Long-acting recombinant human growth hormone

Weekly rhythm. Steadier IGF‑1. Fewer vial excipients.

Pegpesen® is the trade name for inpegsomatropin injection—a PEGylated rhGH developed by Xiamen Amoytop Biotech for pediatric growth hormone deficiency (GHD) where authorized. This site brings together product information, registrational trial summaries, the TopPen I electronic injector, connected care tools, and peer-reviewed literature.

Product information Phase III outcomes
Child smiling in soft natural light—illustrative, not a patient

Photo: Robert Collins / Unsplash

52 wk
Randomized Phase III vs active control
0.14
mg/kg once weekly (recommended dose)
~8 wk
IGF‑1 steady state (~8 wk)
±8%
Stated dose accuracy, TopPen I IFU

Explore the program

Each section targets professionals and caregivers who want detail without promotional language. Cross-links connect the molecule, product pages, trials, and device topics.

Parent and child learning together at home
01

Product & label

Composition, strengths, dosing, missed doses, injection technique, adverse events, precautions, contraindications, interactions, pharmacokinetics, and storage.

Open product hub →
Child reading a picture book—curiosity and learning
02

Molecule & formulation

PEGylated rhGH, Y‑branch architecture (see JCEM), and excipient list without antimicrobial preservatives.

Read science →
Child reading outdoors on a bench—quiet, everyday moment
03

Registrational trials

Phase III confirmatory design, population, primary annualized height velocity, non-inferiority margin versus Norditropin®, and height SDS outcomes—with the Phase II dose-ranging program linked from the trials page for PK/PD context.

See trial data →
Young child smiling outdoors—warm, family-centered tone
04

TopPen I & digital care

Voice-guided electronic pen, on-pen logs, Bluetooth binding, and the Yushida WeChat mini program for plans, reminders, and growth records.

Injector details →
Open book and reading—research and learning
05

Publications

The Y‑shaped PEGylated rhGH Phase III manuscript in J Clin Endocrinol Metab with DOI and bundled PDF.

View references →
Child running on a beach at sunset—space, motion, and light
06

Site guide

How the static HTML sections fit together, where images live, and how to add or edit pages without a build toolchain.

Open site guide →
Children creating art in a classroom—structured learning and growth
07

PK/PD modeling

Dose up-titration and weight-banded regimens simulated from Phase 1–3 data—tables, timelines, and the full J Endocrinol Invest PDF.

Open modeling topic →
Adult and toddler walking together on the seashore
Photo: Sabine Ojeil / Unsplash

Clinical profile at a glance

These bullets condense commonly reviewed points. They do not replace individualized clinical judgment or local product information.

  • Less frequent injections than daily rhGH when using a once-weekly regimen in appropriately selected pediatric patients.
  • IGF‑1 dynamics at the characterized weekly dose: steady state in about eight weeks; median Tmax 48 h at steady state (see clinical pharmacology).
  • Formulation using mannitol, acetate buffer salts, sodium chloride, and lysine acetate—without antimicrobial preservatives in the drug product described on the product pages.
  • Immunogenicity results from the domestic Phase III program (anti-drug and neutralizing antibodies) summarized on the adverse-events and trial pages.