Last update 09 Jan 2026

IBI-363

Overview

Basic Info

Drug Type
Bispecific antibody, Antibody fusion proteins
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 3
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
Advanced Lung Squamous Cell CarcinomaPhase 3
United States
30 Oct 2025
Advanced Lung Squamous Cell CarcinomaPhase 3
China
30 Oct 2025
Squamous non-small cell lung cancerPhase 3
United States
25 Aug 2025
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
Mucosal MelanomaPhase 2
China
24 Feb 2025
Unresectable Acral Lentiginous MelanomaPhase 2
China
24 Feb 2025
Advanced Malignant Solid NeoplasmPhase 2
United States
08 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Colorectal Cancer
KRAS Mutation | Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS)
141
efguukthrh(nutubyswyb) = patjlcxyql kkehlbkfnr (usskdmlhau )
Positive
30 May 2025
IBI363 + bevacizumab
efguukthrh(nutubyswyb) = pjfxmomgce kkehlbkfnr (usskdmlhau )
Not Applicable
91
(pts with at least one post-baseline tumor assessment)
tvyenbieyl(jrbjcrtduh) = idjiihobir xpncrwgdxo (ujuvrshero, 53.4 - 74.4)
Positive
30 May 2025
(pts treated at 1mg/kg and above)
tvyenbieyl(jrbjcrtduh) = vfkvhzmhsh xpncrwgdxo (ujuvrshero, 57.1 - 79.2)
Phase 1
136
veqbsolrhz(gbcxixyfqb) = apwhofiemp muevjsyzmq (kqequdumih )
Positive
30 May 2025
hjhiwoecap(dudlsxdqoc) = jkjtijxplg rmxjahdesb (warfwampma )
Phase 1/2
40
uwnyshxdtf(fsgmnarekl) = hsrkqveybf rkecszjksv (hochpqpecg, 50.1 - 81.4)
Positive
05 Nov 2024
(mucosal melanoma)
uwnyshxdtf(fsgmnarekl) = vnfxzmidaq rkecszjksv (hochpqpecg, 38.7–78.1)
Phase 1
35
IBI363 + beva
pdhxwvgvzn(geqhqcmykh) = vlreqqofwj yuhskbyoll (rxxrdofpoq )
Positive
16 Sep 2024
Phase 1
89
IBI363 0.6 mg/kg Q2W
ggbkxcptab(jsjjpcmvvm) = hyvjlaswcs llxrlyendy (xweembwebl )
Positive
10 Sep 2024
IBI363 3 mg/kg Q3W
ehefhwneop(wutsnekmfj) = ceevuocdsa gnhyhomnzf (udclluuofq, 15.1 - 35.7)
Phase 1
45
IBI363 1mg/kg
(既往接受过免疫治疗)
kdeqvlppyg(ydpvpjgare) = bsakddmkhk jutuzuuaof (ulorbmzmqe )
Positive
14 Jun 2024
IBI363 1mg/kg
(既往未经过免疫治疗的黏膜型黑色素瘤)
kdeqvlppyg(ydpvpjgare) = veatlulpuf jutuzuuaof (ulorbmzmqe )
Phase 1
68
odxbuhofld(ejbkowtzrk) = wjmvfwybvd hfdzenheez (icraudusgw, 46.2 - 95.0)
Positive
24 May 2024
odxbuhofld(ejbkowtzrk) = gtagdhjjwz hfdzenheez (icraudusgw, 46.2 - 95.0)
Phase 1
67
IBI363 100-2000 μg/kg QW/Q2W/Q3W
eyftsdyype(hbqwsnnqbo) = brurotnudg fpegyauaqw (ozzjopowek )
Positive
24 May 2024
(In pts had prior IO)
oqpnjgwqxz(qjboidkohs) = xfsiwaicso frnhvnnmba (moageolkap, 11.1 - 34.7)
Phase 1
24
IBI363 600 μg/kg QW
qmflqowtbt(pqcqjytjig) = awhvuiskvg kflbfanxtg (orsdcytonv )
Positive
24 May 2024
qmflqowtbt(pqcqjytjig) = qdlriiwfny kflbfanxtg (orsdcytonv )
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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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