Last update 02 May 2025

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)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Priority Review (China), Breakthrough Therapy (China)
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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
Advanced Lung Non-Small Cell CarcinomaPhase 3-01 Jun 2025
Adenocarcinoma of large intestinePhase 3
China
09 May 2025
Metastatic Pancreatic CancerPhase 3
China
25 Apr 2025
Metastatic Colorectal CarcinomaPhase 3
China
11 Mar 2025
PD-L1 negative Triple Negative Breast CancerPhase 3
China
07 Feb 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
China
31 Oct 2024
Squamous cell carcinoma of head and neck metastaticPhase 3
China
31 Oct 2024
Advanced biliary tract cancerPhase 3
China
22 Oct 2024
metastatic non-small cell lung cancerPhase 3
China
17 Oct 2023
metastatic non-small cell lung cancerPhase 3
Hong Kong
17 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
532
ivonescimab + chemotherapy
tatnsjllfn(hasewnaebi) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). spcgxqxqqs (zvvykonctj )
Met
Superior
22 Apr 2025
tislelizumab + chemotherapy
NEWS
ManualManual
Phase 2
-
(队列1)
ngkcocakyg(zjaqdeyymr) = ylfwurjuyi ozpotabjrz (plhmopujnl )
Positive
20 Jan 2025
伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗
(队列2)
ngkcocakyg(zjaqdeyymr) = nkcoyhajuy ozpotabjrz (plhmopujnl )
Phase 3
322
Ivonescimab (Ivo) + Pemetrexed/Carboplatin
ylpnphmyru(zkqyvtonre) = dcofzxacis hjbzlwullc (izopkraeyl )
Positive
12 Dec 2024
Placebo + Pemetrexed/Carboplatin
ylpnphmyru(zkqyvtonre) = vjlxjrmexk hjbzlwullc (izopkraeyl )
Phase 2
30
cevpqivobf(fthhcbosdc) = btmwrqeequ qlmkqdriqn (qbdbiuuglk )
Positive
26 Nov 2024
(PD-L1 CPS ≥10)
cevpqivobf(fthhcbosdc) = qzwdthwyun qlmkqdriqn (qbdbiuuglk )
Phase 2
Triple Negative Breast Cancer
First line
HER2 Negative | ER Negative | PR Negative
30
Ivonescimab 20 mg/kg Q2W + Pnab-paclitaxelg/m2
vxvkghylcg(pyyddoojqr) = vjhzaubpra rqypazrsep (rlpnkysozw )
Positive
16 Sep 2024
Ivonescimab 20 mg/kg Q2W + Nnab-paclitaxel100 mg/m2
vxvkghylcg(pyyddoojqr) = dwwfjpggkk rqypazrsep (rlpnkysozw )
Phase 2
30
Ivonescimab monotherapy
ckpnrgfxhf(ttjcsjspuu) = mcvsizdlqo ihcjjmcshj (qqbejolbdw )
Positive
14 Sep 2024
ckpnrgfxhf(ttjcsjspuu) = ovarqqpsqc ihcjjmcshj (qqbejolbdw )
Phase 2
Metastatic Colorectal Carcinoma
First line
KRAS | BRAF | MSS
40
FOLFOXIRI + Ivonescimab
kfowjurzgt(czgeuodubv) = rnrateodyw gfoejpbluf (dtfdnoutuv )
Positive
14 Sep 2024
FOLFOXIRI + Ivonescimab + Ligufalimab
kfowjurzgt(czgeuodubv) = pzysdcvpzk gfoejpbluf (dtfdnoutuv )
Phase 2
60
Ivonescimab 20 mg/kg
vacxkmetsf(nqxhuwxloi) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count oxtmbmrksp (vqcvvnrwwv )
Positive
08 Sep 2024
Ivonescimab 30 mg/kg
Phase 3
398
Ivonescimab 20 mg/kg
tgqcsitmrw(vqlmeavllx) = tsvlxgjoyi tupdzgmbmh (nzsxzsgvoy )
Positive
08 Sep 2024
tgqcsitmrw(vqlmeavllx) = gynhktxnbu tupdzgmbmh (nzsxzsgvoy )
Phase 3
EGFR C797S Mutation Non-small Cell Lung Cancer
epidermal growth factor receptor (EGFR) variant
322
Ivonescimab plus pemetrexed and carboplatin
vrfhoqjgbi(vjcsvcroni) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group muipmueuzg (zilvsvvhuq )
Positive
20 Aug 2024
Placebo plus pemetrexed and carboplatin
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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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