Fujian Akeylink starts Phase 2 test of oral GST-HG131/141 in hepatitis B
The placebo-controlled trial tracks HBsAg decline in patients already on stable antiviral therapy, testing whether a second-generation regimen can move a marker current drugs rarely clear.
Executive Summary
- Fujian Akeylink Biotechnology has opened a Phase 2 trial testing its oral GST-HG131/141 tablet combination against placebo in chronic hepatitis B, adding to a pipeline that already carries an earlier Phase 2 and a Phase 3 study of the same combination.
- The primary measure tracks decline in a hepatitis B surface marker in patients who are already virally suppressed on standard antiviral therapy, a harder bar than viral suppression alone and one current oral antivirals rarely clear.
- The trial enters a hepatitis B field crowded with oral small molecules and interferons but with no other program sharing this asset's specific target, so its result will read against the modality's history rather than a head-to-head comparator.
- As a non-registrational, single-site study, the trial is a portfolio-expansion signal about the sponsor's confidence in its lead combination rather than a near-term regulatory or competitive inflection.
The trial
The study, registered under NCT07709520, is recruiting in China with a target enrollment of 80 patients and three arms under triple masking. Patients must be adults 35 to 65 who have been on stable nucleoside analogue therapy for at least six months, with HBV DNA suppressed below the lower limit of quantification and hepatitis B surface antigen between 100 and 1,500 IU/mL at screening. The primary measure is decline in hepatitis B surface antigen from baseline through day 168, evaluated in an oral, placebo-controlled design. The trial started July 10, 2026, and carries a primary completion date of October 1, 2026, with study completion set for December 1, 2026. NCT07709520Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis BNCT07709520
Portfolio context
This is not the sponsor's first look at GST-HG131. Fujian Akeylink already runs an earlier Phase 2 trial of GST-HG131 alone against placebo (NCT06263959, enrollment 45, primary completion originally set for April 2025) and has advanced a related asset, GST-HG141, into a separate Phase 3 study (NCT07090759). The new trial testing the combination sits alongside those two programs, extending the sponsor's hepatitis B pipeline to a three-trial footprint rather than opening a new therapeutic hypothesis. NCT07709520Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis BNCT07709520
The competitive field
Oral small molecules dominate chronic hepatitis B drug development broadly, with 142 trials in the indication having used the modality. Named comparators in current development include Beijing Continent Pharmaceutical's hydronidone in a Phase 3 liver-fibrosis study, Fujian Shengdi Pharmaceutical's HRS-5635 in Phase 3, and Ausper Biopharma's AHB-137 in Phase 3, alongside GlaxoSmithKline's bepirovirsen, an antisense compound in a long-term follow-up study. None of these programs shares GST-HG131/141's specific mechanism, so the field around this asset is populated on modality and indication but not on target, leaving the sponsor's own two prior GST-HG131/141 trials as the closest points of comparison. NCT07709520Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis BNCT07709520
The bar
Oral nucleos(t)ide analogues such as entecavir, tenofovir disoproxil fumarate, and adefovir dipivoxil are approved in chronic hepatitis B and reliably suppress viral replication, but functional cure, measured by durable loss of the surface antigen this trial targets, remains rare on those regimens. For this readout to be informative beyond the trial itself, GST-HG131/141 would need to show a surface-antigen decline in already-suppressed patients that goes meaningfully beyond what background antiviral therapy alone produces, since the study population starts from viral suppression rather than untreated disease.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.