSF，粒細(xì)胞集落刺激因子NeupogenNeulasta (PEG化)AmgenAmgen1991.22002.1白細(xì)胞減少rh IL-1Ra，IL-1拮抗劑KineretAmgen2001.11類風(fēng)濕關(guān)節(jié)炎Interleukin eleven, IL-11NeumegaWyeth1997.11血小板減少Interleukin two, IL-2ProleukinChiron1

4、992.5腎瘤、黑色素瘤interferon alfacon-1InfergenInterMune/ Amgen1997.10丙肝interferon a-2a，干擾素a-2aRoferon-APegasys (PEG化)Hoffmann-La RocheRoche/Nektar 1986.62002.10乙肝、丙肝、白血病、Kaposi's肉瘤等Interferon a-2b，干擾素a-2bIntron APEG-Intron (PEG化)Rebetron(聯(lián)合病毒唑)Schering-PloughEnzon /Schering-Plough Schering-Plough1986.

5、62001.81998.6乙肝、丙肝、非甲非乙型肝炎、白血病、Kaposi's肉瘤等Interferon b-1b，干擾素b-1bBetaseronBerlex /Chiron1993.8多發(fā)性硬皮病interferon g-1b，干擾素g-1bActimmuneInterMune1990.12慢性肉芽腫??；重度惡性骨骼石化癥疫苗（Vaccine）:OspA lipoprotein，OspA脂蛋白LYMErixGlaxoSmithKline1998.12預(yù)防萊姆病其他:denileukin diftitox, 白喉毒素-IL 2融合蛋白OntakLigand Pharmaceutica

6、ls1999.2T細(xì)胞淋巴瘤酵母表達(dá)的產(chǎn)品（Produced by Yeast）多肽（Polypeptides）:Glucagon(胰高血糖素)GlucaGenNovo Nordisk1998.6低血糖癥激素（Hormones）:human insulin，胰島素NovolinNovolin LNovolin NNovolin RNovolin 70/30VelosulinNovo NordiskNovo NordiskNovo NordiskNovo NordiskNovo NordiskNovo Nordisk1982.101991.61991.71991.61991.61999.7糖尿病

7、insulin aspart，胰島素突變體NovoLogNovo Nordisk2000.5糖尿病酶（Enzymes）:Rasburicase，尿酸降解酶ElitekSanofi-Synthelabo2002.7血漿尿酸癥細(xì)胞因子（Cytokines）:rhGM-SCFLeukine(sargarmostim)Berlex Laboratories1991.3自體骨髓移植；急性髓性白血病化療引起的白細(xì)胞中毒rhPDGF-BB，血小板衍生生長因子Regranex Gel (gel becaplermin)Chiron1997.12糖尿病足潰瘍疫苗（Vaccine）:hepatitis B vac

8、cine，乙肝疫苗Engerix-BRecombivax-HBGlaxoSmithKlineMerck1989.91986.7預(yù)防乙肝其他:Lepirudin，水蛭素RefludanBerlex Laboratories1998.3抗凝哺乳動(dòng)物細(xì)胞表達(dá)的產(chǎn)品（括號(hào)中為宿主細(xì)胞）激素（Hormones）:human somatropin，人生長激素Saizen (Mouse C127)Zorbtive(Mouse C127)Serono S.A.Serono S.A.1996.101996.8矮小癥follitropin beta，促濾泡素-bFollistim (CHO)Akzo Nobel1

9、997.9不孕癥follitropin alfa，促濾泡素-aGonal-F（CHO）Serono S.A.1998.9不孕癥human chorionic gonadotropin，人絨膜促性腺激素OvidrelSerono S.A.2000.9不孕癥thyrotropin alfa，促甲狀腺素Thyrogen (CHO)Genzyme1998.12血清甲狀腺球蛋白測(cè)試酶（Enzymes）:alteplase, tPAActivase (CHO)Genentech1987.11急性心梗；肺栓塞，急性腦中風(fēng)urokinase，尿激酶Abbokinase(胎腎細(xì)胞培養(yǎng))Abbott2002.10

10、肺栓塞Laronidase，粘多糖-a-L-艾杜糖醛酸水解酶Aldurazyme (CHO)Genzyme2003.4粘多糖貯積病Imiglucerase，葡糖腦苷脂酶Cerezyme (CHO)Genzyme1994.5Gaucher's病Algasidase beta，半乳糖苷酶-bFabrazyme (CHO)Genzyme2003.4Fabry's病dornase alfa，DNA酶Pulmozyme (CHO)Genentech1993.12囊性纖維化Tenecteplase，t-PA突變體TNKase (CHO)Genentech2000.6急性心梗凝血因子（Blo

11、od clotting factors）:coagulation factor VIIaNovoSeven (BHK)Novo Nordisk1999.3血友病 A 或 Bcoagulation factor IXBeneFix (CHO)Wyeth1997.2血友病Bantihemophilic factor VIIIBioclateAventis Behring1993.12血友病Aantihemophilic factor VIIIHelixate (BHK)Kogenate FS (BHK)Aventis BehringBayer1994.21989.9血友病Aantihemophil

12、ic factor VIIIRecombinate rAHF (CHO)Baxter Healthcare 1992.2血友病AFactor VIII（無B鏈）ReFacto (CHO)Wyeth2000.3血友病A細(xì)胞因子（Cytokines）:interferon a-N3，干擾素a-N3Alferon(人白細(xì)胞培養(yǎng)誘導(dǎo))Interferon Sciences1989.10生殖器皰疹interferon a-n1，干擾素a-n1Wellferon (人成淋巴細(xì)胞培養(yǎng)與誘導(dǎo))GlaxoSmithKline1999.3丙肝Interferon b-1a，干擾素b-1aAvonex (CHO)R

13、ebif (CHO)Biogen/ IdecSerono S.A./ Pfizer1996.52002.3多發(fā)性硬皮病darbepoetin alfa，EPO突變體Aranesp (CHO)Amgen2001.9腎性貧血epoietin alfa，EPO促紅細(xì)胞生成素Epogen (CHO)ProcritAmgenOrtho Biotech1989.61990.12腎性貧血rh Bone morphogenetic protein-2, rhBMP-2INFUSE Bone Graft /LT-CAGE (CHO)Wyeth and Medtronic Sofamor Danek2002.7脊

14、骨退行性病變的脊骨融合rh Osteogenic protein 1, BMP-7Osigraft(CHO)Stryker2001.8脛骨骨折治療性抗體（Therapeutical Monoclonal Antibodies）:Bevacizumab (anti-EGFR)Avastin (人源化，CHO)Genentech2004.2轉(zhuǎn)移性結(jié)腸癌或直腸癌I-131 Tositumomab (Anti-CD20)Bexxar (鼠源，雜交瘤)Corixa Corp. and GlaxoSmithKline2003.6non-Hodgkin's淋巴瘤Alemtuzumab (anti-C

15、D52) Campath (人源化，CHO)Ilex Oncology/ Millennium Pharmaceuticals/ Berlex Laboratories2001.5B-細(xì)胞慢性淋巴細(xì)胞白血病Cetuximab (anti-EGFR) Erbitux (嵌合，鼠骨髓瘤)ImClone/ BMS2004.2轉(zhuǎn)移性結(jié)腸癌或直腸癌Trastuzumab (antiHER-2) Herceptin (人源化，CHO)Genentech1998.9轉(zhuǎn)移性乳腺癌Adalimumab (anti-TNFa)Humira (人源)CAT/ Abbott 2002.12重度類風(fēng)濕關(guān)節(jié)炎Gemtuz

16、umab ozogamicin (Anti-CD33)Mylotarg (人源化，NS0)Celltech / Wyeth2000.5CD33+急性髓性白血病Muromomab-CD3 (anti-CD3) Orthoclone OKT3(鼠源，雜交瘤)Ortho Biotech1986.6腎移植急性排斥Efalizumab (anti-CD11a) Raptiva (人源化，CHO)Xoma/ Genentech2003.10慢性中重度銀屑病Infliximab(anti-TNFa)Remicade(嵌合，NS0)Centocor1998.8Crohn's?。活愶L(fēng)濕關(guān)節(jié)炎Abcixi

17、mab(Anti-GPIIb/IIIa) ReoPro(嵌合，NS0)Centocor1994.12抗凝Rituximab (Anti-CD20)Rituxan (嵌合，CHO)IDEC/ Genentech1997.11CD20+ B細(xì)胞non-Hodgkin's淋巴瘤Basiliximab (Anti-CD25)Simulect (嵌合，鼠骨髓瘤)Novartis1998.5腎移植急性排斥Palivizumab(Anti-F protein of RSV) Synagis (人源化，NS0)MedImmune1998.6防治小兒下呼吸道合胞病毒感染Omalizumab (Anti-

18、IgE)Xolair (人源化，CHO)Genentech/ Tanox/ Novartis2003.6中重度持續(xù)性哮喘Daclizumab (Anti-CD25)Zenapax (人源化，CHO)Hoffmann-La Roche1997.12腎移植急性排斥Ibritumomab tiuxetan (Anti-CD20)Zevalin (鼠源，雜交瘤)IDEC2002.2B細(xì)胞non-Hodgkin's淋巴瘤體內(nèi)診斷用鼠源單抗成像劑（Imaging agents of murine monoclonal antibodies）Technetium-99 acritumomab,Ant

19、i-CEACEA-ScanImmunomedics1996.6轉(zhuǎn)移性直腸結(jié)腸癌成像Indium-111 Imciromab pentetate, Anti-human cardiac myosinMyoScintnot on marketCentocor1996.5心肌梗死成像Technetium-99 Nofetumomab,Anti-carcinoma-associated antigenVerlumanot on marketBoehringer Ingelheim/NeoRx1996.8小細(xì)胞肺癌成像Indium-111 Capromab pendetide, Anti-PSMA, a

20、 tumor surface antigenProstaScintCytogen1996.10前列腺癌成像Indium-111 satumomab pendetide, Anti-TAG-72, a tumor-associated glycoproteinOncoScint CR/OVnot on marketCytogen1992.12結(jié)腸直腸、卵巢癌成像cell/tissue therapy (tissue engineering products):Living human skin substitute，組織工程皮膚ApligrafOrganogenesis/ Novartis199

21、8.5脛靜脈潰瘍；糖尿病足部潰瘍autologous cultured chondrocytes，組織工程軟骨CarticelGenzyme1997.8重建受損膝蓋關(guān)節(jié)軟骨human dermal substitute，正在工程皮膚DermagraftAdvanced Tissue Sciences Inc./Smith & Nephew plc2001.9糖尿病足部潰瘍composite cultured skin，組織工程皮膚OrCelOrtec International2001.2燒傷Others:Alefacept，LFA3-Fc融合蛋白Amevive (CHO)Biogen

22、/Idec2003.1中重度銀屑病Etanercept，TNFR-Fc融合蛋白ENBREL (CHO)Amgen/Wyeth1998.11中重度類風(fēng)濕關(guān)節(jié)炎；銀屑病Drotrecogin alfa，活化蛋白CXigris (CHO)Eli Lilly2001.11膿毒癥表2 截止至2003年底歐盟批準(zhǔn)的基因重組生物技術(shù)藥物藥物適應(yīng)證公司首次批準(zhǔn)時(shí)間表達(dá)系統(tǒng)基因重組治療性蛋白：Insulin，胰島素糖尿病Lilly IndustriesNovo NordiskHoechst12/1987E coli.YeastInterleukin-2，白介素-2 (IL-2)腎瘤、黑色素瘤Chiron12/1

23、989E coli.Somatotropin，人生長激素矮小癥Lilly PharmaciaSerono PharmaNovo Nordisk02/1991E coli.C127細(xì)胞Glucagon，胰高血糖素低血糖癥Novo Nordisk03/1992YeastErythropoietin b，促紅細(xì)胞生成素-b (EPO-b)腎性貧血Boehringer Mannheim05/1992CHOInterferon g-1b，干擾素 g-1b慢性肉芽腫病Boehringer Ingelheim06/1992E coli.Interferon a-2b，干擾素 a-2b白血病、腫瘤、皰疹Ess

24、ex Pharma03/1993E coli.Erythropoietin a，促紅細(xì)胞生成素-a (EPO-a)腎性貧血Janssen-Cilag04/1993CHOGM-CSF(Molgramostim)白細(xì)胞減少Essex Pharma04/1993YeastInterferon a-2a，干擾素 a-2a白血病、腫瘤、皰疹Hoffmann-La Rochekohl pharma04/1993E coli.Factor VIII，凝血因子VIII血友病ABayerBaxter DeutschlArmour Pharma07/1993BHKCHOG-CSF(glycosylated)，糖基

25、化G-CSF*白細(xì)胞減少Rhône-PoulencRorer GmbHChugai10/1993CHOtissue plasminogen activator，組織型纖溶酶原激活劑 (t-PA) 急性心肌梗死Dr. Karl Thomae04/1994CHOGlucocerebrosidase，葡糖腦苷脂酶Gaucher's病Genzyme B.V.06/1994CHOG-CSF，粒細(xì)胞集落刺激因子白細(xì)胞減少Hoffmann-La Rochekohl pharma08/1994E coli.human DNAse，DNA酶囊性纖維化Hoffmann-La Roche09/19

26、94CHOFollitropin alpha，促濾泡素不孕癥Serono10/1995CHOInterferon b-1b，干擾素b-1b多發(fā)性硬皮癥Schering AG11/1195E coli.Factor VII，凝血因子VII血友病A和BNovo Nordisk02/1996BHKInsulin, Lispro，胰島素突變體（速效）糖尿病Lilly05/1996E coli.Follitropin-b，促濾泡素-b不孕癥Organon10/1996CHOReteplase，t-PA突變體(r-PA)急性心肌梗死Boehringer Mannheim11/1996E coli.Fact

27、or IX，凝血因子IX血友病BGenetics Institute08/1997BHKInterferon beta-1a，干擾素b-1a多發(fā)性硬皮病Biogen France S.A.Ares-Serono 03/1997CHOHirudine，水蛭素抗凝Behringwerke03/1997YeastDesirudine，水蛭素突變體*抗凝Ciba Europharm03/1997YeastCalcitonin，降血鈣素*骨質(zhì)疏松；Pagets??；高鈣血癥Unigene UK01/1999Interferon alfacon-1，超級(jí)a干擾素丙肝Yamanouchi02/1999E co

28、li.rhPDGF，血小板衍生生長因子糖尿病潰瘍Janssen-Cilag03/1999YeastTNFa-1a，腫瘤壞死因子a-1a*腫瘤手術(shù)后的輔助治療Boehringer Ingelheim04/1999E coli.Moroctocog a，凝血因子VIII(無B鏈)血友病Genetics Institute04/1999CHOThyrotropin alfa (TSH)，促甲狀腺素甲狀腺掃描檢查Genzyme07/1999CHOInsulin aspart，胰島素突變體（速效）糖尿病Novo Nordisk09/1999YeastPeginterferon a-2b，PEG化干擾素a

29、-2b丙肝Schering-Plough05/2000E coli.Insulin glargin，胰島素突變體（長效）糖尿病HMR Deutschland /Aventis S.A.06/2000E coli.Etanercept，TNFaR-Fc融合蛋白類風(fēng)濕關(guān)節(jié)炎Wyeth-Lederle02/2000CHORasburicase，尿酸水解酶腫瘤誘發(fā)的高尿酸癥Sanofi S.A.02/2001YeastTenecteplase，t-PA突變體(TNK-tPA) 急性心肌梗死Boehringer Ingelheim02/2001CHOChoriogonadotropin a，絨膜促性腺激

30、素(hCG)不孕癥Ares Serono02/2001CHOLutropin a，促濾泡素突變體*不孕癥Ares Serono02/2001CHODarbepoetin a，EPO突變體腎性貧血Amgen Europe06/2001CHOAgalsidase-a，半乳糖苷酶-a* (a-galactosidase)Fabrys病TKT Europe08/2001CHOAgalsidase-b，半乳糖苷酶-b (b-galactosidase)Fabrys病Genzyme08/2001CHOAnakinra(IL-1Ra)，IL-1受體拮抗劑類風(fēng)濕關(guān)節(jié)炎Amgen GmbH03/2002E co

31、li.Dynepo，EPO-d*腎性貧血Aventis S.A.02/2002CHOPegfilgrastim，PEG化G-CSF白細(xì)胞減少Amgen Europe08/2002E coli.Drotrecogin a，活化蛋白C嚴(yán)重膿毒癥Eli Lilly08/2002CHODibotermin a，骨形成蛋白(BMP)脛骨骨折Genetics Institute 09/2002CHOAldurazyme，粘多糖-a-L-艾杜糖醛酸水解酶(Laronidase)粘多糖貯積病Genzyme06/2003CHO重組治療性抗體：Abciximab(ReoPro®)抗血小板凝聚Centoc

32、or05/1995NS0Votumumab(Humaspect®)*結(jié)腸癌體內(nèi)檢測(cè)Organon Teknika 11/1996動(dòng)物細(xì)胞Rituximab(Mabthera®)non-Hodgkin's淋巴瘤Roche 1998CHOBasiliximab(Simulect®) 腎移植急性排斥Novartis 10/1998鼠骨髓瘤Daclizumab(Zenapax®) 腎移植急性排斥Roche02/1999CHOPalivizumab (Synagis®)呼吸道合胞病毒感染Abbott05/1999NS0Inflixima

33、b(Remicade®)Crohn??；類風(fēng)濕關(guān)節(jié)炎Centocor08/1999NS0Trastuzumab(Herceptin®)轉(zhuǎn)移性乳腺癌Roche09/2000CHOAlemtuzumab(Campath®)慢性淋巴細(xì)胞白血病Millenium/Ilex03/2001CHOAdalimumab(Humira®)重度類風(fēng)濕關(guān)節(jié)炎Abbott03/2003動(dòng)物細(xì)胞Cetuximab(Erbitux®)轉(zhuǎn)移性結(jié)腸癌或直腸癌ImClone/Merck02/2004鼠骨髓瘤基因重組疫苗：hepatitis-B antigen，乙肝小S疫苗預(yù)防乙肝感染SmithKline09/1989YeastTriacelluvax®，three recombinant B. pertussis toxins*預(yù)防破傷風(fēng)、白喉、百日咳Chiron S. p. A.01/1999乙肝大S抗原 (pre-S1, pre-S2, S)*預(yù)防乙肝感染Medeva Pharma 03/00CHOglycosylat