Kanghong starts Phase 3 test of KHN939 in Chinese thyroid eye disease patients
The 60-patient trial joins a second Kanghong study of the same antibody, entering a thyroid eye disease field where every rival program targets a different receptor.
Executive Summary
- Chengdu Kanghong Pharmaceutical Group has registered a Phase 3 trial of its antibody KHN939 in Chinese patients with active thyroid eye disease, testing whether the drug shrinks eye bulging by a clinically defined margin at six months.
- The study is the sponsor's second Phase 3 program for the same antibody, run in parallel with a separate trial in patients whose disease has already become inactive, pointing to a bid for broad label coverage across the disease course rather than a single narrow population.
- The trial enters a thyroid eye disease field crowded with monoclonal antibodies aimed at IGF-1R, FcRn and IL-6 signaling, two of which already carry FDA approval in this indication, while KHN939's own target has not been established in available records.
- The trial has not started recruiting, and its readout will hinge on whether execution stays on the sponsor's stated timeline once dosing begins.
The registration
Chengdu Kanghong Pharmaceutical Group Co., Ltd. added a Phase 3 trial, internally named Halo-1, testing KHN939 in Chinese patients with moderate-to-severe active thyroid eye disease. The trial is not yet recruiting and plans to enroll 60 patients across sites in China, with a target start date of August 1, 2026. It is randomized, quadruple-masked, and uses two arms delivered intravenously over a roughly 28-week course that includes screening, a 21-week treatment period and a 3-week safety follow-up. NCT07720635A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye DiseaseNCT07720635
The endpoint
The primary endpoint is the proptosis responder rate in the study eye at Week 24, defined as a reduction of at least 2 millimeters from baseline in eye bulging without a matching 2-millimeter worsening in the fellow eye, measured by Hertel exophthalmometer. Secondary measures track the Clinical Activity Score, a 7-item scale of inflammatory activity, alongside diplopia severity and quality-of-life scores through Week 24. Eligible patients must have proptosis of at least 18mm and a Clinical Activity Score of 3 or higher, with active symptoms present for no more than 12 months before screening. NCT07720635A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye DiseaseNCT07720635
A two-trial program
KHN939 already carries a second Phase 3 trial in Chinese patients with inactive thyroid eye disease, targeting 117 patients with a primary completion date of May 2027, one month behind the new active-disease study's April 2027 target. Running the two studies together indicates the sponsor is building toward a registrational filing that spans both phases of the disease rather than the active-inflammation population alone.
The competitive field
Thyroid eye disease has drawn a wave of monoclonal antibody programs aimed at different targets: teprotumumab and its biosimilar candidates against IGF-1R, batoclimab and efgartigimod against FcRn, and satralizumab against IL-6 receptor, among others in Phase 3 testing. Two of those, Viridian Therapeutics' veligrotug and Amgen's teprotumumab, are approved by the FDA specifically for thyroid eye disease. KHN939's own target is not established in available records, so it cannot be placed on that target map, but its modality places it in a field where 39 other trials have already used monoclonal antibodies against this indication.
Sponsor footprint
Chengdu Kanghong Pharmaceutical Group runs a 20-trial pipeline spanning multiple stages, with 11 trials not yet recruiting, 5 recruiting, 2 active and not recruiting, and 2 of unknown status. The company has no terminated trials on record, and the registry shows no protocol amendments yet on the new study beyond its initial filing. NCT07720635A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye DiseaseNCT07720635
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.