Growth hormones (Human)

Modality

Growth Hormone (GH)

Human growth hormone (hGH) serves as a major part in the modulation of cell metabolism, body growth, and circadian rhythm. Possessing 109 amino acids, the peptide hormone is secreted by the hypothalamus anterior pituitary gland. hGH is regulated by the GH-releasing factor or somatorelin (stimulatory peptide) and the GH-release inhibiting hormone or somatostatin (inhibitory peptide). GH also has biological effects such as stimulation of protein synthesis, anti-insulin, lipolytic effects, increase of bones, cartilage, and muscle growth, and improvement of renal function.

Therapeutic use of Growth Hormone (GH)

The therapeutic use of GH began in the 1950s when the hormone was obtained directly from the human body, but its safety and availability were concerned. In the 1980s, recombinant Human GH (Somatropin, Nutropin) was first produced in Escherichia coli using recombinant DNA technology.

Clinically approved recombinant hGH is commonly used to treat children’s short stature led by a range of conditions such as GH deficiency, Prader-Willi syndrome, Turner syndrome, homeobox-containing gene deﬁciency, or idiopathic. Moreover, GH has been used to treat developmental delays in children with chronic renal failure and children who are small for gestational age, to regulate metabolism in short bowel syndrome, to treat cachexia caused by acquired immunodeficiency syndrome (AIDS), and as replacement therapy for adults with GH deficiency.

New Growth Hormone Formulations

New formulations of recombinant hGH have focused on extending the half-life of the drug and reducing the doses of administrations required from once daily to once weekly or once monthly. New hGH formulations like PEGlyation, albumin-fusion, and/or mutation/variant (Pegvisomant, Lonapegsomatropin, Somapacitan) have been available on the market. Some others are currently in clinical trials contain: TransCon, a prodrug containing ligand-bound GH, administered weekly in Phase II (adults) and Phase III (children); MOD-4023, a carboxy-terminal peptide-modified GH, administered once weekly in Phase III (adults); GX-H9 (hybrid Fc-fused to GH) and Somapacitan (albumin-bound GH) were administered twice-monthly in Phase II (adults and children) and weekly in Phase III (adults) respectively.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Growth Hormone

Approved Recombinant Growth Hormone (GH)

Generic name	Brand Name/Alternative name	Expression System	Indication	Originator/Manufacture	R&D stage
Somatropin	CRESCORMON, SMP 140, Nutropin, Nutropin Aq, rhGH	Escherichia coli (E. coli)	Turner Syndrome, Idiopathic Short Stature, Growth Retardation, Growth Hormone Deficiency	Genentech, Inc., Ipsen Pharma GmbH	Approval
Pegvisomant	Somavent, SOMAVERT, Trovert, ソマバート, B2036-PEG, G120K-PEG	E. coli	Acromegaly, Pituitary Disease	Pfizer Inc., Pfizer Europe MA EEIG, Pharmacia & Upjohn LLC	Approval
Lonapegsomatropin-tcgd	Skytrofa, ACP 001, TransCon PEG hGH, TransCon PEG somatropin	E. coli	Growth Hormone Deficiency, Hormone Deficiency Disorders, Deficiency Disorders, Pituitary Dwarfism, Pituitary Diseases	Ascendis Pharma A/S, Weisheng Pharmaceutical (Shanghai) Co., Ltd., Ascendis Pharma Endocrinology Division A/S	Approval
Somapacitan-beco	Sogroya, ソグルーヤ, 8FOJ430U94 (UNII code), NN 8640, NNC-0195-0092, Albumin-binding somatropin, Somatropin derivative	E. coli	Growth hormone deficiency, Growth retardation, Dwarfism, Endocrine bone disorders, Pituitary dwarfism	Novo Nordisk A/S, Novo Nordisk Pharma Ltd., Novo Nordisk Pharmaceuticals Pty Ltd., Novo Nordisk, Inc.	Approval
Somatrogon	Ngenla, エヌジェンラ, MOD-401, PF-06836922, hGH-CTP, Human growth hormone-CTP, Lagova	CHO cells	Pituitary dwarfism, Growth hormone deficiency, Growth disorders	OPKO Health, Inc., Pfizer Inc., Pfizer Europe MA EEIG, Pfizer Australia Pty Ltd., Pfizer Japan, Inc.	Approval
Somatropin	诺泽, 诺浩, Norditropin, Norditropin FlexPro, ノルディトロピンフレックスプロ, ノルディトロピン, B-hGH, NN-1610, NNLiquid-1516	E. coli	Growth retardation, Growth disorders, Growth hormone deficiency, Dwarfism, Pituitary dwarfism	Novo Nordisk A/S, Novo Nordisk, Inc., Novo Nordisk Pharma Ltd.	Approval
Somatropin	Humatrope, ヒューマトロープ, LY 137998, Hutrope, Somatropin, Umatrope	E. coli	Leri-Weil syndrome, Pituitary dwarfism, Dwarfism, Growth retardation, Growth hormone deficiency, Idiopathic dwarfism, Turner syndrome	Eli Lilly & Co., Eli Lilly Japan KK	Approval
Somatropin	Omnitrope, PrOmnitrope, somatropin	E. coli	Idiopathic dwarfism, Growth retardation, Growth hormone deficiency, Pituitary dwarfism, Prader-Willi syndrome, Turner syndrome	Sandoz, Inc., Clariant AG, Sandoz GmbH	Approval
Somatropin	健豪宁, Genotropin, ジェノトロピン, PN 180307, SM-9500, Genotonorm, Genotropin MiniQuick	E. coli	Idiopathic short stature, Turner syndrome, Prader-Willi syndrome, Small for gestational age, Growth retardation, Growth hormone deficiency, Dwarfism, Pituitary dwarfism	Pfizer Inc., Pharmacia & Upjohn LLC, Pfizer Japan, Inc.	Approval
Somatropin	BIO-TROPIN, Cryotropin, SciTropin, Tev-Tropin, Zomacton, JR-401A, JR-401S, JR-401X, Somatropin (Horizon Pharma/Ferring)	E. coli	Growth retardation, Growth hormone deficiency	Ferring Pharmaceuticals, Inc.	Approval
Somatropin	思真, Serostim LQ, SJ 0011, SJ-0011, Saizen, Serostim, Zorbtive	Mammalian cell line	Short bowel syndrome, Growth hormone deficiency, HIV infection	EMD Serono, Inc., Merck Serono SA	Approval
Recombinant Somatropin	健豪	Pending update	growth hormone deficiency	Vetter Pharma-Fertigung GmbH & Co. KG	Approval
Recombinant human growth hormone	赛高路, Sai Gao Lu	E. coli	growth hormone deficiency	Shenzhen Kexing Bioengineering Co., Ltd.	Approval
Somatropin biosimilar	安苏萌	E. coli	Noonan syndrome, Burns, Growth hormone deficiency, Idiopathic short stature	Anhui Anke Bioengineering (Group) Co., Ltd.	Approval
Recombinant human growth hormone	赛增, Jintropin, Jintropin AQ	E. coli	Autosomal idiopathic short stature, Noonan syndrome, Burns, Growth disorders, Growth hormone deficiency, Prader-Willi syndrome, Idiopathic short stature, Dwarfism, Disorders of prematurity	Changchun Jinsai Pharmaceutical Co., Ltd.	Approval
Somatropin biosimilar	DA-3002, Growtropin, Growtropin II, Growtropin-AQ, hGH-Dong-A	Pending update	dwarfism, idiopathic short stature	Dong-A ST Co., Ltd.	Approval
Somatropin biosimilar	Somatogen-L	Pending update	growth hormone deficiency	Teva Pharmaceutical Industries Ltd.	Approval
Somatropin biosimilar	Pending update	Pending update	growth hormone deficiency	AMEGA Biotech	Approval
Somatropin biosimilar	Pending update	Pending update	Growth hormone deficiency, Turner syndrome	Sedico BV	Approval
Somatropin biosimilar	Pending update	Pending update	growth hormone deficiency	Union Square Ventures LLC	Approval
Recombinant human growth hormone	Pending update	Pending update	growth hormone deficiency	BioGeneric Pharma SAE	Approval
Somatropin biosimilar	Biotropin	Pending update	growth hormone deficiency	Laboratorios Chalver de Colombia SA	Approval
Somatropin biosimilar	Care Tropin, Caretropin, Somatropin	Pending update	growth hormone deficiency	Daewoong Pharmaceutical Co., Ltd.	Approval
Somatropin biosimilar	Rastan	Pending update	growth hormone deficiency	Cjsc Generium	Approval
Somatropin Recombinant	LB-03002, Declage, Eutrophine, Eutropin, Eutropin Plus, rhGH, SR-rhGH, SR-rhGH (BioPartners GmbH), Valtropin	Pending update	growth hormone deficiency	LG Chem Ltd.	Approval
Human Growth Hormone	海之元, Sinotropin,	Pending update	Growth disorders, Growth hormone deficiency	Zhongshan Sinobioway Hygene Biomedicine	Approval
Recombinant human growth hormone(Shanghai United Cell Biotechnology)重组人生长激素 (上海联合赛尔)	珍怡, Genheal	Pending update	Growth failure	Shanghai Liansaier Bioengineering Co., Ltd.	Approval
Somatropin biosimilar	Pending update	Pending update	Growth failure	Anhui Anke Bioengineering (Group) Co., Ltd.	Approval
Somatropin (genetical recombination)	Growject, グロウジェクト, JR-401-Liq, JR8810, 遺伝子組換えヒト成長ホルモン, rhGH	Pending update	growth hormone deficiency	JCR Pharmaceuticals Co., Ltd. (JCR Pharmaceuticals Co., Ltd.)	Approval
Recombinant human somatropin	Novell-Eutropin	Pending update	Dwarfism, Growth hormone deficiency, Turner syndrome	PT Novell Pharmaceutical Laboratories	Approval
Human growth hormone	Pending update	Pending update	Growth Hormone Deficiency, Heart Failure	Università degli Studi di Napoli Federico II	Phase III
Somatropin biosimilar	Pending update	Pending update	growth hormone deficiency	ATG ( Arya TinaGene) Biopharmaceutical	Phase III
Somatropin	biosynthetic growth hormone, MAXOMAT	Pending update	growth hormone deficiency	Sanofi-Aventis U.S. LLC	Phase III
Somatropin	ALT P1, CJ-40002, hGH-NexP, Recombinant human growth hormone, Somatropin	Pending update	growth hormone deficiency	Alteogen, Inc., HK inno.N Corp.	Phase II
Somatropin	Pending update	Pending update	anterior cruciate ligament injury	University of Michigan College of Engineering	Phase II
Recombinant somatropin	JHM 01, JHM-01, JHM01, TB 03, TB-03, TB03	Pending update	growth hormone deficiency	JHM Biopharm (Hangzhou) Co., Ltd.	Phase I
Somatropin biosimilar	Recombinant somatropin, Somatropin biosimilar	Pending update	-	Bio-Ker s.r.l.	Phase I
Somatropin biosimilar	R-TPR-007, r-hGH, SomatoRel, Somatropin biosimilar	Pending update	growth hormone deficiency	Reliance Life Sciences Pvt Ltd.	clinical trial
Somatropin polysialic	SYN-20100504RU, Polysialic somatropin, Somatropin polysialic	Pending update	growth hormone deficiency	SynBio LLC, Xenetic Biosciences, Inc.	clinical trial
Polyethylene glycol recombinant human somatropin	金赛增, GenSci-004, NNC126-0083, Jintropin, Jintropin AQ, PEG-rhGH, PEG-somatropin, Somatropin pegylated	Pending update	Growth disorders, Growth hormone deficiency, Turner syndrome, Idiopathic short stature, Dwarfism	Changchun Jinsai Pharmaceutical Co., Ltd.	Approval
Erythropoietin	Erythropoietin (Y-shaped pegylation), YPEG-EPO, YPEG-rhEPO	Pending update	Anemia, Renal insufficiency, Anemia associated with chronic kidney disease	Xiamen Tebao Bioengineering Co., Ltd., Xiamen Bosai Gene Transcription Technology Co., Ltd.	Phase II
Eftansomatropin alfa	GX-H9, HL 2356, HL-2356, TJ 101, hGH-hyFc, HyTropin, Recombinant somatropin fusion protein	Pending update	growth hormone deficiency	Patheon Italia SpA, Handok, Inc., Genexine, Inc., I-Mab Biopharma Hong Kong Ltd.	Phase III
PEGylated recombinant somatropin	PEG-somatropin	Pending update	growth hormone deficiency	Anhui Anke Bioengineering (Group) Co., Ltd.	Phase III
Somavaratan	4Y05SI704S (UNII code), VRS-317, XTEN1-hGH-XTEN2, hGH-rPEG, hGH-XTEN	Pending update	Growth disorders, Growth hormone deficiency	Versartis, Inc.	Phase III
Y-shape pegylated somatropin	益佩生, Somatropin, YPEG-GH, YPEG-rhGH	Pending update	Growth disorders, Growth hormone deficiency	Xiamen Bosai Gene Transcription Technology Co., Ltd., Xiamen Tebao	Phase II/III
TV-1106	Albumin/somatropin fusion protein, Albusomatropin, Albutropin, Somatropin/albumin fusion protein	Pending update	Growth disorders, Growth hormone deficiency	Teva Pharmaceutical Industries Ltd.	Phase III
Recombinant growth hormone-albumin fusion protein	Pending update	Pending update	Growth disorders, Growth hormone deficiency	Zhejiang Younuojin Bioengineering Co., Ltd.	Phase II
Efpegsomatropin	HM-10560A, LAPS-hGH, LAPS-rhGH	Pending update	growth hormone deficiency	Hanmi Pharmaceutical Co., Ltd.	Phase II
Recombinant human growth factor-Fc fusion protein	Pending update	Pending update	growth hormone deficiency	Yifan Pharmaceutical Co., Ltd.	Submit for IND
TBR-065	BIM 23B065, BIM-23B065, BIM23B065, TBR 065	Pending update	acromegaly	Ipsen SA, Tiburio Therapeutics, Inc.	Phase II
AK2017	AK 2017, AK-2017, AK2017	Pending update	Growth Hormone Deficiency, Growth Retardation	Anhui Anke Bioengineering (Group) Co., Ltd.	Phase I
Debio 4127	Debio4127	Pending update	neuroendocrine tumors	Debiopharm Group	Phase I
Debio-4126	Debio 4126, Debio-4126, Debio4126	Pending update	Acromegaly, Neuroendocrine Tumors	Debiopharm International SA	Phase I
F-899	Pending update	Pending update	growth hormone deficiency	Yifan Pharmaceutical Co., Ltd.	Phase I
RT-101	Pending update	Pending update	acromegaly	Rani Therapeutics Holdings, Inc.	Phase I
DP2018	Pending update	Pending update	acromegaly	Dauntless Pharmaceuticals, Inc.	Phase I
Ghrelin/Growth hormone	Pending update	Pending update	sepsis	TheraSource LLC	Phase I
ALTSuLIN	Porcine-derived sertoli cell therapy (ALTuCELL)	Pending update	Laron syndrome	GH Care, Inc.	clinical trial

All Categories

Modality

Growth Hormone (GH)

Therapeutic use of Growth Hormone (GH)

New Growth Hormone Formulations

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for Growth Hormone

Approved Recombinant Growth Hormone (GH)

MICROBIAL CDMO

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