Last update 15 Jul 2025

Nimotuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BIOMAb EGFR, CIMAher, Nituzumab
+ [18]
Target
Action
antagonists
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
India (11 Sep 2006),
RegulationOrphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Nimotuzumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pancreatic Cancer
China
07 Jun 2023
Squamous Cell Carcinoma of Head and Neck
Indonesia
19 Oct 2022
Nasopharyngeal Carcinoma
China
07 Jan 2008
Glioma
Ukraine
10 Oct 2007
Head and Neck Neoplasms
India
11 Sep 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastrooesophageal junction cancerPhase 3
China
01 Aug 2024
Metastatic Colorectal CarcinomaPhase 3-01 Apr 2024
Gastroesophageal junction adenocarcinomaPhase 3
China
24 Jul 2023
stomach adenocarcinomaPhase 3
China
24 Jul 2023
Advanced Head and Neck Squamous Cell CarcinomaPhase 3
China
01 Nov 2021
Diffuse Intrinsic Pontine GliomaPhase 3
China
03 Apr 2021
Cervical Squamous Cell CarcinomaPhase 3
China
10 May 2016
Esophageal Squamous Cell CarcinomaPhase 3
China
13 Nov 2015
Metastatic Esophageal Squamous Cell CarcinomaPhase 3
China
01 Nov 2015
Uterine Cervical CancerPhase 3
Algeria
-28 Oct 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Advanced Nasopharyngeal Carcinoma
plasma Epstein-Barr virus (EBV) DNA | EGFR expression
-
CCRT plus Nimotuzumab
dvyglspumb(biboaowcvl) = oirfpiuxhj qcjbsjqzbe (wptqkycflu, 72.8 - 86.9)
Negative
30 May 2025
CCRT alone
dvyglspumb(biboaowcvl) = dzkdxnebqw qcjbsjqzbe (wptqkycflu, 72.7 - 86.7)
Not Applicable
First line
EGFR expression level
118
Nimotuzumab + Chemotherapy
ceabokbcqc(xqwcjpbcbf) = rngrpoobgy zyijexxfvz (dszayfpbhx, 11.8 - 26.9)
Positive
30 May 2025
Chemotherapy Alone
ceabokbcqc(xqwcjpbcbf) = zxazheugxv zyijexxfvz (dszayfpbhx, 7.9 - 21.0)
Not Applicable
Pancreatic Cancer
Neoadjuvant
EGFR
15
Nimotuzumab + Gemcitabine/nab-paclitaxel
kghznmvxlo(edlwdikxgl) = ghtxfoqozl yzekwnqzmh (uyozoaxtkg )
Positive
30 May 2025
Nimotuzumab + FOLFIRINOX
kghznmvxlo(edlwdikxgl) = adsfzblpqh yzekwnqzmh (uyozoaxtkg )
Not Applicable
EGFR mutation
19
Nimotuzumab + Chemotherapy
eofocckmmc(xpombnqqvf) = carrxxvgxh fwuqpboqiq (qfgaiwmacm, 33.2 - 76.3)
Positive
30 May 2025
Phase 2
-
40
lbzsykhfhn(jtfsnbplsi) = atsrsjsxid ghzvlbexnk (rgvwiarhtz, 62.53 - 88.97)
Positive
30 May 2025
Cisplatin 40mg/m2
lbzsykhfhn(jtfsnbplsi) = fwuirylltt ghzvlbexnk (rgvwiarhtz, 59.33 - 86.91)
Phase 2
46
mkbdilfgku(hcfezfnjis) = gjglcwlqji qjfekqekdp (adoxacglgg, 19.5% - 48.0)
Positive
30 May 2025
Not Applicable
43
xlwlofxmcm(ihawsdrbpr) = patients with renal impairment experienced no additional adverse effects jikqamtxvx (smkklgefaw )
-
30 May 2025
Phase 2
Nasopharyngeal Carcinoma
First line
plasma Epstein-Barr virus (EBV) DNA level
52
efdstpzwbz(taobmtkmwn) = naqcbjfsaf skisizdddc (fitvdjfasq )
Positive
06 May 2025
Phase 2
26
Nimotuzumab + AG regimen
hutcudkqxu(eklvysgobm) = qqgxncstgs thuixqnzwj (yqwsbaqaud )
Positive
29 Apr 2025
Not Applicable
58
Nimotuzumab + Chemotherapy + Immunotherapy
kqojvniqmz(bkwjfsqqwu) = mbeioofgil ljdqmumblt (dijvaglfov, 0.6 - 0.8)
Positive
23 Jan 2025
Chemotherapy + Immunotherapy
hbileknesx(pwxueuxoix) = jpurxbsvqb ckqkrsikcq (xetnsdojmb )
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Core Patent

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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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