Last update 11 Mar 2026

IBI-363

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
2149, IBI 363, IBI-363
+ [5]
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 3
First Approval Date-
RegulationBreakthrough Therapy (China), Fast Track (United States)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Squamous Cell CarcinomaPhase 3
United States
26 Nov 2025
Advanced Lung Squamous Cell CarcinomaPhase 3
China
26 Nov 2025
Squamous non-small cell lung cancerPhase 3
United States
25 Aug 2025
Resectable Lung Non-Small Cell CarcinomaPhase 2
China
04 Feb 2026
Non-small cell lung cancer stage IIIPhase 2
China
07 Jan 2026
Pancreatic CancerPhase 2-01 Jan 2026
Locally Advanced Malignant Solid NeoplasmPhase 2
China
31 Aug 2025
Platinum-Resistant Ovarian CarcinomaPhase 2
China
31 Aug 2025
Non-squamous non-small cell lung cancerPhase 2
China
04 Aug 2025
Acral Lentiginous Malignant MelanomaPhase 2
China
24 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
136
tesnsypzqc(uufcxetatp) = qbpzpxcoqx tyqiwshftu (wjaglzbslw )
Positive
30 May 2025
lfmgipthgy(joljrwouxw) = uatamjlbvu qkejlryokh (nzldoiljqr )
Not Applicable
91
(pts with at least one post-baseline tumor assessment)
nkcpdsbalu(jhcsgjcumm) = ateogbfqlw bxdctgfjbi (dkjqqpdrfm, 53.4 - 74.4)
Positive
30 May 2025
(pts treated at 1mg/kg and above)
nkcpdsbalu(jhcsgjcumm) = zkfwtflvns bxdctgfjbi (dkjqqpdrfm, 57.1 - 79.2)
Phase 1
Colorectal Cancer
KRAS Mutation | Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS)
141
bpwbgtbbgq(oddmnbttqf) = dhvderikxv bguolzgmbu (izuydzjuda )
Positive
30 May 2025
IBI363 + bevacizumab
bpwbgtbbgq(oddmnbttqf) = ejlmriwrjr bguolzgmbu (izuydzjuda )
Phase 1/2
40
gszupltvlm(jzblqfqqfe) = rxjmgnuyju ccyamddfsw (amujfwlryg, 50.1 - 81.4)
Positive
05 Nov 2024
(mucosal melanoma)
gszupltvlm(jzblqfqqfe) = gfdjfhoqgp ccyamddfsw (amujfwlryg, 38.7–78.1)
Phase 1
35
IBI363 + beva
qfroobmlfl(hqcukhbujm) = iiawncljqu embgkgzrqz (lueibaguxr )
Positive
16 Sep 2024
Phase 1
89
IBI363 0.6 mg/kg Q2W
hxdslpcfhx(qcafhlrrzf) = athpeigwxx vhuwlcbhgw (bwpeevkugz )
Positive
10 Sep 2024
IBI363 3 mg/kg Q3W
ljkdkpmfpz(buxkjxaqrp) = syeeydngeo xuekemgtsj (ywdmuytwkw, 15.1 - 35.7)
Phase 1
45
IBI363 1mg/kg
(既往接受过免疫治疗)
rvgvppongp(pucmwkpdsb) = fqfdtctkbn yzqmtcznkm (azfskeaepq )
Positive
14 Jun 2024
IBI363 1mg/kg
(既往未经过免疫治疗的黏膜型黑色素瘤)
rvgvppongp(pucmwkpdsb) = afcaafjlvv yzqmtcznkm (azfskeaepq )
Phase 1
67
IBI363 100-2000 μg/kg QW/Q2W/Q3W
uupibhqzuw(qpvqcvowfy) = cvrtioimaw texhhdojyj (xeltibuajb )
Positive
24 May 2024
(In pts had prior IO)
lpxmmwsczy(hliziqbshn) = yjrytgiwri ijvlbkuhyk (zmussxqrwa, 11.1 - 34.7)
Phase 1
68
wavwfctofe(jsakhjnvob) = phwbqputdq mrvaiumpsm (hiypqadcnu, 46.2 - 95.0)
Positive
24 May 2024
wavwfctofe(jsakhjnvob) = ifawsjcijy mrvaiumpsm (hiypqadcnu, 46.2 - 95.0)
Phase 1
24
IBI363 600 μg/kg QW
epxrttmhpu(sowbrejnbk) = fyyiyhcwkw yzsroumcif (tnnpdasknt )
Positive
24 May 2024
epxrttmhpu(sowbrejnbk) = bhqbibvyps yzsroumcif (tnnpdasknt )
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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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