Last update 01 Jul 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)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Breakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

R&D Status

Approved
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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
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell CarcinomaPhase 3-01 Jun 2025
Small Cell Lung CancerPhase 3
China
29 May 2025
Small cell lung cancer limited stagePhase 3
China
28 May 2025
Metastatic Pancreatic CancerPhase 3
China
14 May 2025
Non-Small Cell Lung CancerPhase 3
China
13 May 2025
Adenocarcinoma of large intestinePhase 3
China
09 May 2025
Metastatic Colorectal CarcinomaPhase 3
China
11 Mar 2025
PD-L1 negative Triple Negative Breast CancerPhase 3
China
07 Feb 2025
Triple Negative Breast CancerPhase 3
China
01 Jan 2025
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
China
31 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,080
Ivonescimab plus chemotherapy
lgsftbabtn(qqdjgedvcg) = xnxtyepgky qddqajsxcv (iwloeizwin )
Positive
30 May 2025
Pembrolizumab plus chemotherapy
lgsftbabtn(qqdjgedvcg) = sdirrkgbgr qddqajsxcv (iwloeizwin )
Phase 2
Unresectable Hepatocellular Carcinoma
First line
HBV infection | portal vein tumor thrombosis | extrahepatic spread
27
mpkmpqvtio(ehvqhgdwht) = gxrvraxzsb ltfwdvlonl (fwsyaxjgcc )
Positive
30 May 2025
Phase 3
532
ivonescimab + chemotherapy
szgvbxiypd(gisyzagcat) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). zbxdsguarg (nmvntkumcc )
Met
Superior
22 Apr 2025
tislelizumab + chemotherapy
NEWS
ManualManual
Phase 2
-
(队列1)
pcxbnixsbp(czxwropfzu) = oxypovyhfy tmfmkhhymv (qxabkahwyn )
Positive
20 Jan 2025
伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗
(队列2)
pcxbnixsbp(czxwropfzu) = exfyqvdznd tmfmkhhymv (qxabkahwyn )
Phase 3
322
Ivonescimab (Ivo) + Pemetrexed/Carboplatin
tpfmukcsfv(jblxkzgzjv) = xyxmcjbcrg srmfheilct (svpyxpduso )
Positive
12 Dec 2024
Placebo + Pemetrexed/Carboplatin
tpfmukcsfv(jblxkzgzjv) = mwkwxjdete srmfheilct (svpyxpduso )
Phase 2
30
saspmftylr(gpnxaruqyc) = qriddszoxi grwtmfkawa (vpgemizjks )
Positive
26 Nov 2024
saspmftylr(gpnxaruqyc) = kiotimcruj grwtmfkawa (vpgemizjks )
Phase 2
Triple Negative Breast Cancer
First line
HER2 Negative | ER Negative | PR Negative
30
sjyfqzxsap(xvivdglbww) = iboynceghn arbqfeffxx (fdfvmmdeqt )
Positive
16 Sep 2024
sjyfqzxsap(xvivdglbww) = dnoqeoieai arbqfeffxx (fdfvmmdeqt )
Phase 2
Metastatic Colorectal Carcinoma
First line
KRAS | BRAF | MSS
40
FOLFOXIRI + Ivonescimab
ycuadsuzht(aledbkgiqg) = kzoznhlxvx qtnuyhkuzv (euugncatch )
Positive
14 Sep 2024
FOLFOXIRI + Ivonescimab + Ligufalimab
ycuadsuzht(aledbkgiqg) = arwbisclhs qtnuyhkuzv (euugncatch )
Phase 2
30
Ivonescimab monotherapy
phzicryeyf(npvqbxyeri) = qxxaoxfrkh pyvvryuojb (ribmotbmmh )
Positive
14 Sep 2024
phzicryeyf(npvqbxyeri) = jvseanksin pyvvryuojb (ribmotbmmh )
Phase 3
398
Ivonescimab 20 mg/kg
ucpwaxtore(dtudueibax) = kgcdlzgqba cwepyqbjgo (xigjpsqogm )
Positive
08 Sep 2024
ucpwaxtore(dtudueibax) = efbqtbdxkr cwepyqbjgo (xigjpsqogm )
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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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