A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia

Key Inclusion Criteria:

1. Male and female subjects aged 18 to 65 years (inclusive)

2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia

3. Subjects must meet the criteria for non-transfusion-dependent thalassemia

4. Subjects must have a baseline hemoglobin level between 70-100 g/L(inclusive), basedon 2 consecutive measurements taken at least 1 week apart within 4 weeks beforerandomization

5. Subjects must have evidence of iron overload during screening

6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG)performance score of 0 to 1

7. Subjects must fully understand the study procedures and methods, voluntarilyparticipate in the trial, and sign an informed consent form

Key Exclusion Criteria:

1. Subjects diagnosed with alpha-thalassemia

2. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependentbeta-thalassemia

3. Subjects exhibit severe iron overload at the time of screening

4. In addition to thalassemia, subjects have any other forms of anemia andhematological disorders that the investigator assesses may compromise safety orinfluence study outcomes

5. Combined with any significant systemic diseases or psychiatric disorders

6. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and othercardiovascular diseases within 6 months prior to screening or currently present

7. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), orpresenting an abnormal 12-lead ECG with clinical significance

8. Uncontrolled hypertension before screening

9. A history of malignant neoplasm occurring within the last five years

10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, oruncontrolled systemic bacterial, fungal, or viral active infection

11. Subject have received concomitant treatment that was not permitted by the protocol

12. Subjects whose hematological parameters did not meet the inclusion criteria duringscreening

13. Subjects with a history of substance abuse, as well as those who yield positiveresults on substance abuse screening

14. Subjects who are unable to undergo MRI scans

15. Pregnant or lactating women

16. Subjects presenting any other factors deemed unsuitable for participation assessedby the investigator