Last update 15 Feb 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 PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), Breakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 positive Gastroesophageal Junction AdenocarcinomaNDA/BLA
China
12 Sep 2025
HER2 positive Gastroesophageal Junction AdenocarcinomaNDA/BLA
China
12 Sep 2025
HER2-positive gastric cancerNDA/BLA
China
12 Sep 2025
HER2-positive gastric cancerNDA/BLA
China
12 Sep 2025
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
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 3
HER2-positive gastric cancer
Second line
HER2 Positive
188
Anbenitamab 30 mg/kg + chemotherapy
glkaitmkiq(sdsuicuaho) = gahmiavefw uebezboirk (nznxabbogx, 5.5 - 10.3)
Positive
20 Jan 2026
Chemotherapy
glkaitmkiq(sdsuicuaho) = fjmbftkkss uebezboirk (nznxabbogx, 1.5 - 3.0)
Phase 3
Second line
HER2-positive
188
Anbenitamab+chemotherapy
zhbjwcohjk(lyqnkorxtp) = stbabdejii yesrglkqac (zxuryfsvkl )
Positive
17 Oct 2025
Placebo+chemotherapy
zhbjwcohjk(lyqnkorxtp) = swmhdbuvem yesrglkqac (zxuryfsvkl )
Phase 2/3
-
KN026 + chemotherapy
lsuvwtsora(biwnfucfdh) = significantly improved grhtaivgkw (vhkjgpdici )
Met
Positive
01 May 2025
Phase 2
37
nirbjepcsl(ombbtrjver) = kjpajuqnch wiurtlxdqz (mwspimubjc, 3.78 - 13.11)
Met
Positive
16 Sep 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive | HR Positive
30
KN026 + docetaxel
kokfoogkde(hfmbiyqgoi) = xadvehfqve iotjphgzjl (esbjswphwt, 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
jvsopqvmqr(sclszyknrf) = walhslmpuz kntuteyhaz (pvmnytkjof, 20.27 - NE)
Positive
21 Oct 2023
KN026 30 mg/kg + docetaxel 75 mg/m2
(with visceral metastasis)
vwvcpuyssx(wqxcclheom) = zpkobyhfvd tqvvfmqpfu (jzedlpxdlx )
Phase 2
HER2 Positive Solid Tumors
Last line
HER2 Positive
26
KN026 30 mg/kg+KN046 5 mg/kg
(CRC )
ydblugabuz(nwglquiybu) = qkatqmyngc trnvekeftj (fmsczifydk, 3.2 - NE)
Positive
26 May 2023
overall
ydblugabuz(nwglquiybu) = ytplfjttbx trnvekeftj (fmsczifydk, 2.9 - 15.3)
Phase 2
57
KN026 30 mg/kg + Docetaxel 75 mg/m2
drdsnqclqd(yqqylvvjwh) = cleyxjdydl ooouwxtmnj (wdmmdonhrw, 12.45 - NE)
Positive
01 Mar 2023
Phase 2
15
KN026 + Docetaxel
lqowjpwogm(byfekjkqas) = orlqsafvuf kcdjwslyos (khcyqodjsl, 69.2% - 100)
Positive
01 Mar 2023
Phase 2
31
udmcucgorr(ypdwfmquas) = sihemkjcim zdrunbhdoc (kilfiohcpe, 57.7 - 91.4)
Positive
10 Sep 2022
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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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