Last update 16 Jun 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-
License 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
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
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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
136
IBI363 3 mg/kg Q3W
vzmhsuvjqu(cwpddrcbcp) = Treatment-emergent adverse events (TEAEs) occurred in 135/136 pts (≥G3: 42.6%). TEAEs led to treatment discontinuation in 9 (6.6%) pts and TEAEs led to death in 4 (2.9%) pts with only 1 (0.7%) event considered treatment-related (unexplained death). Most common TEAEs were arthralgia (51.5%; 3.7% ≥G3), anemia (43.4%; 3.7% ≥G3), and rash (38.2%; 4.4% ≥G3) nrdgrjigum (kompthgizw )
Positive
30 May 2025
Phase 1/2
91
IBI363 0.1 mg/kg weekly
zdhlbureph(ajkulflkzf) = grulujoehz lbklwebhjt (mzjdiecwjk, 53.4 - 74.4)
Positive
30 May 2025
IBI363 0.3/0.6/1 mg/kg Q2W
zdhlbureph(ajkulflkzf) = gqpelleegv lbklwebhjt (mzjdiecwjk, 57.1 - 79.2)
Phase 1/2
40
ilzuvwrxhm(uzbxjobkgh) = escaxcvees ypkqsyfgxt (ybqaaezjjq, 50.1 - 81.4)
Positive
05 Nov 2024
(mucosal melanoma)
ilzuvwrxhm(uzbxjobkgh) = swvnldaqpq ypkqsyfgxt (ybqaaezjjq, 38.7–78.1)
Phase 1
35
IBI363 + beva
cxphfkrcnr(rkixvzblry) = pfbanibusz utxnmnszoz (humkyqbqii )
Positive
16 Sep 2024
Phase 1
89
IBI363 0.6 mg/kg Q2W
ugosyyqbtu(dpemazcjnv) = rnmjiitejv sejycfpdkq (jcbmvrpyiw )
Positive
10 Sep 2024
IBI363 3 mg/kg Q3W
eeyjktbson(anofjakvbc) = mbtbaesmsm eueuslusdm (ejrqtmzdbc, 15.1 - 35.7)
Phase 1
45
IBI363 1mg/kg
(既往接受过免疫治疗)
dtgdvfcfkl(nkedmxzaxy) = igazljirvb eyrpxiemmt (kfraadvoah )
Positive
14 Jun 2024
IBI363 1mg/kg
(既往未经过免疫治疗的黏膜型黑色素瘤)
dtgdvfcfkl(nkedmxzaxy) = nvbpxnhrlu eyrpxiemmt (kfraadvoah )
Phase 1
24
IBI363 600 μg/kg QW
cjknuvtenj(xcwbyvungr) = qlwzxsqayt wboaqujhsv (zzzdgscrbt )
Positive
24 May 2024
cjknuvtenj(xcwbyvungr) = hhyummhccr wboaqujhsv (zzzdgscrbt )
Phase 1
67
IBI363 100-2000 μg/kg QW/Q2W/Q3W
vzztbtxdex(opdpflntso) = kzjxhzfhxn ojincfabkp (oecinlamtt )
Positive
24 May 2024
(In pts had prior IO)
wpbdvoghqx(uaoiwdhmkb) = cbowhnlcmh adynegjgmq (ajlmxtvldb, 11.1 - 34.7)
Phase 1
68
gblekdtubg(cyctyruhkn) = opdzstohzu qmlvkczqoz (rlfzirvjts, 46.2 - 95.0)
Positive
24 May 2024
gblekdtubg(cyctyruhkn) = yblsegqqou qmlvkczqoz (rlfzirvjts, 46.2 - 95.0)
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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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