The Antibody Society continuously collects data for approved antibody therapeutics and those in regulatory review. A searchable table of this data is below. Products that were granted approvals but subsequently withdrawn from the market are included in the table. Biosimilar products are excluded.
Format, Fc modification and cell expression system data were compiled by Drs.Alicia Chenoweth and Silvia Crescioli, King’s College London, who also built the data table below.
Please cite our data as follows:
The Antibody Society. Therapeutic monoclonal antibodies approved or in regulatory review. (date accessed); www.antibodysociety.org/antibody-therapeutics-product-data
| International Non-Proprietary Name | Brand Name | Target | Format | Specificity | Sequence source | Backbone | Light Chain | Conjugated / uncognugated | Linker | Payload | Payload Mechanism of Action | Fc Modifications | Reason for Fc Modifications | Therapeutic Area | Indication First Approved or Reviewed | First EU approval year | First US approval year | First global approval (country, year) | Expression system | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Muromonab-CD3 | Orthoclone Okt3 | CD3 | Full-length antibody | Monospecific | Murine | mIgG2a | kappa | Unconjugated | None | - | Immunology | Reversal of kidney transplant rejection | 1986* | 1986# | US, 1986 | Murine hybridoma | ||||
| Efalizumab | Raptiva | CD11a | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Psoriasis | 2004# | 2003# | US, 2003 | Chinese hamster ovary (CHO) cells | ||||
| Tositumomab-I131 | Bexxar | CD20 | Full-length antibody | Monospecific | Murine | mIgG2a | lambda | Radio-immunotherapeutic | Iodine-131 | I-131 produces beta and gamma emissions | None | - | Oncology | Non-Hodgkin Lymphoma | NA | 2003# | US, 2003 | Murine hybridoma | ||
| Nebacumab | Centoxin | Endotoxin | Full-length antibody | Monospecific | Human | hIgM | kappa | Unconjugated | None | - | Infectious Diseases | Gram-negative sepsis | 1991*# | NA | Netherlands, England, France, Germany, 1991 | Heteromyeloma cell line A6(H4C5) | ||||
| Edrecolomab | Panorex | EpCAM | Full-length antibody | Monospecific | Murine | mIgG2a | kappa | Unconjugated | None | - | Oncology | Colon cancer | 1995*# | NA | Germany, 1995 | |||||
| Catumaxomab | Removab | EPCAM, CD3 | Full-length antibody | Bispecific | Hybrid Rat/Mouse | mIgG2a/k and rIgG2b/λ Hybrid | kappa/lambda | Unconjugated | None | - | Oncology | Malignant ascites | 2009# | NA | EU, 2009 | Rat-mouse hybrid-hybridoma cell line | ||||
| Daclizumab | Zinbryta; Zenapax | CD25 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Multiple sclerosis#; prevention of kidney transplant rejection# | 2016#; 1999# | 2016#; 1997# | US, 1997 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Abciximab | Reopro | GPIIb/IIIa | Fab | Monospecific | Chimeric mouse/human | hIgG1 Fab | kappa | Unconjugated | Not applicable | - | Hematological Disorders | Prevention of blood clots in angioplasty | 1995* | 1994 | US, 1994 | Murine myeloma cells (Sp2/0) | ||||
| Rituximab | MabThera, Rituxan | CD20 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Non-Hodgkin lymphoma | 1998 | 1997 | US, 1997 | Chinese hamster ovary (CHO) cells | ||||
| Basiliximab | Simulect | IL-2R | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Prevention of kidney transplant rejection | 1998 | 1998 | US, 1998 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Palivizumab | Synagis | RSV | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Infectious Diseases | Prevention of respiratory syncytial virus infection | 1999 | 1998 | US, 1998 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Infliximab | Remicade | TNF | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Crohn disease | 1999 | 1998 | US, 1998 | Murine myeloma cells (Sp2/0) | ||||
| Trastuzumab | Herceptin | HER2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | Breast cancer | 2000 | 1998 | US, 1998 | Chinese hamster ovary (CHO) cells | ||||
| Adalimumab | Humira | TNF | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Rheumatoid arthritis | 2003 | 2002 | US, 2002 | Chinese hamster ovary (CHO) cells | ||||
| Ibritumomab tiuxetan | Zevalin | CD20 | Full-length antibody | Monospecific | Murine | mIgG1 | kappa | Radio-immunotherapeutic | chalating agent MX-DTPA | Yttrium-90 | Y-90 produces beta emissions | None | - | Oncology | Non-Hodgkin lymphoma | 2004 | 2002 | US, 2002 | Chinese hamster ovary (CHO) cells | |
| Omalizumab | Xolair | IgE | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Asthma | 2005 | 2003 | US, 2003 | Chinese hamster ovary (CHO) cells | ||||
| Cetuximab | Erbitux | EGFR | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Colorectal cancer | 2004 | 2004 | Switzerland, 2003 | Murine myeloma cells (Sp2/0) | ||||
| Bevacizumab | Avastin | VEGF | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | Colorectal cancer | 2005 | 2004 | US, 2004 | Chinese hamster ovary (CHO) cells | ||||
| Natalizumab | Tysabri | a4 integrin | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | None | - | Immunology | Multiple sclerosis | 2006 | 2004 | US, 2004 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Panitumumab | Vectibix | EGFR | Full-length antibody | Monospecific | Human | hIgG2 | kappa | Unconjugated | None | - | Oncology | Colorectal cancer | 2007 | 2006 | US, 2006 | Chinese hamster ovary (CHO) cells | ||||
| Ranibizumab | Lucentis | VEGF | Fab | Monospecific | Humanized | hIgG1 Fab | kappa | Unconjugated | Not applicable | - | Ophthalmology | Macular degeneration | 2007 | 2006 | US, 2006 | E. coli bacteria | ||||
| Eculizumab | Soliris | C5 | Full-length antibody | Monospecific | Humanized | hIgG2(CH1-hinge)/hIgG4(CH2-CH3) | kappa | Unconjugated | None | - | Hematological Disorders | Paroxysmal nocturnal hemoglobinuria | 2007 | 2007 | US, 2007 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Certolizumab pegol | Cimzia | TNF | PEGylated Fab | Monospecific | Humanized | hFab | PEGylated | PEG | extend half life | Not applicable | - | Immunology | Crohn disease | 2009 | 2008 | US, 2008 | E. coli bacteria | |||
| Ustekinumab | Stelara | IL-12/23 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Psoriasis | 2009 | 2009 | EU, 2009 | Murine myeloma cells (Sp2/0) | ||||
| Canakinumab | Ilaris | IL-1β | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Genetic Diseases | Muckle-Wells syndrome | 2009 | 2009 | US, 2009 | Murine myeloma cells (Sp2/0) | ||||
| Golimumab | Simponi | TNF | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 | 2009 | US, 2009 | Murine myeloma cells (Sp2/0) | ||||
| Ofatumumab | Arzerra | CD20 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Chronic lymphocytic leukemia | 2010# | 2009 | US, 2009 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Tocilizumab | RoActemra, Actemra | IL-6R | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Rheumatoid arthritis | 2009 | 2010 | Japan, 2005 | Chinese hamster ovary (CHO) cells | ||||
| Denosumab | Prolia | RANK-L | Full-length antibody | Monospecific | Human | hIgG2 | kappa | Unconjugated | None | - | Musculoskeletal Disorders | Bone Loss | 2010 | 2010 | EU, 2010 | Chinese hamster ovary (CHO) cells | ||||
| Belimumab | Benlysta | BLyS | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Immunology | Systemic lupus erythematosus | 2011 | 2011 | US, 2011 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Ipilimumab | Yervoy | CTLA-4 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Metastatic melanoma | 2011 | 2011 | US, 2011 | Chinese hamster ovary (CHO) cells | ||||
| Brentuximab vedotin | Adcetris | CD30 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | ADC | protease cleavable linker (Cathepsin cleavable valine-citrulline) | Monometyl auristan E (MMAE) | tubulin polymerization inhibitor | None | - | Oncology | Hodgkin lymphoma, systemic anaplastic large cell lymphoma | 2012 | 2011 | US, 2011 | Chinese hamster ovary (CHO) cells | |
| Pertuzumab | Perjeta | HER2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | Breast Cancer | 2013 | 2012 | US, 2012 | Chinese hamster ovary (CHO) cells | ||||
| Ado-trastuzumab emtansine | Kadcyla | HER2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | ADC | Non-cleavable thioether linker | DM1 | tubulin polymerization inhibitor | None | - | Oncology | Breast cancer | 2013 | 2012 | US, 2012 | Chinese hamster ovary (CHO) cells | |
| Raxibacumab | (Pending) | B. anthrasis PA | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Infectious Diseases | Anthrax infection | NA | 2012 | US, 2012 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Obinutuzumab | Gazyva, Gazyvaro | CD20 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Low-fucose | Improve FcγRIIIa binding/Improve ADCC | Oncology | Chronic lymphocytic leukemia | 2014 | 2013 | US, 2013 | Chinese hamster ovary (CHO) cells, Coexpression with GnT III and α-ManII in CHO cells (GlycoMAb Technology) | ||||
| Racotumomab | Vaxira® | GM3 | Full-length antibody | Monospecific | Murine | IgG1 | kappa | - | - | Oncology | Non-small cell lung cancer | NA | NA | Cuba, 2013 | ||||||
| Siltuximab | Sylvant | IL-6 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Castleman disease | 2014 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Ramucirumab | Cyramza | VEGFR2 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Gastric cancer | 2014 | 2014 | US, 2014 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Vedolizumab | Entyvio | α4β7 integrin | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | L235A, G237 | Remove Fc effector functions | Immunology | Ulcerative colitis, Crohn disease | 2014 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Nivolumab | Opdivo | PD1 | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Melanoma, non-small cell lung cancer | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Pembrolizumab | Keytruda | PD1 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Melanoma | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Blinatumomab | Blincyto | CD19, CD3 | Tandem scFv | Bispecific | Murine | Tandem scFv | NA | Unconjugated | Not applicable | - | Oncology | Acute lymphoblastic leukemia | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Alemtuzumab | Lemtrada; MabCampath, Campath-1H | CD52 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | Multiple sclerosis; chronic myeloid leukemia# | 2013; 2001# | 2014; 2001# | US, 2001 | Chinese hamster ovary (CHO) cells | ||||
| Evolocumab | Repatha | PCSK9 | Full-length antibody | Monospecific | Human | hIgG2 | lambda | Unconjugated | None | - | Other | High cholesterol | 2015 | 2015 | EU, 2015 | Chinese hamster ovary (CHO) cells | ||||
| Idarucizumab | Praxbind | Dabigatran | Fab | Monospecific | Humanized | hIgG1 Fab | kappa | Unconjugated | Not applicable | - | Hematological Disorders | Reversal of dabigatran-induced anticoagulation | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | ||||
| Necitumumab | Portrazza | EGFR | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Non-small cell lung cancer | 2015 | 2015 | US, 2015 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Dinutuximab | Unituxin | GD2 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Neuroblastoma | 2017; 2015# | 2015 | US, 2015 | Murine myeloma cells (Sp2/0) | ||||
| Secukinumab | Cosentyx | IL-17a | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Psoriasis | 2015 | 2015 | Japan, 2014 | Chinese hamster ovary (CHO) cells | ||||
| Mepolizumab | Nucala | IL-5 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Severe eosinophilic asthma | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | ||||
| Alirocumab | Praluent | PCSK9 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Other | High cholesterol | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | ||||
| Daratumumab | Darzalex | CD38 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Multiple myeloma | 2016 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | ||||
| Elotuzumab | Empliciti | SLAMF7 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | Multiple myeloma | 2016 | 2015 | US, 2015 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Ixekizumab | Taltz | IL-17a | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Immunology | Psoriasis | 2016 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | ||||
| Reslizumab | Cinqaero, Cinqair | IL-5 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | None | - | Immunology | Asthma | 2016 | 2016 | US, 2016 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Olaratumab | Lartruvo | PDGFRα | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Soft tissue sarcoma | 2016# | 2016 | US, 2016 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Bezlotoxumab | Zinplava | Clostridium difficile enterotoxin B | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Infectious Diseases | Prevention of Clostridium difficile infection recurrence | 2017 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | ||||
| Atezolizumab | Tecentriq | PD-L1 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Aglycosylated (N297A) | Remove Fc effector functions | Oncology | Bladder cancer | 2017 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | ||||
| Obiltoxaximab | Anthim | B. anthrasis PA | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Infectious Diseases | Prevention of inhalational anthrax | 2020 | 2016 | US, 2016 | Murine GS-NS0 myeloma cells | ||||
| Brodalumab | Siliq, LUMICEF, Kyntheum | IL-17R | Full-length antibody | Monospecific | Human | hIgG2 | kappa | Unconjugated | None | - | Immunology | Plaque psoriasis | 2017 | 2017 | Japan, 2016 | Chinese hamster ovary (CHO) cells | ||||
| Dupilumab | Dupixent | IL-4R α | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Immunology | Atopic dermatitis | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Inotuzumab ozogamicin | BESPONSA | CD22 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | ADC | Acid-labile hydrozone linker | Calicheamicin | DNA-binding and double breaks induction | S228P | Hinge stabilising | Oncology | Acute lymphoblastic leukemia | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |
| Guselkumab | TREMFYA | IL-23 p19 | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Immunology | Plaque psoriasis | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Sarilumab | Kevzara | IL-6R | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Immunology | Rheumatoid arthritis | 2017 | 2017 | Canada, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Avelumab | Bavencio | PD-L1 | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Oncology | Merkel cell carcinoma | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Emicizumab | Hemlibra | Factor Ixa, X | Full-length antibody | Bispecific | Humanized | hIgG4 | kappa | Unconjugated | S228P; K196Q; F296Y; E356K; K439E; L445P; G446 > del; K447 > del | Hinge stabilising, asymmetric electrostatic steering mutations for bispecific creation | Hematological Disorders | Hemophilia A | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Ocrelizumab | OCREVUS | CD20 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Multiple sclerosis | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Benralizumab | Fasenra | IL-5R α | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Immunology | Asthma | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | ||||
| Durvalumab | IMFINZI | PD-L1 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | L234F; L235E; P331S | Remove Fc effector functions | Oncology | Bladder cancer | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | ||||
| Gemtuzumab ozogamicin | Mylotarg | CD33 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | ADC | Acid-labile hydrozone linker | Calicheamicin | DNA-binding and double breaks induction | S228P | Hinge stabilising | Oncology | Acute myeloid leukemia | 2018 | 2017; 2000# | US, 2000 | Murine myeloma non-secreting 0 (NS0) cells | |
| Erenumab (erenumab-aooe) | Aimovig | CGRP receptor | Full-length antibody | Monospecific | Human | hIgG2 | lambda | Unconjugated | None | - | Neurological disorders | Migraine prevention | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Galcanezumab (galcanezumab-gnlm) | Emgality | CGRP | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P; F234A; L235A | Remove Fc effector functions | Neurological disorders | Migraine prevention | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Burosumab (burosumab-twza) | Crysvita | FGF23 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Genetic Diseases | X-linked hypophosphatemia | 2018 | 2018 | EU, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Lanadelumab (lanadelumab-flyo) | Takhzyro | Plasma kallikrelin | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Genetic Diseases | Hereditary angioedema attacks | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Mogamulizumab (mogamulizumab-kpkc) | Poteligeo | CCR4 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Oncology | Mycosis fungoides or Sézary syndrome | 2018 | 2018 | Japan, 2012 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | ||||
| Tildrakizumab (tildrakizumab-asmn) | Ilumya | IL-23 p19 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Plaque psoriasis | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Fremanezumab (fremanezumab-vfrm) | Ajovy | CGRP | Full-length antibody | Monospecific | Humanized | hIgG2Δa | kappa | Unconjugated | A330S; P331S | Remove Fc effector functions | Neurological disorders | Migraine prevention | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Ravulizumab (ravulizumab-cwvz) | Ultomiris | C5 | Full-length antibody | Monospecific | Humanized | hIgG2(CH1-hinge)/hIgG4(CH2-CH3) | kappa | Unconjugated | M428L; N434S | Increase half-life | Hematological Disorders | Paroxysmal nocturnal hemoglobinuria | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Cemiplimab (cemiplimab-rwlc) | Libtayo | PD-1 | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Cutaneous squamous cell carcinoma | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Ibalizumab (ibalizumab-uiyk) | Trogarzo | CD4 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | None | - | Infectious Diseases | HIV infection | 2019 | 2018 | US, 2018 | Murine myeloma non-secreting 0 (NS0) cells | ||||
| Emapalumab (emapalumab-lzsg) | Gamifant | IFNg | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Oncology | Primary hemophagocytic lymphohistiocytosis | NA | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | ||||
| Moxetumomab pasudotox (moxetumomab pasudotox-tdfk) | Lumoxiti | CD22 | dsFv immunotoxin | Monospecific | Murine | mIgG1 dsFv fused with PE38 exotoxin | Immunotoxin | PE38 | Not applicable | - | Oncology | Hairy cell leukemia | 2021 | 2018 | US, 2018 | E. coli bacteria | ||||
| Caplacizumab (caplacizumab-yhdp) | Cablivi | von Willebrand factor | Nanobody | Monospecific | Humanized | bivalent Nanobody | NA | Unconjugated | Not applicable | - | Immunology | Acquired thrombotic thrombocytopenic purpura | 2018 | 2019 | EU, 2018 | E. coli bacteria | ||||
| Risankizumab (risankizumab-rzaa) | Skyrizi | IL-23 p19 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | L234A; L235A | Remove Fc effector functions | Immunology | Plaque psoriasis | 2019 | 2019 | Japan, 2019 | Chinese hamster ovary (CHO) cells | ||||
| Polatuzumab vedotin (polatuzumab vedotin-piiq) | Polivy | CD79b | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | ADC | Protease-cleavable linker | Monomethyl Auristatin E (MMAE) | tubulin polimerization inhibitor | None | - | Oncology | Diffuse large B-cell lymphoma | 2020 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells | |
| Romosozumab (romosozumab-aqqg) | Evenity | Sclerostin | Full-length antibody | Monospecific | Humanized | hIgG2 | kappa | Unconjugated | None | - | Musculoskeletal Disorders | Osteoporosis in postmenopausal women at increased risk of fracture | 2019 | 2019 | Japan, 2019 | Chinese hamster ovary (CHO) cells | ||||
| Brolucizumab (brolucizumab-dbll) | Beovu | VEGF-A | scFv | Monospecific | Humanized | hscFv | kappa | Unconjugated | Not applicable | - | Ophthalmology | Neovascular age-related macular degeneration | 2020 | 2019 | US, 2019 | E. coli BL21(DE3) bacteria | ||||
| Crizanlizumab (crizanlizumab-tmca) | Adakveo | CD62 (aka P-selectin) | Full-length antibody | Monospecific | Humanized | hIgG2 | kappa | Unconjugated | None | - | Hematological Disorders | Sickle cell disease | 2020 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells | ||||
| Enfortumab vedotin (enfortumab vedotin-ejfv) | Padcev | Nectin-4 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | ADC | Protease-cleavable linker | Monomethyl Auristatin E (MMAE) | tubulin polymerization inhibitor | None | - | Oncology | Urothelial cancer | 2022 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells | |
| [fam-]trastuzumab deruxtecan, (fam-trastuzumab deruxtecan-nxki) | Enhertu | HER2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | ADC | Protease-cleavable linker | DXd | topoisomerase I inhibitor | None | - | Oncology | HER2+ metastatic breast cancer | 2021 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells | |
| Teprotumumab (teprotumumab-trbw) | Tepezza | IGF-1R | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Ophthalmology | Thyroid eye disease | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Eptinezumab (eptinezumab-jjmr) | VYEPTI | CGRP | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Aglycosylated (N297A) | Remove Fc effector functions | Neurological disorders | Migraine prevention | 2022 | 2020 | US, 2020 | Pichia pastoris yeast cells | ||||
| Isatuximab (isatuximab-irfc) | Sarclisa | CD38 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | None | - | Oncology | Multiple myeloma | 2020 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Sacituzumab govitecan (sacituzumab govitecan-hziy) | TRODELVY | TROP-2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | ADC | pH-sensitive cleavable linker | SN38 | topoisomerase I inhibitor | None | - | Oncology | Triple-neg. breast cancer | 2021 | 2020 | US, 2020 | Murine myeloma cells | |
| Inebilizumab (inebilizumab-cdon) | Uplizna | CD19 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Immunology | Neuromyelitis optica spectrum disorders | 2022 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | ||||
| Tafasitamab (tafasitamab-cxix) | Monjuvi, Minjuvi | CD19 | Full-length antibody | Monospecific | Humanized | hIgG1/2 hybrid | kappa | Unconjugated | S239D; I332E | Improve FcγRIIIa binding/Improve ADCC | Oncology | Diffuse large B-cell lymphoma | 2021 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Belantamab mafodotin (belantamab mafodotin-blmf) | BLENREP | B-cell maturation antigen | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | ADC | noncleavable maleimidocaproyl (mc) linker | Monomethyl Auristatin F (MMAF) | tubulin polymerization inhibitor | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Oncology | Multiple myeloma | 2020 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | |
| Satralizumab (satralizumab-mwge) | Enspryng | IL-6R | Full-length antibody | Monospecific | Humanized | hIgG2 | kappa | Unconjugated | None | - | Immunology | Neuromyelitis optica spectrum disorder | 2021 | 2020 | Canada, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Atoltivimab, maftivimab, and odesivimab-ebgn | Inmazeb | Ebola virus | Full-length antibodies, mixture of 3 | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Infectious Diseases | Ebola virus infection | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Naxitamab-gqgk | DANYELZA | GD2 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Oncology | High-risk neuroblastoma and refractory osteomedullary disease | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Margetuximab-cmkb | MARGENZA | HER2 | Full-length antibody | Monospecific | Chimeric mouse/human | hIgG1 | kappa | Unconjugated | F243L; R292P; Y300L; V305I; P396L | Improve FcγRIIIa binding/Improve ADCC and decrease affinity for human inhibitory FcγRIIB (CD32B) | Oncology | HER2+ metastatic breast cancer | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Ansuvimab-zykl | Ebanga | Ebola virus glycoprotein | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Infectious Diseases | Ebola virus infection | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | ||||
| Evinacumab | Evkeeza | Angiopoietin-like 3 | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Genetic Diseases | Homozygous familial hypercholesterolemia | 2021 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Loncastuximab tesirine | Zynlonta | CD19 | Full-length antibody | Monospecific | Humanized | hIgG1/k | kappa | ADC | Protease-cleavable linker | pyrrolobenzodiazepines (PBD) dimer SG3199 | DNA minor-groove binding | None | - | Oncology | Diffuse large B-cell lymphoma | EU review | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | |
| Dostarlimab | Jemerli | PD-1 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Endometrial cancer | 2021 | 2021 | EU, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Amivantamab | RYBREVANT | EGFR, cMET | Full-length antibody | Bispecific | Human | hIgG1 | Unconjugated | Low-fucose; K409R; F405L | Improve FcγRIIIa binding/Improve ADCC; Controlled Fab arm exchange for bispecific generation | Oncology | NSCLC w/ EGFR exon 20 insertion mutations | 2021 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells, Low-fucose production cells | |||||
| Aducanumab | ADUHELM | Amyloid beta | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | MAA withdrawn | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Tralokinumab | Adtralza | IL-13 | Full-length antibody | Monospecific | Human | hIgG4 | lambda | Unconjugated | None | - | Immunology | Atopic dermatitis | 2021 | 2021 | EU, 2021 | Mouse myeloma cells | ||||
| Teplizumab | (Pending) | CD3 | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | L234A; L235A | Remove Fc effector functions | Immunology | Type 1 diabetes | NA | In review (2nd cycle) | To be confirmed | |||||
| Narsoplimab | (Pending) | MASP-2 | Full-length antibody | Monospecific | Human | hIgG4 | lambda | Unconjugated | S228P | Hinge stabilising | Hematological Disorders | Hematopoietic stem cell transplant-associated thrombotic microangiopathies | NA | In review | To be confirmed | |||||
| Retifanlimab | (Pending) | PD-1 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Carcinoma of the anal canal | MAA withdrawn | In review (2nd cycle) | To be confirmed | |||||
| Oportuzumab monatox | (Pending) | EpCAM | scFv immunotoxin | Monospecific | Humanized | hscFv fused with PE38 exotoxin | To be confirmed | Immunotoxin | PE38 | Not applicable | - | Oncology | Bladder cancer | NA | In review (2nd cycle) | To be confirmed | ||||
| Anifrolumab, anifrolumab-fnia | Saphnelo | IFNAR1 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | L234F; L235E; P331S | Remove Fc effector functions | Immunology | Systemic lupus erythematosus | 2022 | 2021 | US, 2021 | Mouse myeloma cells (NS0) | ||||
| Inolimomb | (Pending) | CD25 | Full-length antibody | Monospecific | Murine | mIgG1 | kappa | Unconjugated | None | - | Immunology | Graft vs. host disease | NA | In review | To be confirmed | |||||
| Bimekizumab | Bimzelx | IL-17A and IL-17F (overlapping binding site) | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Immunology | Psoriasis | 2021 | In review | EU, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Sutimlimab, sutimlimab-jome | Enjaymo | C1s | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P; L235E | Hinge stabilising; remove Fc effector functions | Immunology | Cold agglutinin disease | EU review | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | ||||
| Ublituximab | (Pending) | CD20 | Full-length antibody | Monospecific | Chimeric | hIgG1 | kappa | Unconjugated | Low fucose | Improve FcγRIIIa binding/Improve ADCC | Immunology | Multiple sclerosis | EU review | In review | YB2/0 cells | |||||
| Tisotumab vedotin, tisotumab vedotin-tftv | TIVDAK | Tissue factor | Full-length antibody | Monospecific | Human | hIgG1 | kappa | ADC | Cleavable mc-val-cit-PABC type linker | Monomethyl Auristatin E (MMAE) | tubulin polymerization inhibitor | None | - | Oncology | Cervical cancer | NA | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | |
| Toripalimab | Tuoyi | PD-1 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Nasopharyngeal carcinoma | NA | In review | To be confirmed | |||||
| Sintilimab | Tyvyt | PD-1 | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Non-small cell lung cancer | NA | In review | To be confirmed | |||||
| Tezepelumab | Tezspire | Thymic stromal lymphopoietin | Full-length antibody | Monospecific | Human | hIgG2 | lambda | Unconjugated | None | - | Immunology | Severe asthma | EU review | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Omburtamab | (Pending) | B7-H3 (CD276) | Full-length antibody | Monospecific | Murine | hIgG1 | kappa | Radiolabeled | Iodine-131 | I-131 produces beta and gamma emissions | None | - | Oncology | Central nervous system/leptomeningeal metastasis from neuroblastoma | EU review | In review | To be confirmed | |||
| Penpulimab | (Pending) | PD-1 | Full-length antibody | Monospecific | Humanized | hIgG1 | To be confirmed | Unconjugated | L234A L235A G237A | Reduce Fc effector functions | Oncology | Metastatic nasopharyngeal carcinoma | NA | In review | To be confirmed | |||||
| Faricimab, faricimab-svoa | Vabysmo | VEGF-A, Ang-2 | Full-length antibody | Bispecific | Humanized/human | hIgG1 | kappa/lambda | Unconjugated | L234A; L235A; P329G; I253A; H310A; H435A; S354C + T366W (in heavy chain A); Y349C + T366S + L368A + Y407V (in heavy chain B) | Remove Fc effector functions; Reduce half-life; CrossMab "knob-in-hole" mutations for bispecific generation | Ophthalmology | Neovascular age-related macular degeneration, diabetic macular edema | EU review | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | ||||
| Tebentafusp | KIMMTRAK | gp100, CD3 | TCR-scFv fusion protein | Bispecific | Humanized | hscFV fused with a TCR | To be confirmed | Fusion protein | None | - | Oncology | Metastatic uveal melanoma | 2022 | 2022 | US, 2022 | To be confirmed | ||||
| Tislelizumab | (Pending) | PD-1 | Full-length antibody | Monospecific | Humanized | hIgG4 | kappa | Unconjugated | S228P; E233P, F234V, L235A, D265A | Hinge stabilising; Abrogate FcγRs binding | Oncology | Esophageal squamous cell carcinoma | EU review | In review | To be confirmed | |||||
| Relatlimab | Opdualag | LAG-3 | Full-length antibody | Monospecific | Human | hIgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Oncology | Melanoma | EU review | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | ||||
| Lecanemab | (Pending) | Amyloid beta protofibrils | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | NA | In review | To be confirmed | |||||
| Casirivimab + imdevimab | REGEN-COV, Ronapreve | SARS-CoV-2 | Full-length antibodies, mixture of 2 | Monospecific | Human | hIgG1 | kappa and lambda | Unconjugated | None | - | Infectious diseases | COVID-19 | 2021 | In review | Japan, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Regdanvimab | Regkirona | SARS-CoV-2 | Full-length antibody | Monospecific | Human | hIgG1 | lambda | Unconjugated | None | - | Infectious diseases | COVID-19 | 2021 | NA | Republic of Korea, 2021 | Chinese hamster ovary (CHO)-K1 cells | ||||
| Spesolimab | (Pending) | IL-36 receptor | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | L234A/L235A | Remove Fc effector functions | Immunology | Generalized pustular psoriasis | EU review | In review | To be confirmed | |||||
| Donanemab | (Pending) | Amyloid beta, N3pG (N-terminal truncated) | Full-length antibody | Monospecific | Humanized | hIgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | NA | In review | To be confirmed | |||||
| Sotrovimab | Xevudy | SARS-CoV-2 | Full-length antibody | Monospecific | Human | hIgG1 | kappa | Unconjugated | M428L /N434S | Extends half-life | Infectious diseases | COVID-19 | 2021 | NA | Australia, 2021 | Chinese hamster ovary (CHO) cells | ||||
| Teclistamab | (Pending) | BCMA, CD3 | Full-length antibody | Bispecific | Humanized | IgG4; Hetero H, HL exchanged | lambda | Unconjugated | Hetero HH: F405L-R409K x WT (R409); both chains: S228P and F234A, L235A | Hinge-stabilising (S228P) and Fc-silencing (F234A, L235A) | Oncology | Multiple myeloma | EU review | In review | To be confirmed | |||||
| Mosunetuzumab | Lunsumio | CD20, CD3 | Full-length antibody | Bispecific | Humanized | IgG1; Hetero H, HL assembly | kappa | Unconjugated | Hetero HH: T366W x T366S-L368A-Y407V (KiH); N297G (Fc-aglycosylated) | Improve FcγRIIIa binding/Improve ADCC | Oncology | Follicular lymphoma | 2022 | NA | EU, 2022 | To be confirmed | ||||
| Tremelimumab | (Pending) | CTLA-4 | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Oncology | Antineoplastic; liver cancer | EU review | In review | To be confirmed | |||||
| Nirsevimab | (Pending) | RSV | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E | Extends half-life | Infectious diseases | Respiratory syncytial virus infection | EU review | NA | To be confirmed | |||||
| Tixagevimab, cilgavimab | Evusheld | SARS-CoV-2 | Full-length antibodies, mixture of 2 | Monospecific | Human | IgG1 | kappa | Unconjugated | L234F L235E M252Y S254T T256E P331S | Reduce Fc effector function (L234F L235E P331S) and extend half-life ( M252Y S254T T256E) | Infectious diseases | COVID-19 | 2022 | EUA granted | EU, 2022 | Chinese hamster ovary (CHO) cells | ||||
| Mirvetuximab soravtansine | (Pending) | Folate receptor alpha | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | DM4 | Tubulin polymerization inhibitor | None | - | Oncology | Ovarian cancer | NA | In review | To be confirmed | |||
| Nimotuzumab | TheraCIM, BIOMAB-EGFR | EGFR | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Oncology | Head and neck cancer | NA | NA | Cuba, 2002 | To be confirmed | ||||
| Itolizumab | Alzumab | CD6 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immunology | Psoriasis | NA | NA | India, 2013 | To be confirmed | ||||
| RabiShield | Rabies virus G glycoprotein | Full-length antibody | Monospecific | Human | IgG1 | Unconjugated | Infectious disease | Rabies exposure | NA | NA | India, 2016 | To be confirmed | ||||||||
| Docaravimab and Miromavimab | Twinrab | Rabies virus | Full-length antibody | Two monospecific antibodies | Murine | IgG2b and IgG1 | kappa | Unconjugated | None | - | Infectious disease | Rabies exposure | NA | NA | India, 2019 | To be confirmed | ||||
| Camrelizumab | AiRuiKa | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Oncology | Hodgkin's lymphoma | NA | NA | China, 2019 | To be confirmed | ||||
| Inetetamab | Cipterbin | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | Unconjugated | Enhanced ADCC/ADCP (exact mutations not found) | Oncology | HER2-positive metastatic breast cancer | NA | NA | China, 2020 | To be confirmed | ||||||
| Disitamab vedotin | Aidixi | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | cleavable maleimidocaproyl-valyl-citrullinyl-p-amiobenzyloxycarbonyl (mc-val-cit-PABC) type linker | MMAE | None | - | Oncology | Gastric cancer | NA | NA | China, 2021 | To be confirmed | ||
| Envafolimab | ENWEIDA | PD-L1 | Single domain antibody-Fc | Monospecific | Humanized single doman; human Fc | IgG1 | Unconjugated | C220S/D265A/P331S | Reduce Fc effector function (ADCC/ADCP) | Oncology | Microsatellite instability-high or deficient MisMatch Repair advanced solid tumors | NA | NA | China, 2021 | To be confirmed | |||||
| Sugemalimab | Cejemly® | PD-L1 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilisation | Oncology | Non-small cell lung cancer | NA | NA | China, 2021 | To be confirmed | ||||
| Zimberelimab | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilisation | Oncology | Classical Hodgkin’s lymphoma | NA | NA | China, 2021 | To be confirmed | |||||
| Amubarvimab + Romlusevimab | SARS-CoV-2 | Full-length antibody | Two monospecific antibodies | Human | IgG1 | kappa and lambda2 | Unconjugated | M252Y/S254T/T256E | Half-life extension | Infectious disease | SARS-CoV-2 infection | NA | NA | China, 2021 | To be confirmed | |||||
| Cetuximab saratolacan | Akalux® IV Infusion | EGFR | Full-length antibody | Monospecific | Chimeric | IgG1 | kappa | Photoimmunotherapy | IRDye® 700DX | None | - | Oncology | Head and neck cancer | NA | NA | Japan, 2020 | To be confirmed | |||
| Pabinafusp alfa | IZCARGO | Transferrin receptor | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Immunoconjugate | Iduronate-2-sulfatase | None | - | Metabolic disorders | Mucopolysaccharidosis type II | NA | NA | Japan, 2021 | To be confirmed | |||
| Netakimab | Efleira | IL-17 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y/S254T/T256E | Half-life extension | Immunology | Plaque psoriasis | NA | NA | Russia, 2019 | To be confirmed | ||||
| Levilimab | Ilsira | IL-6 receptor | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | E233P/L234V/L235A and M252Y/S254T/T256E | Reduce Fc effector function and extend half-life | Immunology | Inflammation due to COVID-19 infection | NA | NA | Russia, 2020 | To be confirmed | ||||
| Olokizumab | ARTLEGIA | IL-6 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Immunology | Rheumatoid arthritis | NA | NA | Russia, 2020 | To be confirmed | ||||
| Prolgolimab | Forteca | PD-1 | Full-length antibody | Monospecific | Human | IgG1 | V-lambda C-kappa | Unconjugated | L234A/L235A | Reduce Fc effector function | Oncology | Melanoma | NA | NA | Russia, 2020 | To be confirmed | ||||
| Cadonilimab | PD-1, CTLA4 | Full-length antibody | Bispecific | Humanized | IgG1 | kappa | Unconjugated | L234A/L235A/G237A | Reduce Fc effector function | Oncology | Cervical cancer | NA | NA | China, 2022 | To be confirmed | |||||
| Geptanolimab (Genolimzumab) | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Oncology | Peripheral T cell lymphoma | NA | NA | Regulatory review in China | To be confirmed | |||||
| Ripertamab | CD20 | Full-length antibody | Monospecific | Chimeric | IgG1 | kappa | Unconjugated | None | - | Oncology | Non-Hodgkin's lymphoma | NA | NA | Regulatory review in China | To be confirmed | |||||
| Serplulimab | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Oncology | Microsatellite instability-high solid tumors | NA | NA | China, 2022 | To be confirmed | |||||
| Socazolimab | PD-L1 | Full-length antibody | Monospecific | Human | IgG1 | lambda2 | Unconjugated | None | - | Oncology | Cervical cancer | NA | NA | Regulatory review in China | To be confirmed | |||||
| Ozoralizumab | TNF, albumin | Nanobody | Bispecific | Humanized | Unconjugated | None | - | Immunology | Rheumatoid arthritis | NA | NA | Regulatory review in Japan | To be confirmed | |||||||
| Nemolizumab | Mitchga. | IL-31 receptor alpha | Full-length antibody | Monospecific | Humanized | IgG2 | kappa | Unconjugated | C222S and H268Q | Structure stability, possibly reduce Fc effector function | Immunology | Pruritus with atopic dermatitis | NA | NA | Japan, 2022 | To be confirmed | ||||
| Ormutivimab | Rabies virus surface glycoprotein 4 | Full-length antibody | Monospecific | Human | IgG1 | lambda2 | Unconjugated | None | - | Infectious disease | Post-exposure prophylaxis of rabies | NA | NA | China, 2022 | Chinese hamster ovary (CHO)-K1 cell s | |||||
| Glofitamab | CD20, CD3e | CrossMab; Fab-Fc(G1) x Fab-Fab-Fc | Bispecific | IgG1 | lambda/kappa | Unconjugated | Hetero HH: S354C-T366W x Y349C-T366S-L368A-Y407V (KiH and extra cysteines); HL-pairing: CrossMab; both chains: L234A, L235A, P329G (Fc-silencing) | Chain pairing, Fc silencing | Oncology | Diffuse large B-cell lymphoma | EU review | NA | NA | To be confirmed | ||||||
| Mirikizumab | (Pending) | IL-23p19 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P; F234A, L235A | Hinge stabilisation; Reduce Fc effector function | Immunology | Ulcerative colitis | EU review | In review | To be confirmed | |||||
Table notes: *, Country-specific approval. #, Withdrawn or marketing discontinued. NA, not approved or in review in the EU; not approved or information on review status not available in US.
Sequence and structure information can be accessed on the IMGT/mAb-DB website.
Antibody therapeutics that are approved for marketing in regions other than the EU or US include:
Nimotuzumab (TheraCIM®, BIOMAB-EGFR®), humanized anti-EGFR IgG1 approved in numerous countries for various forms of solid tumors starting in the 2000s.
Itolizumab (Alzumab), humanized anti-CD6 IgG1 approved in India in January 2013 for psoriasis;
Rmab (RabiShield), human anti-rabies virus G glycoprotein IgG1 approved in India in 2016 for post-exposure prophylaxis of rabies;
RabiMabs (Twinrab TM), mixture of 2 anti-rabies virus mAbs approved in India in 2019.
Sintilimab (Tyvyt), human IgG4 anti-PD-1 mAb approved in China in December 2018 for Hodgkin’s lymphoma;
Toripalimab (Tuoyi), humanized anti-PD-1 mAb approved in China in December 2018 for melanoma;
Camrelizumab, humanized anti-PD-1 mAb approved in China in 2019 for Hodgkin’s lymphoma;
Tislelizumab, humanized anti-PD-1 mAb, approved in China in December 2019 as a treatment for classical Hodgkin’s lymphoma;
Disitamab vedotin (Aidixi), anti-HER2 humanized ADC approved in China in June 2021 as a treatment for gastric cancer;
Penpulimab, ant-PD-1 humanized mAb approved in China in August 2021 for Hodgkin’s lymphoma;
Zimberelimab, anti-PD-1 human mAb approved in China in August 2021 for Hodgkin’s lymphoma.
Netakimab (Efleira), anti-IL-17 mAb approved in Russia in 2019 for plaque psoriasis;
Prolgolimab (Forteca), anti-PD-1 mAb approved in Russia in 2020 for melanoma;
Olokizumab (Artlegia), anti-IL-6 humanized IgG4 approved in Russia in 2020 for rheumatoid arthritis;
Levilimab (Ilsira) anti-IL-6R human mAb approved in Russia in 2020 for COVID-19.
Cetuximab saratolacan sodium, anti-EGFR mAb approved in Japan in September 2020 for head and neck cancer;
Pabinafusp alfa (IZCARO), anti-transferrin receptor inmmunoconjuate approve in Japan in March 2021 for Hunter syndrome.
Sotrovimab, anti-SARS-CoV-2 antibody approved in Australia in August 2021.
Regdanvimab, anti-SARS-CoV-2 antibody approved in the Republic of Korea in September 2021.
