SHANGHAI,Oct. 22,2024 -- Minghui Pharmaceutical,Inc.,a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology,today announced positive topline results from its Phase Ib/II clinical trial of MHB018A in patients with active TED. MHB018A is a novel subcutaneous VHH-Fc fusion protein that targets the insulin-like growth factor-1 receptor (IGF-1R),a validated mechanism of action for TED treatment.

This multicenter,double-blind,randomized,placebo-controlled phase Ib/II trial was conducted to evaluate the safety and preliminary efficacy of MHB018A in patients with active,moderate-to-severe TED. The trial included three dosing regimens: a 300 mg fixed-dose once every four weeks (Q4W) for three doses,a 450 mg fixed-dose Q4W for three doses,and a 600 mg loading dose followed by two 300 mg fixed-dose Q4W. A total of 30 participants were enrolled sequentially into the three dose groups. In each group,participants were randomly assigned in a 4:1 ratio to receive subcutaneous injections of either MHB018A or placebo.

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.

Primary Endpoint

Cohort 1

Cohort 2

Cohort 3

All cohorts

MHB018A

MHB018A

MHB018A

Placebo

300 mg Q4W (N=8)

600 mg+300 mg Q4W

(N=8)

450 mg Q4W (N=8)

N=6

W4

W8

W12

W4

W8

W12

W4

W8

W12

W4

W8

W12

Mean reduction in proptosis

from baseline,mm

-2.12

-2.35

-2.37

-1.46

-1.77

-2.69

-1.88

-2.94

-3.43

-0.40

-0.62

-1.13

Proptosis Response Rate

37.5%

62.5%

50.0%

37.5%

37.5%

50.0%

50.0%

87.5%

87.5%

16.7%

16.7%

Clinical benefit was further evident through additional efficacy endpoints,including the overall response rate,defined as the proportion of subjects achieving both a ≥2 mm reduction inproptosis from baseline and an improvement of ≥2 points in the clinical activity score (CAS) in the study eye,as well as the percentage of subjects achieving a CAS of 0 or 1. MHB018A demonstrated significant improvements across all these parameters compared to the placebo.

MHB018A was generally well-tolerated across all dose regimens. Most AEs were Grade 1 or 2 in severity and resolved following the completion of treatment without intervention. No severe hearing impairment was reported. The overall safety profile was consistent with that of other IGF-1R antibodies.

"We are highly encouraged by these results,which demonstrate that subcutaneous administration of MHB018A delivers faster,deeper,and more robust responses in TED patients,particularly at the 450 mg dose," saidGuoqing Cao,Ph.D.,Chief Executive Officer at Minghui Pharmaceutical. "The unique molecular design and superior pharmacological profile of MHB018A are reflected in its promising efficacy and favorable safety outcomes. While these findings are preliminary and from a small cohort,they offer significant potential. A subcutaneous treatment with a great safety profile could represent a major advancement in TED care. Building on these encouraging results,we plan to initiate Phase 3 registrational trials in the first half of 2025."

About TED

Thyroid eye disease (TED) is an autoimmune disorder characterized by the overactivation of orbital fibroblasts driven by autoantibodies targeting thyroid receptors. A key factor in the pathogenesis of TED is the insulin-like growth factor 1 receptor (IGF-1R),which has been validated as an effective therapeutic target.

About Minghui Pharmaceutical Inc.

Minghui Pharmaceutical,established in 2018,is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms,the company is advancing a robust clinical-stage pipeline that features a range of first-in-class or best-in-class product candidates. For more information,please visit www.minghuipharma.com.

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.