Delving into the Latest Updates on Y-shape pegylated somatropin (Xiamen Amoytop Biotech) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Somatropin(Xiamen Amoytop Biotech Co. Ltd.), YPEG-GH, YPEG-rhGH(Xiamen Amoytop Biotech Co. Ltd.)

+ [3]

Target

GHR

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic DiseaseOther Diseases+ [4]

Active Indication

Growth DisordersGrowth hormone deficiencyDwarfism+ [3]

Inactive Indication-

Originator Organization

Xiamen Amoytop Biotech Co. Ltd.

Active Organization

Xiamen Amoytop Biotech Co. Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 26401985

The sequence is quoted from: *****

1.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂单次皮下注射给药在健康受试者中的相对生物利用度； 2.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂在健康受试者中的药代动力学（PK）特征和免疫原性； 3.评估怡培生长激素注射液 4.0 mg/mL 制剂和 10.0 mg/mL 制剂在健康受试者中的安全性；

[Translation]

1. Evaluate the relative bioavailability of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects after single subcutaneous injection; 2. Evaluate the pharmacokinetic (PK) characteristics and immunogenicity of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects; 3. Evaluate the safety of 4.0 mg/mL and 10.0 mg/mL formulations of Yipei growth hormone injection in healthy subjects;

Start Date27 Sep 2024

Sponsor / Collaborator

Xiamen Amoytop Biotech Co. Ltd.

[+1]

CTR20230176

/ CompletedPhase 1

Y 型 PEG 化重组人生长激素注射液在老年人群中的安全耐受性、药代动力学和药效动力学研究。

[Translation] Study on the safety, tolerability, pharmacokinetics and pharmacodynamics of Y-shaped PEGylated recombinant human growth hormone injection in the elderly population.

探索试验药物（Y 型 PEG 化重组人生长激素注射液，益佩生）在老年人群中的安全耐受性，以及药代动力学和药效动力学特征，为后续临床研究提供依据。

[Translation]

Explore the safety and tolerability of the experimental drug (Y-type PEGylated recombinant human growth hormone injection, Yipeisheng) in the elderly population, as well as its pharmacokinetic and pharmacodynamic characteristics, to provide a basis for subsequent clinical research.

Start Date01 Mar 2023

Sponsor / Collaborator

Xiamen Amoytop Biotech Co. Ltd.

[+1]

CTR20213288

/ CompletedPhase 2

Y型PEG化重组人生长激素注射液治疗儿童矮小症的多中心、随机、开放、阳性对照研究

[Translation] A multicenter, randomized, open, positive-controlled study of Y-shaped PEGylated recombinant human growth hormone injection in the treatment of dwarfism in children

探索益佩生治疗儿童矮小症（特发性矮小症、小于胎龄儿、先天性卵巢发育不良综合征）的药代动力学和药效学的剂量效应关系，为儿童矮小症患者的给药剂量和剂量滴定提供依据。评价益佩生治疗儿童矮小症（特发性矮小症、小于胎龄儿、先天性卵巢发育不良综合征）的安全性耐受性和疗效获益。

[Translation]

To explore the pharmacokinetic and pharmacodynamic dose-effect relationship of Yipeisheng in the treatment of dwarfism in children (idiopathic dwarfism, small for gestational age, congenital ovarian hypoplasia syndrome), and provide a basis for dosing and dose titration in dwarf patients. To evaluate the safety, tolerability and efficacy benefits of Yipeisheng in the treatment of dwarfism in children (idiopathic dwarfism, small for gestational age, congenital ovarian hypoplasia syndrome).

Start Date15 Feb 2022

Sponsor / Collaborator

Xiamen Amoytop Biotech Co. Ltd.

[+1]

100 Clinical Results associated with Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

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100 Translational Medicine associated with Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

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100 Patents (Medical) associated with Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

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19

Literatures (Medical) associated with Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

01 Jun 2009·Archives de PédiatrieQ4 · MEDICINE

L’observance thérapeutique chez les enfants traités par hormone de croissance

Q4 · MEDICINE

Article

Author: Tauber, M

01 Jul 2008·Arquivos Brasileiros de Endocrinologia & Metabologia

Baixa estatura na doença renal crônica: fisiopatologia e tratamento com hormônio de crescimento

Article

Author: Spinola-Castro, Angela Maria ; Belangero, Vera Maria Santoro ; Guerra-Junior, Gil ; Oliveira, Josenilson Campos de ; Siviero-Miachon, Adriana A.

01 Jul 2008·Arquivos Brasileiros de Endocrinologia & Metabologia

Tratamento com hormônio de crescimento em crianças com baixa estatura nascidas pequenas para a idade gestacional

Review

Author: Margaret C. S. Boguszewski ; César Luiz Boguszewski

100 Deals associated with Y-shape pegylated somatropin (Xiamen Amoytop Biotech)

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External Link

KEGG	Wiki	ATC	Drug Bank
D02691	-	H01AC01	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Growth Disorders	NDA/BLA	CN	Xiamen Amoytop Biotech Co. Ltd.	11 Jan 2024
Growth hormone deficiency	NDA/BLA	CN	Xiamen Amoytop Biotech Co. Ltd.	11 Jan 2024
Dwarfism	Phase 2	CN	Xiamen Amoytop Biotech Co. Ltd.	15 Feb 2022
Idiopathic short stature	Phase 2	CN	Xiamen Amoytop Biotech Co. Ltd.	15 Feb 2022
Spastic Paraplegia 20, Autosomal Recessive	Phase 2	CN	Xiamen Amoytop Biotech Co. Ltd.	15 Feb 2022
Turner Syndrome	Phase 2	CN	Xiamen Amoytop Biotech Co. Ltd.	15 Feb 2022