China Approves Inpegsomatropin Injection for Children with Growth Hormone Deficiency

China’s National Medical Products Administration (NMPA) has officially approved Inpegsomatropin Injection, a first-in-class, innovative long-acting growth hormone developed by Xiamen Amoytop Biotech Co., Ltd., for the treatment of growth hormone deficiency (GHD) in children aged 3 years and older.

👉 This approval marks a major milestone in providing safer, more effective, and convenient treatment options for children affected by GHD.

A Breakthrough in Pediatric GHD Treatment

Growth hormone deficiency (GHD) is an endocrine disorder caused by insufficient secretion of endogenous growth hormone, characterized primarily by short stature.

😫 Untreated GHD in children can lead to long-term metabolic disorders, psychological challenges, and increased risk of chronic diseases, significantly affecting life quality and overall health.

👉 Early diagnosis and timely growth hormone replacement therapy are essential for improving height, optimizing metabolic outcomes, and supporting healthy development into adulthood.

😔 Traditionally, recombinant human growth hormone (rhGH) requires daily injections, which often result in pain, inconvenience, and poor adherence.

Studies indicate that up to two-thirds of children miss at least one injection per week, directly impacting growth outcomes.

Innovative Long-Acting Technology

✨ Inpegsomatropin Injection is the world’s first Y-shaped 40kD PEGylated long-acting growth hormone, independently developed in China.

Its two Y-shaped PEG chains are linked to the hormone via highly stable amide and C–N bonds, significantly extending the half-life while maintaining high bioactivity.

✅ As the first long-acting growth hormone expressed in a eukaryotic system, its structure closely resembles endogenous growth hormone, enabling lower initial dosing and reduced immunogenicity.

🔬 Pharmacokinetic studies show that Inpegsomatropin injection has a half-life of approximately 65–120 hours, supporting once-weekly dosing, compared with daily injections required for short-acting rhGH.

Clinical Evidence Supporting Safety and Efficacy

A Phase III multicenter, open-label, randomized trial was conducted at 23 centers across China with 391 children diagnosed with GHD.

Participants were randomized 2:1 to receive either weekly Pegpesen (140 μg/kg/week) or daily rhGH (245 μg/kg/week) for 52 weeks.

The primary endpoint was annual growth velocity (GV, cm/year).

👉 Results demonstrated that at 52 weeks, the LS mean GV for the Pegpesen group was 9.910 cm/year, compared with 10.037 cm/year for the daily rhGH group, with an LS mean difference of –0.127, confirming that weekly Yipeisheng is non-inferior to daily rhGH.

Inpegsomatropin injection also offers significant safety and convenience benefits:

• 💉 Reduced injection frequency—only once weekly, reducing the annual injection burden by 313 injections.
• 🤒 Lower immunogenicity—clinical studies reported 0% incidence of new anti-drug or neutralizing antibodies.
• 💪 Improved adherence and quality of life—simplified “single-use prefilled” design, preservative-free formulation, and flexible dosing (0.14–0.28 mg/kg/week) help reduce risk and ease treatment.

To enhance convenience and adherence, Xiamen Amoytop Biotech has also developed a dedicated electronic auto-injector pen for Inpegsomatropin injection.

☀️ The device simplifies injection, provides voice-guided instructions, records dosing data in real-time, and integrates with a mobile app for personalized health management and physician data sharing.

Inpegsomatropin Injection—A Milestone for Pediatric Endocrinology in China

👉 Starting June 19, 2025, Inpegsomatropin injection has been introduced in over 300 hospitals across 27 provinces, marking the start of a new era in long-acting growth hormone therapy in China.

As a first-in-class biologic, Inpegsomatropin injection represents a significant advancement in the treatment and management of pediatric GHD, offering children and families a safer, more effective, and more convenient option.

DengYue Medicine will continue to follow the development of innovative drugs in China, providing the public with more information on new medications and supporting the healthy growth of children.

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