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AboutPricing
Drug ReportsTislelizumab
Tevimbra(tislelizumab)
Tevimbra (tislelizumab) is an antibody pharmaceutical. Tislelizumab was first approved as Tevimbra on 2023-09-15. It is used to treat esophageal squamous cell carcinoma in the USA. It has been approved in Europe to treat esophageal squamous cell carcinoma. The pharmaceutical is active against programmed cell death protein 1.
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
Trade Name
FDA
EMA
Tevimbra
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tislelizumab
Tradename
Proper name
Company
Number
Date
Products
Tevimbratislelizumab-jsgrBeigeneN-761232 RX2024-03-13
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tevimbraBiologic Licensing Application2025-09-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
esophageal squamous cell carcinoma—D000077277—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
— L01FF09: Tislelizumab
HCPCS
No data
Clinical
Clinical Trials
679 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0332——7
Hepatocellular carcinomaD006528—C22.0322——6
Lung neoplasmsD008175—C34.90122——4
Liver neoplasmsD008113EFO_1001513C22.0311——4
Colorectal neoplasmsD015179———31——4
Non-small-cell lung carcinomaD002289———12——3
Microsatellite instabilityD053842————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80108———13
LymphomaD008223—C85.923———4
Urinary bladder neoplasmsD001749—C6714———4
Esophageal squamous cell carcinomaD000077277———3———3
Squamous cell carcinomaD002294———2———2
Non-muscle invasive bladder neoplasmsD000093284———2———2
B-cell chronic lymphocytic leukemiaD015451—C91.111———1
B-cell lymphoma marginal zoneD018442—C88.411———1
Follicular lymphomaD008224—C8211———1
Mantle-cell lymphomaD020522—C83.111———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTislelizumab
INNtislelizumab
Description
Tislelizumab, sold under the brand name Tevimbra among others, is a humanized monoclonal antibody directed against PD-1. It prevents PD-1 from binding to the ligands PD-L1 and PD-L2 (hence it is a checkpoint inhibitor). It is designed to bind less to Fc gamma receptors. It is being developed by BeiGene (after a period with Celgene Corp).
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>7CGW:A,H|Heavy chain of tislelizumab Fab QVQLQESGPGLVKPSETLSLTCTVSGFSLTSYGVHWIRQPPGKGLEWIGVIYADGSTNYNPSLKSRVTISKDTSKNQVSL KLSSVTAADTAVYYCARAYGNYWYIDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPHHHHHH >7CGW:B,L|Light chain of tislelizumab Fab DIVMTQSPDSLAVSLGERATINCKSSESVSNDVAWYQQKPGQPPKLLINYAFHRFTGVPDRFSGSGYGTDFTLTISSLQA EDVAVYYCHQAYSSPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB7BXA, 7CGW
CAS-ID1858168-59-8
RxCUI—
ChEMBL IDCHEMBL4297840
ChEBI ID—
PubChem CID—
DrugBankDB14922
UNII ID0KVO411B3N (ChemIDplus, GSRS)
Target
Agency Approved
PDCD1
PDCD1
Organism
Homo sapiens
Gene name
PDCD1
Gene synonyms
PD1
NCBI Gene ID
5133
Protein name
programmed cell death protein 1
Protein synonyms
CD279, programmed cell death 1 protein, protein PD-1, systemic lupus erythematosus susceptibility 2
Uniprot ID
Q8IX89
Mouse ortholog
Pdcd1 (18566)
programmed cell death protein 1 (Q02242)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Tislelizumab – BeOne Medicines
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,863 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,161 adverse events reported
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