The Antibody Society continuously collects data for approved antibody therapeutics and those in regulatory review in any country. 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 Products that were granted approvals but subsequently withdrawn from the market are included in the table.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 created the data table below.
The table below is an interactive table that can be filtered based on multiple conditions. Please use the filtering criteria above the table and type in the search boxes in the header of each column.
Scroll right to see all the columns.
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
Questions, comments, corrections? Please contact us at info@antibodysociety.com!
INN | Brand Name | Target | Format | Specificity | Sequence source | Backbone | Light Chain | Conjugated / unconjugated | 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) or country in review | Expression system |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[fam-]trastuzumab deruxtecan, (fam-trastuzumab deruxtecan-nxki) | Enhertu | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Glycine-Glycine-Phenylalanine-Glycine (GGFG; Cleavable linker) | DXd | topoisomerase I inhibitor | None | - | Cancer | HER2+ metastatic breast cancer | 2021 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells |
Abciximab | Reopro | GPIIb/IIIa | Fab | Monospecific | Chimeric mouse/human | Fab (CH1 IgG1) | kappa | Unconjugated | Not applicable | - | Cardiovascular / hemostasis | Prevention of blood clots in angioplasty | 1995* | 1994 | US, 1994 | Murine myeloma cells (Sp2/0) | |||
Adalimumab | Humira | TNF | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Rheumatoid arthritis | 2003 | 2002 | US, 2002 | Chinese hamster ovary (CHO) cells | |||
Adebrelimab | Arebelimab | PD-L1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P, F234A, L235A | Hinge stabilisation; abrogate effector function | Cancer | Small cell lung cancer | NA | NA | China, 2023 | To be confirmed | |||
Ado-trastuzumab emtansine | Kadcyla | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Non-cleavable SMCC thioether linker | DM1 | tubulin polymerization inhibitor | None | - | Cancer | Breast cancer | 2013 | 2013 | US, 2013 | Chinese hamster ovary (CHO) cells |
Aducanumab | ADUHELM | Amyloid beta | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | MAA withdrawn | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | |||
Alemtuzumab | Lemtrada; MabCampath, Campath-1H | CD52 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Multiple sclerosis; chronic myeloid leukemia# | 2013; 2001# | 2014; 2001# | US, 2001 | Chinese hamster ovary (CHO) cells | |||
Alirocumab | Praluent | PCSK9 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Metabolic disorders | High cholesterol | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | |||
Amivantamab | RYBREVANT | EGFR, cMET | Full-length antibody | Bispecific | Human | IgG1 | kappa | Unconjugated | Low-fucose; K409R; F405L | Improve FcγRIIIa binding/Improve ADCC; Controlled Fab arm exchange for bispecific generation | Cancer | NSCLC w/ EGFR exon 20 insertion mutations | 2021 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells, Low-fucose production cells | |||
Amubarvimab + Romlusevimab | SARS-CoV-2 | Full-length antibody | Mixture of 2 monospecific antibodies | Human | IgG1 | kappa and lambda2 | Unconjugated | M252Y/S254T/T256E | Half-life extension | Infectious diseases | SARS-CoV-2 infection | NA | NA | China, 2021# | To be confirmed | ||||
Anifrolumab, anifrolumab-fnia | Saphnelo | IFNAR1 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | L234F; L235E; P331S | Reduce Fc effector functions | Immune-mediated disorders | Systemic lupus erythematosus | 2022 | 2021 | US, 2021 | Mouse myeloma cells (NS0) | |||
Ansuvimab-zykl | Ebanga | Ebola virus glycoprotein | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Infectious diseases | Ebola virus infection | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Atezolizumab | Tecentriq | PD-L1 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Aglycosylated (N297A) | Aglycosylation, remove Fc effector functions | Cancer | Bladder cancer | 2017 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | |||
Atoltivimab, maftivimab, and odesivimab-ebgn | Inmazeb | Ebola virus | Full-length antibodies, mixture of 3 | Mixture of 3 monospecific antibodies | Human | IgG1 | kappa | Unconjugated | None | - | Infectious diseases | Ebola virus infection | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Avelumab | Bavencio | PD-L1 | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Cancer | Merkel cell carcinoma | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Basiliximab | Simulect | IL-2R | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Prevention of kidney transplant rejection | 1998 | 1998 | US, 1998 | Murine myeloma non-secreting 0 (NS0) cells | |||
Batoclimab | FcRn | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | L234A, L235A | Reduce Fc effector functions | Immune-mediated disorders | Generalized myasthenia gravis (gMG) | NA | NA | Regulatory review in China | To be confirmed | ||||
Belantamab mafodotin (belantamab mafodotin-blmf) | BLENREP | BCMA | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | noncleavable maleimidocaproyl (mc) linker | Monomethyl Auristatin F (MMAF) | tubulin polymerization inhibitor | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Cancer | Multiple myeloma | 2020 | 2020# | US, 2020 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) |
Belimumab | Benlysta | BLyS | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Immune-mediated disorders | Systemic lupus erythematosus | 2011 | 2011 | US, 2011 | Murine myeloma non-secreting 0 (NS0) cells | |||
Benralizumab | Fasenra | IL-5R α | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Immune-mediated disorders | Asthma | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | |||
Bevacizumab | Avastin | VEGF-A | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Colorectal cancer | 2005 | 2004 | US, 2004 | Chinese hamster ovary (CHO) cells | |||
Bezlotoxumab | Zinplava | Clostridium difficile enterotoxin B | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Infectious diseases | Prevention of Clostridium difficile infection recurrence | 2017 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | |||
Bimekizumab (bimekizumab-bkzx) | Bimzelx | IL-17A and IL-17F (overlapping binding site) | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Psoriasis | 2021 | 2023 | EU, 2021 | Chinese hamster ovary (CHO) cells | |||
Blinatumomab | Blincyto | CD19, CD3 | Tandem scFv | Bispecific | Murine | Tandem scFv | NA | Unconjugated | Not applicable | - | Cancer | Acute lymphoblastic leukemia | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | |||
Brentuximab vedotin | Adcetris | CD30 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | ADC | protease cleavable linker (Cathepsin cleavable valine-citrulline) | Monometyl auristan E (MMAE) | tubulin polymerization inhibitor | None | - | Cancer | Hodgkin lymphoma, systemic anaplastic large cell lymphoma | 2012 | 2011 | US, 2011 | Chinese hamster ovary (CHO) cells |
Brodalumab | Siliq, LUMICEF, Kyntheum | IL-17R | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Immune-mediated disorders | Plaque psoriasis | 2017 | 2017 | Japan, 2016 | Chinese hamster ovary (CHO) cells | |||
Brolucizumab (brolucizumab-dbll) | Beovu | VEGF-A | scFv | Monospecific | Humanized | scFv | kappa | Unconjugated | Not applicable | - | Ophthalmology | Neovascular age-related macular degeneration | 2020 | 2019 | US, 2019 | E. coli BL21(DE3) bacteria | |||
Burosumab (burosumab-twza) | Crysvita | FGF23 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Genetic Diseases | X-linked hypophosphatemia | 2018 | 2018 | EU, 2018 | Chinese hamster ovary (CHO) cells | |||
Cadonilimab | 开坦尼® | PD-1, CTLA4 | Full-length antibody | Bispecific | Humanized | IgG1 | kappa | Unconjugated | L234A/L235A/G237A | Reduce Fc effector function | Cancer | Cervical cancer | NA | NA | China, 2022 | To be confirmed | |||
Camrelizumab | AiRuiKa | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Cancer | Hodgkin's lymphoma | NA | In review | China, 2019 | To be confirmed | |||
Canakinumab | Ilaris | IL-1β | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Genetic Diseases | Muckle-Wells syndrome | 2009 | 2009 | US, 2009 | Murine myeloma cells (Sp2/0) | |||
Caplacizumab (caplacizumab-yhdp) | Cablivi | von Willebrand factor | VHH (bivalent) | Monospecific | Humanized | VHH (bivalent) | NA | Unconjugated | Not applicable | - | Immune-mediated disorders | Acquired thrombotic thrombocytopenic purpura | 2018 | 2019 | EU, 2018 | E. coli bacteria | |||
Casirivimab + imdevimab | REGEN-COV, Ronapreve | SARS-CoV-2 | Full-length antibodies, mixture of 2 | Mixture of 2 monospecific antibodies | Human | IgG1 | kappa and lambda | Unconjugated | None | - | Infectious diseases | COVID-19 | 2021 | EUA# | Japan, 2021 | Chinese hamster ovary (CHO) cells | |||
Catumaxomab | Korjuny, Removab | EPCAM, CD3 | Full-length antibody | Bispecific | Hybrid Rat/Mouse | mIgG2a/k and rIgG2b/λ Hybrid | kappa/lambda | Unconjugated | None | - | Cancer | Malignant ascites | 2024 Pos. opinion after review; 2009# | NA | EU, 2009 | Rat-mouse hybrid-hybridoma cell line | |||
Cemiplimab (cemiplimab-rwlc) | Libtayo | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Cutaneous squamous cell carcinoma | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Certolizumab pegol | Cimzia | TNF | PEGylated Fab | Monospecific | Humanized | Fab (CH1 IgG1) | kappa | PEGylated | PEG | extend half life | Not applicable | - | Immune-mediated disorders | Crohn disease | 2009 | 2008 | US, 2008 | E. coli bacteria | |
Cetuximab | Erbitux | EGFR | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Cancer | Colorectal cancer | 2004 | 2004 | Switzerland, 2003 | Murine myeloma cells (Sp2/0) | |||
Cetuximab saratolacan | Akalux® IV Infusion | EGFR | Full-length antibody | Monospecific | Chimeric | IgG1 | kappa | Photoimmunotherapy | IRDye® 700DX | None | - | Cancer | Head and neck cancer | NA | NA | Japan, 2020 | To be confirmed | ||
Concizumab | Alhemo™ | Tissue factor pathway inhibitor | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge-stabilization | Cardiovascular / hemostasis | Hemophilia A or B | Pos. opinion after review | In Review | Canada, 2023 | To be confirmed | |||
Cosibelimab | (Pending) | PD-L1 | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | Cancer | Squamous cell carcinoma | NA | In review | To be confirmed | |||||
Crizanlizumab (crizanlizumab-tmca) | Adakveo | CD62 (aka P-selectin) | Full-length antibody | Monospecific | Humanized | IgG2 | kappa | Unconjugated | None | - | Cardiovascular / hemostasis | Sickle cell disease | 2020# | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells | |||
Crovalimab | 派圣凯®, PiaSky | Complement C5 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L235R, G236R, S239K, A327G, A330S, P331S; M428L, N434A, Q438R, S440E | Impair Fc binding/effector functions; increase FcnR binding without increasing RF binding | Cardiovascular / hemostasis | Atypical hemolytic uremic syndrome | 2024 | 2024 | China, 2024 | To be confirmed | |||
Daclizumab | Zinbryta; Zenapax | CD25 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Multiple sclerosis#; prevention of kidney transplant rejection# | 2016#; 1999# | 2016#; 1997# | US, 1997 | Murine myeloma non-secreting 0 (NS0) cells | |||
Daratumumab | Darzalex | CD38 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Multiple myeloma | 2016 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | |||
Denosumab | Prolia | RANK-L | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Musculoskeletal Disorders | Bone Loss | 2010 | 2010 | EU, 2010 | Chinese hamster ovary (CHO) cells | |||
Dinutuximab | Unituxin | GD2 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Cancer | Neuroblastoma | 2017; 2015# | 2015 | US, 2015 | Murine myeloma cells (Sp2/0) | |||
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 | - | Cancer | Gastric cancer | NA | NA | China, 2021 | To be confirmed | |
Divozilimab | Ivlizi | CD20 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | Immune-mediated disorders | Multiple sclerosis | NA | NA | Russia, 2023 | To be confirmed | ||||
Docaravimab and Miromavimab | Twinrab | Rabies virus | Full-length antibody, mixture of 2 | Mixture of 2 monospecific antibodies | Murine | mIgG2b and mIgG1 | kappa | Unconjugated | None | - | Infectious diseases | Rabies exposure | NA | NA | India, 2019 | To be confirmed | |||
Donanemab | Kisunla | Amyloid beta, N3pG (N-terminal truncated) | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | EU review | 2024 | US, 2024 | To be confirmed | |||
Dostarlimab | Jemerli | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Endometrial cancer | 2021 | 2021 | EU, 2021 | Chinese hamster ovary (CHO) cells | |||
Dupilumab | Dupixent | IL-4Rα | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Immune-mediated disorders | Atopic dermatitis | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Durvalumab | IMFINZI | PD-L1 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | L234F; L235E; P331S | Reduce Fc effector functions | Cancer | Bladder cancer | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Ebronucimab | 伊喜宁 | PCSK9 | Full-length antibody | Monospecific | Human | IgG1 | lambda2 | Unconjugated | None | Metabolic disorders | Primary hypercholesterolemia and mixed hyperlipidemia, and heterozygous familial hypercholesterolemia | NA | NA | China, 2024 | To be confirmed | ||||
Eculizumab | Soliris | Complement C5 | Full-length antibody | Monospecific | Humanized | IgG2(CH1-hinge)/IgG4(CH2-CH3) | kappa | Unconjugated | None | - | Cardiovascular / hemostasis | Paroxysmal nocturnal hemoglobinuria | 2007 | 2007 | US, 2007 | Murine myeloma non-secreting 0 (NS0) cells | |||
Edrecolomab | Panorex | EpCAM | Full-length antibody | Monospecific | Murine | mIgG2a | kappa | Unconjugated | None | - | Cancer | Colon cancer | 1995*# | NA | Germany, 1995 | To be confirmed | |||
Efalizumab | Raptiva | CD11a | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Psoriasis | 2004# | 2003# | US, 2003 | Chinese hamster ovary (CHO) cells | |||
Elotuzumab | Empliciti | SLAMF7 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Multiple myeloma | 2016 | 2015 | US, 2015 | Murine myeloma non-secreting 0 (NS0) cells | |||
Elranatamab | Elrexfio | BCMA, CD3 | Full-length antibody | Bispecific | Humanized | IgG2 | kappa | Unconjugated | : IgG1RRR: 221R, 228R, K409R or IgG2deltaA-RRRR: 223R, 225R, 228R, K409R; Target antibody: IgG1EEE: 221E, 228E, L368E or IgG2deltaA-EEEE: 223E, 225E, 228E, L368E, Exchange with 1-2 mM GSH). | Strop Fab-arm exchange method | Cancer | Multiple myeloma | 2023 | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Emapalumab (emapalumab-lzsg) | Gamifant | IFNg | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Cancer | Primary hemophagocytic lymphohistiocytosis | NA | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Emicizumab | Hemlibra | Factor IXa, Factor X | Full-length antibody | Bispecific | Humanized | IgG4 | kappa | Unconjugated | S228P; K196Q; F296Y; E356K; K439E; L445P; G446 > del; K447 > del | Hinge stabilising, asymmetric electrostatic steering mutations for bispecific creation | Cardiovascular / hemostasis | Hemophilia A | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Enfortumab vedotin (enfortumab vedotin-ejfv) | Padcev | Nectin-4 | Full-length antibody | Monospecific | Human | IgG1 | kappa | ADC | Protease-cleavable Valine-Citrulline (mc-val-cit PABC linker | Monomethyl Auristatin E (MMAE) | tubulin polymerization inhibitor | None | - | Cancer | Urothelial cancer | 2022 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells |
Enlonstobart | Enshuxing, 恩舒幸® | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Cervical cancer | NA | NA | China, 2024 | Chinese hamster ovary (CHO) cells | |||
Envafolimab | ENWEIDA | PD-L1 | VHH-Fc | Monospecific | Humanized single doman; human Fc | VHH-Fc (Fc IgG1) | Unconjugated | C220S/D265A/P331S | Reduce Fc effector function (ADCC/ADCP) | Cancer | Microsatellite instability-high or deficient MisMatch Repair advanced solid tumors | NA | NA | China, 2021 | To be confirmed | ||||
Epcoritamab | TEPKINLY, EPKINLY™ | CD20, CD3 | Full-length antibody | Bispecific | Humanized | IgG1; Hetero H | lambda/kappa | Unconjugated | Hetero HH, HL exchanged: L234F x K409R (bispecific assembly) both chains L234F, L235E, D265A (Fc silencing) | Chain pairing, Reduce Fc effector function | Cancer | Diffuse large B-cell lymphoma | 2023 | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Eptinezumab (eptinezumab-jjmr) | VYEPTI | CGRP | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Aglycosylated (N297A) | Aglycosylation, remove Fc effector functions | Neurological disorders | Migraine prevention | 2022 | 2020 | US, 2020 | Pichia pastoris yeast cells | |||
Erenumab (erenumab-aooe) | Aimovig | CGRP receptor | Full-length antibody | Monospecific | Human | IgG2 | lambda | Unconjugated | None | - | Neurological disorders | Migraine prevention | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Evinacumab | Evkeeza | Angiopoietin-like 3 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Metabolic disorders | Homozygous familial hypercholesterolemia | 2021 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | |||
Evolocumab | Repatha | PCSK9 | Full-length antibody | Monospecific | Human | IgG2 | lambda | Unconjugated | None | - | Metabolic disorders | High cholesterol | 2015 | 2015 | EU, 2015 | Chinese hamster ovary (CHO) cells | |||
Faricimab, faricimab-svoa | Vabysmo | VEGF-A, Ang-2 | Full-length antibody | Bispecific | Humanized/human | IgG1 | kappa/lambda | Unconjugated | L234A; L235A; P329G; I253A; H310A; H435A; S354C + T366W (in heavy chain A); Y349C + T366S + L368A + Y407V (in heavy chain B) | Reduce Fc effector functions; Reduce half-life; CrossMab "knob-in-hole" mutations for bispecific generation | Ophthalmology | Neovascular age-related macular degeneration, diabetic macular edema | 2022 | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | |||
Fremanezumab (fremanezumab-vfrm) | Ajovy | CGRP | Full-length antibody | Monospecific | Humanized | IgG2Δa | kappa | Unconjugated | A330S; P331S | Reduce Fc effector functions | Neurological disorders | Migraine prevention | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Galcanezumab (galcanezumab-gnlm) | Emgality | CGRP | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P; F234A; L235A | Remove Fc effector functions | Neurological disorders | Migraine prevention | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Gemtuzumab ozogamicin | Mylotarg | CD33 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | ADC | Acid-labile hydrozone linker | Calicheamicin | DNA-binding and double breaks induction | S228P | Hinge stabilising | Cancer | Acute myeloid leukemia | 2018 | 2017; 2000# | US, 2000 | Murine myeloma non-secreting 0 (NS0) cells |
Glofitamab | COLUMVI® | CD20, CD3e | Fab-Fc x Fab-Fab-Fc | Bispecific | Humanized | IgG1; CrossMab; Fab-Fc(G1) x Fab-Fab-Fc | 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, Reduce Fc effector function | Cancer | Diffuse large B-cell lymphoma | 2023 | 2023 | Canada, 2023 | Chinese hamster ovary (CHO) cells | |||
Golimumab | Simponi | TNF | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 | 2009 | US, 2009 | Murine myeloma cells (Sp2/0) | |||
Guselkumab | TREMFYA | IL-23 p19 | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Immune-mediated disorders | Plaque psoriasis | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Ibalizumab (ibalizumab-uiyk) | Trogarzo | CD4 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | None | - | Infectious diseases | HIV infection | 2019 | 2018 | US, 2018 | Murine myeloma non-secreting 0 (NS0) cells | |||
Ibritumomab tiuxetan | Zevalin | CD20 | Full-length antibody | Monospecific | Murine | mIgG1 | kappa | RIC | chalating agent MX-DTPA | Yttrium-90 | Y-90 produces beta emissions | None | - | Cancer | Non-Hodgkin lymphoma | 2004 | 2002 | US, 2002 | Chinese hamster ovary (CHO) cells |
Idarucizumab | Praxbind | Dabigatran | Fab | Monospecific | Humanized | Fab (CH1 IgG1) | kappa | Unconjugated | Not applicable | - | Cardiovascular / hemostasis | Reversal of dabigatran-induced anticoagulation | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | |||
Inebilizumab (inebilizumab-cdon) | Uplizna | CD19 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Immune-mediated disorders | Neuromyelitis optica spectrum disorders | 2022 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | |||
Infliximab | Remicade | TNF | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Crohn disease | 1999 | 1998 | US, 1998 | Murine myeloma cells (Sp2/0) | |||
Inotuzumab ozogamicin | BESPONSA | CD22 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | ADC | Acid-labile hydrozone linker | Calicheamicin | DNA-binding and double breaks induction | S228P | Hinge stabilising | Cancer | Acute lymphoblastic leukemia | 2017 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells |
Ipilimumab | Yervoy | CTLA-4 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Metastatic melanoma | 2011 | 2011 | US, 2011 | Chinese hamster ovary (CHO) cells | |||
Isatuximab (isatuximab-irfc) | Sarclisa | CD38 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Cancer | Multiple myeloma | 2020 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Itolizumab | Alzumab | CD6 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Psoriasis | NA | NA | India, 2013 | To be confirmed | |||
Ixekizumab | Taltz | IL-17A | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Immune-mediated disorders | Psoriasis | 2016 | 2016 | US, 2016 | Chinese hamster ovary (CHO) cells | |||
Lanadelumab (lanadelumab-flyo) | Takhzyro | Plasma kallikrelin | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Genetic Diseases | Hereditary angioedema attacks | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Lebrikizumab | EBGLYSS | IL-13 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge-stabilization | Immune-mediated disorders | Atopic dermatitis | 2023 | In review | EU, 2023 | Chinese hamster ovary (CHO) cells | |||
Lecanemab | Leqembi | Amyloid beta protofibrils | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Neurological disorders | Alzheimer's disease | EU review | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Levilimab | Ilsira | IL-6R | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | E233P/L234V/L235A and M252Y/S254T/T256E | Reduce Fc effector function and extend half-life | Immune-mediated disorders | Inflammation due to COVID-19 infection | NA | NA | Russia, 2020 | To be confirmed | |||
Loncastuximab tesirine | Zynlonta | CD19 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Protease-cleavable Valine-Citrulline linker | pyrrolobenzodiazepines (PBD) dimer SG3199 | DNA minor-groove binding | None | - | Cancer | Diffuse large B-cell lymphoma | 2022 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells |
Margetuximab-cmkb | MARGENZA | HER2 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | F243L; R292P; Y300L; V305I; P396L | Improve FcγRIIIa binding/Improve ADCC and decrease affinity for human inhibitory FcγRIIB (CD32B) | Cancer | HER2+ metastatic breast cancer | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Mepolizumab | Nucala | IL-5 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Severe eosinophilic asthma | 2015 | 2015 | US, 2015 | Chinese hamster ovary (CHO) cells | |||
Mirikizumab | Omvoh | IL-23p19 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P; F234A, L235A | Hinge stabilisation; Reduce Fc effector function | Immune-mediated disorders | Ulcerative colitis | 2023 | 2023 | Japan, 2023 | Chinese hamster ovary (CHO) cells | |||
Mirvetuximab soravtansine | ELAHERE | FR𝛂 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | cleavable sulfo-SPDB linker | DM4 | Tubulin polymerization inhibitor | None | - | Cancer | Ovarian cancer | 2024 | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells |
Mogamulizumab (mogamulizumab-kpkc) | Poteligeo | CCR4 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Afucosylated | Improve FcγRIIIa binding/Improve ADCC | Cancer | Mycosis fungoides or Sézary syndrome | 2018 | 2018 | Japan, 2012 | Chinese hamster ovary (CHO) cells, FUT8−/− CHO cells (Potelligent® Technology) | |||
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) | KiH; aglycosylation, remove Fc effector functions | Cancer | Follicular lymphoma | 2022 | 2022 | EU, 2022 | Chinese hamster ovary (CHO) cells | |||
Moxetumomab pasudotox (moxetumomab pasudotox-tdfk) | Lumoxiti | CD22 | dsFv immunotoxin | Monospecific | Murine | dsFv fused with PE38 exotoxin | Immunoconjugate | PE38 | Not applicable | - | Cancer | Hairy cell leukemia | 2021# | 2018# | US, 2018 | E. coli bacteria | |||
Muromonab-CD3 | Orthoclone Okt3 | CD3 | Full-length antibody | Monospecific | Murine | mIgG2a | kappa | Unconjugated | None | - | Immune-mediated disorders | Reversal of kidney transplant rejection | 1986* | 1986# | US, 1986 | Murine hybridoma | |||
Narlumosbart | Jinlitai, 津立泰 | RANK-L | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Musculoskeletal Disorders | Giant cell tumor of bone | NA | NA | China, 2023 | Chinese hamster ovary (CHO) cells, cell line CHO-S, glycoform alfa | |||
Narsoplimab | (Pending) | MASP-2 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilising | Cardiovascular / hemostasis | Hematopoietic stem cell transplant-associated thrombotic microangiopathies | NA | In review | To be confirmed | ||||
Natalizumab | Tysabri | a4 integrin | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | None | - | Immune-mediated disorders | Multiple sclerosis | 2006 | 2004 | US, 2004 | Murine myeloma non-secreting 0 (NS0) cells | |||
Naxitamab-gqgk | DANYELZA | GD2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | High-risk neuroblastoma and refractory osteomedullary disease | NA | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Nebacumab | Centoxin | Endotoxin | Full-length antibody | Monospecific | Human | IgM | kappa | Unconjugated | None | - | Infectious diseases | Gram-negative sepsis | 1991*# | NA | Netherlands, England, France, Germany, 1991 | Heteromyeloma cell line A6(H4C5) | |||
Necitumumab | Portrazza | EGFR | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Non-small cell lung cancer | 2015 | 2015 | US, 2015 | Murine myeloma non-secreting 0 (NS0) cells | |||
Nemolizumab (nemolizumab-ilto) | Mitchga, Nemluvio | IL-31R𝛂 | Full-length antibody | Monospecific | Humanized | IgG2 | kappa | Unconjugated | C222S and H268Q | Structure stability, possibly reduce Fc effector function | Immune-mediated disorders | Pruritus with atopic dermatitis | EU review | 2024 | Japan, 2022 | To be confirmed | |||
Netakimab | Efleira | IL-17 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y/S254T/T256E | Half-life extension | Immune-mediated disorders | Plaque psoriasis | NA | NA | Russia, 2019 | To be confirmed | |||
Nimotuzumab | TheraCIM, BIOMAB-EGFR | EGFR | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Head and neck cancer | NA | NA | Cuba, 2002 | To be confirmed | |||
Nirsevimab | Beyfortus | RSV | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E | Extends half-life | Infectious diseases | Prevention of respiratory syncytial virus infection | 2022 | 2023 | EU, 2022 | Chinese hamster ovary (CHO) cells | |||
Nivolumab | Opdivo | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Melanoma, non-small cell lung cancer | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | |||
No INN; Cipterbin | Cipterbin | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | To be confirmed | Unconjugated | Enhanced ADCC/ADCP (exact mutations not found) | Cancer | HER2-positive metastatic breast cancer | NA | NA | China, 2020 | To be confirmed | ||||
No INN; RabiShield | RabiShield | Rabies virus G glycoprotein | Full-length antibody | Monospecific | Human | IgG1 | To be confirmed | Unconjugated | Infectious diseases | Rabies exposure | NA | NA | India, 2016 | To be confirmed | |||||
Obiltoxaximab | Anthim | B. anthrasis PA | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Infectious diseases | Prevention of inhalational anthrax | 2020 | 2016 | US, 2016 | Murine GS-NS0 myeloma cells | |||
Obinutuzumab | Gazyva, Gazyvaro | CD20 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Low-fucose | Improve FcγRIIIa binding/Improve ADCC | Cancer | Chronic lymphocytic leukemia | 2014 | 2013 | US, 2013 | Chinese hamster ovary (CHO) cells, Coexpression with GnT III and α-ManII in CHO cells (GlycoMAb Technology) | |||
Ocrelizumab | OCREVUS | CD20 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Multiple sclerosis | 2018 | 2017 | US, 2017 | Chinese hamster ovary (CHO) cells | |||
Ofatumumab | Arzerra | CD20 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Chronic lymphocytic leukemia | 2010# | 2009 | US, 2009 | Murine myeloma non-secreting 0 (NS0) cells | |||
Olaratumab | Lartruvo | PDGFRα | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Soft tissue sarcoma | 2016# | 2016 | US, 2016 | Murine myeloma non-secreting 0 (NS0) cells | |||
Olokizumab | ARTLEGIA | IL-6 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Immune-mediated disorders | Rheumatoid arthritis | NA | NA | Russia, 2020 | To be confirmed | |||
Omalizumab | Xolair | IgE | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Asthma | 2005 | 2003 | US, 2003 | Chinese hamster ovary (CHO) cells | |||
Ongericimab | 君适达® | PCSK9 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Metabolic disorders | Hypercholesterolemia | NA | NA | China, 2024 | To be confirmed | |||
Ormutivimab | (Pending) | Rabies virus surface glycoprotein 4 | Full-length antibody | Monospecific | Human | IgG1 | lambda2 | Unconjugated | None | - | Infectious diseases | Post-exposure prophylaxis of rabies | NA | NA | China, 2022 | Chinese hamster ovary (CHO)-K1 cells | |||
Ozoralizumab | NanozoraⓇ | TNF, albumin | VHH (trivalent) | Bispecific | Humanized | VH-VH'-VH | Unconjugated | None | - | Immune-mediated disorders | Rheumatoid arthritis | NA | NA | Japan, 2022 | 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 | ||
Palivizumab | Synagis | RSV | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Infectious diseases | Prevention of respiratory syncytial virus infection | 1999 | 1998 | US, 1998 | Murine myeloma non-secreting 0 (NS0) cells | |||
Panitumumab | Vectibix | EGFR | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Cancer | Colorectal cancer | 2007 | 2006 | US, 2006 | Chinese hamster ovary (CHO) cells | |||
Pembrolizumab | Keytruda | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Melanoma | 2015 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | |||
Penpulimab | ANNIKO | PD-1 | Full-length antibody | Monospecific | Humanized | IgG1 | To be confirmed | Unconjugated | L234A L235A G237A | Reduce Fc effector functions | Cancer | Metastatic nasopharyngeal carcinoma | NA | In review | China, 2021 | To be confirmed | |||
Pertuzumab | Perjeta | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Breast Cancer | 2013 | 2012 | US, 2012 | Chinese hamster ovary (CHO) cells | |||
Polatuzumab vedotin (polatuzumab vedotin-piiq) | Polivy | CD79b | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Protease-cleavable Valine-Citrulline (mc-val-cit PABC linker | Monomethyl Auristatin E (MMAE) | tubulin polimerization inhibitor | None | - | Cancer | Diffuse large B-cell lymphoma | 2020 | 2019 | US, 2019 | Chinese hamster ovary (CHO) cells |
Pozelimab | VEOPOZ | Complement C5 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Cardiovascular / hemostasis | CHAPLE disease | NA | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Prolgolimab | Forteca | PD-1 | Full-length antibody | Monospecific | Human | IgG1 | V-lambda C-kappa | Unconjugated | L234A/L235A | Reduce Fc effector function | Cancer | Melanoma | NA | NA | Russia, 2020 | To be confirmed | |||
Pucotenlimab | Puyouheng | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P, S254T, V308P, N434A | Hinge stabilsation, half-life extension | Cancer | Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, | NA | NA | China, 2022 | To be confirmed | |||
Racotumomab | Vaxira® | GM3 | Full-length antibody | Monospecific | Murine | mIgG1 | kappa | Unconjugated | - | - | Cancer | Non-small cell lung cancer | NA | NA | Cuba, 2013 | To be confirmed | |||
Ramucirumab | Cyramza | VEGFR2 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Cancer | Gastric cancer | 2014 | 2014 | US, 2014 | Murine myeloma non-secreting 0 (NS0) cells | |||
Ranibizumab | Lucentis | VEGF-A | Fab | Monospecific | Humanized | Fab (CH1 IgG1) | kappa | Unconjugated | Not applicable | - | Ophthalmology | Macular degeneration | 2007 | 2006 | US, 2006 | E. coli bacteria | |||
Ravulizumab (ravulizumab-cwvz) | Ultomiris | Complement C5 | Full-length antibody | Monospecific | Humanized | IgG2(CH1-hinge)/IgG4(CH2-CH3) | kappa | Unconjugated | M428L; N434S | Increase half-life | Cardiovascular / hemostasis | Paroxysmal nocturnal hemoglobinuria | 2019 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Raxibacumab | (Pending) | B. anthrasis PA | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Infectious diseases | Anthrax infection | NA | 2012 | US, 2012 | Murine myeloma non-secreting 0 (NS0) cells | |||
Regdanvimab | Regkirona | SARS-CoV-2 | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | None | - | Infectious diseases | COVID-19 | 2021 | NA | Republic of Korea, 2021 | Chinese hamster ovary (CHO)-K1 cells | |||
Relatlimab | Opdualag (relatlimab + nivolumab combo) | LAG-3 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Melanoma | 2022 | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | |||
Reslizumab | Cinqaero, Cinqair | IL-5 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | None | - | Immune-mediated disorders | Asthma | 2016 | 2016 | US, 2016 | Murine myeloma non-secreting 0 (NS0) cells | |||
Retifanlimab | Zynyz | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Merkel cell carcinoma | 2024 | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Ripertamab | Anpingxi | CD20 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Cancer | Non-Hodgkin's lymphoma | NA | NA | China, 2022 | To be confirmed | |||
Risankizumab (risankizumab-rzaa) | Skyrizi | IL-23 p19 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A; L235A | Reduce Fc effector functions | Immune-mediated disorders | Plaque psoriasis | 2019 | 2019 | Japan, 2019 | Chinese hamster ovary (CHO) cells | |||
Rituximab | MabThera, Rituxan | CD20 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Cancer | Non-Hodgkin lymphoma | 1998 | 1997 | US, 1997 | Chinese hamster ovary (CHO) cells | |||
Romosozumab (romosozumab-aqqg) | Evenity | Sclerostin | Full-length antibody | Monospecific | Humanized | IgG2 | kappa | Unconjugated | None | - | Musculoskeletal Disorders | Osteoporosis in postmenopausal women at increased risk of fracture | 2019 | 2019 | Japan, 2019 | Chinese hamster ovary (CHO) cells | |||
Rozanolixizumab | RYSTIGGO® | FcRn | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge-stabilization | Immune-mediated disorders | Generalized myasthenia gravis | 2024 | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells, DG44 | |||
Sacituzumab govitecan (sacituzumab govitecan-hziy) | TRODELVY | TROP-2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | pH-sensitive cleavable linker | SN38 | topoisomerase I inhibitor | None | - | Cancer | Triple-neg. breast cancer | 2021 | 2020 | US, 2020 | Murine myeloma cells |
Sarilumab | Kevzara | IL-6R | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Rheumatoid arthritis | 2017 | 2017 | Canada, 2017 | Chinese hamster ovary (CHO) cells | |||
Satralizumab (satralizumab-mwge) | Enspryng | IL-6R | Full-length antibody | Monospecific | Humanized | IgG2 | kappa | Unconjugated | None | - | Immune-mediated disorders | Neuromyelitis optica spectrum disorder | 2021 | 2020 | Canada, 2020 | Chinese hamster ovary (CHO) cells | |||
Secukinumab | Cosentyx | IL-17A | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Psoriasis | 2015 | 2015 | Japan, 2014 | Chinese hamster ovary (CHO) cells | |||
Serplulimab | Hetronifly, HANSIZHUANG | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Cancer | Microsatellite instability-high solid tumors | Pos. opinion after review | NA | China, 2022 | To be confirmed | |||
Siltuximab | Sylvant | IL-6 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Castleman disease | 2014 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | |||
Sintilimab | Tyvyt | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Non-small cell lung cancer | NA | In review | China, 2018 | To be confirmed | |||
Socazolimab | Shan Keyu | PD-L1 | Full-length antibody | Monospecific | Human | IgG1 | lambda2 | Unconjugated | None | - | Cancer | Cervical cancer | NA | NA | China, 2023 | To be confirmed | |||
Sotrovimab | Xevudy | SARS-CoV-2 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | M428L /N434S | Extends half-life | Infectious diseases | COVID-19 | 2021 | NA | Australia, 2021 | Chinese hamster ovary (CHO) cells | |||
Spesolimab | SPEVIGO® | IL-36R | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A/L235A | Reduce Fc effector functions | Immune-mediated disorders | Generalized pustular psoriasis | 2022 | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | |||
Sugemalimab | Cejemly® | PD-L1 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilisation | Cancer | Non-small cell lung cancer | 2024 | NA | China, 2021 | To be confirmed | |||
Sutimlimab (sutimlimab-jome) | Enjaymo | Complement C1s | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P; L235E | Hinge stabilising; remove Fc effector functions | Immune-mediated disorders | Cold agglutinin disease | 2022 | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | |||
Tafasitamab (tafasitamab-cxix) | Monjuvi, Minjuvi | CD19 | Full-length antibody | Monospecific | Humanized | IgG1/2 hybrid | kappa | Unconjugated | S239D; I332E | Improve FcγRIIIa binding/Improve ADCC | Cancer | Diffuse large B-cell lymphoma | 2021 | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Tafolecimab | SINTBILO | PCSK9 | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Metabolic disorders | Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia | NA | NA | China, 2023 | To be confirmed | |||
Tagitanlimab | (Pending) | PD-L1 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A L235A G237A | Reduce Fc effector function | Cancer | Nasopharyngeal carcinoma, solid tumor | NA | NA | Regulatory review in China | To be confirmed | |||
Talquetamab (talquetamab-tgvs) | Talvey | GPCR5D, CD3 | Full-length antibody | Bispecific | Humanized | IgG4 | lambda/kappa | Unconjugated | Hetero HH: F405L-R409K x WT; both chains: S228P, F234A-L235A | Hinge-stabilization (S228P), Reduce Fc effector function (F234A-L235A) | Cancer | Multiple myeloma | 2023 | 2023 | US, 2023 | Chinese hamster ovary (CHO) cells | |||
Tebentafusp | KIMMTRAK | gp100, CD3 | scFv-TCR fusion protein | Bispecific | Humanized | scFv fused with a TCR | To be confirmed | Immunoconjugate | None | - | Cancer | Metastatic uveal melanoma | 2022 | 2022 | US, 2022 | E. coli bacteria | |||
Teclistamab | TECVAYLI | 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) | Cancer | Multiple myeloma | 2022 | 2022 | EU, 2022 | Chinese hamster ovary (CHO) cells | |||
Teplizumab | TZIELD | CD3 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A; L235A | Reduce Fc effector functions | Immune-mediated disorders | Type 1 diabetes | NA | 2022 | US, 2022 | Chinese hamster ovary (CHO) cells | |||
Teprotumumab (teprotumumab-trbw) | Tepezza | IGF-1R | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Ophthalmology | Thyroid eye disease | EU review | 2020 | US, 2020 | Chinese hamster ovary (CHO) cells | |||
Tezepelumab | Tezspire | Thymic stromal lymphopoietin | Full-length antibody | Monospecific | Human | IgG2 | lambda | Unconjugated | None | - | Immune-mediated disorders | Severe asthma | 2022 | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells | |||
Tildrakizumab (tildrakizumab-asmn) | Ilumya | IL-23 p19 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Plaque psoriasis | 2018 | 2018 | US, 2018 | Chinese hamster ovary (CHO) cells | |||
Tislelizumab | Tevimbra | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P; E233P, F234V, L235A, D265A | Hinge stabilising; Abrogate FcγRs binding | Cancer | Esophageal squamous cell carcinoma | 2023 | 2024 | China, 2019 | Chinese hamster ovary (CHO) cells | |||
Tisotumab vedotin, tisotumab vedotin-tftv | TIVDAK | Tissue factor | Full-length antibody | Monospecific | Human | IgG1 | kappa | ADC | Cleavable mc-val-cit-PABC type linker | Monomethyl Auristatin E (MMAE) | tubulin polymerization inhibitor | None | - | Cancer | Cervical cancer | EU review | 2021 | US, 2021 | Chinese hamster ovary (CHO) cells |
Tixagevimab, cilgavimab | Evusheld | SARS-CoV-2 | Full-length antibodies, mixture of 2 | Mixture of 2 monospecific antibodies | 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# | EU, 2022 | Chinese hamster ovary (CHO) cells | |||
Tocilizumab | RoActemra, Actemra | IL-6R | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Rheumatoid arthritis | 2009 | 2010 | Japan, 2005 | Chinese hamster ovary (CHO) cells | |||
Toripalimab | LOQTORZI, Tuoyi | PD-1 | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilising | Cancer | Nasopharyngeal carcinoma | 2024 | 2023 | China, 2018 | Chinese hamster ovary (CHO) cells | |||
Tositumomab-I131 | Bexxar | CD20 | Full-length antibody | Monospecific | Murine | mIgG2a | lambda | RIC | Iodine-131 | I-131 produces beta and gamma emissions | None | - | Cancer | Non-Hodgkin Lymphoma | NA | 2003# | US, 2003 | Murine hybridoma | |
Tralokinumab | Adtralza | IL-13 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | None | - | Immune-mediated disorders | Atopic dermatitis | 2021 | 2021 | EU, 2021 | Mouse myeloma cells | |||
Trastuzumab | Herceptin | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Cancer | Breast cancer | 2000 | 1998 | US, 1998 | Chinese hamster ovary (CHO) cells | |||
Trastuzumab duocarmazine | (Pending) | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | cleavable linker-drug (vc-seco-DUBA) | Duocarmycin | DNA minor-groove-binding alkylation | None | - | Cancer | Breast cancer | MAA withdrawn | In review | To be confirmed | |
Tremelimumab | Imjudo | CTLA-4 | Full-length antibody | Monospecific | Human | IgG2 | kappa | Unconjugated | None | - | Cancer | Antineoplastic; liver cancer | 2023 | 2022 | US, 2022 | Murine myeloma non-secreting 0 (NS0) cells | |||
Ublituximab | BRIUMVI | CD20 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | Low fucose | Improve FcγRIIIa binding/Improve ADCC | Immune-mediated disorders | Multiple sclerosis | 2023 | 2022 | US, 2022 | YB2/0 cells | |||
Ustekinumab | Stelara | IL-12/23 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Psoriasis | 2009 | 2009 | EU, 2009 | Murine myeloma cells (Sp2/0) | |||
Vedolizumab | Entyvio | α4β7 integrin | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L235A, G237 | Reduce Fc effector functions | Immune-mediated disorders | Ulcerative colitis, Crohn disease | 2014 | 2014 | US, 2014 | Chinese hamster ovary (CHO) cells | |||
Zimberelimab | YuTuo® | PD-1 | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilisation | Cancer | Classical Hodgkin’s lymphoma | NA | NA | China, 2021 | To be confirmed | |||
Zolbetuximab | VYLOY | Claudin-18.2 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | Cancer | HER2-negative gastric or gastroesophageal junction adenocarcinoma | 2024 | 2024 | Japan, 2024 | To be confirmed | ||||
Zuberitamab | Enrexib | CD20 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | Cancer | CD20-positive diffuse large B-cell lymphoma | NA | NA | China, 2023 | To be confirmed | ||||
Odronextamab | Ordspono | CD20, CD3 | Full-length antibody | Bispecific | Human | IgG4 Hetero H, cL | kappa | Unconjugated | Hetero HH: WT x H435R-Y436F; HL-pairing: cL ; both chains: E233P, F234V, L235A, G236del; S228P | Hetero HH: WT x H435R-Y436F (limits binding of the anti-CD3 Fc to Protein A, purification); HL-pairing: cL ; both chains: E233P, F234V, L235A, G236del (Fc-silencing), S228P (hinge-stabilization) | Cancer | Relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma | 2024 | In review | EU, 2024 | Chinese hamster ovary (CHO) cells | |||
Recaticimab | (Pending) | PCSK9 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E | Extends half-life | Metabolic disorders | Hypercholesterolemia | NA | NA | Regulatory review in China | To be confirmed | |||
Vunakizumab | (Pending) | IL-17A | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | Immune-mediated disorders | Psoriasis | NA | NA | China, 2024 | To be confirmed | ||||
Ivonescimab | 依達方® | PD-1, VEGF | Full-length IgG1 kappa - [scFv]2 | Bispecific | IgG1 | kappa | Unconjugated | L234A, L235A | Reduce Fc effector functions | Cancer | Non-small cell lung cancer | NA | NA | China, 2024 | To be confirmed | ||||
Ebdarokimab | (Pending) | IL-12/23p40 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | Immune-mediated disorders | Psoriasis | NA | NA | Regulatory review in China | To be confirmed | ||||
Benmelstobart | Andewei | PD-L1 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | D265A | Reduce Fc effector functions | Cancer | Small cell lung cancer | NA | NA | China, 2024 | To be confirmed | |||
Vilobelimab | Gohibic | Complement C5a | Full-length antibody | Monospecific | Chimeric mouse/human | IgG4 | kappa | Unconjugated | None | Hemostasis | SARS-CoV-2 induced septic acute respiratory distress syndrome | EU review | NA | To be confirmed | |||||
Suciraslimab | (Pending) | CD22 | Full-length antibody | Monospecific | Chimeric mouse/human | IgG1 | kappa | Unconjugated | None | Immune-mediated disorders | Rheumatoid arthritis | NA | NA | Regulatory review in China | To be confirmed | ||||
Trastuzumab botidotin | (Pending) | HER2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Cleavable valine-citrulline linker | Duostatin-5 | Tubulin inhibitor | None | Cancer | Breast cancer | NA | NA | Regulatory review in China | To be confirmed | |
Iparomlimab | (Pending) | PD-1 | Full-length antibody | Monospecific | Humanized/chimeric | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Cancer | Cervical cancer | NA | NA | Regulatory review in China | To be confirmed | |||
Iparomlimab, tuvonralimab | 齐倍安® | PD-1, CTLA-4 | Full-length antibody | Mixture of 2 monospecific antibodies | Humanized/chimeric, humanized | IgG4 (anti-PD-1); IgG1 (anti-CTLA4) | kappa | Unconjugated | IgG4: S228P; IgG1: K147D, F170C, V173C, C220G, R255K, D399R, K409E on the heavy chain, and S131K, Q160C, S162C, C214S on the light chain | Hinge stabilisation; heavy and light chain pairing | Cancer | Cervical cancer | NA | NA | China, 2024 | To be confirmed | |||
Xeligekimab | 金立希 | IL-17A | Full-length antibody | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Immune-mediated disorders | Plaque Psoriasis | NA | NA | China, 2024 | To be confirmed | |||
Marstacimab | Hympavzi | Tissue factor pathway inhibitor | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | L234A, L235A, G237A | Reduce Fc effector functions | Cardiovascular / hemostasis | Hemophilia | Pos. opinion after review | 2024 | US, 2024 | Chinese hamster ovary (CHO) cells | |||
Garadacimab | (Pending) | Factor XIIa | Full-length antibody | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P | Hinge stabilisation | Cardiovascular / hemostasis | Prevention of hereditary angioedema attacks | EU review | In review | To be confirmed | ||||
Stapokibart | Kangyueda, 康悦达 | IL-4R alpha | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Immune-mediated disorders | Atopic dermatitis | NA | NA | China, 2024 | To be confirmed | |||
Tarlatamab | IMDELLTRA | DLL3, CD3 | scFv-scFv-scFc | Bispecific | Unconjugated | R292C, N297G, V302C | Aglycosylation, CH2 stabilization (in the absence of glycosylation) | Cancer | Small cell lung cancer | NA | 2024 | US, 2024 | Chinese hamster ovary (CHO) cells | ||||||
Patritumab deruxtecan | (Pending) | HER3 | Full-length antibody | Monospecific | Human | IgG1 | kappa | ADC | GGFG; Cleavable linker | DXd/DX-8951 | Topoisomerase I inhibitor | None | Cancer | Non-small cell lung cancer | NA | In review | To be confirmed | ||
Sacituzumab tirumotecan | 佳 泰 萊® | TROP-2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Stable linker | Topoisomerase I inhibitor | None | Cancer | Breast cancer | NA | NA | China, 2024 | To be confirmed | ||
Axatilimab, axatilimab-csfr | Niktimvo | CSF-1R | Full-length antibody | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilisation | Immune-mediated disorders | Graft vs. host disease | NA | 2024 | US, 2024 | Chinese hamster ovary (CHO) cells | |||
Zanidatamab, zanidatamab-hrii | Ziihera® | HER2, HER2 (biparatopic) | scFv-Fc x Fab-Fc | Bispecific | Humanized | Unconjugated | T350V-L351Y-F405A-Y407V x T350V-T366L-K392L-T394W | Hetero HH | Cancer | Biliary tract cancers | EU review | 2024 | US, 2024 | To be confirmed | |||||
Linvoseltamab | (Pending) | BCMA, CD3 | Full-length antibody | Bispecific | Human | IgG4 | kappa | Unconjugated | S228P; Hetero H, cL. Hetero HH: WT x H435R-Y436F; both chains: E233P, F234V, L235A, G236del | Hinge stabilization; Limits binding to Protein A, purification; Fc-silencing | Cancer | Multiple myeloma | EU review | In review | To be confirmed | ||||
Datopotamab deruxtecan | (Pending) | TROP-2 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Glycine-Glycine-Phenylalanine-Glycine; Tetrapeptide-based cleavable linker | DXd/DX-8951 | Topoisomerase I inhibitor | None | Cancer | Non-small cell lung cancer | EU review | In review | To be confirmed | ||
Zenocutuzumab, zenocutuzumab-zbco | BIZENGRI® | HER2, HER3 | Full-length antibody | Bispecific | Humanized | IgG1 | kappa | Unconjugated | L351K, T366K | Heterodimerization | Cancer | Neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer | NA | FDA | US, 2024 | To be confirmed | |||
Nurulimab | Nurdati | CTLA-4 | Full-length antibody | Monospecific | Human | IgG1 | kappa | Unconjugated | Cancer | Melanoma | NA | NA | Russia, 2023 | To be confirmed | |||||
Seniprutug | Tribuvia | TCR Vbeta9 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None | - | Immune-mediated disorders | Axial Spondyloarthritis | NA | NA | Russia, 2024 | To be confirmed | |||
Suvemcitug | (Pending) | VEGF | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Cancer | Recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer | NA | NA | Regulatory review in China | To be confirmed | |||||
No INN; Genakumab | (Pending) | IL-1beta | Full-length antibody | Monospecific | Unconjugated | Immune-mediated disorders | Acute gouty arthritis | NA | NA | Regulatory review in China | To be confirmed | ||||||||
No INN; TNM002 | (Pending) | Tetanus toxin | Full-length antibody | Monospecific | Human | Unconjugated | Infectious disease | Tetanus | NA | NA | Regulatory review in China | To be confirmed | |||||||
No INN; IBI311 | (Pending) | IGF-1R | Full-length antibody | Monospecific | ADC | Undisclosed | Undisclosed | Undisclosed | Immune-mediated disorders | Thyroid Eye Disease | NA | NA | Regulatory review in China | To be confirmed | |||||
Bifikafusp alfa, Onfekafusp alfa | Nidlegy™ | Fibronectin extra-domain B | scFv fused with IL-2, scFv fused with TNF | Mixture of 2 monospecific antibodies | Human | kappa | Immunocytokine | IL-2, TNF | Cancer | Melanoma | EU review | NA | To be confirmed | ||||||
Bentracimab | (Pending) | Ticagrelor | Fab | Monospecific | Human | lambda | Unconjugated | NA | - | Cardiovascular / hemostasis | Reversal of the antiplatelet effects of ticagrelor | NA | In review | To be confirmed | |||||
Nipocalimab | (Pending) | FcRn | Full-length antibody | Monospecific | Human | IgG1 | lambda | Unconjugated | N297A | Fc-aglycosylated | Immune-mediated disorders | Generalized myasthenia gravis | EU review | In review | To be confirmed | ||||
Mazorelvimab, Zamerovimab | 克瑞毕® | Rabies virus glycoprotein | Full-length antibody | Mixture of 2 monospecific antibodies | Humanized | IgG1 | kappa | Unconjugated | None | Infectious disease | Rabies prevention | NA | NA | China, 2024 | To be confirmed | ||||
Picankibart | (Pending) | IL-23p19 | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E | Extends half-life | Immune-mediated disorders | Psoriasis | NA | NA | Regulatory review in China | To be confirmed | |||
Telisotuzumab vedotin | (Pending) | cMET | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Valine–citrulline (Cleavable linker) | MMAE | K222C T223del T225del K447del | Cancer | Nonsquamous non-small cell lung cancer | NA | In review | To be confirmed | |||
Finotonlimab | (Pending) | PD-1 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P | Hinge stabilization | Cancer | Hepatocellular carcinoma | NA | NA | Regulatory review in China | To be confirmed | |||
Retlirafusp alfa | (Pending) | PD-L1, TGF beta | Full length Ab fusion | Bispecific | Human | IgG4 | kappa | Immunoconjugate | TGFbeta receptor II ECD | S228P | Hinge stabilization | Cancer | Gastric and gastroesophageal junction adenocarcinoma | NA | NA | Regulatory review in China | To be confirmed | ||
Becotatug vedotin | (Pending) | EGFR | Full-length antibody | Monospecific | Humanized | IgG1 | kappa | ADC | Valine–citrulline (Cleavable linker) | MMAE | None found | Cancer | Head and neck cancer | NA | NA | Regulatory review in China | To be confirmed | ||
No INN; SSGJ-608, 608 | (Pending) | IL-17A | Full-length antibody | Monospecific | TBD | TBD | TBD | Unconjugated | TBD | Immune-mediated disorders | Psoriasis | NA | NA | Regulatory review in China | 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.
In the backbone column, the isotype refers to human unless indicated otherwise with the prefix m- (murine) or r- (rat).
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.