pegylated somatropin (Gensci 004) / GeneScience - LARVOL DELTA

Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature (clinicaltrials.gov) - P2 | N=96 | Active, not recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Unknown status ➔ Active, not recruiting | Trial completion date: Dec 2017 ➔ Dec 2025

Enrollment closed • Trial completion date • Small for Gestational Age • IGF1

Long-acting PEGylated Recombinant Human Growth Hormone (Jintrolong) in Short Children Born Small for Gestational Age: 4-Year Results from a Multicenter, Randomized, Dose-Response Trial in China (ESPE-ESE 2025) - P2 | "Our 4-year data show that long-term continuous Jintrolong PEG-rhGH treatment at an initial dose of 0.2 mg/kg/week, up to a maximum of 0.4 mg/kg/week in short children born SGA results in a normalization of height during childhood followed by growth along the target height SDS."

Clinical • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Small for Gestational Age • IGF1

The Effects of Long-acting PEGylated Recombinant Human Growth Hormone (Jintrolong) on Body Composition and Bone Mass in Transitional Growth Hormone Deficiency (ESPE-ESE 2025) - "Our findings indicate that PEG-rhGH therapy is effective in enhancing lean body mass and reducing body fat percentage. These results suggest that PEG-rhGH, with high adherence, may be beneficial in improving BC and BMD in patients with TGHD."

Dyslipidemia • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Positional isoform analysis of PEGylated biotherapeutic protein using a novel peptide-based reversed-phase liquid chromatography with UV detection. (PubMed, J Pharm Biomed Anal) - "This study developed a reversed-phase ultra-performance liquid chromatography (RP-UPLC) method for the separation and quantification of positional isoforms in commercial PEGylated recombinant human growth hormone (PEG-rhGH) at the peptide level...As a result, it offers improved robustness and accuracy. Furthermore, the proposed RP-UPLC method exhibited outstanding repeatability across various storage conditions, making it a reliable tool for quality control and product release in the biopharmaceutical industry."

Journal

A Bioequivalence Study of Two Different PEG-rhGH Preparations (clinicaltrials.gov) - P1 | N=87 | Active, not recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Bioavailability Study of Two Different PEG-rhGH Preparations. (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Mar 2025

Trial completion • Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations (clinicaltrials.gov) - P1 | N=87 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Bioequivalence Study of Two Different PEG-rhGH Preparations (clinicaltrials.gov) - P1 | N=87 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

Real world study of PEG-rhGH treatment for growth hormone deficiency patients in Western China (ChiCTR) - P4 | N=1000 | Sponsor: Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China; Chengdu Women's and Chi

New P4 trial • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Real-world Study of Long-acting Growth Hormone Injection for Turner Syndrome (clinicaltrials.gov) - P=N/A | N=743 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New trial • Real-world • Real-world evidence • Genetic Disorders • Turners Syndrome

A Bioequivalence Study of Two Different PEG-rhGH Preparations. (clinicaltrials.gov) - P1 | N=87 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ Aug 2024

Trial completion • Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Study on the Efficacy and Safety of Pegylated Recombinant Human Growth Hormone (Jintrolong®) in Children with Idiopathic Short Stature (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: Children's Hospital,Zhejiang University School of Medicine; Children's Hospital,Zhejiang University School of Medicine

New P4 trial • Idiopathic Short Stature

Effect of long-acting PEGylated growth hormone for catch-up growth in children with idiopathic short stature: a 2-year real-world retrospective cohort study. (PubMed, Eur J Pediatr) - "PEG-rhGH demonstrated superior effectiveness and adherence compared to daily rhGH in the treatment of children with ISS. The safety profiles were similar between the two treatments."

Journal • Real-world • Real-world evidence • Retrospective data • Idiopathic Short Stature

A Bioavailability Study of Two Different PEG-rhGH Preparations. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Bioequivalence Study of Two Different PEG-rhGH Preparations. (clinicaltrials.gov) - P1 | N=87 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

ESCALATE: A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P3 trial • Endocrine Disorders • Growth Hormone Deficiency

ELEVATE: A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=162 | Not yet recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Head-to-Head • New P3 trial • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: GeneScience Pharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Jun 2030 | Trial primary completion date: Dec 2022 ➔ Jun 2030

Enrollment closed • Trial completion date • Trial primary completion date • Endocrine Disorders • Idiopathic Short Stature • IGF1

Efficacy, safety, quality of life, adherence and cost-effectiveness of long-acting growth hormone replacement therapy compared to daily growth hormone in children with growth hormone deficiency: a systematic review and meta-analysis. (PubMed, Pharmacol Res) - "Pooled mean differences of mean annualized height velocity (cm/year) showed no difference between LAGH and daily GH: Eutropin Plus® vs Eutropin® [-0.14 (-0.43, 0.15)], Eutropin Plus® vs Genotropin® [-0.74 (-1.83, 0.34)], Jintrolong® vs Jintropin AQ® [0.05 (-0.54, 0.65)], Somatrogon vs Genotropin® [-1.40 (-2.91, 0.10)], TransCon vs Genotropin® [0.93 (0.26, 1.61)]...Adherence and QoL should be addressed from real-world data studies for both the mid and long term and in a larger population. Cost-effectiveness studies are needed to measure the economic impact of LAGH from the healthcare payer's perspective."

Adherence • Cost effectiveness • HEOR • Journal • Retrospective data • Review • Endocrine Disorders • Growth Hormone Deficiency

A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants (clinicaltrials.gov) - P4 | N=138 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world • Real-world evidence • CNS Disorders • Developmental Disorders • Psychiatry • Small for Gestational Age

Long-acting PEGylated growth hormone in children with idiopathic short stature: time to reconsider our diagnostic and treatment policy? (PubMed, Eur J Endocrinol) - "In this commentary, we discuss whether the recent data on genetic causes of short stature in children who initially were labelled ISS, and data on the long-term safety of daily rhGH, may influence the balance between risks and benefits of rhGH treatment in children with ISS. We further discuss the pharmacokinetic and -dynamic profile of PEG-rhGH and its potential consequences for long-term safety."

Journal • Idiopathic Short Stature • Pediatrics