MHB018A / Minghui Pharma - LARVOL DELTA

MHB018A-P-302: MHB018A Treatment in Patients With Chronic Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Subcutaneous MHB018A, a N Ovel Anti- IGF-1R VHH Antibody, for Thyroid Eye Disease (TED): Results from a Phase 1/2 Study in Patients with Active and Chronic TED (ENDO 2026) - "MHB018A demonstrated clinically meaningful and consistent efficacy in both active and chronic TED, particularly at the 450 mg dose. The favorable tolerability profile and feasibility of subcutaneous administration support continued clinical development of MHB018A as a differentiated IGF-1R-targeted therapy for TED."

Clinical • P1/2 data • Ophthalmology • Thyroid Eye Disease • IGF1 • IGF2

Treatment of Chronic Thyroid Eye Disease With MHB018A (clinicaltrials.gov) - P3 | N=135 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study (clinicaltrials.gov) - P3 | N=84 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Open-Label Extension Study of MHB018A in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=219 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

MHB018A Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Trial completion date: Jul 2028 ➔ Jul 2027 | Trial primary completion date: Jan 2027 ➔ Jul 2026

Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=258 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2027 ➔ Jan 2030 | Trial primary completion date: Jun 2027 ➔ Jan 2029

Enrollment open • Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

MHB018A-P-302: MHB018A Treatment in Patients With Chronic Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2027 ➔ Aug 2028 | Initiation date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2027

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Minghui Pharmaceutical Announces FDA clearance of IND to Initiate Global Phase Ⅲ Trials of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody, in Thyroid Eye Disease (The Manila Times) - "'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.'"

IND • New P3 trial • Thyroid Eye Disease

Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=258 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Interventional: MHB018A Treatment in Patients With Chronic Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

MHB018A Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

Subcutaneous MHB018A, a novel IGF-1R VHH-Fc Antibody, for Thyroid Eye Disease (TED): Results from a Phase 1/2 Study in Patients with Active and Chronic TED [WITHDRAWN] (ATA 2025) - No abstract available

Clinical • Late-breaking abstract • P1/2 data • Ophthalmology • Thyroid Eye Disease

MHB018A Treatment in Patients With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Not yet recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P3 trial • Ophthalmology • Thyroid Eye Disease

Minghui Pharmaceutical Inc. Announces Positive Topline Results from Phase Ib/II Clinical Trial of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody, in Patients with Active, Moderate-to-Severe Thyroid Eye Disease (TED) (PRNewswire) - P1/2 | N=30 | "Minghui Pharmaceutical, Inc...announced positive topline results from its Phase Ib/II clinical trial of MHB018A in patients with active TED....The proptosis response rate (the percentage of participants who achieves a reduction in proptosis of ≥2 mm compared to baseline) at week 12 for the study eye was 50.0%, 50.0% and 87.5% for the 300 mg, 600 mg+300 mg and 450 mg groups, respectively, compared to 16.7% in the placebo group (See table below). The 450 mg group demonstrated rapid, profound, and sustained responses, with 50.0% (4/8) and 87.5% (7/8) of patients achieving a ≥2 mm reduction in proptosis at week 4 and 8, respectively....'Building on these encouraging results, we plan to initiate Phase 3 registrational trials in the first half of 2025.'"

New P3 trial • P1/2 data • Thyroid Eye Disease