Inclusion Criteria:
* Fully informed and signed the Informed Consent Form (ICF);
* Diagnosed with gout per the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, with a screening serum uric acid (sUA) level ≥7.0 mg/dL, and in a non-acute phase at the time of first dose;
* Aged 18-70 years (inclusive), male or female;
* Body mass index (BMI) ≥18.5 kg/m²;
* Failure to achieve sUA \<7.0 mg/dL after ≥8 weeks of standardized treatment with conventional urate-lowering therapy (ULT) (effective doses include but are not limited to: allopurinol ≥300 mg/day, febuxostat ≥40 mg/day, or benzbromarone ≥50 mg/day; investigators may adjust doses based on tolerance and renal/hepatic function) OR contraindication/intolerance to ULT; No use of oral urate-lowering drugs within 1 week prior to randomization;
* Negative serum pregnancy test for women of childbearing potential;
* Agreement by subjects and their partners of childbearing potential to use highly effective contraception or practice abstinence during the study and for 6 months after the last dose;
* Ability to understand and comply with protocol requirements; investigators anticipate completion of the entire study.
Exclusion Criteria:
* Intolerance to multiple intramuscular injections.
* Known hypersensitivity to the investigational drug, PEG-containing drugs, NSAIDs (e.g., ibuprofen, acetaminophen), or therapeutic protein products (e.g., fresh/frozen plasma, human serum albumin, cytokines, interleukins).
* History of severe allergic reactions or hypersensitivity to foods, inhalants, contact substances, or drugs, or being allergy-prone (multiple drug/food allergies).
* Acute gout flare within 2 weeks prior to baseline.
* History of organ transplantation requiring immunosuppressive therapy.
* Use of prednisone \>10 mg/day (or equivalent) within 1 week prior to screening.
* Contraindications to antihistamine use.
* History of severe diseases (digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematologic, or immune systems) within 3 months prior to screening.
* New or worsening coronary artery disease or congestive heart failure within 3 months prior to screening, or history of:
1. Acute coronary syndrome (e.g., acute myocardial infarction \[AMI\], unstable angina).
2. Coronary interventions (e.g., CABG, PTCA).
3. Stroke or transient ischemic attack.
* Uncontrolled hypertension (resting systolic blood pressure \[SBP\] ≥180 mmHg and/or diastolic blood pressure \[DBP\] ≥110 mmHg). Exception: Subjects with controlled blood pressure after adjustment of antihypertensives per guidelines may be enrolled if rechecked during screening.
* Severe peripheral vascular disease (e.g., disabling claudication, unhealed ischemic ulcers, or conditions requiring surgery/angioplasty).
* Poorly controlled diabetes (HbA1c \>9.0%).
* Vaccination within 1 month prior to baseline or plans to receive non-inactivated vaccines during the study. Note: Inactivated vaccines require a 2-week interval from study drug administration.
* Active malignancy or history of malignancy within 5 years prior to screening (exceptions: basal/squamous cell skin cancer, excised cervical intraepithelial neoplasia, or carcinoma in situ).
* History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD level below the lower limit of normal. Testing sources: Results from the study site, tertiary hospitals, or Guangzhou Kingmed Center for Clinical Laboratory Co., Ltd. are acceptable. Sample disposal: Processed by Guangdong Environmental Living Waste Disposal Center Co., Ltd.
* Laboratory abnormalities:
A. Hemoglobin \<10 g/dL. B. Active hepatitis B (HBsAg+ with HBV DNA ≥500 IU/mL or 2500 copies/mL), HCV antibody+, HIV antibody+, or syphilis antibody+ (RPR/TPPA+).
C. White blood cells \<3.0×10⁹/L. D. Platelets \<75×10⁹/L. E. ALT/AST \>3× upper limit of normal (ULN).
* Participation in conflicting clinical trials (device or PEG/uricase-based drugs) within 12 weeks prior to screening.
* Participation in other drug-intervention trials within 4 weeks prior to screening (or within 5 half-lives of the drug).
* Blood donation/loss ≥400 mL or transfusion within 3 months prior to screening (excluding physiological blood loss in females).
* Excessive alcohol consumption (\>14 units/week) within 4 weeks prior to screening (1 unit = 285 mL beer \[3.5%\], 25 mL spirits \[40%\], or 100 mL wine \[10%\]).
* History of alcohol/drug abuse within 1 year prior to screening.
* Pregnancy, lactation, or plans for pregnancy during the study.
* Poor compliance (investigator's judgment).
* Major surgery within 8 weeks prior to baseline or planned surgery during the study posing unacceptable risks.
* Any other condition deemed by the investigator to compromise safety, validity, or suitability for the study.
