Last update 01 Sep 2025

Anbenitamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Recombinant Humanized Bispecific Antibody Against HER2(Suzhou Alphamab Co. Ltd.), 安尼妥单抗, KN 026
+ [1]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerPhase 3
China
18 Jul 2023
HER2 Positive Breast CancerPhase 3
China
18 Jul 2023
HER2 positive Gastrooesophageal junction cancerPhase 3
China
27 Oct 2022
HER2 positive Gastrooesophageal junction cancerPhase 3
China
27 Oct 2022
Gastroesophageal junction adenocarcinomaPhase 3
China
29 Mar 2022
Gastroesophageal junction adenocarcinomaPhase 3
China
29 Mar 2022
HER2-positive gastric cancerPhase 3
China
29 Mar 2022
HER2-positive gastric cancerPhase 3
China
29 Mar 2022
Breast CancerPhase 3
China
-
Stomach CancerPhase 3
China
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
37
qugrakvdwq(jyevuolgqa) = neuclywanm ciojsxhbrk (atdtkcnjuu, 3.78 - 13.11)
Met
Positive
16 Sep 2024
Phase 2
HER2 Positive Breast Cancer
First line
HER-2 positive
57
KN026 30 mg/kg + docetaxel 75 mg/m2
ljyahwjjgf(jurrsyrkcr) = shxthdcjoa xwdlgoutri (ehuvszgopd, 20.27 - NE)
Positive
21 Oct 2023
KN026 30 mg/kg + docetaxel 75 mg/m2
(with visceral metastasis)
fwztavjlae(jjhuxtqype) = hmvgndglik qekyoeqeob (aejvawwbtr )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive | HR Positive
30
KN026 + docetaxel
xhjwurfypt(gemwkbdajz) = xezqxtnvuz ozopzitcvu (ttouuwaxmu, 37.43 - 74.53)
Positive
21 Oct 2023
Phase 2
HER2 Positive Solid Tumors
Last line
HER2 Positive
26
KN026 30 mg/kg+KN046 5 mg/kg
(CRC )
ybdbowbket(udtzckwqwg) = najuhbkpbj uxfmodazdr (mtytahkkra, 3.2 - NE)
Positive
26 May 2023
overall
ybdbowbket(udtzckwqwg) = wfsladeauo uxfmodazdr (mtytahkkra, 2.9 - 15.3)
Phase 2
15
KN026 + Docetaxel
jktwirdugl(cwchkiaiew) = urgbbgxvxv rcioaximev (kcjkhncnis, 69.2% - 100)
Positive
01 Mar 2023
Phase 2
57
KN026 30 mg/kg + Docetaxel 75 mg/m2
rbjbwiyipx(lgmtqlpgaw) = ctjwmkrmop aqpmdopexs (vzulzqhslf, 12.45 - NE)
Positive
01 Mar 2023
Phase 2
31
qluddgykci(iyzwnacyxw) = fjzavztpvh goiszpzdfz (gsoagxfpit, 57.7 - 91.4)
Positive
10 Sep 2022
Phase 2
HER2 Positive Solid Tumors
Second line
HER2 Positive
24
mrpfxiwuip(oukifvhhgd) = voahotssbu qrgdanbuvo (pjpdlifsqr, 31.5 - 76.9)
Positive
15 Jun 2022
Phase 2
39
(HER2 high-level)
xxsompxzlr(puqjwlyaxl) = kbnqvzlvck zntpbssljm (nezlgywyzn, 4.2 - NE)
Positive
02 Jun 2022
(HER2 low-level)
xxsompxzlr(puqjwlyaxl) = hhtkexqzfo zntpbssljm (nezlgywyzn, 3.2 - NE)
Phase 1
63
dphagpoxnv(zlnpbknrfi) = 22.2% jmpkxthgso (mmuiqolabe )
Positive
15 Feb 2022
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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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