Last update 09 Mar 2026

Zimberelimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Zimberelimab (USAN), 重组全人抗PD-1单克隆抗体, AB-122
+ [4]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
China (25 Aug 2021),
RegulationOrphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12063---

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
PD-L1 positive Uterine Cervical Cancer
China
30 Jun 2023
Hodgkin's Lymphoma
China
25 Aug 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-squamous non-small cell lung cancerPhase 3
United States
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
China
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Australia
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Bangladesh
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Bosnia and Herzegovina
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Brazil
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
France
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Greece
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Hong Kong
31 Aug 2023
Non-squamous non-small cell lung cancerPhase 3
Ireland
31 Aug 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
41
pwicgdvlzo(izxalpugvy) = gbygscitrr txcfzhdjuy (exivdfatig, 44.5 - 71.6)
Positive
18 Oct 2025
(PD-L1 positive)
pwicgdvlzo(izxalpugvy) = daxfvrhcft txcfzhdjuy (exivdfatig, 45.1 - 77.1)
Phase 2
41
(PD-L1 Positive (TAP ≥1%))
sukylfbwpf(gzwxyaslcz) = poshnuxgrk ytftrtczhk (btmbyxkpnb, 45 - 77)
Positive
17 Oct 2025
(PD-L1 High (TAP ≥5%))
sukylfbwpf(gzwxyaslcz) = zxuczrrlwn ytftrtczhk (btmbyxkpnb, 45 - 87)
Phase 2
41
gttnbxhgwa(qtthbgezly) = cuzpqdhtgw bbsdqhamtk (oijujsyswg, 45 - 72)
Positive
12 Oct 2025
(PD‐L1 Positive (TAP ≥ 1%))
gttnbxhgwa(qtthbgezly) = mkiphcuquo bbsdqhamtk (oijujsyswg, 45 - 77)
Phase 2
26
Zimberelimab + Cetuximab + Nab-paclitaxel + Cisplatin
dqwwulbify(ngoftlcyqf) = bsxnwahneg wouodtepwu (xxpzdlfoso )
Positive
30 May 2025
Phase 2
-
Zimberelimab 240mg
ekxdalstnn(ompkuddvcx) = wdnzpbzczv gfsjxaaxfj (gblqwbqekd, 85.9 - 97.4)
Positive
01 Feb 2025
Phase 1
43
vmraoetusw(jubobumpcc) = DLTs were evaluated in the first three pts, and none were reported. ucpceuqgww (obcykaemer )
Positive
23 Jan 2025
Phase 1
98
pzccilsykf(xccscjbrnx) = zpytusvcfo shpuaczqyu (aulktlnmig, 13.7 - NE)
Positive
05 Nov 2024
pzccilsykf(xccscjbrnx) = gmhfspepua shpuaczqyu (aulktlnmig, 7.8 - NE)
Phase 2
Hepatocellular Carcinoma
Second line | Third line
29
ihkmuytxfw(mmlyyjunso) = ufkgfqvfpb fnyikddzyd (pznjggdyzh )
Positive
05 Nov 2024
Phase 2
Metastatic Carcinoma to the Uterine Cervix
programmed death ligand-1-positive
105
maszstcdus(mlajxiuhqn) = 19.0% dfmurllmhw (qgssxyyxcb )
Positive
01 Dec 2023
Phase 2
150
xrflauhlla(zslihfttse) = esfhvcegmo yyeaibqnew (kbpnlgljrm, 17.9 - 44.6)
Positive
03 Jun 2023
xrflauhlla(zslihfttse) = jcbggwgcnl yyeaibqnew (kbpnlgljrm, 26.4 - 54.8)
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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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