Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease

Inclusion Criteria

• •1. Subjects voluntarily participating in the study and signing the informed consent form;
• •2. Aged 18-75 years (inclusive), of any gender;
• •3. Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).
• •4. Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a \<2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and/or who meet the retreatment criteria for relapse during the safety follow-up period.
• •5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
• •6. Diabetic subjects must have well-controlled stable disease.
• •7. Sufficient bone marrow and organ function.
• •8. Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.
• •9. Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
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