Clinical Research Directory

Inclusion Criteria: * Prepubertal (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening. * Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year). * Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1. * Gestational age at birth ≥28 weeks. * Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2. * Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3. * Peak GH level ≥10.0 ng/mL in at least one prior GH stimulation test. * No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc. * Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent should be formally documented. Exclusion Criteria: * Subjects with closed epiphyses. * Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism. * Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening. * Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening. * Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin. * Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal \[ULN\], Cr \> ULN). * Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization. * Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B). * Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders. * Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis. * History of intracranial hypertension. * Past or current history of malignant tumors, including intracranial tumors. * Known allergy to growth hormone or any of its excipients. * Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.