Kanghong registers second Phase 3 for its TED antibody KHN939 in China
The new inactive-disease trial joins Kanghong's active-TED study, putting KHN939 up against Amgen's Tepezza and Viridian's veligrotug in an already-crowded antibody field.
Executive Summary
- Chengdu Kanghong Pharmaceutical Group has registered a Phase 3 trial testing its antibody KHN939 in patients with the inactive form of thyroid eye disease, a companion to a separate Phase 3 study already registered in active disease.
- Thyroid eye disease already has two approved antibody treatments, so this trial's job is less about opening a new mechanism and more about establishing whether KHN939 can carry a distinct clinical claim in patients whose disease has settled into an inactive, largely irreversible phase.
- The field is dense with monoclonal antibodies targeting different receptors, and Kanghong's own two Phase 3 studies split the same drug across active and inactive disease stages, a design choice that expands where KHN939 could eventually be used rather than concentrating risk in one population.
- The trial has not yet started recruiting, and its enrollment and completion timeline place any readout more than a year out, so KHN939's competitive position stays undetermined until data post.
The trial
The study, internally named Halo-2, is a randomized, quadruple-masked, two-arm Phase 3 trial testing KHN939 given intravenously against placebo in Chinese patients with moderate-to-severe inactive thyroid eye disease. Enrollment is anticipated at 117 patients, with dosing running through a 21-week treatment period followed by a 3-week safety follow-up, for roughly 28 weeks of total observation per patient. The trial has not yet started recruiting; its start date is set for August 2026 and its primary completion date for May 2027. NCT07720648A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye DiseaseNCT07720648
The primary 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 protrusion, measured by Hertel exophthalmometer, without a matching 2mm or greater increase in the untreated eye. Secondary measures include change in the Clinical Activity Score, diplopia severity on the Gorman scale, and quality-of-life scores using the GO-QoL instrument, all assessed at Weeks 12 and 24. Eligible patients must have had thyroid eye disease for two to ten years, with disease activity quiet for at least six months before screening. NCT07720648A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye DiseaseNCT07720648
A two-track program
Kanghong is also running a separate Phase 3 trial of KHN939, NCT07720635, in patients with active rather than inactive thyroid eye disease, with 60 patients targeted and a primary completion date of April 2027. Splitting the same antibody across active and inactive disease stages in parallel studies signals a strategy to establish KHN939 across the full course of the condition rather than in a single population. NCT07720648A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye DiseaseNCT07720648
The competitive field
Thyroid eye disease already has an established antibody landscape: teprotumumab, an IGF-1R inhibitor sold as Tepezza, is approved in the indication and sponsored in China-focused trials by Innovent Biologics, and veligrotug, also targeting IGF-1R, is approved as Lumvoa by Viridian Therapeutics. Neither shares KHN939's molecular target, which is not established in available records, but both compete for the same patient population and set the efficacy bar KHN939 will be read against. Other active programs include Viridian's VRDN-003, Zai Lab's ZL-1109, Minghui Pharmaceutical's MHB018A, and FcRn-targeting antibodies from argenx (efgartigimod) and Immunovant (batoclimab), all in Phase 3 testing in the same indication. Across the indication, 39 trials have already used monoclonal antibodies against thyroid eye disease, making KHN939's modality a crowded rather than novel entry.
Sponsor context
Chengdu Kanghong Pharmaceutical Group carries 20 trials across its pipeline, with 11 not yet recruiting, 5 recruiting, 2 active and not recruiting, and 2 of unknown status, indicating an active but early-stage overall portfolio rather than a single-asset company. KHN939 itself has no completed, terminated, or withdrawn Phase 3 trials in thyroid eye disease on record, leaving no track record yet to judge execution against.
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.