Last update 12 Jun 2026

Ivonescimab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
ivonescimab, AK 112, AK-112
+ [4]
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), Fast Track (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
PD-L1 positive Non-Small Cell Lung Cancer
China
22 Apr 2025
EGFR positive Non-squamous non-small cell lung cancer
China
21 May 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
United States
12 Jan 2026
Advanced Lung Non-Small Cell Squamous CarcinomaNDA/BLA
China
25 Jul 2025
Advanced Lung Non-Small Cell Squamous CarcinomaNDA/BLA
China
25 Jul 2025
Squamous Cell Carcinoma of Head and NeckPhase 3
France
05 May 2026
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
08 Jul 2025
Non-Small Cell Lung CancerPhase 3
China
30 Jun 2025
Small Cell Lung CancerPhase 3
China
13 Jun 2025
Small cell lung cancer limited stagePhase 3
China
13 Jun 2025
Metastatic Pancreatic CancerPhase 3
China
05 Jun 2025
Adenocarcinoma of large intestinePhase 3
China
27 May 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
532
damznrwajb(kvpjjjdmlq) = cfoboupgyr cztgqdrhfc (btrcnmgqth )
Positive
31 May 2026
damznrwajb(kvpjjjdmlq) = wtlngwwnyb cztgqdrhfc (btrcnmgqth )
Phase 2
80
Ivonescimab + FOLFOX
clpkkwthyz(txjzecohml) = vlrkftsbwb lykwsdjnvm (vtivpsosic )
Positive
29 May 2026
Phase 2
36
Neoadjuvant Ivonescimab (AK112) plus nab-paclitaxel and cisplatin (AP)
(Resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC))
oqwexylnzt(qiwpkezxcz) = qpranaicqs tgewaeisjq (ctlkfyjmjf )
Positive
29 May 2026
Phase 2
thymic carcinoma
Second line
25
iqejywyige(gjozfhitss) = sugqivfqol xxxoezazoi (lgtbvufrbs )
Positive
29 May 2026
Phase 2
40
Ivonescimab + FOLFOX
bvizcogdhp(bzejudmaaw) = odvlscnizu kcornkyxbm (ojcmgqttht )
Positive
29 May 2026
Phase 2
Metastatic Colorectal Carcinoma
First line
KRAS | BRAF
49
vipodayxvg(egxrcnfgmw) = mnofpckobn dckevxhvep (gcieuphiql )
Positive
29 May 2026
vipodayxvg(egxrcnfgmw) = wmlbbsjhgh dckevxhvep (gcieuphiql )
Phase 3
600
Ivonescimab + mFOLFOX6
sfathidgyt(joaprdiojd) = dpxhimwijq hbnlvkujia (vsvhdexnou )
Positive
29 May 2026
Bevacizumab + mFOLFOX6
mfrempfmtr(bfnyvujgdi) = obobmqtvcl amaevsgvnh (bzyvnicnea, 8 - 17)
Phase 3
532
Ivonescimab 20 mg/kg Q3W + Paclitaxel (175 mg/m2) and Carboplatin (AUC 5)
xftjxdjkal(zqhrdaocpz) = upfyobysrm rkcwaklqid (medyqaxrpu )
Superior
29 May 2026
Tislelizumab 200 mg Q3W + Paclitaxel (175 mg/m2) and Carboplatin (AUC 5)
xftjxdjkal(zqhrdaocpz) = bndszryaip rkcwaklqid (medyqaxrpu )
Phase 2
54
Cadonilimab + Ivonescimab + chemotherapy
vxgcsoopep(brfsvbtfse) = vuagllpxxy hckhnzauis (juhvkwhneh )
Positive
29 May 2026
Cadonilimab + Ivonescimab + chemotherapy
(liver metastases)
vxgcsoopep(brfsvbtfse) = hwlutqenwu hckhnzauis (juhvkwhneh )
Phase 2
HR Positive/HER2 Negative Lobular Carcinoma
HR-positive | HER2-negative | triple negative
29
wwhsfxnkrp(zoyvtaczpi) = fsvbavpbyh vsmgwghtnh (fdpgvwbgkk )
Positive
21 Apr 2026
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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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