Clinical Trials
Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
- By IPP Bureau
| December 17, 2025
Minghui Pharmaceutical, a late-stage biopharmaceutical company focused on transformative immunology and oncology therapies, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to launch global Phase III trials of MHB018A for thyroid eye disease (TED).
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies, testing the efficacy and safety of subcutaneous MHB018A administered every four weeks (Q4W).
“FDA Clearance of our Phase III IND marks an important milestone and brings us a step closer to delivering a best-in-class therapeutic option to the large and underserved TED community,” said Guoqing Cao, Chief Executive Officer of Minghui Pharmaceutical.
He added, “We are eager to advance MHB018A, our next-generation subcutaneous IGF-1R antibody with a differentiated profile. In China, we initiated a Phase III trial in active TED in July 2025 and expect topline data in Summer 2026. We plan to begin enrollment of the Phase III trial in chronic TED in early 2026.
"In the U.S., we anticipate initiating Phase III trials in the first half of 2026. As these global efforts progress, our focus remains on moving MHB018A efficiently toward registration and ultimately providing a meaningful treatment option for patients living with TED.”
