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Peer-reviewedCC BY-NC 4.0Hormone Research in Pædiatrics

Long-Acting PEGylated Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age in China: 4-Year Results from a Randomized Phase 2 Study

  • Ling Hou1
  • Xiaoping Luo1
  • Xiaobo Chen2
  • Hongwei Du3
  • Yu Yang4
  • Feihong Luo5
  • Yanling Chen6
  • Dingaiyao Ma6
  • Wei Xiang6
  • Xiaoyan Zhu6
6 affiliations
  1. 1Department of Pediatrics, Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology, Wuhan, China
  2. 2Department of Endocrinology, Children's Hospital, Capital Institute of Pediatrics, Beijing, China
  3. 3Department of Pediatrics, The First Hospital of Jilin University, Jilin, China
  4. 4Department of Endocrinology and Genetics, Jiangxi Provincial Children's Hospital, Jiangxi, China
  5. 5Department of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China
  6. 6Changchun GeneScience Pharmaceutical Co., Ltd., Shanghai, China
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Abstract

Introduction: Children born small for gestational age (SGA) who failed to achieve catch-up growth are at risk of persistent short stature and associated metabolic complications. Daily recombinant human growth hormone (rhGH) therapy improves growth but is limited by adherence challenges. This study evaluated the long-term efficacy and safety of once-weekly PEGylated recombinant human growth hormone (PEG-rhGH, Jintrolong) in short children born SGA.

Methods: This multicenter, randomized, open-label, dose-response, phase 2 study comprised a 52-week main phase and an ongoing extension (NCT02375620) across 9 and 7 sites in China, respectively. Ninety-six GH-treatment-naive, non-GH-deficient, prepubertal children born SGA (aged 3 to <8 years) were randomized (1:1) to PEG-rhGH 0.1 or 0.2 mg/kg/week for 52 weeks. After 52 weeks, sixty-six children proceeded to the extension phase continuing PEG-rhGH treatment (initial dose: 0.2 mg/kg/week; maximum: 0.4 mg/kg/week) until near-adult height.

Results: After 208 weeks, the mean (SD) ΔHT-SDS was 1.746 (0.488) and 1.660 (0.710) in the original 0.2 and 0.1 mg/kg/week groups, respectively. Overall, 90.9% (60/66) of patients achieved height > −2 SDS and 53.0% (35/66) reached their target height SDS. The mean annualized height velocity remained within the normal range. Long-term PEG-rhGH treatment was well tolerated, with most treatment‐emergent adverse events being mild and consistent with known GH-related effects.

Conclusion: Once-weekly PEG-rhGH provided sustained improvement in height and growth velocity over 4 years of treatment in short children born SGA. Its favorable safety and adherence profile supports long-acting GH as an alternative to daily GH therapy for managing growth failure in SGA children.

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Cite

BibTeXRIS
BibTeX
@article{hou2026longacting,
  title = {{Long-Acting PEGylated Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age in China: 4-Year Results from a Randomized Phase 2 Study}},
  author = {Ling Hou and Xiaoping Luo and Xiaobo Chen and Hongwei Du and Yu Yang and Feihong Luo and Yanling Chen and Dingaiyao Ma and Wei Xiang and Xiaoyan Zhu},
  journal = {Hormone Research in Pædiatrics},
  year = {2026},
  month = oct,
  doi = {10.1159/hrp/adaag021},
  url = {https://doi.org/10.1159/hrp/adaag021},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Long-Acting PEGylated Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age in China: 4-Year Results from a Randomized Phase 2 Study
AU  - Ling Hou
AU  - Xiaoping Luo
AU  - Xiaobo Chen
AU  - Hongwei Du
AU  - Yu Yang
AU  - Feihong Luo
AU  - Yanling Chen
AU  - Dingaiyao Ma
AU  - Wei Xiang
AU  - Xiaoyan Zhu
PY  - 2026
DA  - 2026/10/07
JO  - Hormone Research in Pædiatrics
DO  - 10.1159/hrp/adaag021
UR  - https://doi.org/10.1159/hrp/adaag021
AB  - Introduction: Children born small for gestational age (SGA) who failed to achieve catch-up growth are at risk of persistent short stature and associated metabolic complications. Daily recombinant human growth hormone (rhGH) therapy improves growth but is limited by adherence challenges. This study evaluated the long-term efficacy and safety of once-weekly PEGylated recombinant human growth hormone (PEG-rhGH, Jintrolong) in short children born SGA.  Methods: This multicenter, randomized, open-label, dose-response, phase 2 study comprised a 52-week main phase and an ongoing extension (NCT02375620) across 9 and 7 sites in China, respectively. Ninety-six GH-treatment-naive, non-GH-deficient, prepubertal children born SGA (aged 3 to <8 years) were randomized (1:1) to PEG-rhGH 0.1 or 0.2 mg/kg/week for 52 weeks. After 52 weeks, sixty-six children proceeded to the extension phase continuing PEG-rhGH treatment (initial dose: 0.2 mg/kg/week; maximum: 0.4 mg/kg/week) until near-adult height.  Results: After 208 weeks, the mean (SD) ΔHT-SDS was 1.746 (0.488) and 1.660 (0.710) in the original 0.2 and 0.1 mg/kg/week groups, respectively. Overall, 90.9% (60/66) of patients achieved height > −2 SDS and 53.0% (35/66) reached their target height SDS. The mean annualized height velocity remained within the normal range. Long-term PEG-rhGH treatment was well tolerated, with most treatment‐emergent adverse events being mild and consistent with known GH-related effects.  Conclusion: Once-weekly PEG-rhGH provided sustained improvement in height and growth velocity over 4 years of treatment in short children born SGA. Its favorable safety and adherence profile supports long-acting GH as an alternative to daily GH therapy for managing growth failure in SGA children.
SN  - 1663-2818
SN  - 1663-2826
ER  -