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-

License 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

Growth hormone (GH) is a key polypeptide hormone secreted by somatotroph cells in the anterior pituitary gland, essential for postnatal growth, metabolism, and systemic homeostasis. Its secretion is regulated by hypothalamic neuropeptides, including GH-releasing hormone and somatostatin. GH exerts effects through direct interaction with the growth hormone receptor and indirect pathways mediated by the GH-IGF-I axis. GHR activation triggers signaling pathways, such as JAK-STAT, PI3K/AKT, and MAPK, promoting cellular proliferation, differentiation, and metabolic balance. The GH-IGF-I axis is critical for bone growth, lipid and carbohydrate metabolism, and organ-specific physiological functions. Dysregulation of GH results in diverse disorders. Congenital deficiencies, like isolated GH deficiency and syndromic conditions (e.g., Turner syndrome), stem from genetic mutations. Acquired deficiencies arise from trauma, tumors, infections, or autoimmune damage, while GH overproduction causes gigantism in children and acromegaly in adults, often due to pituitary adenomas. Idiopathic deficiencies, lacking identifiable causes, complicate management further. Advances in therapy have transformed outcomes for GH disorders. Recombinant human growth hormone provides effective replacement therapy for deficiencies. Somatostatin analogs, dopamine receptor agonists, and GH receptor antagonists are pivotal for managing GH excess. Surgical and radiotherapeutic interventions remain essential for pituitary adenomas. However, GH therapy requires close monitoring to prevent side effects like insulin resistance and metabolic complications. This review provides a comprehensive evaluation of the molecular mechanisms underlying GH action, its physiological roles, GH-related disorders, and therapeutic approaches to optimize patient outcomes.

01 Sep 2025·Journal of Pharmaceutical and Biomedical Analysis

Positional isoform analysis of PEGylated biotherapeutic protein using a novel peptide-based reversed-phase liquid chromatography with UV detection

Article

Author: Zhang, Jinliang ; Wang, Min ; Liu, Junnan ; Zhai, Jianping ; Cong, Jielun ; Chen, Yunting ; Jia, Xuejiao ; Wang, Yingwu ; Wang, Jingdi ; Jia, Yujia ; Liu, Hailong

PEGylation, the covalent attachment of poly(ethylene glycol) (PEG) to biomolecules, is a well-established molecular modification strategy that enhances the pharmacological properties of conjugated proteins by improving stability, reducing immunogenicity, extending half-life, and increasing solubility. Despite its benefits, PEGylated proteins are often heterogeneous mixtures containing positional isoforms that are challenging to eliminate and can significantly impact the biological activity of drugs. 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. In this strategy, PEG-rhGH was digested into peptides via trypsin treatment and then separated and quantified using RP-UPLC. Under the chromatography condition optimized from Quality by Design (QbD) principles, this method can effectively distinguish the PEGylated peptides in five isomers. MALDI-TOF MS, SDS-PAGE and Edman degradation indicated that each of these five isomers was conjugated with one 40 kDa branched PEG at a specific lysine residue and the N-terminal. Through the concentration correction of PEGylated peptides varying in sequence lengths, the proportion of five modified sites can be quantified. The comparative assay showed that this strategy effectively addresses the limitations of the commonly used IEC method, especially under challenging conditions like post-translational modifications (e.g., oxidation, deamidation, and cyclization) and conformational changes. 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.

01 Mar 2025·Growth Hormone & IGF Research

Identification and differentiation of somapacitan, a long-acting growth hormone derivative, and recombinant human growth hormone in equine plasma by LC-HRMS for doping control purpose

Article

Author: Saito, Kazunobu ; Hirano-Kodaira, Misato ; Shimizu, Yoshibumi ; Sugai-Bannai, Michiko ; Leung, Gary Ngai-Wa

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.

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	(bsyiphbqqo) = haycmerqyk riqpdshcac (cjglrxucla ) View more	-	21 Sep 2023
PSAT108 (ENDO2022)	Not Applicable	Dwarfism	40	Prepubertal boys with significant short stature receiving rhGH	ccrehptrcs(vdozgtincu) = wspbwzxcnu hirluqzulk (mpnhqfhsdm ) View more	Positive	01 Nov 2022
				recombinant human growth hormone (Age-matched healthy controls growing normally)	ccrehptrcs(vdozgtincu) = iwbhkcuhat hirluqzulk (mpnhqfhsdm ) View more
ESPE2022	Not Applicable	Neurofibromatosis-Noonan Syndrome	1	Recombinant human growth hormone	(bkizfkbnbc) = xcmoylmzet rmiziokhye (msnkhwdzrr )	-	15 Sep 2022
LG Growth Study (ESPE2022)	Not Applicable	Growth Disorders inulin like growth factor-1 (IGF-1)	-	recombinant human growth Hormone	vzkukxxjgt(mpyrnocspo) = wglohdogdd jocohgukge (rysnysqhzu )	-	15 Sep 2022
				recombinant human growth Hormone	vzkukxxjgt(mpyrnocspo) = vkprhipdmc jocohgukge (rysnysqhzu )
IAS2002	Not Applicable	Diabetes Mellitus, Lipoatrophic	12	Recombinant human growth hormone (rhGH)	fpnyefnhji(qvsnwkembo) = miuetdjdml bkrjqudjjr (dbraarvjuw ) View more	-	01 Jan 2002
				Placebo	wmkggwbena(nmbrmpqfnj) = gcljsixswh auymwpkdto (qwlwzchgmi )

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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