pegylated somatropin (Gensci 004) / GeneScience - LARVOL DELTA

Gensci134, A Long-Acting GHR-Agonistic VHH-Fc Fusion Protein, Demonstrates Sustained GH-Mimetic Activity and Enhanced Metabolic and Skeletal Effects in Preclinical Models (ENDO 2026) - "Adult and juvenile animals were treated with GenSci134 and compared with short-acting recombinant human GH (rhGH) and long-acting PEG-rhGH...These results suggest that GenSci134 has the potential to be an optimal therapeutic option for GHD patients. GenSci134 is currently being evaluated for its safety, tolerability, PK/PD profiles, and immunogenicity in healthy adult males via single subcutaneous injection."

Preclinical • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • IGF1 • IGFBP3

Comparative Efficacy and Safety of Jintrolong and Other Long-Acting Growth Hormones for Growth Hormone Deficiency in East Asia: A Systematic Review and Network Meta-Analysis. (PubMed, Endocr Pract) - "Jintrolong® showed more favorable growth responses in 52 weeks compared with other LAGHs and daily GH without increasing safety risks."

Journal • Retrospective data • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Efficacy and Safety of PEGylated Recombinant Human Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature: A Real-World Cohort Study. (PubMed, Int J Endocrinol) - "However, children with ISS required a longer duration to achieve catch-up growth to normal height, potentially due to reduced GH sensitivity and a need for higher dosing. PEG-rhGH was well tolerated, with a favorable safety profile in both cohorts."

Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Idiopathic Short Stature • IGF1

A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P2 trial • Small for Gestational Age

Efficacy And Safety Of Weekly PEGylated Recombinant Human Growth Hormone (Jintrolong) In Prepubertal Children With Turner Syndrome: 3-year Results From A Multicenter, Randomized Study In China (ENDO 2025) - P2 | "Objective: To evaluate the efficacy and safety of weekly PEGylated recombinant human growth hormone (PEG-rhGH, Jintrolong) over 3-year in prepubertal children with Turner Syndrome (TS). This multicenter, randomized, negative-controlled phase 2 study (NCT03189160) included a 52-week main phase followed by an ongoing open-label extension... Weekly Jintrolong at 0.1 to 0.4 mg/kg/week provided sustained and clinically meaningful growth improvements over 3 years in girls with TS. Most patients required dose escalation after the first year to achieve optimal growth velocity. This dosing range was appropriate for most patients and associated with a favorable long-term safety profile."

Clinical • Late-breaking abstract • Genetic Disorders • Turners Syndrome • IGF1

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

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

Comparison between long-acting pegylated and daily recombinant human growth hormone for pediatric growth hormone deficiency a systematic review. (PubMed, Sci Rep) - "PEG-rhGH showed superior efficacy to DGH at 12 months and comparable efficacy at other time points. The safety profiles were similar for the two treatments."

Clinical • Journal • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Phase 1 Study and Population PK/PD Modeling of Long-Acting Growth Hormone, GB08, to Guide Pediatric Dosing. (PubMed, Eur J Endocrinol) - "GB08 provides notable advantages over traditional therapies, like short-acting GH, by enhancing treatment adherence and offering a potentially safer alternative. The findings from this study will guide dosing strategies for Phase 2 trial in children with GHD."

Clinical • Journal • P1 data • PK/PD data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

Five-year safety and growth response of long-acting PEGylated recombinant human growth hormone in children with growth hormone deficiency-data from CGLS database. (PubMed, Eur J Pediatr) - "CGLS data showed that five-year PEG-rhGH treatment in children with PGHD was associated with a favourable safety profile and sustained height gain."

Journal • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

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