Amoytop Biotech Wins NMPA Approval for Weekly Inpegsomatropin in Pediatric Growth Deficiency

Amoytop Biotech Wins NMPA Approval for Weekly Inpegsomatropin in Pediatric Growth Deficiency

Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its inpegsomatropin therapy. The product is indicated for the treatment of growth retardation caused by growth hormone deficiency (GHD) in children aged 3 and above.

Inpegsomatropin: A Long-Acting Biologic Innovation
Inpegsomatropin is a Category 1 biologic product featuring a long-acting formulation utilizing 40kD Y-branched polyethylene glycol (PEG) for single-molecule modification. This innovative approach optimizes the selection of modification components, focusing on non N-terminal sites to enhance biological specific activity. By extending the half-life of the drug, this formulation allows for reduced dosing frequency while maintaining efficacy and improving long-term drug safety.

Benefits for Pediatric Patients
Compared with short-acting formulations requiring daily injections, inpegsomatropin can be administered once a week. This regimen significantly reduces the frequency of medication for patients, providing substantial physical and mental relief for children and their families. The improved dosing schedule also aims to enhance medication compliance, ensuring better treatment outcomes for pediatric patients with growth hormone deficiency.-Fineline Info & Tech