Minghui Pharmaceutical Receives FDA Clearance for Phase III Trials of Novel Thyroid Eye Disease Treatment
核心洞察
The FDA has cleared Minghui Pharmaceutical (搜索)'s IND application to initiate global Phase III clinical trials of MHB018A, a subcutaneous IGF-1R (搜索) antibody for thyroid eye disease (搜索) treatment.
Phase II data showed MHB018A achieved 81% proptosis response rate in active TED (搜索) and 76% in chronic TED at the 450 mg dose, outperforming historical results from intravenous IGF-1R (搜索) antibodies.
The novel VHH-based antibody demonstrates superior biological activity with two- to three-fold stronger ligand-blocking potency compared to existing IGF-1R (搜索) antibodies.
Minghui Pharmaceutical (搜索) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to initiate global Phase III clinical trials of MHB018A for treating thyroid eye disease (搜索). The randomized, double-blind, placebo-controlled studies will evaluate the efficacy and safety of subcutaneous MHB018A administered every four weeks in both active and chronic TED (搜索) patients.
Compelling Phase II Results Drive Advancement
The Phase III advancement is supported by strong Phase II efficacy data across both TED (搜索) patient populations. In active TED, MHB018A achieved an 81% proptosis response rate at Week 12 with the 450 mg dose in 32 patients, demonstrating stronger efficacy than reported for intravenous IGF-1R (搜索) antibodies. The treatment showed a favorable safety profile with no unique toxicities or Grade ≥3 hearing-related adverse events observed.
For chronic TED (搜索) patients, the 450 mg dose achieved a 76% proptosis response rate at Week 24 in 33 patients, exceeding historical results for intravenous IGF-1R (搜索) antibodies. The 24-week treatment was well tolerated, with no treatment-emergent adverse events leading to discontinuation, death, or premature withdrawal. No serious adverse events and no severe hearing-related adverse events were reported.
Differentiated Molecular Profile
MHB018A is positioned as a potentially best-in-class therapy through its novel VHH-based IGF-1R (搜索) antibody design. The drug demonstrates superior biological activity with two- to three-fold stronger ligand-blocking potency compared with existing IGF-1R antibodies. Its dual IGF-1/IGF-2 blockade potentially suppresses the downstream growth and inflammatory pathways central to TED (搜索) pathology.
The innovative molecule design potentially enables improved tissue penetration and enhanced efficacy. Clinical data from 98 TED (搜索) patients showed no reports of severe hearing damage, addressing a significant safety concern associated with this therapeutic class.
Global Development Timeline
"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 (搜索) community," said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical (搜索).
The company initiated a Phase III trial in active TED (搜索) in China in July 2025 and expects topline data in Summer 2026. Enrollment for the Phase III trial in chronic TED is planned to begin in early 2026. In the U.S., the company anticipates initiating Phase III trials in the first half of 2026.
Addressing Significant Unmet Need
Thyroid eye disease (搜索) is an autoimmune disorder characterized by inflammation, expansion and remodeling of orbital tissues, most commonly associated with Graves' disease (搜索). Insulin-like growth factor 1 receptor (搜索) serves as a key driver in TED (搜索) pathogenesis and represents a validated therapeutic target.
The global prevalence of TED (搜索) was approximately 17.1 million people in 2024 and is projected to reach 20.3 million by 2035. China accounted for about 26% of global TED cases in 2024, representing a significant addressable population for targeted therapies.
Detailed Phase II results will be presented at upcoming medical conferences, with the program highlighted at the 8th Evercore Healthcare Conference in December 2025.