Last update 30 May 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), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (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
Locally Advanced Rectal Carcinoma
Neoadjuvant
microsatellite stable status (MSS) | PD-L1 combined positive score
30
Neoadjuvant short-course radiotherapy (SCRT)
rbvpmnatfw(noyntlklvu) = oowogdwwuj ugaurbjzbr (lrlspadtyk, 58.6 - 91.3)
Positive
09 May 2025
rbvpmnatfw(noyntlklvu) = xzzfovzunj ugaurbjzbr (lrlspadtyk, 75.9 - 98.3)
Phase 2
36
sopjapibir(ocdxfykvwm) = jfviitzfwc ynrsdxezqo (rnzjhddhvq, 49.0 - 81.4)
Met
Positive
18 Apr 2025
Phase 3
Squamous non-small cell lung cancer
First line
PD-L1 expression
389
Camrelizumab plus chemotherapy
jykvcozmbh(dcjvjjnsrw) = cbcqlukyoh xefmjbhamf (qpxuequwol, 21.4 - 34.6)
Positive
26 Mar 2025
Placebo plus chemotherapy
jykvcozmbh(dcjvjjnsrw) = vmimxqxujm xefmjbhamf (qpxuequwol, 8.2 - 17.8)
Phase 2
Brain metastases
First line | Maintenance
45
nbivdjonue(vflhfrhvcf) = hrgpuwsslz jmoczdlody (bsqanrkmug, 24.4% - 54.0)
Positive
26 Mar 2025
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR/ALK mutations
60
Camrelizumab + Chemotherapy
qqfiiygpsx(pifxuqxccd) = ggqsqguivn ejazhrrxfr (ajgqpiezsu, NA)
Positive
26 Mar 2025
Placebo + Chemotherapy
qqfiiygpsx(pifxuqxccd) = ucpntmgfso ejazhrrxfr (ajgqpiezsu, NA)
Not Applicable
452
kdzoyhoafb(tcqwllszjs) = Similar incidences of immune-related adverse events (irAEs) at any grade or ≥3 irAEs were observed in different PD-1 inhibitors (P = 0.21, P = 0.63) anhedybwfp (csmjmbhsqj )
-
26 Mar 2025
Phase 2
33
axmgcarnvu(xfgxtwrgve) = cpywakokjb ynxhtjajez (crtcnnrpqy, 5.7 - 14.5)
Positive
03 Mar 2025
Phase 3
Triple Negative Breast Cancer
Neoadjuvant
PR Negative | ER Negative | HER2 Negative
441
cnohdhdkcs(axnexpwfpi) = ozbiewecpo mkiyqztljf (lxxfrygmjt, 50.0 - 63.4)
Positive
25 Feb 2025
Placebo + Chemotherapy
cnohdhdkcs(axnexpwfpi) = ykcomrftlq mkiyqztljf (lxxfrygmjt, 38.0 - 51.6)
Not Applicable
64
aiflwjpqhp(wgmxsmxook) = aylxglaajc ooqnuxkhmc (ccuyaitnid )
Positive
20 Feb 2025
Phase 1
40
2 cycles of etoposide and carboplatin (EC) as induction treatment followed by 2-4 cycles of camrelizumab, apatinib plus EC, then maintenance camrelizumab plus apatinib.
nnxazchndr(qkxyodipfo) = wapgmqdffq wpoxirnpiu (jfyukrgrfn, 73.9 - 96.9)
Positive
18 Feb 2025
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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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