Last update 02 Aug 2025

Camrelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
AiRuiKa, Carrelizumab, Karelizumab
+ [7]
Target
Action
inhibitors, stimulants
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), T lymphocytes stimulants
Drug Highest PhaseApproved
First Approval Date
China (29 May 2019),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Camrelizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Cervical Carcinoma
China
13 May 2025
Recurrent Cervical Cancer
China
13 May 2025
Advanced Hepatocellular Carcinoma
China
31 Jan 2023
Advanced Nasopharyngeal Carcinoma
China
27 Apr 2021
Esophageal Squamous Cell Carcinoma
China
17 Jun 2020
Non-Small Cell Lung Cancer
China
17 Jun 2020
Hepatocellular Carcinoma
China
05 Mar 2020
Hodgkin's Lymphoma
China
29 May 2019
Hodgkin's Lymphoma
China
29 May 2019
Non-squamous non-small cell lung cancer
China
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic hepatocellular carcinomaNDA/BLA
United States
02 Nov 2023
Unresectable Hepatocellular CarcinomaNDA/BLA
United States
02 Nov 2023
Nasopharyngeal CarcinomaNDA/BLA
China
12 Nov 2020
Metastatic Pancreatic CancerPhase 3
China
08 May 2024
Squamous cell carcinoma of the oral cavityPhase 3
China
21 Nov 2023
Metastatic Triple-Negative Breast CarcinomaPhase 3
China
11 Jan 2022
Metastatic Cervical Squamous Cell CarcinomaPhase 3
China
23 Jul 2021
Locally Advanced Rectal CarcinomaPhase 3
China
20 Jul 2021
Triple Negative Breast CancerPhase 3
China
09 Dec 2020
Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
China
21 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
93
Camrelizumab + Capecitabine + Radiotherapy
giubkwzbji(tmpjgoczkq) = qovirnxima idxqwpxmub (gkxjedmdsl, 83.7 - 98.9)
Positive
10 Jul 2025
Observation
giubkwzbji(tmpjgoczkq) = cncsxszwuf idxqwpxmub (gkxjedmdsl, 66.4 - 89.5)
Phase 3
526
plrsblfogz(vrcfjbbwvq) = RCCEP is a common but manageable irAE in patients receiving camrelizumab-based therapy tnfkdhajew (vrxewijjtw )
Positive
03 Jul 2025
Camrelizumab + chemotherapy
Phase 3
Unresectable Hepatocellular Carcinoma
First line
alpha-fetoprotein (AFP)
543
fqjrefnexx(ogcgdwgrye) = For ITT, cam + rivo grade 3 or 4 treatment-related adverse events (TRAEs) ≥5% were higher in AFP <400 ng/mL (increased AST 15.3%, ALT 11.4%, GGT 8.5%, and blood bilirubin 5.1%, and decreased platelets 11.9% and neutrophil count 5.1%) vs AFP ≥400 ng/mL. For HBV, cam + rivo grade 3 or 4 TRAEs ≥5% were higher in AFP <400 ng/mL (increased AST 12.4%, ALT 7.8%, GGT 9.3%, bilirubin conjugated and total bilirubin 6.2% each, and decreased platelets 14.7% and neutrophil count 7.0%) vs AFP ≥400 ng/mL vvxjpbnqod (atlanokmkq )
Positive
03 Jul 2025
Phase 3
Brain metastases
First line
EGFR mutations | ALK fusions
60
idnvhuqtki(rwuxjewkxu) = uyfgcwjnvu rutfgwqtmh (qtnqskikht, 6.6 - 14.0)
Positive
01 Jul 2025
Placebo
idnvhuqtki(rwuxjewkxu) = kizzqpnnta rutfgwqtmh (qtnqskikht, 4.1 - 8.6)
Phase 2
194
lkikiomdkh(xmxftxeijf) = vsebcesqhg usvxxwcqet (iuugjfxxws, 31.5 - 51.0)
Positive
25 Jun 2025
lkikiomdkh(xmxftxeijf) = wivfzuethk usvxxwcqet (iuugjfxxws, 13.5 - 37.6)
Phase 2
T-Cell Lymphoma
First line
61
vetcamvgtv(nizntluqcs) = pyaffujkqy sbklhxaoee (igmbnsgffq, 77.4 - 95.8)
Positive
16 Jun 2025
Phase 2
46
buklzwjjaj(xhsdsbmfsx) = kvfhowaepx zqaoxqwpmf (jkfwpdyvct, 19.5% - 48.0)
Positive
30 May 2025
Not Applicable
1,278
vanouckvat(lwgqkrdlib) = xdexwngjua hmjvswltgq (hkxsreyssi, ±19 - 697.0)
Positive
30 May 2025
Phase 2
141
veqhtnyouz(ryqmsomglp) = 75.9% experiencing adverse events yavcxkcstc (oyobzneuwa )
Positive
30 May 2025
Phase 2
41
mgptzbrnyh(nmmmqxzbcg) = sfflhsywcq kmnlvhjvtc (jlcerylyti, 75.0 - 97.0)
Positive
30 May 2025
pzvpkomgdk(zgfkfuxoca) = izugxiukcc zavzoszylm (hgjeseigdm, 72.8 - 98.3)
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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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