- MHB018A demonstrated outstanding clinical activity in both active and chronic thyroid eye disease
- At 450 mg Q4W, MHB018A achieved a remarkable 81% proptosis response at Week 12 in active TED and a 76% proptosis response at Week 24 in chronic TED
- MHB018A was generally well tolerated among 98 treated patients, demonstrating an excellent safety profile, with all hearing-related adverse events reported as Grade 1 and no severe or permanent hearing damage
- MHB018A is being evaluated in ongoing Phase III trials in China, with topline results anticipated in Q3 2026; global Phase III trials have been initiated, with first patient enrollment targeted for Q4 2026
SHANGHAI and HANGZHOU, China and WILMINGTON, Del., June 16, 2026 /PRNewswire/ -- Minghui Pharmaceutical ("Minghui"), a late-stage clinical biopharmaceutical company focused on developing innovative therapies for oncology and autoimmune diseases, today presented complete Phase I/II clinical data of MHB018A, a novel subcutaneous anti-IGF-1R antibody, in patients with active and chronic thyroid eye disease ("TED"). The data were featured in an oral presentation at ENDO 2026, the Endocrine Society's Annual Meeting (Chicago, USA).
The selection of MHB018A for oral presentation at ENDO 2026 underscores the significant scientific and clinical interest in this highly differentiated subcutaneous IGF-1R-targeted therapy. At the recommended Phase III dose of 450 mg once every four weeks ("Q4W"), MHB018A delivered robust and highly compelling clinical activity across both active and chronic TED populations.
Clinical Activity:
Active TED (aTED) – Week 12, 450 mg Q4W, N=32
Endpoints | Results |
Proptosis response | 81 % |
Proptosis mean change | -2.83 mm |
CAS of 0 or 1 | 84 % |
Overall response | 78 % |
Diplopia response | 85 % |
Diplopia complete resolution | 59 % |
Chronic TED (cTED) – Week 24, 450 mg Q4W, N=33
Endpoints | Results |
Proptosis response | 76 % |
Proptosis mean change | -2.65 mm |
Diplopia response | 61 % |
Diplopia complete resolution | 50 % |
Safety Profile
MHB018A was generally well tolerated in the Phase I/II study. Most adverse events were mild and consistent with the known mechanism of IGF-1R inhibition. All hearing-related adverse events were Grade 1 in severity, and no severe or permanent hearing damage was reported.
"We are pleased to present the complete Phase I/II clinical results for MHB018A in TED in an oral session at ENDO 2026," said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "MHB018A is a novel antibody targeting IGF-1R, designed to fully block both IGF-1- and IGF-2-mediated signaling. In this study, MHB018A delivered outstanding clinical activity across both active and chronic TED, including remarkable improvements in proptosis and diplopia. In active TED, we also observed a very high proportion of patients achieving a CAS of 0 or 1, suggesting great control of inflammatory disease activity."
Dr. Cao continued, "Importantly, MHB018A demonstrated an excellent safety profile among 98 treated patients, with no severe or permanent hearing damage reported. Together with its remarkable efficacy and convenient subcutaneous administration, we believe that MHB018A represents a highly differentiated and competitive IGF-1R-targeted therapy with best-in-class potential for TED. MHB018A is currently being evaluated in ongoing Phase III trials in China, with topline results anticipated in Q3 2026. We are also advancing global Phase III development, with first patient enrollment targeted for Q4 2026."
About Minghui Pharmaceutical
Minghui Pharmaceutical is a late-stage clinical biopharmaceutical company focused on developing innovative medicines to address unmet needs in oncology and immunology. The company is advancing a pipeline of differentiated antibody and antibody-drug conjugate candidates designed to address significant unmet medical needs globally.
Forward-Looking Statements （Related： Quest Global Launches Neprion to Accelerate AI Smart Wearables Launch Readiness ｜ Latest ）
This press release contains forward-looking statements regarding MHB018A and its clinical development plans, including potential therapeutic benefits, ongoing and planned clinical studies, regulatory expectations, and future development activities. These statements are based on the Company's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially from those expressed or implied herein, including risks related to clinical development, regulatory review, manufacturing, intellectual property protection, and other factors. The Company undertakes no obligation to update any forward-looking statements except as required by applicable laws and regulations.
