Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)

Inclusion Criteria:

• Must be willing to participate in the study and provide written informed consent.

• Male or female aged 18 ≤ age < 75 at the time of signing the informed consent.

• Must have had prior liver biopsy within 180 days of randomization with fibrosisstage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobularinflammation and ballooning degeneration.

• Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived protondensity fat fraction (MRI-PDFF).

• Weight changes≤5% in the 6 weeks prior to randomization.

• No qualitative change in dose for the drugs listed below:

1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2inhibitors): for at least 3 months

2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months

3. Statins: for at least 3 months

• Females of childbearing potential must practice a consistent and proper use ofhighly effective method of contraception throughout the study and for 6 month aftertreatment discontinuation.

Exclusion Criteria:

• Documented causes of chronic liver disease other than NASH

• Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% atscreening，Fasting blood glucose≥13.9mmol/l

• Uncontrolled hypertension at Screening (values ≥160/100 mm Hg)

• History or presence of cirrhosis

• Subjects with any type of active malignancy or a history of malignancy (exceptcervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cellcarcinoma and papillary thyroid carcinoma) that has been cured for more than 5 yearsprior to the screening period;

• Unable or unwilling to undergo liver biopsy according to research requirements.

• History of weight loss surgery within 5 years (inclusive) prior to screening

• A major surgery was performed 3 months prior to signing the Informed Consent Form (ICF), or planned during the study period.

• Have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months priorto screening.

• When screening, according to the results of dual energy X-ray absorptiometry (DXA)examination, it meets the criteria for osteoporosis: T≤ -2.5

• Recent history of drug abuse (defined as ≤ 2 years).

• Patient participating in other clinical trials of drugs or medical devices within 3months prior to screening.

• Abnormal laboratory test values：ALT or AST >5 × ULN；Serum ALP≥2×ULN；eGFR<60mL/min；INR>1.3× ULN；platelets < LLN.

• Pregnant or breastfeeding women.

• Liver transplantation history or planned liver transplantation

• Contraindications for MRI examination

• Any other condition which, in the opinion of the Investigator, would impedecompliance, hinder completion of the study, compromise the well-being of thepatient, or interfere with the study outcomes.