The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature

Inclusion Criteria: * Prepubertal children: boys aged ≥3 years and \<11 years at screening with testicular volume \<4 mL; girls aged ≥3 years and \<10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue. * Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year). * Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1. * Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2. * Peak GH level ≥10.0 ng/ml in at least one GH stimulation test. * No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc. * The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented. Exclusion Criteria: * Individuals with closed epiphyses; * Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, sh…