SHANGHAI and HANGZHOU, China, Dec. 15, 2025 -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to initiate global Phase Ⅲ clinical trials of MHB018A for the treatment of thyroid eye disease (TED). The trials in both active and chronic TED are randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy and safety of subcutaneous MHB018A administered every four weeks (Q4W).
MHB018A, a novel VHH-based IGF-1R antibody, is emerging as a potential best-in-class therapy, supported by compelling Phase Ⅱ data:
- Active TED: At the 450 mg dose (n=32), MHB018A achieved an 81% proptosis response rate at Week 12, demonstrating stronger efficacy than reported for intravenous IGF-1R antibodies. The treatment was well tolerated, with a favorable safety profile. No unique toxicities or Grade≥3 hearing-related AEs were observed.
- Chronic TED: At the 450 mg dose (n=33), MHB018A achieved a 76% proptosis response rate at Week 24, exceeding historical results for intravenous IGF-1R antibodies. The 24-week treatment was well tolerated, with no TEAE leading to discontinuation, death, or premature withdrawal from the study. No SAEs and no severe hearing-related AEs were reported.
Detailed Phase Ⅱ results will be presented at upcoming medical conferences. The program was also highlighted at the 8th Evercore Healthcare Conference in December 2025.
"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, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "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."
About TED
Thyroid eye disease (TED) is an autoimmune disorder characterized by inflammation, expansion and remodeling of orbital tissues, most commonly in association with Graves' disease. Insulin-like growth factor 1 receptor (IGF-1R) is a key driver in the pathogenesis of TED and a validated therapeutic target. The global prevalence of TED 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 target therapies.
About MHB018A
MHB018A is a novel subcutaneous IGF-1R VHH-based antibody with a differentiated profile: (i) innovative molecule design, potentially enabling improved tissue penetration and enhanced efficacy; (ii) superior biological activity, demonstrating two- to three-fold stronger ligand-blocking potency compared with existing IGF-1R antibodies; (iii) dual IGF-1/IGF-2 blockade, potentially suppressing the downstream growth and inflammatory pathways central to TED pathology; and (iv) low hearing loss risk, with clinical data from 98 TED patients showing no reports of severe hearing damage. These attributes position MHB018A as a well-differentiated, potentially best-in-class IGF-1R therapy for patients with TED.
About Minghui Pharmaceutical
Founded in 2018, Minghui Pharmaceutical is a near-commercial biotechnology innovator with two complementary growth engines: a robust clinical oncology portfolio built on its proprietary antibody-drug conjugate (ADC) platform and a novel PD-1/VEGF bispecific antibody (bsAb), and late-stage autoimmune assets advancing toward commercialization. The Company's pipeline includes 13 candidates, 10 of which are in clinical development. Autoimmune assets are positioned for near-term revenue, including a first-in-class topical prodrug of tofacitinib under NDA review and a novel subcutaneous IGF-1R antibody in Phase Ⅲ trials. Oncology programs are focused on advancing combination strategies of ADCs and PD-1/VEGF bsAb to transform front-line cancer treatment.
Forward-Looking Statements
This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances, except as required by law.
