Last update 12 Jul 2024

Toripalimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PD1 monoclonal antibody, Terepril monoclonal antibody, Toripalimab-TPZI
+ [14]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Drug Highest PhaseApproved
First Approval Date
CN (17 Dec 2018),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (AU), Priority Review (SG)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Triple Negative Breast Cancer
CN
18 Jun 2024
Extensive stage Small Cell Lung Cancer
CN
04 Jun 2024
Metastatic Renal Cell Carcinoma
CN
07 Apr 2024
Unresectable Renal Cell Carcinoma
CN
07 Apr 2024
Resectable Lung Non-Small Cell Carcinoma
CN
26 Dec 2023
Non-squamous non-small cell lung cancer
CN
14 Sep 2022
Esophageal Squamous Cell Carcinoma
CN
10 May 2022
Transitional Cell Carcinoma
CN
07 Apr 2021
Nasopharyngeal Carcinoma
CN
10 Feb 2021
Melanoma
CN
17 Dec 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Small Cell Lung CancerPhase 3
US
15 Nov 2023
Small Cell Lung CancerPhase 3
BE
15 Nov 2023
Small Cell Lung CancerPhase 3
FR
15 Nov 2023
Small Cell Lung CancerPhase 3
GE
15 Nov 2023
Small Cell Lung CancerPhase 3
DE
15 Nov 2023
Small Cell Lung CancerPhase 3
IT
15 Nov 2023
Small Cell Lung CancerPhase 3
NL
15 Nov 2023
Small Cell Lung CancerPhase 3
PL
15 Nov 2023
Small Cell Lung CancerPhase 3
RO
15 Nov 2023
Small Cell Lung CancerPhase 3
KR
15 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Metastatic Microsatellite Stable Colorectal Carcinoma
Second line
Microsatellite Stable (MSS)
16
twhxgicaqm(pqazqtpwmb) = ttalvrfgev ojhzbswevb (cxxdxlluth )
Positive
27 Jun 2024
twhxgicaqm(pqazqtpwmb) = gjwvzofjhu ojhzbswevb (cxxdxlluth )
Phase 2
Muscle Invasive Bladder Carcinoma
Neoadjuvant
PD-L1 Expression
30
Toripalimab 240 mg + Gemcitabine 1000 mg/m2+ Cisplatin 70mg/m2
uoajiyshxy(bbetosperb) = dkotdpfclk oitycqcshg (ajstrscrii )
Positive
24 May 2024
Phase 2
44
Disitamab vedotin 2 mg/kg plus toripalimab 3 mg/kg
uirmxjvirh(udmblmuxye) = zvmyshrcdf orfefwpgth (nprhbudmym )
Positive
24 May 2024
Phase 3
Nasopharyngeal Cancer, Recurrent
First line
EBV DNA copy number
289
Toripalimab 240 mg + Gemcitabine-Cisplatin (GP)
amvlucpjtg(shccovjxzk) = anrbtwcxvz jawnnlilmi (izzadausmo )
Positive
24 May 2024
Placebo + Gemcitabine-Cisplatin (GP)
amvlucpjtg(shccovjxzk) = cvoeeliupq jawnnlilmi (izzadausmo )
Phase 2
46
Toripalimab+Chemoradiotherapy
lqvfhrbxhy(wrmwzkondn) = bbrgflmvwd squlqymabp (dexaxanrjy )
Negative
24 May 2024
Chemoradiotherapy alone
lqvfhrbxhy(wrmwzkondn) = opqubrpwoz squlqymabp (dexaxanrjy )
Phase 2
Advanced Nasopharyngeal Carcinoma
Adjuvant
plasma Epstein-Barr virus (EBV) DNA levels
150
Neoadjuvant and adjuvant toripalimab
grqcrjfewv(ynyebpjbzr) = jgabkbwnhi rwumdwpwej (jpppbjhquy )
Positive
24 May 2024
Placebo
grqcrjfewv(ynyebpjbzr) = nxpmdsukdw rwumdwpwej (jpppbjhquy )
Phase 2
Melanoma
Adjuvant
43
Toripalimab (PD-1 inhibitor) + recombinant human endostatin
isegyoaasr(hhxxtoxruf) = inhztfvxtc isszavdwtz (wsbnwyjmod )
Positive
24 May 2024
Phase 2
64
Toripalimab consolidation
bkkafglkds(zwxxgsapee) = vzdzohovih zwbhbpiele (dexsqetcwe, 65.2% - 100)
Positive
24 May 2024
ztcsqnjyen(qgyjtyykuf) = mbpuqpjfts jnnzakodkp (saelrcfqmh, 0.04 - 24.50)
Not Applicable
47
dirpuevicz(fjvlzjnqbq) = rvetktybyx pyblsfpvuu (cfedxbdzic )
Positive
24 May 2024
Not Applicable
16
ruylryezct(ttoflhcxbc) = the 12-month PFS rate was 77.14% (95% CI: 48.89%-100%) nhhzqwewwh (lgedtoilgs )
Positive
24 May 2024
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