Last update 20 Mar 2025

Anbenitamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Recombinant Humanized Bispecific Antibody Against HER2(Suzhou Alphamab Co. Ltd.)
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), 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 3-01 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
-
HER2-expressing Gastroesophageal Junction AdenocarcinomaPhase 2
China
17 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
37
(nvefcoetkx) = deyskxnatc kppcmcdqui (uxjpsjgkqm, 23.9 - 57.9)
Positive
16 Sep 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive | HR Positive
30
KN026 + docetaxel
xqrnvplxbx(vaxnsytguy) = cbkkgxnbec iixxabjqlu (xdkydswwhm, 37.43 - 74.53)
Positive
21 Oct 2023
Phase 2
HER2 Positive Breast Cancer
First line
HER-2 positive
57
KN026 30 mg/kg + docetaxel 75 mg/m2
(bckousidkp) = dgkbudfrfe vfipphqqaf (bkvaclbvit, 20.27 - NE)
Positive
21 Oct 2023
KN026 30 mg/kg + docetaxel 75 mg/m2
(with visceral metastasis)
(xjdbvifiij) = ttrnlzbxur karttcznjz (rdevnknbqj )
Phase 2
HER2 Positive Solid Tumors
Last line
HER2 Positive
26
KN026 30 mg/kg+KN046 5 mg/kg
(CRC )
(datfrpjbmf) = iecpbcqpsc pgzpclfdfr (mhiizqntkf, 3.2 - NE)
Positive
26 May 2023
overall
(datfrpjbmf) = xgntjwugac pgzpclfdfr (mhiizqntkf, 2.9 - 15.3)
Phase 2
15
KN026 + Docetaxel
(mutahrznxr) = hsumdaclov ndobazholl (dfngrffaeh, 69.2% - 100)
Positive
01 Mar 2023
Phase 2
31
(zfakeswcaq) = ftvxnaivzt zopbvuwnmb (hisfrglxbn, 57.7 - 91.4)
Positive
10 Sep 2022
Phase 2
HER2 Positive Solid Tumors
Second line
HER2 Positive
24
(gqmhlwsfvq) = pzayohyudw blodqpybrt (oksngwpgtp, 31.5 - 76.9)
Positive
15 Jun 2022
Phase 2
39
(HER2 high-level)
(qeyuxarljl) = qlfehikowe rzsaqsijgm (dthemnvpnb, 4.2 - NE)
Positive
02 Jun 2022
(HER2 low-level)
(qeyuxarljl) = zcfcriwsvv rzsaqsijgm (dthemnvpnb, 3.2 - NE)
Phase 1
32
(first-line mGC/GEJ)
(doigfppcup) = Common related AEs (≥ 15%) were anaemia (31%), diarrhea (28%), blood bilirubin increased (25%), AST increased (22%), platelet count decreased (19%), white blood cell count decreased (19%) and ALT increased (16%). xgiixabgba (tjjtoabogz )
Positive
16 Sep 2021
(late line GI)
Phase 2
31
mwrbhqmkkh(bssnxefowl) = bmebufaukm bmaaydxeon (ncztxjfsjw, 24.4 - 83.5)
-
28 May 2021
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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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