全球抗体药物研究现状 Therapeutic monoclonal antibodies approved or in review in the European Union or United States(2014. 07) International non- Trade name Type Indication first approved First EU(US) proprietary name Muromonab-CD3 Orthoclone Okt3 Anti-CD3: Murine Igg2a Reversal of kidney transplant 1986*(1986#) rejection Abciximab Anti-GPllb/llla: Chimeric Prevention of blood clots in IgGl Fab angioplasty 1995*(1994) Rituximab Mabthera Rituxan Anti-CD20; Chimeric IgGl Non-Hodgkins lymphoma 1998(1997) Basiliximab Simulect Anti-IL2R; Chimeric IgGl Prevention of kidney transplant 1998(1998) rejection Daclizumab Zenapax Anti-IL2R; Humanized Iggl Prevention of kidney transplan 1999(1997),# Palivizumab Synagis Anti-RSV; Humanized IgGl Prevention of respiratory syncytial 1999(1998) Infliximab Remicade Anti-TNF: Chimeric IgGI Crohn disease 1999(1998) Trastuzumab Anti-HER2, Humanized IgGl Breast cancer 2000(1998) Gemtuzumab OzogamIcin Mylotarg Anti-CD33; Humanized IgG4 Acute myeloid leukemia NA(2000#) Alemtuzumab MabCampath Anti-CD52; Humanized IgGl Chronic myeloid leukemia 2001(2001) Adalimumab Anti-TNF; Human IgGl Rheumatoid arthritis 2003(2002 Tositumomab-1131 Bex Anti-CD20: Murine IgG2a Non-Hodgkin lymphoma NA(2003) Efalizumab Anti-CDlla: Humanized Iggl Psoriasis 2004(2003);# Cetuximab Erbitux Anti-EGFR; Chimeric IgGI Colorectal cancer 2004(2004 Ibritumomab tiuxetan Zevalin Anti-CD20; Murine IgGI gkin's lympho 2004(2002)
International non- proprietary name Trade name Type Indication first approved First EU (US) approval year Muromonab-CD3 Orthoclone Okt3 Anti-CD3; Murine IgG2a Reversal of kidney transplant rejection 1986* (1986#) Abciximab Reopro Anti-GPIIb/IIIa; Chimeric IgG1 Fab Prevention of blood clots in angioplasty 1995* (1994) Rituximab MabThera, Rituxan Anti-CD20; Chimeric IgG1 Non-Hodgkin's lymphoma 1998 (1997) Basiliximab Simulect Anti-IL2R; Chimeric IgG1 Prevention of kidney transplant rejection 1998 (1998) Daclizumab Zenapax Anti-IL2R; Humanized IgG1 Prevention of kidney transplant rejection 1999 (1997); # Palivizumab Synagis Anti-RSV; Humanized IgG1 Prevention of respiratory syncytial virus infection 1999 (1998) Infliximab Remicade Anti-TNF; Chimeric IgG1 Crohn disease 1999 (1998) Trastuzumab Herceptin Anti-HER2; Humanized IgG1 Breast cancer 2000 (1998) Gemtuzumab ozogamicin Mylotarg Anti-CD33; Humanized IgG4 Acute myeloid leukemia NA (2000#) Alemtuzumab MabCampath, Campath-1H Anti-CD52; Humanized IgG1 Chronic myeloid leukemia 2001 (2001) Adalimumab Humira Anti-TNF; Human IgG1 Rheumatoid arthritis 2003 (2002) Tositumomab-I131 Bexxar Anti-CD20; Murine IgG2a Non-Hodgkin lymphoma NA (2003) Efalizumab Raptiva Anti-CD11a; Humanized IgG1 Psoriasis 2004 (2003); # Cetuximab Erbitux Anti-EGFR; Chimeric IgG1 Colorectal cancer 2004 (2004) Ibritumomab tiuxetan Zevalin Anti-CD20; Murine IgG1 Non-Hodgkin's lymphoma 2004 (2002) Therapeutic monoclonal antibodies approved or in review in the European Union or United States (2014. 07)
全球抗体药物研究现状 International non- Trade name Ty Indication first approved First EU (US) proprietary name approval year Anti-IgE, Humanized IgGl 2005(2003) Bevacizumab Avastin Anti-VEGF, Humanized Iggl Colorectal cancer 2005(2004) Natalizumab Anti-a4 integrin; Humanized multiple sclerosis 2006(2004) Ranibizumab Lucentis Anti-VEGF;Humanized IgGI Macular degeneration 2007(2006) Pani Vectibix Anti-EGFR; Human IgG2 Colorect 2007(2006 Eculizumab Soliris Anti-C5: Humanized IgG2/4 Paroxysmal nocturnal 20072007) emoglooinurla Certolizumab pegol Cl Anti-TNF Humanized Fab Crohn disease pegylated 2009(2008) Golimumab Anti-TNF: Human Iggl Rheumatoid and psoriatic arthritis nkylosing spondylitis 2009(2009) Canakinumab laris Anti-ILlb: Human Iggl Muckle-Wells syndrome 2009(2009) Catumaxomab Removab Anti-EPCAM/CD3- Rat/mouse Malignant ascites 009(NA) Ustekinumab Anti-IL12/23: Human IgGI Psoriasis 2009(2009) Tocilizumab LoActemra, Anti-IL6R; Humanized iggl Rheumatoid arthritis 009(2010) Ofatumumab arter Anti-CD20: Human IgGI Chronic lymphocytic leukemia 2010(2009) Denosumab Anti-RANK-L: Human Igg2 2010(2010) Belimumab Anti-BLyS; Human IgGl matosus 2011(2011) envoy Anti-CTLA-4; Human Iggl Metastatic melanoma 2011(2011)
International non- proprietary name Trade name Type Indication first approved First EU (US) approval year Omalizumab Xolair Anti-IgE; Humanized IgG1 Asthma 2005 (2003) Bevacizumab Avastin Anti-VEGF; Humanized IgG1 Colorectal cancer 2005 (2004) Natalizumab Tysabri Anti-a4 integrin; Humanized IgG4 Multiple sclerosis 2006 (2004) Ranibizumab Lucentis Anti-VEGF; Humanized IgG1 Fab Macular degeneration 2007 (2006) Panitumumab Vectibix Anti-EGFR; Human IgG2 Colorectal cancer 2007 (2006) Eculizumab Soliris Anti-C5; Humanized IgG2/4 Paroxysmal nocturnal hemoglobinuria 2007 (2007) Certolizumab pegol Cimzia Anti-TNF; Humanized Fab, pegylated Crohn disease 2009 (2008) Golimumab Simponi Anti-TNF; Human IgG1 Rheumatoid and psoriatic arthritis, ankylosing spondylitis 2009 (2009) Canakinumab Ilaris Anti-IL1b; Human IgG1 Muckle-Wells syndrome 2009 (2009) Catumaxomab Removab Anti-EPCAM/CD3;Rat/mouse bispecific mAb Malignant ascites 2009 (NA) Ustekinumab Stelara Anti-IL12/23; Human IgG1 Psoriasis 2009 (2009) Tocilizumab RoActemra, Actemra Anti-IL6R; Humanized IgG1 Rheumatoid arthritis 2009 (2010) Ofatumumab Arzerra Anti-CD20; Human IgG1 Chronic lymphocytic leukemia 2010 (2009) Denosumab Prolia Anti-RANK-L; Human IgG2 Bone Loss 2010 (2010) Belimumab Benlysta Anti-BLyS; Human IgG1 Systemic lupus erythematosus 2011 (2011) Ipilimumab Yervoy Anti-CTLA-4; Human IgG1 Metastatic melanoma 2011 (2011)
全球抗体药物研究现状 International non- Trade name Ty Indication first approved First EU (US) proprietary name approval year Brentuximab vedotin Adcetris Anti-CD30: Chimeric IgGI Hodgkin lymphoma 2012(2011) Perjeta Anti-HER2; humanized Iggl Breast Cancer 2013(2012) Raxibacumab (Pending) Anti-B anthrasis PA: Human Anthrax infection NA(2012) Trastuzumab emtansine Kadcvla Breast cancer munoconjugate 2013(2013) Vedolizumab Entyvio Anti-alpha4beta7 integrin humanized IggI Ulcerative colitis. Crohn disease 2014(2014) Ramucirumab Cyramza Anti-VEGFR2: Human Iggl Gastric cancer n review(2014) Obinutuzumab Anti-CD20 Humanized IgGl, Chronic lymphocytic leukemia In review(2013) Sylvan Anti-IL-6: Chimeric IgGl Castleman disease In review(2014) Secukinumab (Pe Anti-IL-17a, Human IgGI In review(In munsu NA (NA) Nivolumab Anti-PDI; Human IgG4 Melanoma [Approved Japan] Pembrolizumab ( Pending) Anti-PDI; Humanized IgG4 Melanoma In review) Dinutuximab Anti-GD2; Chimeric Igg Neuroblastoma n review (NA)
International non- proprietary name Trade name Type Indication first approved First EU (US) approval year Brentuximab vedotin Adcetris Anti-CD30; Chimeric IgG1; immunoconjugate Hodgkin lymphoma 2012 (2011) Pertuzumab Perjeta Anti-HER2; humanized IgG1 Breast Cancer 2013 (2012) Raxibacumab (Pending) Anti-B. anthrasis PA; Human IgG1 Anthrax infection NA (2012) Trastuzumab emtansine Kadcyla Anti-HER2; humanized IgG1; immunoconjugate Breast cancer 2013 (2013) Vedolizumab Entyvio Anti-alpha4beta7 integrin; humanized IgG1 Ulcerative colitis, Crohn disease 2014 (2014) Ramucirumab Cyramza Anti-VEGFR2; Human IgG1 Gastric cancer In review (2014) Obinutuzumab Gazyva Anti-CD20; Humanized IgG1; Glycoengineered Chronic lymphocytic leukemia In review (2013) Siltuximab Sylvant Anti-IL-6; Chimeric IgG1 Castleman disease In review (2014) Secukinumab (Pending) Anti-IL-17a; Human IgG1 Immunosuppression In review (In review) Nivolumab (Pending) Anti-PD1; Human IgG4 Melanoma NA (NA) [Approved in Japan] Pembrolizumab (previously named Lambrolizumab) (Pending) Anti-PD1; Humanized IgG4 Melenoma In review (In review) Dinutuximab (Pending) Anti-GD2; Chimeric IgG1 Neuroblastoma In review (NA)
全球抗体药物研究现状 7654321 year 治疗性抗体的市场是近年来所有制药工业中增长最快的 领域:抗体药物增长率高达21%,而新小分子化合物药物的 增长率仅为5%
抗体药物增长率高达21%, 而新小分子化合物药物的 增长率仅为5%
全球抗体药物研究现状 68 51 40 20.6 14 10.5 10 20042005200620072008200920102015E 全球单克隆抗体销售额 In 2012, global sales of antibody-based therapeutic products exceeded $50 billion; among the 15 top-selling drugs in that year, six are antibody-based molecules
In 2012, global sales of antibody-based therapeutic products exceeded $50 billion; among the 15 top-selling drugs in that year, six are antibody-based molecules. 全球单克隆抗体销售额 B i l l i o n