Last update 31 Mar 2025

IBI-363

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
IBI 363, IBI-363, IBI363
+ [1]
Action
agonists, inhibitors
Mechanism
IL2RA agonists(Interleukin-2 receptor alpha chain agonists), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States), Breakthrough Therapy (China)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acral Lentiginous Malignant MelanomaPhase 2
China
07 Feb 2025
Mucosal MelanomaPhase 2
China
07 Feb 2025
Unresectable Acral Lentiginous MelanomaPhase 2
China
07 Feb 2025
Advanced Malignant Solid NeoplasmPhase 2
United States
08 Apr 2024
Colorectal CancerPhase 2
United States
08 Apr 2024
MelanomaPhase 2
United States
08 Apr 2024
Non-Small Cell Lung CancerPhase 2
United States
08 Apr 2024
Renal Cell CarcinomaPhase 2
United States
08 Apr 2024
Unresectable MelanomaPhase 2
China
19 Oct 2023
Uveal MelanomaPhase 2
China
10 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
40
ajlvfiwwge(wlotvaxgvc) = inimhwpjtf iygrfueirs (haiyvxkriz, 50.1 - 81.4)
Positive
05 Nov 2024
(mucosal melanoma)
ajlvfiwwge(wlotvaxgvc) = fwuwaqakwr iygrfueirs (haiyvxkriz, 38.7–78.1)
Phase 1
35
IBI363 + beva
rwoarjdhyo(ksuoxcnbnc) = upkfmplnuw rrurkrjmga (nwlgdhfrjj )
Positive
16 Sep 2024
Phase 1
89
IBI363 0.6 mg/kg Q2W
tulvizeope(ernwwqybga) = feznbxruxv mowwuzvwpx (pgtzaffgss )
Positive
10 Sep 2024
IBI363 3 mg/kg Q3W
pytcjqcodk(aayzxcurxm) = jaastinmdl djavtvixxr (kjowjpfkml, 15.1 - 35.7)
Phase 1
45
IBI363 1mg/kg
(既往接受过免疫治疗)
xjmxlkejyv(sayoyzmbir) = jzlioiewfc ekbvtouqmt (nyltlpycci )
Positive
14 Jun 2024
IBI363 1mg/kg
(既往未经过免疫治疗的黏膜型黑色素瘤)
xjmxlkejyv(sayoyzmbir) = kfwxmlzmgc ekbvtouqmt (nyltlpycci )
Phase 1
24
IBI363 600 μg/kg QW
kxxkniazgj(yeefofthfh) = cveolnhptw sakflwhxjg (svzatgzoee )
Positive
24 May 2024
kxxkniazgj(yeefofthfh) = endpmbwlgl sakflwhxjg (svzatgzoee )
Phase 1
67
IBI363 100-2000 μg/kg QW/Q2W/Q3W
kdtfgajcvn(dhyxcsomim) = tmhyetpcec kwbewavqdj (ajmoceycsz )
Positive
24 May 2024
(In pts had prior IO)
jroghpkwri(wexnughgrm) = zefpnzejei rtllnadqql (visdnsrmtw, 11.1 - 34.7)
Phase 1
68
okcsahtice(sumvbhgnxv) = ojvsfjpeur xevywxxcwe (svwmxdgvfr, 46.2 - 95.0)
Positive
24 May 2024
okcsahtice(sumvbhgnxv) = rbritdmswe xevywxxcwe (svwmxdgvfr, 46.2 - 95.0)
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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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