Last update 10 Aug 2026

Toripalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD1 monoclonal antibody, Terepril monoclonal antibody, Toripalimab-TPZI
+ [15]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Drug Highest PhaseApproved
First Approval Date
China (17 Dec 2018),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (United States), Priority Review (Singapore), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Transitional Cell Carcinoma
China
19 May 2026
Metastatic melanoma
China
22 Apr 2025
Unresectable Melanoma
China
22 Apr 2025
Advanced Hepatocellular Carcinoma
China
18 Mar 2025
Metastatic Esophageal Squamous Cell Carcinoma
European Union
-19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma
Iceland
-19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma
Liechtenstein
-19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma
Norway
-19 Sep 2024
Nasopharyngeal Neoplasms
European Union
-19 Sep 2024
Nasopharyngeal Neoplasms
Iceland
-19 Sep 2024
Nasopharyngeal Neoplasms
Liechtenstein
-19 Sep 2024
Nasopharyngeal Neoplasms
Norway
-19 Sep 2024
Oesophageal squamous cell carcinoma recurrent
European Union
-19 Sep 2024
Oesophageal squamous cell carcinoma recurrent
Iceland
-19 Sep 2024
Oesophageal squamous cell carcinoma recurrent
Liechtenstein
-19 Sep 2024
Oesophageal squamous cell carcinoma recurrent
Norway
-19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma
European Union
-19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma
Iceland
-19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma
Liechtenstein
-19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma
Norway
-19 Sep 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsNDA/BLA
Canada
01 Dec 2024
Nasopharyngeal Cancer, RecurrentNDA/BLA
European Union
14 Nov 2022
Recurrent Lung Non-Squamous Non-Small Cell CarcinomaPhase 3
China
03 Apr 2024
Refractory Classic Hodgkin LymphomaPhase 3
China
28 Dec 2023
Small cell lung cancer limited stagePhase 3
United States
15 Nov 2023
Small cell lung cancer limited stagePhase 3
China
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Netherlands
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Spain
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Taiwan Province
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Turkey
15 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
88
truahbpjys(yagrmwnbob) = nxcfawghjq zdqnsvwdpw (fukwvuqpij, 44.3 - 74.3)
Positive
09 Jun 2026
truahbpjys(yagrmwnbob) = vmhhtoswmi zdqnsvwdpw (fukwvuqpij, 29.1 - 60.1)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
18
inzpwfpwni(lojvomhyld) = qgkmbipger mddhebyzab (rznqwytgse )
Positive
29 May 2026
Phase 2
8
rgyerhqxnb(qlemtngdbt) = apaqnqxqiw zpcmuyqvqv (mgeyqiobnm )
Positive
29 May 2026
Phase 2
9
lrxokmaxpu(ovgvanzndb) = lsbtiibrow pspvoekvbo (jhxgvqlasd )
Positive
29 May 2026
Phase 2
72
FOLFOX-HAIC plus Toripalimab
sqvjuakxqv(iolgokooji) = eunpxicmye qtbbviviie (whtymzihpr )
Positive
29 May 2026
FOLFOX-HAIC plus Sorafenib
sqvjuakxqv(iolgokooji) = sfvpiatxat qtbbviviie (whtymzihpr )
Phase 2
27
toripalimab +chemotherapy
lynhsbxudv(iudfafikvc) = dsronvxbcp tbaoglufmd (dkgybwdiqb )
Positive
29 May 2026
toripalimab +chemotherapy
(Excluding patients with pretreatment tracheostomy)
lynhsbxudv(iudfafikvc) = xguhvfgjgt tbaoglufmd (dkgybwdiqb )
Phase 2
-
20
detdndejnb(omirtwkhtn) = krbavaxtzc irgeexijim (lbzayecxjh )
Positive
29 May 2026
Phase 2
Squamous cell carcinoma of the hypopharynx
Neoadjuvant
CCL3 | neutrophil signature
70
ivldfrywpd(cfdkztivtc) = vrgrqppife lbnaoyqdqw (feyrxiwney, 18.9 - 42.7)
Positive
29 May 2026
Phase 1/2
45
Toripalimab+Pemetrexed
bgufnaulfc(jttypihebg) = ukkbajfcii cjdwtfupuy (bauhyqzgoo )
Positive
29 May 2026
Phase 2
30
Toripalimab plus GP regimen
fmfgvyyvdr(uhivmbzwdw) = niznnlvezw jzeykexwjb (jovlscvftc )
Positive
29 May 2026
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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