Minghui Pharmaceutical Advances Thyroid Eye Disease Treatment with FDA Approval for Phase Ⅲ Trials

Minghui Pharmaceutical Receives FDA Clearance for Phase Ⅲ Trials of MHB018A

Introduction
Minghui Pharmaceutical, a biopharmaceutical leader focused on immunology and oncology advancements, recently announced it has secured the U.S. FDA's approval for their Investigational New Drug (IND) application to initiate global Phase Ⅲ clinical trials of MHB018A. This subcutaneous single-domain IGF-1R antibody targets thyroid eye disease (TED), a condition that affects millions worldwide.

Significance of FDA Clearance

The FDA's clearance to initiate Phase Ⅲ trials is a significant milestone for Minghui, underscoring its commitment to address the needs of the underserved TED population. Dr. Guoqing Cao, CEO of Minghui, noted that this represents a pivotal step towards providing a best-in-class therapeutic option for TED, which is notoriously difficult to treat.

Overview of MHB018A

MHB018A is designed as a novel subcutaneous IGF-1R antibody, boasting an innovative VHH-based structure. This allows for improved tissue penetration and a potentially enhanced efficacy profile in comparison to existing therapies. Early data from Phase Ⅱ trials have showcased the promising results of MHB018A in treating both active and chronic instances of TED.

Phase Ⅱ Trials Results

Active TED:
In trials involving patients with active TED, MHB018A demonstrated an impressive 81% response rate in proptosis reduction at the 12-week mark. This result is notably superior to that of intravenous IGF-1R antibodies reported in historical data. Furthermore, the treatment showed a favorable safety profile, with no severe adverse effects reported.

Chronic TED:
For chronic TED patients, the results were equally compelling. At the 24-week mark, a 76% response rate was observed in proptosis improvement at the same 450 mg dosage, surpassing the efficacy noted for intravenous treatment options. The treatments were well tolerated with no significant adverse effects leading to study withdrawal.

Future Directions

The upcoming global Phase Ⅲ trials will encompass not only active TED but also chronic forms, with enrollment expected to begin in early 2026 across the U.S. Minghui's efforts also extend to other critical markets, with a Phase Ⅲ trial for active TED already underway in China since July 2025 and anticipated topline data set to be released in Summer 2026.

Dr. Cao emphasized the urgency of advancing MHB018A, seeking to bridge the gap for patients navigating the challenges of TED.

Understanding Thyroid Eye Disease

Thyroid eye disease, often linked with Graves' Disease, is a debilitating autoimmune condition resulting in inflammation and remodeling of ocular tissues. As of 2024, TED affected approximately 17.1 million people globally, with projections suggesting this figure could reach 20.3 million by 2035. Notably, China accounted for about 26% of TED cases in 2024, highlighting a substantial market for targeted therapeutic solutions.

Conclusion

MHB018A's approval to proceed with Phase Ⅲ trials presents a noteworthy step forward for treating thyroid eye disease. The positive Phase Ⅱ results indicate a strong potential for MHB018A, positioning it as a frontrunner in the evolving landscape of TED therapies. Minghui Pharmaceutical is dedicated to driving this innovative solution towards eventual market release, benefiting patients worldwide.

About Minghui Pharmaceutical
Founded in 2018, Minghui specializes in progressive biopharmaceutical innovations with a pipeline that boasts both oncology and autoimmune therapeutic candidates. With a significant focus on delivering transformative healthcare solutions, the company is positioned for impactful contributions to global health challenges.