The remarkable increase in the number of antibody therapeutics in late-stage clinical studies that occurred between 2010 and 2022 has been documented in the ‘Antibodies to watch‘ article series, which describes monoclonal antibodies in late-stage clinical studies (i.e., pivotal Phase 2, Phase 2/3 or Phase 3). All articles in the series were published in mAbs, and they are all freely available.
The table below is derived from data included in the latest article in the series, Antibodies to Watch in 2024, published in January 2023. The Antibody Society will update the data every quarter during 2023. Last table update: December 1, 2024.
Data for antibody therapeutic products that have advanced to regulatory review or approval in any country have been excluded from this table, but they are included in a searchable table that can be found here.
Biosimilar antibodies have been excluded from both tables.
Format and Fc modification 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. Antibody therapeutics in late-stage clinical studies. (date accessed); www.antibodysociety.org/antibodies-in-late-stage-clinical-studies/
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.
Drug Code(s) | INN | Target | Format | Specificity | Sequence source | Isotype (Fc) | Light Chain | Conjugated/Fused | Linker | Payload/Fused moiety | Fc Mutations/Modifications | Phase of Clinical Development | Late-stage Clinical Study Indications | Therapeutic Area | Company | Licensee/Partner |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
9MW2821 | Nectin-4 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Valine-Citrulline (Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | TBD | Phase 3 | Urothelial carcinoma (NCT06196736 / CTR20234024, NCT06592326), Cervical Cancer (NCT06692166) | Cancer | Mabwell (Shanghai) Bioscience Co. Ltd. | ||
AB154 | Domvanalimab | TIGIT | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A (impair Fc effector functions) | Phase 3 | Gastrointestinal tract adenocarcinoma (NCT05568095); Non-small cell lung cancer (NCT05211895, NCT05502237, NCT04736173) | Cancer | Arcus Biosciences Inc. | Gilead Sciences, Taiho Pharma | ||
ABBV-151, ARGX-115, PR-1762844 | Livmoniplimab | GARP/TGF beta complex | Full length Ab | Monospecific | Chimeric / Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 2/3 | Non-small cell lung cancer (NCT06236438), Hepatocellular Carcinoma (NCT06109272) | Cancer | argenx | Eli Lilly and Company | ||
ABBV-181 | Budigalimab | PD-1 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A (impair Fc effector functions) | Phase 2/3 | Non-small cell lung cancer (NCT06236438), Hepatocellular Carcinoma (NCT06109272) | Cancer | AbbVie | |||
ABBV-383, TNB-383B | BCMA, CD3 | Fragment-Fc - Fab-h-CH2-CH3 x VH-VH-h-CH2-CH3 | Bispecific | Human | IgG4 | kappa | Unconjugated | TBD | Phase 3 | Multiple myeloma (NCT06158841) | Cancer | Amgen | AbbVie | |||
ABBV-400 | Telisotuzumab adizutecan | cMET | Full length Ab | Monospecific | Humanized | IgG1 | kappa | ADC | Valine-Alanine | Topoisomerase I inhibitor, Camptothecin | TBD | Phase 3 | Colorectal cancer (NCT06614192) | Cancer | Pierre Fabre | AbbVie |
ABBV-IMAB-TJC4, TJ011133, TJ133, TJC4 | Lemzoparlimab | CD47 | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Myelodysplastic Syndromes (MDS) (NCT05709093) | Cancer | I-Mab Biopharma Co. Ltd. | |||
ABC008 | Ulviprubart | KLRG1 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 2/3 | Inclusion Body Myositis (NCT05721573, NCT06450886) | Immune-mediated / inflammatory disorders | Abcuro Inc. | |||
ABT-981 | Lutikizumab | IL-1 alpha, IL-1 beta | Appended Ig - 2+2 symmetric, DVD-Ig | Bispecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A (impair Fc effector functions) | Phase 3 | Hidradenitis Suppurativa (NCT06468228) | Immune-mediated / inflammatory disorders | AbbVie | |||
ACT017 | Glenzocimab | GP VI | Fragment - Fab | Monospecific | Humanized | NA | kappa | Unconjugated | None found | Phase 2/3 | Acute ischemic stroke (NCT05070260, NCT05559398) | Cardiovascular / hemostasis disorders | Acticor Biotech | |||
AGEN1181 | Botensilimab | CTLA-4 | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | S239D, A330L, I332E (enhanced effector function) | Phase 2 pivotal | Colorectal cancer (NCT05608044) | Cancer | Agenus Inc. | |||
AGEN2034 | Balstilimab | PD-1 | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 2 pivotal | Metastatic Colorectal Cancer (NCT05608044) | Cancer | Agenus Inc. | Betta Pharmaceuticals, Recepta biopharma | ||
AK109 | Pulocimab | VEGFR2 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma (NCT06341335 / CTR20241225) | Cancer | Akesobio Australia Pty Ltd | |||
AK111 | Gumokimab | IL-17A | Full length Ab | Monospecific | TBD | IgG1 | kappa | Unconjugated | None found | Phase 3 | Plaque psoriasis (CTR20230111 / NCT06066125); ankylosing spondylitis (NCT06378697) | Immune-mediated / inflammatory disorders | Akesobio Australia Pty Ltd | |||
AK117 | Ligufalimab | CD47 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 | Head & neck cancer (NCT06601335) | Cancer | Akesobio Australia Pty Ltd | |||
AK120 | Manfidokimab | IL-4R alpha | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Atopic dermatitis (NCT06383468) | Immune-mediated / inflammatory disorders | Akesobio Australia Pty Ltd | |||
ALXN1720 | Gefurulimab | Complement C5, albumin | Fragment - sdAb, VHH-VHH' | Bispecific | Humanized | NA | NA | Unconjugated | NA | Phase 3 | Generalized myasthenia gravis (NCT05556096, NCT06607627 not yet recruiting) | Immune-mediated / inflammatory disorders | AstraZeneca | |||
ALXN2220, NI006, NI301A | Amyloid transthyretin | Full length Ab | Monospecific | Human | IgG1 | TBD | Unconjugated | TBD | Phase 3 | Transthyretin amyloid cardiomyopathy (NCT06183931) | Cardiovascular / hemostasis disorders | Neurimmune AG | AstraZeneca | |||
ANB019 | Imsidolimab | IL-36R | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Generalized pustular psoriasis (NCT05352893) | Immune-mediated / inflammatory disorders | AnaptysBio Inc. | |||
AntiBKV, MTX-005, mAb129 | BK virus | Full length Ab | Monospecific | Human | TBD | TBD | Unconjugated | TBD | Phase 2/3 | BK Viremia (NCT05769582) | Infectious diseases | Memo Therapeutics AG | ||||
ANX005 | Complement C1q | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | None found | Phase 3 | Guillain-Barré syndrome (NCT04701164) | Muscular disorders | Annexon Inc. | ||||
ANX007 | Complement C1q | Fragment - Fab | Monospecific | Humanized | NA | kappa | Unconjugated | NA | Phase 3 | Geographic Atrophy (NCT06510816) | Ophthalmic disorders | Annexon Inc. | ||||
AR-301, KBSA301 | Tosatoxumab | S. aureus alpha toxin | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | None found | Phase 3 | Ventilator-associated pneumonia caused by S. aureus (NCT03816956) | Infectious diseases | Kenta Biotech Ltd | Aridis Pharmaceuticals, Serum AMR, Shenzhen Arimab Biopharmaceuticals Co. Ltd. | ||
ARX788, JNJ-0683, NCB-001 | Anvatabart opadotin | HER2 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Oxime (Non-cleavable linker) | Tubulin inhibitor, Amberstatin 269 (Auroxime) | A114pAF (non-natural amino acid for site specific conjugation) | Phase 3 | Breast cancer (NCT05426486) | Cancer | Johnson & Johnson | NovoCodex, Zhejiang Medicine Co. Ltd |
ASKB589 | Claudin-18.2 | Full length Ab | Monospecific | Humanized | IgG1 | TBD | Unconjugated | TBD | Phase 3 | Gastric or gastroesophageal junction adenocarcinoma (NCT06206733 / CTR20233416) | Cancer | Jiangsu Aosaikang Pharmaceutical Co. Ltd. | ||||
AV299, SCH900105 | Ficlatuzumab | HGF | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Head and neck cancer (NCT06064877) | Cancer | LG Chem Ltd. | Biodesix | ||
AZD0486, TNB-486 | CD19, CD3 | Fragment-Fc | Bispecific | TBD | IgG4 | TBD | Unconjugated | Hinge stabilized, Fc silenced, knob in a hole heterodimerization strategy | Phase 3 | Follicular lymphoma (NCT06549595) | Cancer | AstraZeneca | ||||
AZD0901, CMG901, MRG005 | Claudin-18.2 | Full length Ab conjugate | Monospecific | TBD | TBD | TBD | ADC | Cleavable linker | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | TBD | Phase 3 | Gastric Cancer and Gastroesophageal Junction Cancer (NCT06346392) | Cancer | LEPU Biopharma, Shanghai Miracogen Inc. | AstraZeneca, Keymed Biosciences Inc. | |
AZD2936 | Rilvegostomig | PD-1, TIGIT | Full length Ab | Bispecific | Humanized | IgG1 | kappa/lambda | Unconjugated | L234F/L235E/P331S (reduced effector function), S354C/T366W (knob) and Y349C/T366S/L368A/Y407V (hole) (heavy chain heterodimerization) | Phase 3 | Biliary tract cancer (NCT06109779, NCT06467357), Non-Small Cell Lung Cancer (NCT06357533, NCT06564844, NCT06692738 not yet recruiting), Non-squamous Non-Small Cell Lung Cancer (NCT06627647 not yet recuiting) | Cancer | AstraZeneca | Compugen Ltd. | ||
B001 | CD20 | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Neuromyelitis optica (NCT06413654 / CTR20241605) | Immune-mediated / inflammatory disorders | Shanghai Pharmaceuticals Holding | ||||
B007 | CD20 | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Pemphigus (NCT06454357 / CTR20240985), Generalized Myasthenia Gravis (NCT06447597), Primary membranous nephropathy (NCT06470191) | Immune-mediated / inflammatory disorders | Shanghai Jiaolian Drug Research and Development Co. Ltd | ||||
BAT1308 | PD-1 | Full length Ab | Monospecific | Humanized | IgG4 | TBD | Unconjugated | TBD | Phase 2/3 | Cervical cancer (NCT06123884 / CTR20232394), Endometrial Cancer (NCT06321068) | Cancer | Bio-Thera Solutions Ltd. | ||||
BAT4406F | CD20 | Full length Ab | Monospecific | TBD | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Neuromyelitis optica spectrum disorder (CTR20231610) | Immune-mediated / inflammatory disorders | Bio-Thera Solutions Ltd. | ||||
BAT5906 | VEGF-A | Full length Ab | Monospecific | TBD | IgG1 | kappa | Unconjugated | None found | Phase 3 | Neovascular (Wet) Age-related Macular Degeneration (NCT05439629) | Ophthalmic disorders | Bio-Thera Solutions Ltd. | ||||
BGB-A1217 | Ociperlimab | TIGIT | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Non-small cell lung cancer (NCT04746924) | Cancer | BeiGene Ltd. | |||
BIIB059 | Litifilimab | BDCA2 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Cutaneous lupus erythematosus (NCT05531565, NCT06044337); Systemic lupus erythematosus (NCT05352919, NCT04961567, NCT04895241) | Immune-mediated / inflammatory disorders | Biogen | |||
BL-B01D1 | Izalontamab brengitecan | EGFR, HER3 | Appended Ig conjugate - 2+2 symmetric, IgG-(scFv)2 | Bispecific | TBD | IgG1 | kappa/lambda | ADC | Cathepsin B (Cleavable linker) | Topoisomerase I inhibitor, Ed-04 | None found | Phase 3 | Nasopharyngeal carcinoma (NCT06118333 / CTR20233419); Esophageal Squamous Cell Carcinoma (NCT06304974), Small Cell Lung Cancer (NCT06500026), Non-small Cell Lung Cancer (NCT06382129, NCT06382116), Triple-Negative Breast Cancer (NCT06382142), HR+HER2- Breast Cancer (NCT06343948) | Cancer | Sichuan Baili Pharmaceutical Co. Ltd., Systimmune | Bristol Myers Squibb |
BL-M07D1 | HER2 | Full length Ab conjugate | Monospecific | TBD | IgG1 | kappa | ADC | Undisclosed | Topoisomerase I inhibitor, Ed-04 | TBD | Phase 3 | Breast cancer (NCT06316531 /CTR20240858) | Cancer | Sichuan Baili Pharmaceutical Co. Ltd., Systimmune | ||
BMS-986012, MDX1110 | Fucosyl-GM1 | Full length Ab | Monospecific | Human | IgG1 | TBD | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 3 pending | Small cell lung cancer (NCT06646276) | Cancer | Bristol Myers Squibb | ||||
BNT316, ONC-392 | Gotistobart | CTLA-4 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E (half-life extension); S298A, E333A, K334A (enhanced ADCC) | Phase 3 | Non-small cell lung cancer (NCT05671510) | Cancer | OncoC4 Inc. | BioNTech SE | ||
CAEL-101, Ch mAb 11-1F4 | Anselamimab | Amyloid light chain | Full length Ab | Monospecific | Chimeric | IgG1 | kappa | Unconjugated | None found | Phase 3 | Light chain (AL) amyloidosis (NCT04512235, NCT04504825) | Immune-mediated / inflammatory disorders | AstraZeneca | |||
CBP-201 | Rademikibart | IL-4R alpha | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Atopic dermatitis (CTR20242160 / NCT06477835), Asthma (CTR20242195 / NCT06488755) | Immune-mediated / inflammatory disorders | Suzhou Connect Biopharmaceuticals Ltd. | Simcere Pharmaceutical Co. Ltd | ||
CC-93538, RPC4046; ABT-308, 13C5.5 | Cendakimab | IL-13 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A (impair Fc effector functions) | Phase 3 | Eosinophilic gastroenteritis (NCT05214768); Eosinophilic esophagitis (NCT04753697, NCT04991935) | Immune-mediated / inflammatory disorders | AbbVie | Bristol Myers Squibb | ||
CDP-7657 | Dapirolizumab pegol | CD40L | Fragment conjugate - Fab, pegylated | Monospecific | Humanized | NA | kappa | Immunoconjugate, Pegylated | PEG | None found | Phase 3 | Systemic lupus erythematosus (NCT04976322, NCT04294667, NCT06617325 not yet recruiting) | Immune-mediated / inflammatory disorders | UCB Biopharma | Biogen | |
CDX-0159 | Barzolvolimab | c-Kit | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235Q, K322Q (reduced effector function), M252Y, S254T, T256E (half life extension) | Phase 3 | Chronic Spontaneous Urticaria (NCT06455202, NCT06445023) | Immune-mediated / inflammatory disorders | Celldex | |||
COR-001, WBP216 , MEDI5117 | Ziltivekimab | IL-6 | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E (half life extension) | Phase 3 | Atherosclerotic cardiovascular disease, chronic kidney disease (NCT05021835, NCT06118281); Heart Failure (NCT05636176, NCT06200207); Atherosclerosis and inflammation (NCT06263244 not yet recuiting) | Cardiovascular / hemostasis disorders | AstraZeneca | Novo Nordisk | ||
CS1003 | Nofazinlimab | PD-1 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Hepatocellular carcinoma (NCT04194775) | Cancer | Cstone Pharma | EQRx | ||
CSL300, ALD518; BMS-945429 | Clazakizumab | IL-6 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | N297A (Fc-aglycosylated) | Phase 3 | Atherosclerotic Cardiovascular Disease, End-stage kidney disease (NCT05485961) | Immune-mediated / inflammatory disorders | H. Lundbeck A/S | Vitaeris | ||
DB-1303, BNT323 | HER2 | Full length Ab conjugate | Monospecific | TBD | IgG1 | TBD | ADC | Enzymatically cleavable peptide linker | Topoisomerase I inhibitor, P1003 | TBD | Phase 3 | Breast cancer (NCT06265428, NCT06018337); Endometrial cancer (NCT06340568 not yet recruiting) | Cancer | Duality Biologics (Suzhou) Co. Ltd. | BioNTech SE | |
DP303c | HER2 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Cleavable linker | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | None found | Phase 3 | Breast cancer (NCT05901935) | Cancer | CSPC Pharmaceutical Group Limited | ||
DS-6000A | Raludotatug deruxtecan | Cadherin-6 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Glycine-Glycine-Phenylalanine-Glycine (GGFG; Cleavable linker) | Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a) | None found | Phase 2/3 | Ovarian cancer (NCT06161025) | Cancer | Daiichi Sankyo Co. Ltd | Merck |
DS-7300a | Ifinatamab deruxtecan | B7-H3 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Glycine-Glycine-Phenylalanine-Glycine (GGFG; Tetrapeptide-based cleavable linker) | Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a) | None found | Phase 3 | Small cell lung cancer (NCT06236438), Esophageal Squamous Cell Carcinoma (NCT06644781 not yet recruiting) | Cancer | Daiichi Sankyo Co. Ltd | Merck Sharp & Dohme |
E2814 | Etalanetug | Tau (MTBR) | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 2/3 | Dominantly inherited Alzheimer's Disease (NCT05269394, NCT01760005) | Neurological disorders | Eisai Inc. | University College London | ||
EB05, NI-0101 | Paridiprubart | TLR4 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | N325S, L328F (abrogates C1q and FcγRIII binding, increases FcγRII binding, retains FcγRI high affinity binding) | Phase 2/3 | COVID-19-related acute respiratory distress syndrome (NCT04401475) | Immune-mediated / inflammatory disorders | NovImmune SA | Edesa Biotech, Genentech | ||
ES102, INBRX-106 | OX40 | Fragment-Fc - (VHH-VHH-VHH)2-Fc | Monospecific | Humanized | TBD | NA | Unconjugated | None found | Phase 2/3 | Head and neck cancer (NCT06295731) | Cancer | Inhibrx Biosciences Inc. | Elpiscience Biopharma Ltd. | |||
ES104, CTX-009, TR009, NOV1501, ABL001 | DLL4, VEGF-A | Appended Ig - scFv-scFv-Full-length antibody | Bispecific | TBD | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Biliary tract cancers (NCT05506943) | Cancer | National OncoVenture | Compass Therapeutics Inc., Elpiscience Biopharmaceuticals, ABL Bio Inc. | |||
ESG401, ESG-401, STI-3258 | TROP-2 | Full length Ab conjugate | Monospecific | Humanized | TBD | TBD | ADC | Undisclosed | Topoisomerase I inhibitor, SN38 (irinotecan active metabolite) | TBD | Phase 3 | Metastatic Breast Cancer (NCT06383767) | Cancer | Sorrento Therapeutics Inc. | Escugen Biotechnology Co Ltd., Levena (Suzhou) Biopharma Co. Ltd. | |
MK-3000, EYE103, F4L5.13, ANT-39, Restoret™ | FZD4, LRP5, LRP5 | Fragment-Fc - 1+1 asymmetric, Diabody-Fc-Diabody | Multispecific, Trispecific | TBD | TBD | TBD | Unconjugated | None found | Phase 2/3 | Diabetic macular edema and neovascular age-related macular degeneration (NCT06571045) | Ophthalmic disorders | AntlerA Therapeutics | Merck | |||
F520 | Rulonilimab | PD-1 | Full length Ab | Monospecific | Chimeric | IgG1 | kappa | Unconjugated | N297A (Fc-aglycosylated); T250Q, M428L (half life extension) | Phase 2/3 | Hepatocellular carcinoma (NCT05408221) | Cancer | Shandong New Time Pharmaceutical Co. LTD | |||
FDA018, FDA018-ADC | TROP-2 | TBD | Monospecific | TBD | TBD | TBD | ADC | Undisclosed | Topoisomerase I inhibitor, SN38 (irinotecan active metabolite) | TBD | Phase 3 | Triple-negative Breast Cancer (NCT06519370 / CTR20242630) | Cancer | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd | ||
FG-M108, M108 | Claudin-18.2 | Full length Ab | Monospecific | TBD | IgG1 | TBD | Unconjugated | TBD | Phase 3 | Gastric or gastroesophageal junction adenocarcinoma (NCT06177041) | Cancer | FutureGen Biopharmaceutical (Beijing) Co. Ltd | ||||
FPA144 | Bemarituzumab | FGFR2b | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 3 | Gastric cancer/gastroesophageal junction adenocarcinoma (NCT05111626, NCT05052801) | Cancer | Amgen | Zai Lab | ||
FUB523, BION-1301 | Zigakibart | APRIL | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | IgA nephropathy (NCT05852938) | Immune-mediated / inflammatory disorders | Novartis Pharmaceuticals | |||
GEN1046, DuoBody-PD-L1x4, BNT311 | Acasunlimab | PD-L1, 4-1BB | Full length Ab - Duobody | Bispecific | Humanized | IgG1 | kappa/lambda | Unconjugated | L234F, L235E, D265A (reduced effector function), F405L or K409R (heterodimerization, cFAE) | Phase 3 | Non-Small Cell Lung Cancer (NCT06635824) | Cancer | Genmab | |||
GMA-102 (diabetes indication), GMA-105 (obesity indication), Glutazumab (not WHO assigned INN) | Gulgafafusp alfa | GLP-1R | Full length Ab fusion | Monospecific | Humanized | IgG2 | TBD | Immunoconjugate | GLP-1 peptide | None found | Phase 3 | Type 2 diabetes (CTR20222558, CTR20211661) | Metabolic disorders | Gmax Biopharm Australia Pty Ltd | ||
GR1801 | Silevimig | Rabies virus (glycoprotein) | Fragment-Fc - scFv-Fc-Fab | Bispecific | Human | IgG1 | TBD | Unconjugated | None found | Phase 3 | Rabies (NCT05846568) | Infectious diseases | Genrix (Shanghai) Biopharmaceutical Co. Ltd. | |||
GR1802, GR-1802 | IL-4R alpha | Full length Ab | Monospecific | TBD | IgG1 | kappa | Unconjugated | TBD | Phase 3 | Atopic dermatitis (NCT06216392 / CTR20233857), Chronic Rhinosinusitis With Nasal Polyps (NCT06516302) | Immune-mediated / inflammatory disorders | Genrix (Shanghai) Biopharmaceutical Co. Ltd. | ||||
GSK3511294 | Depemokimab | IL-5 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E (half-life extension) | Phase 3 | Hypereosinophilic syndrome (NCT05334368); Eosinophilic granulomatosis with polyangiitis (NCT05263934); Nasal polyps (NCT05274750, NCT05281523); Severe uncontrolled asthma with an eosinophilic phenotype (NCT05243680, NCT04719832, NCT04718103, NCT04718389) | Immune-mediated / inflammatory disorders | GSK | |||
GSK4069889, TSR-022 | Cobolimab | TIM3 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 2/3 | Non-small cell lung cancer (NCT04655976) | Cancer | GSK | |||
GSK4428859, EOS884448, EOS-448, RCA-2 | Belrestotug | TIGIT | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | None found | Phase 3 | Non-small cell lung cancer (NCT06472076) | Cancer | iTEOS Therapeutics | GSK | ||
GSK4527226, AL001 | Latozinemab | Sortilin | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | L234A, L235A, P331S (remove Fc effector functions) | Phase 3 | Frontotemporal dementia (NCT04374136) | Neurological disorders | Alector Inc. | GSK | ||
HB0017 | IL-17A | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | TBD | Phase 3 | Plaque psoriasis (CTR20240521 / NCT06477237) | Immune-mediated / inflammatory disorders | Huabo Biopharm Co. Ltd. | ||||
HB0034 | IL-36R | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Generalized pustular psoriasis (NCT06477536) | Immune-mediated / inflammatory disorders | Shanghai Huaota Biopharmaceutical Co. Ltd. | ||||
HLX22, AC-101 | HER2 | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 3 | Gastric cancer (CTR20243366 / NCT06532006) | Cancer | Alligator Bioscience AB | Shanghai Henlius Biotech Co. Ltd., AbClon Inc. | |||
HS-20093, GSK5764227 | B7-H3 | Full length Ab | Monospecific | Humanized | IgG1 | TBD | ADC | Undisclosed | Topoisomerase I inhibitor | TBD | Phase 3 | Small cell lung cancer (NCT06498479, CTR20242440 / NCT06526624 not yet recruiting) | Cancer | Shanghai Hansoh Biomedical Co. Ltd | GSK | |
I-131-BC8 | Apamistamab-Iodine (131I) | CD45 | Full length Ab conjugate | Monospecific | Murine | IgG1 | kappa | RIC | I-131 | None found | Phase 3 | Acute myeloid leukemia (NCT02665065) | Cancer | Actinium Pharmaceuticals | Immedica AB | |
IAH0968 | HER2 | Full length Ab | Monospecific | TBD | TBD | TBD | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 2/3 | Colorectal Cancer (NCT05673512), Gastric cancer (NCT06504732 not yet recruiting) | Cancer | SUNHO (China) BioPharmaceutical Co. Ltd., Beijing Sunho Pharmaceutical Co. | ||||
IBI343 | Claudin-18.2 | Full length Ab conjugate | Monospecific | TBD | TBD | TBD | ADC | Undisclosed | Topoisomerase I inhibitor, Exatecan | TBD | Phase 3 | Gastric or gastroesophageal junction adenocarcinoma (NCT06238843 enrolling by invitation) | Cancer | Innovent Biologics (Suzhou) Co. Ltd. | ||
IKS014, LCB14-0110, FS-1502 | Caxmotabart entudotin | HER2 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | β-glucuronidase (BG) Cleavable linker | Tubulin inhibitor, Monomethyl auristatin F (MMAF) | None found | Phase 3 | Breast Cancer (CTR20230426 / NCT05755048) | Cancer | LegoChem Biosciences Inc. | IKSUDA Therapeutics, Shanghai Fosun Pharmaceutical Development Co Ltd. |
IMC-F106C | PRAME, CD3 | Fragment fusion - scFv-TCR | Bispecific | TBD | NA | TBD | Immunoconjugate | T cell receptor | NA | Phase 3 | Melanoma (NCT06112314) | Cancer | Immunocore Ltd | |||
IMGN632 | Pivekimab sunirine | CD123 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Alanine-Alanine (Cleavable linker) | DNA binding, DGN549 IGN (indolino-benzodiazepine) | S442C (site-specific conjugation) | Phase 2 pivotal | Blastic plasmacytoid dendritic cell neoplasm (NCT03386513 CADENZA) | Cancer | ImmunoGen | |
JCT205, INBRX-109 | Ozekibart | DR5 | Fragment-Fc - (VHH-VHH)2-Fc | Monospecific | Humanized | IgG1 | NA | Unconjugated | E233>del,L234>del, L235>del (reduced effector function: CDC and ADCC) | Phase 2 pivotal | Conventional Chondrosarcoma (NCT04950075) | Cancer | Inhibrx Biosciences Inc. | Transcenta Holding Limited | ||
JMT101 | Becotatug | EGFR | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 2 pivotal | Non-small cell lung cancer (CTR20212469, NCT06319313 / CTR20240822, NCT06380348 / CTR20241252) | Cancer | CSPC Pharmaceutical Group Limited | |||
JNJ-63723283 | Cetrelimab | PD-1 | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Bladder cancer (NCT04658862, NCT05714202) | Cancer | Janssen Research & Development LLC | Xoma | ||
JS004, TAB004 | Tifcemalimab | BTLA | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 | Small cell lung cancer (NCT06095583 / CTR20233182), Hodgkin Lymphoma (NCT06170489 / CTR20234002) | Cancer | Shanghai Junshi Bioscience Co Ltd | |||
JS005 | Roconkibart | IL-17A | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 | Plaque Psoriasis (NCT05975268) | Immune-mediated / inflammatory disorders | Shanghai Junshi Bioscience Co Ltd | |||
JSKN003, JSKN033 (combo of JSKN003 and envafolimab) | HER2, HER2 | Full length Ab conjugate | Bispecific, Biparatopic | Humanized | TBD | TBD | ADC | Undisclosed | Topoisomerase I inhibitor | TBD | Phase 3 | Breast cancer (NCT06079983) | Cancer | Alphamab (Australia) Co Pty Ltd. | ||
KHK4083, AMG451 | Rocatinlimab | OX40 | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | None found | Phase 3 | Atopic dermatitis (NCT05398445, NCT05633355, NCT05651711, NCT05724199, NCT05704738, NCT05882877, NCT05899816, NCT06224192), Prurigo Nodularis (NCT06527404) | Immune-mediated / inflammatory disorders | Kyowa Hakko Kirin | Amgen | ||
Kintuximab, gentuximab, cintuximab (not WHO assigned INN) | VEGFR2 | Full length Ab | Monospecific | Chimeric | TBD | TBD | Unconjugated | TBD | Phase 3 | Advanced gastric or gastroesophageal junction adenocarcinoma (NCT05919381 / CTR20220815) | Cancer | GeneScience Pharmaceuticals Co. Ltd. | Changchun Jinsai Pharmaceutical Co. Ltd. | |||
KN026 | Anbenitamab | HER2, HER2 | Full length Ab | Bispecific, Biparatopic | Humanized | IgG1 | kappa | Unconjugated | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 3 | Gastric (NCT05427383), breast cancer (NCT05838066) | Cancer | Jiangsu Alphamab Biopharmaceuticals Co. Ltd | Sanofi | ||
KN046 | Erfonrilimab | PD-L1, CTLA-4 | Fragment-Fc - 2+2 symmetric, (VHH-VHH')2-Fc, Tandem-VHH-Fc | Bispecific | Chimeric, Humanized | IgG1 | NA | Unconjugated | Hetero HH, HL-pairing: cL: S354C-T366W-K409A x Y349C-T366S-L368A-F405K-Y407V (bispecific assembly) | Phase 3 | Non-small-cell lung cancer (NCT04474119), Advanced Pancreatic Ductal Adenocarcinoma (NCT05149326) | Cancer | Alphamab (Australia) Co Pty Ltd. | Pfizer, Zelgen, Sunny Lake, Kintor, Sinovent, InxMed | ||
KSI-301, OG1953 | Tarcocimab tedromer | VEGF-A | Full length Ab conjugate - ABC | Monospecific | Humanized | IgG1 | kappa | Immunoconjugate | Biopolymer | L234A, L235A, G237A (impair Fc effector functions), L443C (Cys for site specific conjugation) | Phase 3 | Non-proliferative Diabetic Retinopathy (NCT06270836), Wet Age-related Macular Degeneration (NCT06556368) | Ophthalmic disorders | Kodiak Sciences Inc | ||
L19-TNF, L19TNF, L19(scFv)2-TNF | Onfekafusp alfa | Fibronectin EDB, TNF | Fragment fusion - scFv-TNF | Monospecific | Human | NA | TBD | Immunoconjugate - Immunocytokine | TNF | NA | Phase 3 | Soft tissue sarcoma (NCT04650984) | Cancer | Philogen S.p.A. | Sun Pharma, Merck Sharp & Dohme | |
LMN-201 | C. difficile (exotoxin TcdB) | Fragment - sdAb, VHH dimers | Mixture of 3 monospecific antibodies | TBD | NA | NA | Unconjugated | NA | Phase 2/3 | Clostridioides Difficile Infection (NCT05330182) | Infectious diseases | Lumen Bioscience Inc. | ||||
LY3372993 | Remternetug | Amyloid beta (N3pG) | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | None found | Phase 3 | Alzheimer's Disease (NCT05463731, NCT06653153 not yet recruiting) | Neurological disorders | Eli Lilly and Company | |||
M1095, MSB0010841, ALX-0761 | Sonelokimab | IL-17A, IL17F, Albumin | Fragment - sdAb, VHH-VHH'-VHH | Multispecific, Trispecific | Humanized | NA | NA | Unconjugated | NA | Phase 3 | Hidradenitis Suppurativa (NCT06411899, NCT06411379), Psoriatic arthritis (NCT06641076 not yet recruiting, NCT06641089 not yet recruiting) | Immune-mediated / inflammatory disorders | Merck Serono | MoonLake Immunotherapeutics AG, Bond Avillion 2 Development LP | ||
M701 | EpCAM, CD3 | Fragment-Fc - YBODY | Bispecific | Chimeric | TBD | TBD | Unconjugated | TBD | Phase 3 | Malignant ascities (NCT06432296) | Cancer | Wuhan YZY Biopharma Co. Ltd. | ||||
MAA868, NOV-12 | Abelacimab | Factor XI | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | D265A P329A. Reduced effector functions | Phase 3 | Venous thromboembolism (NCT05171075, NCT05171049), Atrial Fibrillation (NCT05712200) | Cardiovascular / hemostasis disorders | Novartis Pharmaceuticals | Anthos Therapeutics, MorphoSys | ||
SYSA1801 | Claudin-18.2 | Full length Ab | Monospecific | Human | IgG1 | TBD | ADC | Valine-Citrulline (Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | None found | Phase 3 pending | CTR20244240 (gastric or gastroesophageal junction adenocarcinoma not yet recruiting) | Cancer | CSPC Pharmaceutical Group Limited | Elevation Oncology Inc. | |
MCLA-158 | Petosemtamab | EGFR, LGR5 | Full length Ab - Biclonic | Bispecific | Human | IgG1 | kappa | Unconjugated | Low fucose; L351D, L368E x L351K, T366K (heterodimerization) | Phase 3 | Head and neck cancer (NCT06496178, NCT06525220) | Cancer | Merus B.V. | |||
MEDI3506 | Tozorakimab | IL-33 | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | None found | Phase 3 | Chronic obstructive pulmonary disease (NCT05166889, NCT05158387, NCT05742802, NCT06040086); Acute respiratory failure (NCT05624450) | Respiratory diseases | AstraZeneca | |||
MEDI5752 | Volrustomig | CTLA-4, PD-1 | Full length Ab | Bispecific | Human | IgG1 | kappa/lambda | Unconjugated | Reduced effector functions | Phase 3 | Cervical cancer (NCT06079671); Non-small cell lung cancer (NCT05984277), Head and Neck Squamous Cell Carcinoma (NCT06129864), Pleural Mesothelioma (NCT06097728) | Cancer | AstraZeneca | |||
MEDI9447 | Oleclumab | CD73 | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | L234F, L235E, P331S (reduced effector function) | Phase 3 | Non-small cell lung cancer (NCT05221840) | Cancer | AstraZeneca | |||
MG-K10, BC005 | Comekibart | IL-4R alpha | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization), M428L, N434S (half life increase) | Phase 3 | Atopic Dermatitis (CTR20232813 / NCT06026891) | Immune-mediated / inflammatory disorders | Shanghai Meiji Biotechnology Co Ltd | |||
MIL62 | CD20 | Full length Ab | Monospecific | Humanized | TBD | TBD | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 3 | Neuromyelitis optica spectrum disorder (NCT05314010); Follicular lymphoma and marginal zone lymphoma (NCT04834024); Systemic Lupus Erythematosus (NCT05796206); Primary Membranous Nephropathy (NCT05862233) | Cancer | Beijing Mabworks Biotech Co. Ltd. | ||||
MK-1308, AK107 | Quavonlimab | CTLA-4 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Renal cell carcinoma (NCT04736706, NCT05899049) | Cancer | Akeso Inc. | Merck | ||
MK-4280 | Favezelimab | LAG-3 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Hodgkin lymphoma (NCT05508867); Colorectal cancer (NCT05600309, NCT05064059) | Cancer | Merck Sharp & Dohme Corp | |||
MK-7684 | Vibostolimab | TIGIT | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Non-small cell lung cancer (NCT04738487; NCT05298423; NCT05226598); Small cell lung cancer (NCT05224141); Melanoma (NCT05665595) | Cancer | Merck Sharp & Dohme Corp. | |||
MRG002 | HER2 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | TBD | ADC | Valine-Citrulline (Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | Hyperfucosylated (reduce Fc𝛾RIIIa binding/reduce ADCC) | Phase 3 | Breast Cancer (NCT04924699), Urothelium Cancer (NCT05754853) | Cancer | LEPU Biopharma, Shanghai Miracogen Inc. | ||
MTIG7192A, RO7092284, RG6058 | Tiragolumab | TIGIT | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | None found | Phase 3 | Non-small cell lung cancer (NCT04294810, NCT04513925, NCT04619797, NCT06267001); Esophageal cancer (NCT04543617, NCT04540211), Small Cell Lung Carcinoma (NCT04665856, NCT04256421), Hepatocellular carcinoma (NCT05904886) | Cancer | Genentech | |||
NEOD001; murine parent is 2A4 | Birtamimab | Amyloid light chain | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Light chain (AL) amyloidosis (NCT04973137) | Cardiovascular / hemostasis disorders | Onclave Therapeutics Limited | Prothena | ||
NN-7769, NNC0365-3769, Mim8 | Denecimig | Factor IXa, Factor X | Full length Ab - Duobody | Bispecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Hemophilia A with or without inhibitors (NCT05306418, NCT05053139, NCT05685238, NCT05878938) | Cardiovascular / hemostasis disorders | Novo Nordisk | Genmab | ||
NN8765, IPH-2201, NNC141-0100 | Monalizumab | NKG2A | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Squamous Cell Carcinoma of the Head and Neck (NCT04590963); Non-small Cell Lung Cancer (NCT05221840) | Cancer | Novo Nordisk | AstraZeneca, Innate Pharma | ||
PF-06801591 | Sasanlimab | PD-1 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Non-muscle invasive bladder cancer (NCT04165317) | Cancer | Pfizer | |||
PF-06823859, PF06823859 | Dazukibart | IFN beta | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A, G237A (impair Fc effector functions) | Phase 3 | Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] (NCT05895786, NCT06698796 not yet recruiting) | Immune-mediated / inflammatory disorders | Pfizer | |||
PF-07940370, RO4905417, RG1512 | Inclacumab | P-selectin | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization); L235E (impair Fc effector function) | Phase 3 | Vaso-occlusive crisis in sickle cell disease patients (NCT05348915, NCT04935879) | Cardiovascular / hemostasis disorders | Hoffmann-La Roche | Pfizer | ||
PM8002, BNT327 | PD-L1, VEGF A | Appended Ig - VHH-IgG | Bispecific | TBD | IgG1 | TBD | Unconjugated | Fc silencing mutations (specific ones unknown); anti-PDL1 VHH fused to the antibody to become bispecific | Phase 2/3 | Non-small Cell Lung Cancer (NCT05756972); Small Cell Lung Cancer (NCT05844150, NCT06616532 not yet recruiting), Triple negative breast cancer (NCT06419621) | Cancer | Biotheus Inc. | BioNTech | |||
PRA023, MK-7240 | Tulisokibart | TL1a | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | L234A, L235A, P329A (impair Fc effector functions) | Phase 3 | Ulcerative colitis (NCT06052059), Crohn's Disease (NCT06430801), Crohn's Disease and Ulcerative colitis (NCT06651281 not yet recruiting) | Immune-mediated / inflammatory disorders | Merck Sharp & Dohme LLC | |||
QX002N | IL-17A | Full length Ab | Monospecific | Humanized | IgG1 | TBD | Unconjugated | TBD | Phase 3 | Ankylosing spondylitis (CTR20232574) | Immune-mediated / inflammatory disorders | Jiangsu Qyuns Therapeutics Co. Ltd. | ||||
QX005N, SNC005 | IL-4R alpha | Full length Ab | Monospecific | TBD | TBD | TBD | Unconjugated | TBD | Phase 3 | Atopic dermatitis (CTR20241068), Nodular prurigo (CTR20241660) | Immune-mediated / inflammatory disorders | Jiangsu Qyuns Therapeutics Co. Ltd. | ||||
REGN2477 | Garetosmab | Activin A | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Fibrodysplasia ossificans progressiva (NCT05394116) | Skeletal disorders | Regeneron Pharmaceuticals | |||
REGN3500, SAR440340 | Itepekimab | IL-33 | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Chronic obstructive pulmonary disease (NCT04751487, NCT04701983, NCT06208306) | Respiratory diseases | Regeneron Pharmaceuticals | |||
REGN3767 | Fianlimab | LAG-3 | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization); E233P, F234V, L235A, G236del (reduced effector function) | Phase 3 | Melanoma (NCT05352672, NCT05608291, NCT06190951, NCT06246916); Non-small Cell Lung Cancer (NCT05785767, NCT05800015) | Cancer | Regeneron Pharmaceuticals | Sanofi | ||
REGN4461 | Mibavademab | LEPR | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 pending | Generalized Lipodystrophy (NCT06548100) | Metabolic disorders | Regeneron Pharmaceuticals | |||
REGN5713-5714-5715 | Atisnolerbart, bremzalerbart, umesolerbart | Bet v 1 | Full length Ab | Mixture of 3 monospecific antibodies | Human | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Seasonal allergic rhinitis (NCT04709575) | Immune-mediated / inflammatory disorders | Regeneron Pharmaceuticals | |||
RO5509554, RG7155 | Emactuzumab | CSF-1R | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Tenosynovial giant cell tumor (NCT05417789) | Cancer | Hoffmann-La Roche | SynOx Therapeutics | ||
RO7187807, MSTT1041A, RG6149, AMG282 | Astegolimab | IL-33R | Full length Ab | Monospecific | Human | IgG2 | kappa | Unconjugated | None found | Phase 3 | Chronic obstructive pulmonary disease (NCT05595642, NCT05878769) | Immune-mediated / inflammatory disorders | Amgen | Genentech | ||
RO7200220, RG6179, EBI-031 | Vamikibart | IL-6 | Full length Ab | Monospecific | Humanized | IgG2 | kappa | Unconjugated | H310A (half life extension) | Phase 3 | Uveitic macular edema (NCT05642325, NCT05642312) | Ophthalmic disorders | Sesen Bio | Hoffmann-La Roche | ||
RO7204239, GYM329, RG6237 | Myostatin | Full length Ab | Monospecific | TBD | TBD | TBD | Unconjugated | Specific mutations not found; engineered for selective and enhanced binding to the human FcγRIIb and for stronger affinity to FcRn in acidic pH conditions | Phase 2/3 | Spinal muscular atrophy (NCT05115110) | Neurological disorders | Chugai Pharmaceutical Co. Ltd. | ||||
RVT-3101, PF-06480605, RG6631, RO7790121 | Afimkibart | TL1a | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | L234A, L235A, G237A (impair Fc effector functions) | Phase 3 | Crohn Disease, Ulcerative colitis (NCT06588855, NCT06589986) | Immune-mediated / inflammatory disorders | Pfizer | Hoffmann-La Roche, Roivant Sciences | ||
RZ358, XOMA 358, XMetD | Ersodetug | Insulin receptor | Full length Ab | Monospecific | Human | IgG2 | kappa | Unconjugated | None found | Phase 3 | Congenital hyperinsulinism (NCT06208215) | Metabolic disorders | XOMA | Rezolute Inc | ||
SAR441344, INX-021 | Frexalimab | CD40L | Full length Ab | Monospecific | Chimeric | IgG1 | kappa | Unconjugated | V215A E269R K322A (enhanced effector functions) | Phase 3 | Multiple sclerosis (NCT06141473, NCT06141486) | Immune-mediated / inflammatory disorders | ImmuNext | Sanofi | ||
SAR445088, BIVV020 | Riliprubart | Complement C1s | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge-stabilization); L235E (impair Fc effector function) | Phase 3 | Inflammatory Demyelinating Polyneuropathy (NCT06290128, NCT06290141) | Immune-mediated / inflammatory disorders | Sanofi | |||
SAR445229, KY1005 | Amlitelimab | OX40L | Full length Ab | Monospecific | Human | IgG4 | kappa | Unconjugated | S228P (hinge stabilization); L235E ( reduce effector function); M428L, N434S (Half life extension) | Phase 3 | Atopic dermatitis (NCT05492578, NCT06130566, NCT06407934, NCT06181435, NCT06224348, NCT06241118) | Immune-mediated / inflammatory disorders | Sanofi | |||
SG301, SG301SC | CD38 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | TBD | Phase 3 | Multiple Myeloma (NCT06508983 / CTR20241042) | Cancer | Hangzhou Sumgen Biotech Co. Ltd. | ||||
SGN-B6A | Sigvotatug vedotin | Integrin beta-6 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Valine-Citrulline (Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | None found | Phase 3 | Non-small cell lung cancer (NCT06012435) | Cancer | Seagen Inc. | |
SHR-1703 | IL-5 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E (half life extension) | Phase 3 pending | Eosinophilic Asthma (NCT06653322), Eosinophilic Granulomatosis With Polyangiitis (NCT05979051) | Immune-mediated / inflammatory disorders | Jiangsu HengRui Medicine Co. Ltd. | Atridia Pty Ltd. | |||
SHR-1819 | Drotokibart | IL-4R alpha | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 2/3 | Atopic Dermatitis (NCT06468956 not yet recruiting), Prurigo Nodularis (NCT06554509) | Immune-mediated / inflammatory disorders | Shanghai Hengrui Pharmaceutical Co. Ltd. | Atridia Pty Ltd. | ||
SHR-8068 | CTLA-4 | TBD | Monospecific | Human | TBD | TBD | Unconjugated | TBD | Phase 3 pending | Non-squamous Non-small cell lung cancer (NCT06335355), Hepatocellular carcinoma (NCT06618664 / CTR20243670) | Cancer | Hengrui Pharmaceutical | Suzhou Suncadia Biopharmaceuticals Co. Ltd. | |||
SHR-A1904 | Claudin-18.2 | Full length Ab | Monospecific | Humanized | IgG1 | TBD | ADC | Cleavable linker | Topoisomerase I inhibitor | TBD | Phase 3 pending | Gastric or Gastroesophageal Junction Adenocarcinoma (NCT06649292 not yet recruiting) | Cancer | Shanghai Hengrui Pharmaceutical Co. Ltd. | Merck KGaA | |
SHR-A1921 | TROP-2 | Full length Ab conjugate | Monospecific | TBD | IgG1 | kappa | ADC | Undisclosed | Topoisomerase I inhibitor, SHR9265 | TBD | Phase 2/3 and Phase 3 pending | Ovarian cancer (NCT06211023 / CTR20240254, NCT06394492) | Cancer | Shanghai Hengrui Pharmaceutical Co. Ltd. | Suzhou Suncadia Biopharmaceuticals Co. Ltd., Atridia Pty Ltd. | |
SHR-A2009 | HER3 | Full length Ab | Monospecific | Human | IgG1 | TBD | ADC | Cleavable linker | Topoisomerase I inhibitor | TBD | Phase 3 pending | Non-small cell lung cancer (NCT06671379 / CTR20244118) | Cancer | Jiangsu HengRui Medicine Co. Ltd. | ||
SI-B001 | Izalontamab | EGFR, HER3 | Appended Ig - 2+2 symmetric, IgG-(scFv)2 | Bispecific | Chimeric / Humanized | IgG1 | kappa/lambda | Unconjugated | None found | Phase 2/3 | Non-small cell lung cancer (NCT05020769, NCT05943795) | Cancer | Sichuan Biokin Pharmaceutical | SystImmune Inc., Sichuan Baili Pharmaceutical Co. Ltd | ||
SRK-015 | Apitegromab | Myostatin | Full length Ab | Monospecific | Human | IgG4 | lambda | Unconjugated | S228P (hinge-stabilization) | Phase 3 | Spinal muscular atrophy (NCT05156320, NCT05626855) | Muscular disorders | Scholar Rock | |||
SSGJ-601, 601 | VEGF-A | Full length Ab | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 3 | Branch retinal vein occlusion (NCT05520177) | Ophthalmic disorders | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd | ||||
SSGJ-610, 610 | IL-5 | Full length Ab | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 3 | Asthma (NCT06323213 / CTR20241581) | Immune-mediated / inflammatory disorders | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd | 3SBio | |||
SSGJ-611, 611 | IL-4R alpha | Full length Ab | Monospecific | Humanized | IgG4 | TBD | Unconjugated | TBD | Phase 3 | Atopic dermatitis (NCT06173284, NCT06554847), Sinusitis with nasal polyps (NCT06639295 not yet recruiting) | Immune-mediated / inflammatory disorders | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd | 3SBio | |||
SSGJ-613 | IL-1 beta | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 3 | Gouty arthritis (CTR20233982 / NCT06169891) | Immune-mediated / inflammatory disorders | Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. | 3SBio | |||
STRO-002 | Luveltamab tazevibulin | FR alpha | Full length Ab conjugate | Monospecific | Human | IgG1 | kappa | ADC | Valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclooctyne (DBCO) (Cleavable linker) | Tubulin inhibitor, SC209 (Hemiasterlin) | Y180pAMF, F404pAMF (non-natural amino acid for site specific conjugation) | Phase 2/3 | Ovarian Cancer, Fallopian Tube Cancer (NCT05870748) | Cancer | Sutro Biopharma | Tasly Biopharmaceuticals Co. Ltd. |
TJ004309, TJ4309, TJD5 | Uliledlimab | CD73 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | N297A (Fc-aglycosylated) | Phase 2/3 | Non-small cell lung cancer (CTR20240650) | Cancer | TRACON Pharmaceuticals | I-Mab Biopharma | ||
TJ202, MOR202, MOR03087 | Felzartamab | CD38 | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | None found | Phase 3 | Antibody-mediated rejection (NCT06685757) | Cancer | MorphoSys AG | Human Immunology Biosciences Inc. (HIBio), I-Mab Biopharma | ||
TLX591, ATL-101, Lu-177-huJ591, Rosopatamab-177Lu-DOTA | Rosopatamab tetraxetan 177Lu | PSMA | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | RIC | Lu-177 | None found | Phase 3 | Prostate cancer (NCT04876651, NCT06520345) | Cancer | Telix Pharmaceuticals Ltd | ||
TNM001 | RSV (F glycoprotein) | Full length Ab | Monospecific | Human | TBD | TBD | Unconjugated | TBD | Phase 2/3 | Preventing lower respiratory tract infections caused by respiratory syncytial virus in infants (NCT06083623) | Infectious diseases | Zhuhai Trinomab Biotechnology Co Ltd. | ||||
TPX-4589, LM-302 | Claudin-18.2 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | TBD | ADC | Valine-Alanine (Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | TBD | Phase 3 | Gastric or Gastroesophageal Junction Adenocarcinoma (NCT06351020) | Cancer | LaNova Medicines Zhejiang Co. Ltd. | Bristol Myers Squibb | |
TQH2722 | IL-4R alpha | TBD | Monospecific | Human | TBD | TBD | Unconjugated | TBD | Phase 3 | Atopic dermatitis (NCT06552520 / CTR20242940) | Immune-mediated / inflammatory disorders | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co. Ltd. | ||||
UX143, BPS804, MOR05813 | Setrusumab | Sclerostin | Full length Ab | Monospecific | Human | IgG2 | lambda | Unconjugated | None found | Phase 3 | Osteogenesis imperfecta (NCT05125809, NCT05768854, NCT06636071) | Skeletal disorders | Mereo BioPharma Group plc | Ultragenyx Pharmaceutical Inc. | ||
VAY736, NOV-5 | Ianalumab | BAFFR | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | Afucosylated (improve FcγRIIIa binding/improve ADCC) | Phase 3 | Sjogren syndrome (NCT05350072, NCT05349214, NCT05985915); Autoimmune hepatitis (NCT03217422); Lupus nephritis (NCT05126277); Systemic Lupus Erythematosus (NCT05624749, NCT05639114, NCT06133972); Warm Autoimmune Hemolytic Anemia (wAIHA) (NCT05648968); Primary Immune Thrombocytopenia (ITP) (NCT05653349, NCT05653219) | Immune-mediated / inflammatory disorders | Novartis Pharmaceuticals | |||
VIS649 | Sibeprenlimab | APRIL | Full length Ab | Monospecific | Humanized | IgG2 | kappa | Unconjugated | None found | Phase 3 | IgA nephropathy (NCT05248646; NCT05248659) | Immune-mediated / inflammatory disorders | Otsuka Pharmaceutical Development & Commercialization Inc. | |||
VLS-101, MK-2140 | Zilovertamab vedotin | ROR1 | Full length Ab conjugate | Monospecific | Humanized | IgG1 | kappa | ADC | Valine-citrulline (Maleimidocaproyl-valine-citrulline-para-aminobenzoate; Cleavable linker) | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | None found | Phase 2/3 | Diffuse large B-cell lymphoma (NCT05139017) | Cancer | Merck Sharp & Dohme LLC | |
VRDN-003 | IGF-1R | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | M252Y, S254T, T256E (half-life extension) | Phase 3 | Thyroid eye disease (NCT06625398, NCT06625411) | Immune-mediated / inflammatory disorders | Viridian Therapeutics Inc. | ||||
VYD222 | Pemivibart | SARS-CoV-2 (spike protein) | Full length Ab | Monospecific | Human | IgG1 | lambda | Unconjugated | Half-life extension | Phase 3, Emergency use authorization | COVID-19 (NCT06039449) | Infectious diseases | Invivyd Inc. | |||
XKH004, LZM-012, LZM012 | IL-17A, IL-17F | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | TBD | Phase 3 | Psoriasis (NCT06110676) | Immune-mediated / inflammatory disorders | Xinkanghe Biomedicine | Livzon Pharmaceutical Group Inc. | |||
YL201 | B7-H3 | Full length Ab | Monospecific | Human | TBD | TBD | ADC | Tumor Microenviroment Activable Linker | Topoisomerase I inhibitor, YL0010014 | Phase 3 pending | Nasopharyngeal Carcinoma (NCT06629597), Small cell lung cancer (NCT06612151) | Cancer | MediLink Therapeutics (Suzhou) Co. Ltd. | |||
ZB001, VRDN-001, IMGN164, AVE1642 | Veligrotug | IGF-1R | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 | Thyroid Eye Disease (NCT05176639, NCT06021054) | Immune-mediated / inflammatory disorders | Sanofi | Zenas Biopharma, miRagen | ||
ZB012, XMAB5871 | Obexelimab | CD19 | Full length Ab | Bispecific | Humanized | IgG1 | kappa | Unconjugated | S267E, L328F (increase binding to FcγRIIb) | Phase 3 | IgG4 Related Disease (NCT05662241); Warm Autoimmune Hemolytic Anemia (NCT05786573) | Immune-mediated / inflammatory disorders | Xencor | Bristol Myers Squibb, Zenas BioPharma Ltd, Amgen | ||
GS-5745 | Andecaliximab | MMP9 | Full length Ab | Monospecific | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 | Fibrodysplasia ossificans progressiva (NCT06508021) | Skeletal disorders | Gilead Sciences Inc | āshibio | ||
REGN1908-1909 | Freneslerbart, mevonlerbart | Fel d 1 | Full length Ab | Mixture of 2 monospecific antibodies | Humanized | IgG4 | kappa | Unconjugated | S228P (hinge stabilization) | Phase 3 | Cat allergy (NCT06602726 not yet recruiting) | Immune-mediated / inflammatory disorders | Regeneron Pharmaceuticals | Sanofi | ||
KN057 | Tissue factor pathway inhibitor | TBD | Monospecific | TBD | TBD | TBD | Unconjugated | TBD | Phase 3 | Hemophilia A and Hemophilia B (NCT06312475, NCT06569108) | Cardiovascular / hemostasis disorders | Suzhou Alphamab Biotechnology Co. Ltd | Sichuan Yuanda Shuyang Pharmaceutical Co. Ltd. | |||
GNR-055 | Verenafusp alfa | Insulin receptor | Fragment fusion | Monospecific | Chimeric | NA | kappa | Immunoconjugate | IDS | NA | Phase 2/3 | Mucopolysaccharidosis Type II (NCT05208281) | Metabolic disorders | AO GENERIUM | ||
LBL-024 | PD-L1, 4-1BB | Appended Ig - scFv-IgG | Bispecific | TBD | TBD | TBD | Unconjugated | TBD | Phase 2 pivotal | Neuroendocrine Carcinoma (NCT06157827) | Cancer | Nanjing Leads Biolabs Co. Ltd | ||||
Lu AF82422 | Amlenetug | Alpha synuclein | Full length Ab | Monospecific | Human | IgG1 | kappa | Unconjugated | None found | Phase 3 pending | Multiple System Atrophy (NCT06706622) | Neurological disorders | H. Lundbeck A/S | Genmab | ||
GR2001 | Tetanus toxin | TBD | TBD | TBD | TBD | TBD | Unconjugated | TBD | Phase 3 | Tetanus prophylaxis (NCT06635798 / CTR20243076) | Infectious diseases | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | ||||
SYS6010, CPO301 | EGFR | TBD | Monospecific | TBD | TBD | TBD | ADC | TBD | TBD | Phase 1/3 pending | Non-small cell lung cancer (CTR20243230 not yet recruiting) | Cancer | CSPC Pharmaceutical Group Limited | |||
LP003 | IgE | TBD | Monospecific | Humanized | TBD | TBD | Unconjugated | TBD | Phase 3 pending | Seasonal allergic rhinitis (CTR20241964 not yet recruiting) | Immune-mediated / inflammatory disorders | Longbio Pharma (Suzhou) Co. Ltd. | Tianchen Biopharmaceutical (Suzhou) Co. Ltd. | |||
AMG 509 | Xaluritamig | STEAP1, CD3 | Fragment-Fc | Bispecific | Humanized | TBD | TBD | Unconjugated | S267K (reduced effector function), N293G (no glycosylation), R302C, V302C (additional disulfide bridges) | Phase 3 pending | Prostate cancer (NCT06691984 not yet recruiting) | Cancer | Amgen | Xencor, BeiGene | ||
TQB2102 | HER2, HER2 | Fragment-Fc conjugate | ADC, Bispecific, Biparatopic | Humanized | TBD | TBD | ADC | Cleavable linker | Topoisomerase I inhibitor | TBD | Phase 3 | Breast cancer (NCT06561607 / CTR20242868) | Cancer | Chia Tai Tianqing Pharmaceutical Group Co. Ltd., Sino Biopharmaceutical | ||
TST001, MSB018 | Osemitamab | Claudin-18.2 | Full length Ab | Monospecific | Humanized | IgG1 | kappa | Unconjugated | None found | Phase 3 pending | Cancer | Transcenta Holding Ltd., Maibos Bio | ||||
TORL-1-23 | Claudin-6 | TBD | ADC | TBD | TBD | TBD | ADC | Cleavable linker | Tubulin inhibitor, Monomethyl auristatin E (MMAE) | TBD | Phase 2 pivotal | Ovarian cancer (NCT06690775) | Cancer | TORL Biotherapeutics LLC |
Table notes:
- in the “Backbone” column, the isotype refers to human unless indicated otherwise with the prefix m- (murine) or r- (rat).
- in the “Format” column is reported format and format details.
- information on general molecular category (ADC, RIC, immunoconjugates, immunocytokines, unconjugated) and details is reported in the column “Conjugated/Fused”.