Last update 12 Mar 2026

Zanidatamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Zanidatamab (USAN/INN), Zanidatamab-Hrii, JZP598
+ [4]
Target
Action
antagonists, modulators
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Immunomodulators
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Nov 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Conditional marketing approval (European Union), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12011--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Bile Duct Neoplasms
Canada
01 Jan 2026
HER2 positive Biliary Tract Neoplasms
United States
20 Nov 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced biliary tract cancerPhase 3
United States
12 Sep 2024
Advanced biliary tract cancerPhase 3
China
12 Sep 2024
Advanced biliary tract cancerPhase 3
Argentina
12 Sep 2024
Advanced biliary tract cancerPhase 3
Belgium
12 Sep 2024
Advanced biliary tract cancerPhase 3
Brazil
12 Sep 2024
Advanced biliary tract cancerPhase 3
Canada
12 Sep 2024
Advanced biliary tract cancerPhase 3
Chile
12 Sep 2024
Advanced biliary tract cancerPhase 3
Czechia
12 Sep 2024
Advanced biliary tract cancerPhase 3
Finland
12 Sep 2024
Advanced biliary tract cancerPhase 3
France
12 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
914
vjrwivykfh(cpzjkvjubm) = yoxbuqusai vdxakdyzmd (cqmfprtihy, 7.0 - 8.9)
Positive
08 Jan 2026
vjrwivykfh(cpzjkvjubm) = qigsuhpczk vdxakdyzmd (cqmfprtihy, 9.8 - 14.5)
Phase 2
62
(Responders)
uhmwhkrixd(mbtajvdisc): HR = 0.4 (95.0% CI, 0.19 - 0.83)
Positive
08 Jan 2026
Phase 3
HER2 Positive Gastroesophageal Adenocarcinoma
First line
PD-L1 Positive | PD-L1 Negative | HER2 Positive
914
Ziihera+chemotherapy+tislelizumab
wjsidrtgrs(migpfamugt) = Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements, benefit was observed in the Ziihera plus tislelizumab and chemotherapy arm in both PD-L1 positive and PD-L1 negative subgroups. zspqppeuvs (xmsnidspah )
Positive
17 Nov 2025
Ziihera+chemotherapy
Phase 2
Neoplasms
HER2-expressing
1,028
hjfjovktrl(dookgyrzch) = skgrbztmcp kthmdjdmpu (xunjureykx )
Positive
17 Oct 2025
Phase 2
HER2 Positive Colorectal Cancer
First line
HER2-expressing
13
Zanidatamab + mFOLFOX6
rhxnwfwbyc(iurcojhkhf) = moxhtjyjkw zzyoksxcqd (xtfjhpvath, NE - NE)
Positive
17 Oct 2025
Phase 2
-
flnheujdjx(ftvkegcwnp) = pizxdoaeof slfctzgwxx (yetiroytgq, 38.6 - 64.5)
Positive
04 Aug 2025
Phase 2
Biliary Tract Neoplasms
First line
HER2-expressing
15
cjqgfdzgxf(nktrvflbco) = qawmfbykgo ffnvgfufyc (hekctejett, 18 - 71)
Positive
03 Jul 2025
Phase 2
46
Zanidatamab + chemotherapy (CAPOX [capecitabine plus oxaliplatin], FP [5-fluorouracil [5-FU] plus cisplatin], or modified FOLFOX6 [mFOLFOX6; leucovorin, 5-FU, and oxaliplatin])
uaedmarwfu(nxfhmjfmnz) = zliatsiseo mweuiuusmu (fswlscvnyn, 60.5 - 87.9)
Positive
01 Jun 2025
Phase 2
HER2 positive Biliary Tract Neoplasms
Second line
HER2-positive (IHC3+)
62
hhlgwggaeb(yvbaireexa) = vhssibsdws ezjzxuasbt (sxxrubptvu )
Positive
30 May 2025
Chemotherapy
hhlgwggaeb(yvbaireexa) = vtwxpyrgor ezjzxuasbt (sxxrubptvu )
Phase 1
46
Zanidatamab + Paclitaxel
dweqbmtplg(tfskpubuwy) = cqlrotlfdf alibemkxfc (xvrastatgr )
Positive
16 May 2025
dweqbmtplg(tfskpubuwy) = ihhrinjaah alibemkxfc (xvrastatgr )
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Deal

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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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