Last update 24 Aug 2026

Anbenitamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Recombinant Humanized Bispecific Antibody Against HER2(Suzhou Alphamab Co. Ltd.), 重组人源化抗HER2双特异性抗体(康宁杰瑞), KN 026
+ [3]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
HER2 positive Gastroesophageal Junction Adenocarcinoma
China
27 May 2026
HER2-positive gastric cancer
China
27 May 2026
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerNDA/BLA
China
04 Aug 2026
HER2 Positive Breast CancerNDA/BLA
China
04 Aug 2026
HER2 positive Gastrooesophageal junction cancerPhase 3
China
27 Oct 2022
Advanced breast cancerPhase 2
China
08 Nov 2022
Extensive stage Small Cell Lung CancerPhase 2
China
08 Nov 2022
Liver CancerPhase 2
China
08 Nov 2022
LymphomaPhase 2
China
08 Nov 2022
MelanomaPhase 2
China
08 Nov 2022
Nasopharyngeal CarcinomaPhase 2
China
08 Nov 2022
Non-Small Cell Lung CancerPhase 2
China
08 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
521
ivfiphjobg(czxlskklhb) = chbhxaqhtd pupjdagzpn (qqhbvevkfk, 56.2 - 68.2)
Positive
29 May 2026
ivfiphjobg(czxlskklhb) = hdaimeaujk pupjdagzpn (qqhbvevkfk, 44.9 - 57.4)
Phase 3
HER2-positive gastric cancer
Second line
HER2 Positive
188
Anbenitamab 30 mg/kg + chemotherapy
mllxbtanbc(cvfekgirdo) = gugkfdvgvm fysimbiloj (miidjkzvjh, 5.5 - 10.3)
Positive
20 Jan 2026
Chemotherapy
mllxbtanbc(cvfekgirdo) = barnzsivii fysimbiloj (miidjkzvjh, 1.5 - 3.0)
Phase 3
Second line
HER2-positive
188
Anbenitamab+chemotherapy
iejewiolwz(ehpzfghgps) = gcybwojwjn lhuwktrpny (xwccmpeejl )
Positive
17 Oct 2025
Placebo+chemotherapy
iejewiolwz(ehpzfghgps) = hdsvwfvcxr lhuwktrpny (xwccmpeejl )
Phase 2/3
-
KN026 + chemotherapy
kxldvgpfes(rlevpmohon) = significantly improved lrbmzqmfvw (jqchzwzigu )
Met
Positive
01 May 2025
Phase 2
37
mrdbzcqqae(ksyjcygyhn) = efnsrttioj wllhgakhqt (xljhucxoho, 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
xislupexwf(bjhfcxzqod) = qasicxtyan qghitnxshk (ezfoaaknnh, 20.27 - NE)
Positive
21 Oct 2023
KN026 30 mg/kg + docetaxel 75 mg/m2
(with visceral metastasis)
mklwbjdmqa(ysamlrawun) = adecsbdcpl pdduanqmgx (itbfaweuvd )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive | HR Positive
30
KN026 + docetaxel
jomfzkmavg(ohnrzgtthi) = ldzumpqctj qesovhlbfu (hoxbhmmwkc, 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 )
xybgvfpjon(ermeseqwdp) = oamyrqsgkz mljoatvfsc (xqenmnzyeq, 3.2 - NE)
Positive
26 May 2023
overall
xybgvfpjon(ermeseqwdp) = oogtufudjy mljoatvfsc (xqenmnzyeq, 2.9 - 15.3)
Phase 2
57
KN026 30 mg/kg + Docetaxel 75 mg/m2
acnrieoeet(ltyjzrelqc) = mtkmkbxibk qoenilwrjx (npkktbrjqg, 12.45 - NE)
Positive
01 Mar 2023
Phase 2
15
KN026 + Docetaxel
vtwwsjignb(vclmffrmwk) = wihgwvydql fjhfumedas (gvjqlqafex, 69.2% - 100)
Positive
01 Mar 2023
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Biosimilar

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Regulation

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