美国欧盟中国生物技术药物比较表

1、美国、欧盟和中国生物技术药物的比较表1 至2004年2月美国FDA批准的生物技术药物产品商品名公司首次批准时间适应证大肠杆菌表达得产品（produced by E coli.）多肽（Polypeptides）:Teriparatide，甲状旁腺激素1-34FORTEOEli Lilly2002.11骨质疏松Nesiritide，利尿钠肽，hBNPNatrecorScios2001.8充血性心力衰竭激素（Hormones）:human somatropin人生长激素BioTropinGenoTropinHumatropeNorditropinNutropin DepotNutropin AQPr

2、otropinSOMAVERT(PEG化)Biotech GeneralPharmaciaEli LillyNovo NordiskGenentechGenentechGenentechNektar/ Pfizer1995.51995.81996.81995.51999.121993.111985.102003.3矮小症肢端肥大症human insulin，胰岛素HumulinEli Lilly1982.10糖尿病insulin lispro，胰岛素突变体HumalogHumalog Mix75/25Eli LillyEli Lilly1996.61996.6糖尿病糖尿病insulin gla

3、rgine，胰岛素突变体LantusAventis2000.4糖尿病酶（Enzymes）:Reteplase，t-PA突变体RetavaseCentocor1996.10急性心梗细胞因子（Cytokines）:rhG-CSF，粒细胞集落刺激因子NeupogenNeulasta (PEG化)AmgenAmgen1991.22002.1白细胞减少rh IL-1Ra，IL-1拮抗剂KineretAmgen2001.11类风湿关节炎Interleukin eleven, IL-11NeumegaWyeth1997.11血小板减少Interleukin two, IL-2ProleukinChiron1

4、992.5肾瘤、黑色素瘤interferon alfacon-1InfergenInterMune/ Amgen1997.10丙肝interferon a-2a，干扰素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，干扰素a-2bIntron APEG-Intron (PEG化)Rebetron(联合病毒唑)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，干扰素b-1bBetaseronBerlex /Chiron1993.8多发性硬皮病interferon g-1b，干扰素g-1bActimmuneInterMune1990.12慢性肉芽肿病；重度恶性骨骼石化症疫苗（Vaccine）:OspA lipoprotein，OspA脂蛋白LYMErixGlaxoSmithKline1998.12预防莱姆病其他:denileukin diftitox, 白喉毒素-IL 2融合蛋白OntakLigand Pharmaceutica

6、ls1999.2T细胞淋巴瘤酵母表达的产品（Produced by Yeast）多肽（Polypeptides）:Glucagon(胰高血糖素)GlucaGenNovo Nordisk1998.6低血糖症激素（Hormones）:human insulin，胰岛素NovolinNovolin LNovolin NNovolin RNovolin 70/30VelosulinNovo NordiskNovo NordiskNovo NordiskNovo NordiskNovo NordiskNovo Nordisk1982.101991.61991.71991.61991.61999.7糖尿病

7、insulin aspart，胰岛素突变体NovoLogNovo Nordisk2000.5糖尿病酶（Enzymes）:Rasburicase，尿酸降解酶ElitekSanofi-Synthelabo2002.7血浆尿酸症细胞因子（Cytokines）:rhGM-SCFLeukine(sargarmostim)Berlex Laboratories1991.3自体骨髓移植；急性髓性白血病化疗引起的白细胞中毒rhPDGF-BB，血小板衍生生长因子Regranex Gel (gel becaplermin)Chiron1997.12糖尿病足溃疡疫苗（Vaccine）:hepatitis B vac

8、cine，乙肝疫苗Engerix-BRecombivax-HBGlaxoSmithKlineMerck1989.91986.7预防乙肝其他:Lepirudin，水蛭素RefludanBerlex Laboratories1998.3抗凝哺乳动物细胞表达的产品（括号中为宿主细胞）激素（Hormones）:human somatropin，人生长激素Saizen (Mouse C127)Zorbtive(Mouse C127)Serono S.A.Serono S.A.1996.101996.8矮小症follitropin beta，促滤泡素-bFollistim (CHO)Akzo Nobel1

9、997.9不孕症follitropin alfa，促滤泡素-aGonal-F（CHO）Serono S.A.1998.9不孕症human chorionic gonadotropin，人绒膜促性腺激素OvidrelSerono S.A.2000.9不孕症thyrotropin alfa，促甲状腺素Thyrogen (CHO)Genzyme1998.12血清甲状腺球蛋白测试酶（Enzymes）:alteplase, tPAActivase (CHO)Genentech1987.11急性心梗；肺栓塞，急性脑中风urokinase，尿激酶Abbokinase(胎肾细胞培养)Abbott2002.10

10、肺栓塞Laronidase，粘多糖-a-L-艾杜糖醛酸水解酶Aldurazyme (CHO)Genzyme2003.4粘多糖贮积病Imiglucerase，葡糖脑苷脂酶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囊性纤维化Tenecteplase，t-PA突变体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（无B链）ReFacto (CHO)Wyeth2000.3血友病A细胞因子（Cytokines）:interferon a-N3，干扰素a-N3Alferon(人白细胞培养诱导)Interferon Sciences1989.10生殖器疱疹interferon a-n1，干扰素a-n1Wellferon (人成淋巴细胞培养与诱导)GlaxoSmithKline1999.3丙肝Interferon b-1a，干扰素b-1aAvonex (CHO)R

13、ebif (CHO)Biogen/ IdecSerono S.A./ Pfizer1996.52002.3多发性硬皮病darbepoetin alfa，EPO突变体Aranesp (CHO)Amgen2001.9肾性贫血epoietin alfa，EPO促红细胞生成素Epogen (CHO)ProcritAmgenOrtho Biotech1989.61990.12肾性贫血rh Bone morphogenetic protein-2, rhBMP-2INFUSE Bone Graft /LT-CAGE (CHO)Wyeth and Medtronic Sofamor Danek2002.7脊

14、骨退行性病变的脊骨融合rh Osteogenic protein 1, BMP-7Osigraft(CHO)Stryker2001.8胫骨骨折治疗性抗体（Therapeutical Monoclonal Antibodies）:Bevacizumab (anti-EGFR)Avastin (人源化，CHO)Genentech2004.2转移性结肠癌或直肠癌I-131 Tositumomab (Anti-CD20)Bexxar (鼠源，杂交瘤)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-细胞慢性淋巴细胞白血病Cetuximab (anti-EGFR) Erbitux (嵌合，鼠骨髓瘤)ImClone/ BMS2004.2转移性结肠癌或直肠癌Trastuzumab (antiHER-2) Herceptin (人源化，CHO)Genentech1998.9转移性乳腺癌Adalimumab (anti-TNFa)Humira (人源)CAT/ Abbott 2002.12重度类风湿关节炎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，杂交瘤)Ortho Biotech1986.6肾移植急性排斥Efalizumab (anti-CD11a) Raptiva (人源化，CHO)Xoma/ Genentech2003.10慢性中重度银屑病Infliximab(anti-TNFa)Remicade(嵌合，NS0)Centocor1998.8Crohn's病；类风湿关节炎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细胞non-Hodgkin's淋巴瘤Basiliximab (Anti-CD25)Simulect (嵌合，鼠骨髓瘤)Novartis1998.5肾移植急性排斥Palivizumab(Anti-F protein of RSV) Synagis (人源化，NS0)MedImmune1998.6防治小儿下呼吸道合胞病毒感染Omalizumab (Anti-

18、IgE)Xolair (人源化，CHO)Genentech/ Tanox/ Novartis2003.6中重度持续性哮喘Daclizumab (Anti-CD25)Zenapax (人源化，CHO)Hoffmann-La Roche1997.12肾移植急性排斥Ibritumomab tiuxetan (Anti-CD20)Zevalin (鼠源，杂交瘤)IDEC2002.2B细胞non-Hodgkin's淋巴瘤体内诊断用鼠源单抗成像剂（Imaging agents of murine monoclonal antibodies）Technetium-99 acritumomab,Ant

19、i-CEACEA-ScanImmunomedics1996.6转移性直肠结肠癌成像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小细胞肺癌成像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结肠直肠、卵巢癌成像cell/tissue therapy (tissue engineering products):Living human skin substitute，组织工程皮肤ApligrafOrganogenesis/ Novartis199

21、8.5胫静脉溃疡；糖尿病足部溃疡autologous cultured chondrocytes，组织工程软骨CarticelGenzyme1997.8重建受损膝盖关节软骨human dermal substitute，正在工程皮肤DermagraftAdvanced Tissue Sciences Inc./Smith & Nephew plc2001.9糖尿病足部溃疡composite cultured skin，组织工程皮肤OrCelOrtec International2001.2烧伤Others:Alefacept，LFA3-Fc融合蛋白Amevive (CHO)Biogen

22、/Idec2003.1中重度银屑病Etanercept，TNFR-Fc融合蛋白ENBREL (CHO)Amgen/Wyeth1998.11中重度类风湿关节炎；银屑病Drotrecogin alfa，活化蛋白CXigris (CHO)Eli Lilly2001.11脓毒症表2 截止至2003年底欧盟批准的基因重组生物技术药物药物适应证公司首次批准时间表达系统基因重组治疗性蛋白：Insulin，胰岛素糖尿病Lilly IndustriesNovo NordiskHoechst12/1987E coli.YeastInterleukin-2，白介素-2 (IL-2)肾瘤、黑色素瘤Chiron12/1

23、989E coli.Somatotropin，人生长激素矮小症Lilly PharmaciaSerono PharmaNovo Nordisk02/1991E coli.C127细胞Glucagon，胰高血糖素低血糖症Novo Nordisk03/1992YeastErythropoietin b，促红细胞生成素-b (EPO-b)肾性贫血Boehringer Mannheim05/1992CHOInterferon g-1b，干扰素 g-1b慢性肉芽肿病Boehringer Ingelheim06/1992E coli.Interferon a-2b，干扰素 a-2b白血病、肿瘤、疱疹Ess

24、ex Pharma03/1993E coli.Erythropoietin a，促红细胞生成素-a (EPO-a)肾性贫血Janssen-Cilag04/1993CHOGM-CSF(Molgramostim)白细胞减少Essex Pharma04/1993YeastInterferon a-2a，干扰素 a-2a白血病、肿瘤、疱疹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*白细胞减少Rhône-PoulencRorer GmbHChugai10/1993CHOtissue plasminogen activator，组织型纤溶酶原激活剂 (t-PA) 急性心肌梗死Dr. Karl Thomae04/1994CHOGlucocerebrosidase，葡糖脑苷脂酶Gaucher's病Genzyme B.V.06/1994CHOG-CSF，粒细胞集落刺激因子白细胞减少Hoffmann-La Rochekohl pharma08/1994E coli.human DNAse，DNA酶囊性纤维化Hoffmann-La Roche09/19

26、94CHOFollitropin alpha，促滤泡素不孕症Serono10/1995CHOInterferon b-1b，干扰素b-1b多发性硬皮症Schering AG11/1195E coli.Factor VII，凝血因子VII血友病A和BNovo Nordisk02/1996BHKInsulin, Lispro，胰岛素突变体（速效）糖尿病Lilly05/1996E coli.Follitropin-b，促滤泡素-b不孕症Organon10/1996CHOReteplase，t-PA突变体(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，干扰素b-1a多发性硬皮病Biogen France S.A.Ares-Serono 03/1997CHOHirudine，水蛭素抗凝Behringwerke03/1997YeastDesirudine，水蛭素突变体*抗凝Ciba Europharm03/1997YeastCalcitonin，降血钙素*骨质疏松；Pagets病；高钙血症Unigene UK01/1999Interferon alfacon-1，超级a干扰素丙肝Yamanouchi02/1999E co

28、li.rhPDGF，血小板衍生生长因子糖尿病溃疡Janssen-Cilag03/1999YeastTNFa-1a，肿瘤坏死因子a-1a*肿瘤手术后的辅助治疗Boehringer Ingelheim04/1999E coli.Moroctocog a，凝血因子VIII(无B链)血友病Genetics Institute04/1999CHOThyrotropin alfa (TSH)，促甲状腺素甲状腺扫描检查Genzyme07/1999CHOInsulin aspart，胰岛素突变体（速效）糖尿病Novo Nordisk09/1999YeastPeginterferon a-2b，PEG化干扰素a

29、-2b丙肝Schering-Plough05/2000E coli.Insulin glargin，胰岛素突变体（长效）糖尿病HMR Deutschland /Aventis S.A.06/2000E coli.Etanercept，TNFaR-Fc融合蛋白类风湿关节炎Wyeth-Lederle02/2000CHORasburicase，尿酸水解酶肿瘤诱发的高尿酸症Sanofi S.A.02/2001YeastTenecteplase，t-PA突变体(TNK-tPA) 急性心肌梗死Boehringer Ingelheim02/2001CHOChoriogonadotropin a，绒膜促性腺激

30、素(hCG)不孕症Ares Serono02/2001CHOLutropin a，促滤泡素突变体*不孕症Ares Serono02/2001CHODarbepoetin a，EPO突变体肾性贫血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受体拮抗剂类风湿关节炎Amgen GmbH03/2002E co

31、li.Dynepo，EPO-d*肾性贫血Aventis S.A.02/2002CHOPegfilgrastim，PEG化G-CSF白细胞减少Amgen Europe08/2002E coli.Drotrecogin a，活化蛋白C严重脓毒症Eli Lilly08/2002CHODibotermin a，骨形成蛋白(BMP)胫骨骨折Genetics Institute 09/2002CHOAldurazyme，粘多糖-a-L-艾杜糖醛酸水解酶(Laronidase)粘多糖贮积病Genzyme06/2003CHO重组治疗性抗体：Abciximab(ReoPro®)抗血小板凝聚Centoc

32、or05/1995NS0Votumumab(Humaspect®)*结肠癌体内检测Organon Teknika 11/1996动物细胞Rituximab(Mabthera®)non-Hodgkin's淋巴瘤Roche 1998CHOBasiliximab(Simulect®) 肾移植急性排斥Novartis 10/1998鼠骨髓瘤Daclizumab(Zenapax®) 肾移植急性排斥Roche02/1999CHOPalivizumab (Synagis®)呼吸道合胞病毒感染Abbott05/1999NS0Inflixima

33、b(Remicade®)Crohn病；类风湿关节炎Centocor08/1999NS0Trastuzumab(Herceptin®)转移性乳腺癌Roche09/2000CHOAlemtuzumab(Campath®)慢性淋巴细胞白血病Millenium/Ilex03/2001CHOAdalimumab(Humira®)重度类风湿关节炎Abbott03/2003动物细胞Cetuximab(Erbitux®)转移性结肠癌或直肠癌ImClone/Merck02/2004鼠骨髓瘤基因重组疫苗：hepatitis-B antigen，乙肝小S疫苗预防乙肝感染SmithKline09/1989YeastTriacelluvax®，three recombinant B. pertussis toxins*预防破伤风、白喉、百日咳Chiron S. p. A.01/1999乙肝大S抗原 (pre-S1, pre-S2, S)*预防乙肝感染Medeva Pharma 03/00CHOglycosylat