Delving into the Latest Updates on Polyethylene glycol recombinant human somatropin(Changchun Genescience) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

JINTOPIN AQ, Jintrolong, Jintropin

+ [8]

Target

GHR

Action

agonists

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Other DiseasesNervous System DiseasesCardiovascular Diseases+ [4]

Active Indication

Idiopathic short statureGrowth hormone deficiencyTurner Syndrome+ [3]

Inactive Indication-

Originator Organization

Changchun Genescience Pharmaceuticals Co., Ltd.

Active Organization

Changchun Genescience Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (06 Jan 2014),

Growth Disorders

RegulationPriority Review (China)

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Structure/Sequence

Sequence Code 26401985

Somapacitan, a long-acting growth hormone derivative, and recombinant human growth hormone (rhGH) are protein-based drugs generally used to treat growth disorders and GH deficiency in humans. Due to their potential to enhance the horse performance, the use of these drugs is prohibited at-all-times by the International Federation of Horseracing Authorities for horseracing and the Fédération Equestre Internationale for equestrian sports. In this study, we developed a test method for the identification and differentiation of somapacitan and rhGH in equine plasma by using liquid chromatography high-resolution mass spectrometry (LC-HRMS). The method involved C4 solid-phase extraction after ammonium sulfate precipitation, followed by chloroform/methanol precipitation, trypsin digestion, and analysis by LC-HRMS. The discriminative identification of somapacitan and rhGH was successfully achieved through the detection of their respective unique T10 peptide fragments. Noteworthy, the T10 peptide fragment of somapacitan was detected with its side chain structure remaining intact. The limit of identification (confirmation) (LOI) was determined to be 5 ng/mL for somapacitan and 2 ng/mL for rhGH in equine plasma, while the limit of detection (LOD) was 5 ng/mL for somapacitan and 1 ng/mL for rhGH. Furthermore, using the peptide fragments T1, T8, and T9 (which are shared between somapacitan and rhGH), the presence of somapacitan in equine plasma could be confirmed with higher sensitivity, achieving down to LOIs of 2 ng/mL and LODs of 1 ng/mL. The method was validated with respect to specificity, identification capability, robustness, precision, and reproducibility, paving the way for the analysis of post-administration samples from our already planned administration trials and future potential positive cases.

01 Feb 2025·Hormone and Metabolic Research

Improvement of Bone Metabolism in Prepubertal Girls with Turner Syndrome Following Long-term Pegylated Growth Hormone Treatment

Article

Author: Gao, Xinying ; Gong, Chunxiu ; Chen, Jiajia ; Liu, Meijuan ; Peng, Yaguang ; Cao, Bingyan

AbstractThe study aims to assess the improvement in bone metabolism in prepubertal girls with Turner Syndrome (TS) after long-term polyethylene glycol recombinant human Growth Hormone (PEG-rhGH) treatment. A 12-month longitudinal prospective study was conducted with 28 prepubertal girls diagnosed with TS. Participants were divided into two groups: 18 received PEG-rhGH therapy (0.1–0.25 mg/kg/week) and 10 did not. Anthropometric measurements, bone turnover markers (BTMs), and serum levels of IGF-1, calcium, and phosphate were collected at baseline and after 12 months. BTMs included bone alkaline phosphatase (BAP), Type I collagen propeptide (CICP), Type I collagen telopeptide (CTX), and fibroblast growth factor 23 (FGF23). After 12 months of PEG-rhGH therapy, the treatment group showed significant increases in growth velocity (GV) and height standard deviation scores (HtSDS). Serum IGF-1 levels increased rapidly within one month and remained elevated. BTMs indicated enhanced bone formation, significantly increasing BAP and CICP, while CTX levels remained low. FGF23 levels initially rose slightly but declined below baseline by 12 months. Elevated blood phosphate levels were observed. PEG-rhGH therapy in children with TS significantly improves linear growth and enhances bone formation markers, benefiting bone metabolism.

15 Nov 2024·Medicine

A retrospective study of recombinant human growth hormone in the treatment of school-aged pediatric patients with idiopathic short stature

Article

Author: Chen, Yao ; Li, Yun-Hai ; Zhang, Xue-Rong

The present study aims to investigate the clinical efficacy of recombinant human growth hormone (r-hGH) in the treatment of school-age pediatric patients with idiopathic short stature (ISS). Pediatric patients who were diagnosed with ISS and treated with r-hGH at our hospital were enrolled as research subjects. The main outcome indicators included the serum level of insulin-like growth factor-1, insulin-like growth factor binding protein-3, baseline height standard deviation scores, and posttreatment height standard deviation scores and retrospective analysis was performed. This study complies with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. A total of 42 pediatric patients with a diagnosis of ISS were enrolled in the present study (24 males and 18 females). Following treatment, the levels of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 were significantly higher than the baseline level and the difference was statistically significant. The posttreatment height standard deviation scores was significantly higher than the baseline height standard deviation scores and the difference was statistically significant. There were no significant differences between male and female participants in height standard deviation scores, either before or following treatment. This study found that r-hGH therapy may increase height in school-age pediatric patients with ISS and is therefore worthy of clinical application.

100 Deals associated with Polyethylene glycol recombinant human somatropin(Changchun Genescience)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Polyethylene glycol recombinant human somatropin(Changchun Genescience)	H01AC01	DB15112

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Idiopathic short stature	China	Changchun Genescience Pharmaceuticals Co., Ltd.	29 Oct 2024
Growth hormone deficiency	China	Changchun Genescience Pharmaceuticals Co., Ltd.	13 Aug 2024
Turner Syndrome	China	Changchun Genescience Pharmaceuticals Co., Ltd.	13 Aug 2024
Growth Disorders	China	Changchun Genescience Pharmaceuticals Co., Ltd.	06 Jan 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Growth hormone deficiency	Phase 3	-	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Dec 2023
Growth hormone deficiency	Phase 3	United States	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Dec 2023
Dwarfism	Phase 2	China	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Oct 2014
Small-for-dates baby	Phase 2	China	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Dec 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2023	Not Applicable	Dwarfism IGF1R	-	Recombinant human growth hormone treatment	(xjtdvzcdyc) = fvplyxgwsd uvbjzhhcfr (vkaewcgahy ) View more	-	21 Sep 2023
PSAT108 (ENDO2022)	Not Applicable	Dwarfism	40	Prepubertal boys with significant short stature receiving rhGH	wbtjqbccsg(qixjmkqpfh) = pifzwejaid sqglvqhblw (iuagytoidm ) View more	Positive	01 Nov 2022
				recombinant human growth hormone (Age-matched healthy controls growing normally)	wbtjqbccsg(qixjmkqpfh) = xcfvodaciw sqglvqhblw (iuagytoidm ) View more
LG Growth Study (ESPE2022)	Not Applicable	Growth Disorders inulin like growth factor-1 (IGF-1)	-	recombinant human growth Hormone	pdogacdopg(ywpjvowehc) = ihptmqpwyk rjfxkpwayq (rtcysqsnhn )	-	15 Sep 2022
				recombinant human growth Hormone	pdogacdopg(ywpjvowehc) = hhvttjmacb rjfxkpwayq (rtcysqsnhn )
ESPE2022	Not Applicable	Neurofibromatosis-Noonan Syndrome	1	Recombinant human growth hormone	(utjefceoqy) = zjoaibrrwz vlpzgwlpsy (yyfwdpcuvs )	-	15 Sep 2022
IAS2002	Not Applicable	Diabetes Mellitus, Lipoatrophic	12	Recombinant human growth hormone (rhGH)	grbbouunru(rstevbjcvn) = dsznvejlnn jmlngerzsj (ltdmpsmeza ) View more	-	01 Jan 2002
				Placebo	jtmjeddrtz(snanoqztqn) = gmbajmsjdf qurxgkerjq (ruqmkvcbyl )

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