Delving into the Latest Updates on Human Growth Hormone (Anhui Anke) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Somatropin biosimilar (Anhui Anke), 生长激素类似物 (安徽安科), 安苏萌

Target

GHR

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [4]

Active Indication

Idiopathic short statureShort Bowel SyndromeNoonan Syndrome+ [2]

Inactive Indication-

Originator Organization

Anhui Anke Biotechnology (Group) Co., Ltd.

Active Organization

Anhui Anke Biotechnology (Group) Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 1999),

BurnsGrowth hormone deficiency

RegulationPriority Review (CN)

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Gene Sequence

Sequence Code 26401985

The sequence is quoted from: *****

1. To evaluate the effectiveness of recombinant human growth hormone for injection in the treatment of idiopathic dwarfism 2. To evaluate the safety of recombinant human growth hormone for injection in the treatment of idiopathic dwarfism through observation of clinical adverse events and laboratory indicators

Start Date25 Jul 2016

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20160635 / Completed

重组人生长激素注射液与注射用重组人生长激素在中国健康成年志愿者中单次给药的生物等效性研究

[Translation] Bioequivalence study of recombinant human growth hormone injection and recombinant human growth hormone for injection after single administration in healthy adult volunteers in China

评价单次给药后重组人生长激素注射液与安苏萌的主要药代动力学参数Cmax、AUC(0- t)、AUC(0-∞)的生物等效性；评价单次给药后重组人生长激素注射液与安苏萌的其他药代动力学参数的相似性及用药的安全性。

[Translation]

To evaluate the bioequivalence of the main pharmacokinetic parameters Cmax, AUC(0-t), and AUC(0-∞) of recombinant human growth hormone injection and Ansumen after a single dose; to evaluate the similarity of other pharmacokinetic parameters and the safety of recombinant human growth hormone injection and Ansumen after a single dose.

Start Date01 Jun 2016

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

100 Clinical Results associated with Human Growth Hormone (Anhui Anke)

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100 Translational Medicine associated with Human Growth Hormone (Anhui Anke)

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100 Patents (Medical) associated with Human Growth Hormone (Anhui Anke)

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229

Literatures (Medical) associated with Human Growth Hormone (Anhui Anke)

01 Jan 2024·Hormone Research in Paediatrics

Development of a Minimum Dataset for the Monitoring of Recombinant Human Growth Hormone Therapy in Children with Growth Hormone Deficiency: A GloBE-Reg Initiative

Article

Author: Hoffman, Andrew R ; Bryce, Jillian ; Chen, Minglu ; Wajnrajch, Michael ; Chen, Suet Ching ; Sävendahl, Lars ; Ahmed, S Faisal ; Dou, Xinyu ; Hamza, Rasha ; Vitali, Diana ; Jorge, Alexander Augusto de Lima ; Roehrich, Sebastian ; Choi, Jin-Ho ; Horikawa, Reiko ; Johannson, Gudmundur ; Tseretopoulou, Xanthippi ; Miller, Bradley S ; Harvey, Jamie ; Charmandari, Evangelia ; Gong, Chunxiu

Introduction: Although there are some recommendations in the literature on the assessments that should be performed in children on recombinant human growth hormone (rhGH) therapy, the level of consensus on these measurements is not clear. The objective of the current study was to identify the minimum dataset (MDS) that could be measured in a routine clinical setting across the world, aiming to minimise burden on clinicians and improve quality of data collection. Methods: This study was undertaken by the growth hormone (GH) scientific study group in GloBE-Reg, a new project that has developed a common registry platform that can support long-term safety and effectiveness studies of drugs. Twelve clinical experts from 7 international endocrine organisations identified by the GloBE-Reg Steering Committee, 2 patient representatives, and representatives from 2 pharmaceutical companies with previous GH registry expertise collaborated to develop this recommendation. A comprehensive list of data fields routinely collected by each of the clinical and industry experts for children with growth hormone deficiency (GHD) was compiled. Each member was asked to determine the: (1) importance of the data field and (2) ease of data collection. Data fields that achieved 70% consensus in terms of importance qualified for the MDS, provided <50% deemed the item difficult to collect. Results: A total of 246 items were compiled and 27 were removed due to redundancies, with 219 items subjected to the grading system. Of the 219 items, 111 achieved at least 70% consensus as important data to collect when monitoring children with GHD on rhGH treatment. Sixty-nine of the 219 items were deemed easy to collect. Combining the criteria of importance and ease of data collection, 63 met the criteria for the MDS. Several anomalies to the MDS rule were identified and highlighted for discussion, including whether the patients were involved in current or previous clinical trials, need for HbA1c monitoring, other past medical history, and adherence, enabling formulation of the final MDS recommendation of 43 items; 20 to be completed once, 14 every 6 months, and 9 every 12 months. Conclusion: In summary, this exercise performed through the GloBE-Reg initiative provides a recommendation of the MDS requirement, collected through real-world data, for the monitoring of safety and effectiveness of rhGH in children with GHD, both for the current daily preparations and the newer long-acting GH.

01 Sep 2023·Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme

Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in Children Born Small for Gestational Age.

Article

Author: Gong, Chunxiu ; Hu, Yuhua ; Luo, Xiaoping ; Fu, Junfen ; Li, Pin ; Wu, Wei ; Huang, Ke ; Gong, Haihong ; Li, Yuchuan

There is a lack of long-term data on the benefit of growth hormone (GH) treatment in Chinese children born small for gestational age (SGA). This study was conducted to assess the long-term efficacy and safety of GH treatment in children born SGA. One hundred and twenty prepubertal SGA children who did not achieve catch-up growth with height remained less than -2 standard deviations (SD) below gender-specific height were enrolled in this two-year, randomized, dose-comparative study followed by an extension study of up to 10 years. Daily subcutaneous injections of 0.23 mg/kg/week [low-dose (LD) group] or 0.46 mg/kg/week [high-dose (HD) group] somatropin were given for 104 weeks. Dosing in the extension study was≤0.46 mg/kg/week. The main outcome measures were change in height SD score (ΔHT-SDS), height velocity, insulin-like growth factor (IGF)-1, and IGF-1/IGF binding protein-3 (IGFBP-3) molar ratio. ΔHT-SDS at week 104 was 0.91±0.53 and 1.52±0.64 in the LD and HD groups (intergroup p<0.0001), respectively, and continued in an upward trend throughout the extension study, remaining above+2 for those who received treatment for a total of 7 years or more. At week 104, significant improvements were observed in height velocity, IGF-1 SDS, and IGF-1/IGFBP-3 molar ratio. Adult HT-SDS was -0.81±1.68 for boys and -0.82±1.05 for girls (p=0.9837). Glucose metabolism and thyroid function were within the normal reference range throughout treatment. Long-term recombinant human GH treatment was tolerable and effective at improving height in children born SGA.

05 Jul 2023·Children (Basel, Switzerland)

Initial Effect of Recombinant Human Growth Hormone Treatment in a Patient with Löwe Syndrome.

Author: Levkova, Mariya ; Karamfilova, Teodora ; Bliznakova, Dimitrichka ; Iotova, Violeta ; Gaydarova, Mariya ; Galcheva, Sonya

OBJECTIVESLöwe syndrome (the oculocerebrorenal syndrome of Löwe, OCRL, OMIM #309000, ORPHA: 534) is a very rare multisystem X-linked disorder characterized by ocular, kidney and nervous system anomalies.CASE PRESENTATIONWe present the first Bulgarian genetically confirmed patient with OCRL. The patient had facial dysmorphism, cryptorchidism, congenital cataracts, nystagmus, delayed physical and mental development, and poor nutritional status. He had severe rickets, metabolic acidosis, hypokalaemia, hypophosphataemia, and low IGF-1 levels at the age of three, in addition to his developmental delay. The molecular-genetic analysis reported a pathogenic variant c.1124A>G, p.H375R in the OCRL gene. This variant was inherited from the mother, who was a carrier. Following the diagnosis of OCRL, treatment with potassium citrate, phosphate, and calcitriol was initiated, along with an increase in caloric intake. Following general physical and biochemical improvement, therapy with rhGH started 4 years ago, and current results are presented.CONCLUSIONSThe patient with Löwe syndrome who was presented with a 6-year follow-up demonstrates the complexity of rare disease cases and the value of multidisciplinary care together with growth hormone treatment for better results in these patients.

100 Deals associated with Human Growth Hormone (Anhui Anke)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Idiopathic short stature	CN	Anhui Anke Biotechnology (Group) Co., Ltd.	13 Sep 2021
Short Bowel Syndrome	CN	Anhui Anke Biotechnology (Group) Co., Ltd.	05 Feb 2020
Noonan Syndrome	CN	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jun 2019
Burns	CN	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jan 1999
Growth hormone deficiency	CN	Anhui Anke Biotechnology (Group) Co., Ltd.	01 Jan 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2019	Not Applicable	Complication \| Proteinuria \| Hematuria rhGH \| IGF-1	169	Recombinant Human Growth Hormone	(gdfwcjrxzn) = In our study, 19 patients (14.3%) who underwent rhGH therapy showed renal complication such as microscopic hematuria and/or proteinuria. In patients with TS, eight (32.0%) out of 25 patients revealed renal complication. afeqjktxwb (xiemxjtbli )	Negative	19 Sep 2019
				Recombinant Human Growth Hormone