On May 29, Amoytop Biotech's independently developed Class 1 new drug, Inpegsomatropin Injection(trade name: Pegpesen^®), the world's first Y-shaped 40-kDa PEGylated long-acting growth hormone, officially received market approval from the National Medical Products Administration (NMPA). This drug is indicated for the treatment of growth failure in children aged 3 and older due to growth hormone deficiency (GHD).

Screenshot cr: official website, National Medical Products Administration

Human growth hormone (hGH), a single-chain, non-glycosylated polypeptide produced by the anterior pituitary gland, plays vital physiological roles in regulating metabolism, stimulating protein synthesis, and accelerating fat metabolism. It promotes the growth and development of skeletal and muscular tissues. Inpegsomatropin exerts effects equivalent to endogenous human growth hormone.

Inpegsomatropin Injection(trade name: Pegpesen^®), developed independently by Amoytop, is a next-generation long-acting recombinant human growth hormone (rhGH). It employs site-specific mono-molecule modification using a novel 40-kDa Y-shaped branched polyethylene glycol (PEG). By optimizing the modification profile to primarily target non-N-terminal sites, the product achieves enhanced specific biological activity and a prolonged half-life. This results in effective therapeutic outcomes at reduced dosages and improves long-term drug safety. Compared to short-acting formulations requiring daily administration, Pegpesen^® enables once-weekly dosing. This significantly reduces the frequency of medication for patients, effectively alleviating treatment burden, and improving medication adherence. It provides a more convenient and effective treatment option for patients with growth hormone deficiency and related conditions.

The approval and market launch of Pegpesen^® further enhances Amoytop's product portfolio, strengthening its capability to meet diverse patient needs. This milestone lays a solid foundation for Amoytop's sustained development in the fields of immunology and metabolism. Moving forward, Amoytop Biotech will continue leveraging its professional expertise, dedicatedly safeguarding human health and propelling the Healthy China initiative to new heights.