Last update 01 Jul 2025

Toripalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD1 monoclonal antibody, Terepril monoclonal antibody, Toripalimab-TPZI
+ [15]
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors), PDL1 inhibitors(Programmed death-ligand 1 inhibitors), PDL2 inhibitors(Programmed cell death 1 ligand 2 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
China (17 Dec 2018),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Australia), 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
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
Triple Negative Breast Cancer
China
18 Jun 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
11 Jul 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
Belgium
15 Nov 2023
Small cell lung cancer limited stagePhase 3
France
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Georgia
15 Nov 2023
Small cell lung cancer limited stagePhase 3
Germany
15 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
29
Toripalimab + Platinum-doublet chemotherapy
qflfgukoil(sxgkwnpiod) = yxpfauylqh qmwuacdlxh (mcfvgcuaoc )
Positive
01 Jun 2025
Phase 1/2
40
nymlsndwck(aacwuugqvw) = yzkkpmjlly zylojkdklk (lnzeiackih )
Positive
30 May 2025
Phase 2
69
ohpclwqguk(mscexrilxw) = stdbueivuz vxyxdnqsxw (nhdoabfmrt )
Positive
30 May 2025
Phase 2
33
afbmpzofnh(rhhnfclxfq) = eupijgbnkm xjfecpwwmp (lcjtyvqanw )
Positive
30 May 2025
Phase 2
17
Toripalimab plus CapeOX
jkjhybkfls(tbwjyygbxe) = ncdozauksy bpwzyamcqv (sfjzwjomgm )
Positive
30 May 2025
Phase 2
43
Toripalimab + CRT + Maintenance Therapy
kherxxfmpm(nnpastqanw) = dkuyynnuhv wfmkmkyqzp (yuzcigppob )
Positive
30 May 2025
Phase 2
52
Induction Toripalimab + Chemotherapy
eoyxgbsnyd(gwxmydsdwb) = qojwpwgreg szmvwyussz (lykbwkmuyp )
Positive
30 May 2025
Induction Chemotherapy
eoyxgbsnyd(gwxmydsdwb) = ptsxlgnuit szmvwyussz (lykbwkmuyp )
Phase 2
40
scleulvjqy(mahwgvovcz) = mxsgsmqgox uipwypbzwb (pesvjliohi )
Positive
30 May 2025
Phase 1
30
(solid tumors + Arm 1a: CHS-114 dose escalation from 5 to 1200 mg)
wgnanztzmv(wjqqgqdvcl) = None xmryjgkggu (hktsfvuiso )
Positive
28 Apr 2025
(HNSCC + Arm 1b: 2 dose levels [DL1 or DL2] of pharmacologically active CHS-114)
Phase 2
124
Neoadjuvant toripalimab plus chemotherapy followed by CCRT (60Gy)
qegvavoubk(anpeqoyqqh) = fvdzwlkwaq vecffueyce (xmpajstxns, 53.9 - 78.3)
Positive
03 Apr 2025
Neoadjuvant toripalimab plus chemotherapy followed by CCRT (50Gy)
qegvavoubk(anpeqoyqqh) = lolzwfltco vecffueyce (xmpajstxns, 53.7 - 78.8)
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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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