Toripalimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Toripalimab
- loqtorzi
- Loqtorzi
- 5 fluorouracil cisplatin toripalimab
- anti pd i mab shanghai junshi
- Anti-pd-i mab-shanghai junshi
- chs 007
- CHS-007
- immunoglobulin g4 anti human programmed cell death protein 1 human monoclonal js001 gamma 4 chain disulfide with human monoclonal js001 kappa chain dimer
- IMMUNOGLOBULIN G4, ANTI-(HUMAN PROGRAMMED CELL DEATH PROTEIN 1) (HUMAN MONOCLONAL JS001 .GAMMA.4-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL JS001 .KAPPA.-CHAIN, DIMER
- Induction Immunotherapy-Toripalimab
- js 001
- Js-001
- JS-001
- js001
- Js001
- JS001
- JS001(Toripalimab Injection)
- PD-1 antibody (Toripalimab)
- tab 001
- TAB-001
- tab001
- TAB001
- teriprizumab
- Teriprizumab
- toripalimab
- Toripalimab
- TORIPALIMAB
And 30 more, listed on the interactive page.
- ATC classification codes
- L01FF13
Sources for recorded values
- CAS registry numbers
- 1924598-82-2
- ChEMBL ID
- CHEMBL4297843
- FDA ingredient codes (UNII)
- 8JXN261VVA
- 2669406
- 2669407
- Applicant
- COHERUS BIOSCIENCES INC
- Approval date
- 27 Oct 2023
- Application number
- BLA761240
- Status
- Authorised
- Status date
- 19 Sept 2024
- Authorisation date
- 19 Sept 2024
- Approved indications
- Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
- Product number
- EMEA/H/C/006120
- Authorisation holder
- Topalliance Biosciences Europe Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Esophageal Squamous Cell Carcinoma
- Nasopharyngeal Carcinoma
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 27 Oct 2030
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- toripalimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 8.68
- Affinity units
- pKd
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Liposarcoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000569
- Subject identifier
- D008080
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Epstein-Barr Virus Infections
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000769
- Subject identifier
- D020031
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000770
- Subject identifier
- D008654
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001416
- Subject identifier
- D002583
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002617
- Subject identifier
- D008545
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Hypopharyngeal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002938
- Subject identifier
- D007012
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003826
- Subject identifier
- D012468
And 38 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000199
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000756
- Condition identifier
- EFO_0000769
- Condition identifier
- EFO_0000770
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002617
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002938
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003891
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003897
- Condition identifier
- EFO_0004252
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004288
- Condition identifier
- EFO_0005221
- Highest recorded phase
- 2
And 120 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 730
- Reporting signal score
- 1,468.33
- Event
- alanine aminotransferase increased
- Reports
- 10
- Reporting signal score
- 27.8235
- Event
- anaemia
- Reports
- 18
- Reporting signal score
- 46.0066
- Event
- aspartate aminotransferase increased
- Reports
- 10
- Reporting signal score
- 28.9693
- Event
- autoimmune colitis
- Reports
- 196
- Reporting signal score
- 654.57
- Event
- colitis
- Reports
- 1,502
- Reporting signal score
- 2,530.13
- Event
- diarrhoea
- Reports
- 13
- Reporting signal score
- 17.8051
- Event
- fatigue
- Reports
- 15
- Reporting signal score
- 21.7943
- Event
- fulminant type 1 diabetes mellitus
- Reports
- 239
- Reporting signal score
- 791.299
- Event
- haematotoxicity
- Reports
- 4
- Reporting signal score
- 15.136
- Event
- hepatic function abnormal
- Reports
- 7
- Reporting signal score
- 21.6882
- Event
- hepatitis
- Reports
- 629
- Reporting signal score
- 631.24
- Event
- hyperbilirubinaemia
- Reports
- 6
- Reporting signal score
- 24.5678
- Event
- hypertension
- Reports
- 14
- Reporting signal score
- 33.8432
- Event
- hyperthyroidism
- Reports
- 589
- Reporting signal score
- 951.239
- Event
- hypoalbuminaemia
- Reports
- 6
- Reporting signal score
- 26.7832
- Event
- hypophysitis
- Reports
- 568
- Reporting signal score
- 1,773.17
- Event
- hypothyroidism
- Reports
- 1,115
- Reporting signal score
- 1,876.7
- Event
- immune-mediated adverse reaction
- Reports
- 307
- Reporting signal score
- 1,046.18
- Event
- immune-mediated enterocolitis
- Reports
- 469
- Reporting signal score
- 1,624.26
- Event
- immune-mediated hepatitis
- Reports
- 305
- Reporting signal score
- 1,032.45
- Event
- injection site pain
- Reports
- 4
- Reporting signal score
- 579.434
- Event
- leukopenia
- Reports
- 12
- Reporting signal score
- 38.9835
- Event
- malignant neoplasm progression
- Reports
- 3,087
- Reporting signal score
- 5,644.87
- Event
- myasthenia gravis
- Reports
- 302
- Reporting signal score
- 625.68
And 17 more, listed on the interactive page.
- NCT02838823
- NCT04389073
- NCT04418154
- NCT05749575
- NCT06178159
- NCT06389006
- NCT02857166
- NCT03810339
- NCT04137900
- NCT04169672
- NCT04280341
- NCT04284488
- NCT04322006
- NCT04337463
- NCT04357756
- NCT04481009
- NCT04645069
- NCT04727164
- NCT04737122
- NCT04914286
- NCT04991506
- NCT05061628
- NCT05102006
- NCT05149027
- NCT05165849
And 238 more, listed on the interactive page.
- Dose
- 240 mg
- Route
- Intravenous
- How often
- Every three weeks
- If no reactions, subsequent infusions over 30 minutes
- Infuse over 60 minutes for first infusion
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- 302 $ 302''''
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QGQLVQSGAEVKKPGASVKVSCKASGYTFTDYEMHWVRQAPIHGLEWIGVIESETGGTAYNQKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCAREGITTVATTYYWYFDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DVVMTQSPLSLPVTLGQPASISCRSSQSIVHSNGNTYLEWYLQKPGQSPQLLIYKVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHVPLTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- 302 $ 302''
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-93' $ 23'''-93''' $ 139'-199' $ 139'''-199''' $ 139-219' $ 139''-219''' $ 152-208 $ 152''-208'' $ 231-231'' $ 234-234'' $ 266-326 $ 266''-326'' $ 372-430 $ 372''-430''
- 70114-340
Related records
Trials (628)
- 9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma
- 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
- 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
- 9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
- A Clinical Study for the Safety and Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
- A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
- A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer
- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
- A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer
- A Clinical Study of TAB006 in Patients With Previously Treated, Advanced Malignancies
- A Clinical Study to Evaluate the Safety and Tolerability of JS001sc in Advanced Nasopharyngeal Carcinoma
- A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors
- A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
- A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
- A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
- A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
- A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)
- A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer
- A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
- A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)
Approved for (4)
- Cancer
- Nasopharyngeal carcinoma
- Neoplasm
- Niemann-Pick disease type B
In development for (63)
- Biliary tract cancer Phase 2
- Biliary tract neoplasm Phase 2
- Bladder transitional cell carcinoma Phase 2
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 3
- Cervical adenocarcinoma Phase 2
- Cervical cancer Phase 2
- Cholangiocarcinoma Phase 3
- Colonic neoplasm Phase 1
- Colorectal cancer Phase 2
- Colorectal carcinoma Phase 2
- Cutaneous melanoma Phase 3
- Epstein-Barr virus infection Early phase 1
- Esophageal cancer Phase 3
- Esophageal squamous cell carcinoma Phase 3
- Exocrine pancreatic carcinoma Phase 2
- Extranodal nasal NK/T cell lymphoma Phase 2
- Gastric adenocarcinoma Phase 2
Targets (1)
- PDCD1 Programmed cell death protein 1 antagonist