Asset profile

IBI305

Monoclonal antibody

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Reliablesignal

Evidence outlook · lead readout

NCT02954172 · NSCLC

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT02954172: This was a randomized, double-blind, active-controlled trial with 450 enrolled participants (220 and 221 in the reported primary analysis groups). Its primary clinical endpoint, objective response rate at 18 weeks, met the prespecified equivalence criterion: 44.3% with IBI305 versus 46.4% with bevacizumab, with the 90% confidence interval for the odds ratio entirely within the 0.75–1.33 equivalence margin.

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Competitive landscape

61 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 58 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
IBI305: this drugPhase 3Monoclonal antibodyVEGF
SAR402663Phase 1/2Gene therapy / editingVEGF
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A
BinimetinibApprovedSmall moleculeMEK1/2
BrigatinibApprovedSmall moleculeALK
CapmatinibApprovedSmall moleculeMET
CemiplimabApprovedMonoclonal antibodyPD-1
CeritinibApprovedSmall moleculeALK

…and 46 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
April 2027 (1)
Phase 2HCC - Hepatocellular Carcinoma, Conversion TherapyRecruiting
Est. primary completion 2027-04 · NCT07560488 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (2)
Phase 2/3 (1)
Phase 2 (8)
Phase 1 (2)
Appears in other studies (1)