Jintrolong® New Dosage Form of Long-acting Somatropin Injection Approved

August 20th, 2024, Shanghai-GenSci has announced that the New Drug Application for Jintrolong® Polyethylene Glycol Recombinant Human Somatropin Injection (hereinafter referred to as PEG-rhGH) has received approval from the Center for Drug Evaluation, NMPA. The approved dosage form is 27 IU/4.5 mg/0.5 ml per vial. PEG-rhGH is indicated for the treatment of growth disorders attributable to gonadal dysgenesis, such as Turner Syndrome, a condition predominantly affecting females, which can lead to developmental issues including short stature, ovarian dysgenesis, and congenital heart defects.This is the first long-acting somatropin product of this dosage approved for this specific indication globally.

The clinical trial results from studies conducted within China demonstrate that PEG-rhGH exhibits excellent safety and tolerability. The newly approved dosage form caters to the medication requirements of pediatric patients of diverse body weights, effectively fulfilling the unmet clinical needs in the treatment of short stature associated with Turner Syndrome, thereby supporting the comprehensive health development of children.