Asset profile

SH-1028

Small molecule

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Reliablesignal

Evidence outlook · lead readout

NCT04239833 · Non-Small Cell Lung Cancer

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

NCT04239833: In this randomized, double-blind, active-controlled Phase 3 trial in patients with EGFR-mutated non-small-cell lung cancer, SH-1028 significantly extended progression-free survival compared with gefitinib, the standard EGFR-targeted therapy (median 19.3 months vs 9.8 months).

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Competitive landscape

102 competitors in this universe: 41 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
SH-1028: this drugPhase 3Small moleculeEGFR
GefitinibApprovedSmall moleculeEGFR
LazertinibApprovedSmall moleculeEGFR
Osimertinib (Tagrisso)ApprovedSmall moleculeEGFR
SunvozertinibApprovedSmall moleculeEGFR
AlflutinibPhase 3Small moleculeEGFR
AlmonertinibPhase 3Small moleculeEGFR
BefotertinibPhase 3Small moleculeEGFR
BPI-7711Phase 3Small moleculeEGFR
CPO301Phase 3Antibody–drug conjugateEGFR
FHND9041Phase 3Small moleculeEGFR
IcotinibPhase 3Small moleculeEGFR
JMT101Phase 3Monoclonal antibodyEGFR
LimertinibPhase 3Small moleculeEGFR, EGFR T790M (resistant mutant, selective over wild-type EGFR)
PLB1004Phase 3Small moleculeEGFR
TY-9591Phase 3Small moleculeEGFR

…and 87 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.

2028 (1)
February 2028 (1)
Phase 3Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-02-01 · NCT06080776 · 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 (1)
Phase 1 (5)