Somatropin (genetical recombination)(JCR)(Somatropin (genetical recombination)(JCR)) - 药物靶点：GHR_在研适应症：矮身材同源框基因缺乏症，侏儒症，小于胎龄儿_专利_临床

概要

基本信息

药物类型

激素

别名

rhGH、遺伝子組換えヒト成長ホルモン

+ [4]

靶点

GHR

作用方式

激动剂

作用机制

GHR激动剂(生长激素受体激动剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [4]

在研适应症

矮身材同源框基因缺乏症侏儒症小于胎龄儿+ [2]

非在研适应症-

原研机构

JCR Pharmaceuticals Co., Ltd.

在研机构

JCR Pharmaceuticals Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

9

项与 Somatropin (genetical recombination)(JCR) 相关的临床试验

ChiCTR2400093110

/ SuspendedN/AIIT

Evaluation of the efficacy of GnRHa combined with PEG-rhGH / rhGH in the treatment of idiopathic central precocious puberty and fast progressive pubertal girls' height

开始日期2024-12-01

申办/合作机构-

ChiCTR2000035769

/ Suspended早期临床1期IIT

Study on the clinical effect of Zhibai Fuxia decoction combined with rhGH on prediction of adult height in children with precocious puberty

开始日期2021-01-01

申办/合作机构-

JPRN-jRCT2031200425

/ Not yet recruitingN/AIIT

An extention study of JR-401 in short stature patients with SHOX deficiency

开始日期2020-09-02

申办/合作机构-

100 项与 Somatropin (genetical recombination)(JCR) 相关的临床结果

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100 项与 Somatropin (genetical recombination)(JCR) 相关的转化医学

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100 项与 Somatropin (genetical recombination)(JCR) 相关的专利（医药）

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35

项与 Somatropin (genetical recombination)(JCR) 相关的文献（医药）

2021-08-01·Endocrine Connections3区 · 医学

Mapping the journey of transition: a single-center study of 170 childhood-onset GH deficiency patients

3区 · 医学

ArticleOA

作者: Stanimirovic, Aleksandar ; Djukic, Aleksandar ; Savic, Dragan ; Miljic, Dragana ; Vukovic, Rade ; Todorovic, Sladjana ; Soldatovic, Ivan ; Petakov, Milan ; Milenkovic, Tatjana ; Grujicic, Danica ; Stojanovic, Marko ; Manojlovic-Gacic, Emilija ; Pekic, Sandra ; Milicevic, Mihajlo ; Jesic, Maja ; Zdravkovic, Vera ; Doknic, Mirjana ; Mitrovic, Katarina ; Bogosavljevic, Vojislav

ObjectiveTo analyze metabolic parameters, body composition (BC), and bone mineral density (BMD) in childhood-onset GH deficiency (COGHD) patients during the transition period (TP).DesignSingle- center, retrospective study was performed on 170 consecutive COGHD patients (age 19.2 ± 2.0 years, range 16–25) transferred after growth completion from two pediatric clinics to the adult endocrine unit. Two separate analyses were performed: (i) cross-sectional analysis of hormonal status, metabolic parameters, BC, and BMD at first evaluation after transfer from pediatrics to the adult department; (ii) longitudinal analysis of BC and BMD dynamics after 3 years of GH replacement therapy (rhGH) in TP.ResultsCOGHD was of a congenital cause (CONG) in 50.6% subjects, tumor-related (TUMC) in 23.5%, and idiopathic (IDOP) in 25.9%. TUMC patients had increased insulin and lipids levels (P < 0.01) and lower Z score at L-spine (P < 0.05) compared to CONG and IDOP groups. Patients treated with rhGH in childhood demonstrated lower fat mass and increased BMD compared to the rhGH-untreated group (P < 0.01). Three years of rhGH after growth completion resulted in a significant increase in lean body mass (12.1%) and BMD at L-spine (6.9%), parallel with a decrease in FM (5.2%).ConclusionThe effect of rhGH in childhood is invaluable for metabolic status, BC, and BMD in transition to adulthood. Tumor-related COGHD subjects are at higher risk for metabolic abnormalities, alteration of body composition, and decreased BMD, compared to those with COGHD of other causes. Continuation of rhGH in transition is important for improving BC and BMD in patients with persistent COGHD.

2021-01-01·Clinical Pediatric Endocrinology

Newly formulated GROWJECT<sup>®</sup> is bioequivalent to the prior GROWJECT<sup>®</sup> formulation and causes less injection-associated pain

Article

作者: Namba, Noriyuki ; Yasukawa, Hidehito ; Mita, Yoko ; Owada, Yasuko ; Yamaoka, Mariko ; Hanada, Takashi ; Asano, Yuuka

Daily treatment with subcutaneous injections of recombinant human GH can be physically and emotionally stressful for children and their caregivers owing to the pain caused by injection. In this study, 52 healthy male subjects were randomized to investigate the bioequivalence and compare the safety and injection-associated pain between the prior GROWJECT^® sc formulation and the new formulation, which contains less phosphate buffer. Single subcutaneous doses of each formulation were administered in a crossover manner. Adverse events were monitored throughout the study and subjects rated injection site pain on a 5-point scale. The 90% confidence intervals of the geometric least square means ratio for the area under the human GH concentration-time curve from 0 to 24 h and maximum concentration were 1.002-1.049 and 0.971-1.075 following 6 mg and 0.992-1.038 and 0.973-1.058 following 12 mg, respectively. No severe adverse events were observed. The mean pain score was significantly higher (i.e., less painful) with the new formulation than with the prior formulation regardless of the order of treatment. The new GROWJECT^® sc formulation was bioequivalent to the prior formulation and associated with less injection site pain.

2017-04-01·American Journal of Physiology-Regulatory, Integrative and Comparative Physiology2区 · 医学

Oxygen-sensitive regulation and neuroprotective effects of growth hormone-dependent growth factors during early postnatal development

2区 · 医学

Article

作者: Doerr, Helmuth-Guenther ; Jung, Susan ; Trollmann, Regina ; Boie, Gudrun

Perinatal hypoxia severely disrupts metabolic and somatotrophic development, as well as cerebral maturational programs. Hypoxia-inducible transcription factors (HIFs) represent the most important endogenous adaptive mechanisms to hypoxia, activating a broad spectrum of growth factors that contribute to cell survival and energy homeostasis. To analyze effects of systemic hypoxia and growth hormone (GH) therapy (rhGH) on HIF-dependent growth factors during early postnatal development, we compared protein (using ELISA) and mRNA (using quantitative RT PCR) levels of growth factors in plasma and brain between normoxic and hypoxic mice (8% O2, 6 h; postnatal day 7, P7) at P14. Exposure to hypoxia led to reduced body weight ( P < 0.001) and length ( P < 0.04) compared with controls and was associated with significantly reduced plasma levels of mouse GH ( P < 0.01) and IGF-1 ( P < 0.01). RhGH abrogated these hypoxia-induced changes of the GH/IGF-1 axis associated with normalization of weight and length gain until P14 compared with controls. In addition, rhGH treatment increased cerebral IGF-1, IGF-2, IGFBP-2, and erythropoietin mRNA levels, resulting in significantly reduced apoptotic cell death in the hypoxic, developing mouse brain. These data indicate that rhGH may functionally restore hypoxia-induced systemic dysregulation of the GH/IGF-1 axis and induce upregulation of neuroprotective, HIF-dependent growth factors in the hypoxic developing brain.

1

项与 Somatropin (genetical recombination)(JCR) 相关的新闻（医药）

2024-12-20

·PipelineReview

JCR Pharmaceuticals Initiates Phase III Clinical Trial of JR-142 in Japan, a Long-Acting Growth Hormone Therapy

HYOGO, Japan I December 20, 2024 I JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”) today announced that the first patient has been dosed in the Phase III clinical trial of JR-142 (INN: redalsomatropin alfa) in Japan, marking a significant milestone in the development of this innovative treatment. JR-142 is a long-acting growth hormone therapy and is being studied in patients with pediatric growth hormone deficiency. The trial involves 54 pediatric patients and will compare the efficacy of JR-142 to JCR’s existing product, Growject ® . Patients will receive treatment over a 52-week period, with growth outcomes serving as the primary measure of success. Detailed trial information is available through Japan Register of Clinical Trials ( jRCT2031240282 ). “I am thrilled to see progress in the development of treatments for pediatric patients,” said Professor Noriyuki Namba, Division of Pediatrics and Perinatology at Tottori University Faculty of Medicine, and the Medical Expert of the study. “Growth hormone therapy typically requires daily injections, but JR-142, as a long-acting therapy, offers the possibility of once-weekly dosing. This advancement has the potential to significantly ease the burden on children and their families, improving both convenience and quality of care while maintaining high safety standards.” JCR remains committed to the growth hormone field by ensuring a stable supply of high-quality pharmaceuticals and expanding treatment options to meet diverse patient needs. About Growject ® Growject ® is an injectable preparation containing recombinant human growth hormone, first launched in Japan by JCR in 1995. The dosage is administered subcutaneously 6–7 times per week, adjusted according to the indicated condition. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceuticals company that is expanding possibilities for people with rare and genetic diseases worldwide. We continue to build upon our 49-year legacy in Japan while expanding our global footprint into the US, Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. JCR strives to expand the possibilities for patients while accelerating medical advancement at a global level. Our core values – reliability, confidence, and belief – benefit all our stakeholders, including patients, partners, and employees. For more information, please visit https://www.jcrpharm.co.jp/en/site/en/ . SOURCE: JCR Pharmaceuticals

临床3期临床2期

100 项与 Somatropin (genetical recombination)(JCR) 相关的药物交易

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外链

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研发状态

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适应症	国家/地区	公司	日期
矮身材同源框基因缺乏症	日本	JCR Pharmaceuticals Co., Ltd.	2023-06-26
侏儒症	日本	JCR Pharmaceuticals Co., Ltd.	2016-08-08
小于胎龄儿	日本	JCR Pharmaceuticals Co., Ltd.	2012-08-24
生长激素缺乏症	日本	JCR Pharmaceuticals Co., Ltd.	2009-07-07
特纳综合症	日本	JCR Pharmaceuticals Co., Ltd.	1999-12-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESPE2023	N/A	生长激素缺乏症 insulin-like growth factor 1 (IGF-1)	319	rhGH	構夢鏇鑰顧範鏇範淵積(製觸淵遞製膚觸襯憲齋) = 糧醖顧醖鹽蓋構淵夢壓餘齋鏇積鹽鬱鏇窪壓顧 (齋獵鏇獵醖鑰膚膚衊構 )	-	2023-09-21
ESPE2023	N/A	慢性肾病	87	Patients treated with rhGH	(壓醖顧鏇艱築艱築鑰遞) = 壓衊廠鹽獵願襯膚醖遞觸構獵製積夢窪繭鏇憲 (製壓鑰築鑰構積鑰製窪 ) 更多	积极	2023-09-21
				rhGH	(壓醖顧鏇艱築艱築鑰遞) = 觸遞壓築膚範繭窪選遞觸構獵製積夢窪繭鏇憲 (製壓鑰築鑰構積鑰製窪 ) 更多
ESPE2023	N/A	性早熟	55	GnRHa alone	(積鏇觸蓋鬱淵蓋築網醖) = no obvious adverse effects occured 鏇繭淵鏇遞醖廠鹽蓋鬱 (繭壓襯製鹽廠廠製網蓋 )	-	2023-09-21
				GnRHa+rhGH
PSAT108 (ENDO2022)	N/A	侏儒症	40	Prepubertal boys with significant short stature receiving rhGH	齋製壓選構糧窪構憲齋(廠糧鹽範憲廠選範齋獵) = 繭繭簾窪網窪鏇構膚窪獵製鏇製願顧鬱鏇淵廠 (夢範淵齋窪膚鬱糧獵鹹 ) 更多	积极	2022-11-01
				recombinant human growth hormone (Age-matched healthy controls growing normally)	齋製壓選構糧窪構憲齋(廠糧鹽範憲廠選範齋獵) = 選齋觸餘觸願網膚願鑰獵製鏇製願顧鬱鏇淵廠 (夢範淵齋窪膚鬱糧獵鹹 ) 更多
ESPE2022	N/A	小于胎龄儿	-	rhGH	(鬱鏇鬱觸壓網製廠鹹鬱) = 鏇憲鏇築鑰願鹹糧構廠鹽衊網網鏇窪構願鹽蓋 (網顧製願衊醖夢網餘憲, 0.8) 更多	不佳	2022-09-15
				rhGH	(鬱鏇鬱觸壓網製廠鹹鬱) = 築獵顧窪壓範醖製衊窪鹽衊網網鏇窪構願鹽蓋 (網顧製願衊醖夢網餘憲, 1.22)
ESPE2019	N/A	-	-	rhGH	網願廠繭壓鏇淵築蓋範(艱獵製廠淵壓艱築鑰廠) = During the treatment of combination group 3 boys suffered fractures, ultrasound bone density scan showed serious shortage of bone mineral density, after supplemental calcium and calcitriol, bone density increased within 3 to 6 months, no recurrence of fracture 襯憲鑰壓願窪蓋夢鏇觸 (蓋獵範願遞蓋繭淵夢鏇 )	积极	2019-09-19
				GnRHa+rhGH
Pfizer International Growth Database (ESPE2016)	N/A	努南综合征 \| 特纳综合症	-	rhGH	夢網鏇鹹觸膚觸鏇淵觸(積襯築餘鬱鏇製襯範艱) = 網構鬱醖鏇網遞醖鑰積願壓鹽膚選構鑰構鹽鹽 (鏇觸範糧繭夢鏇餘襯糧 )	-	2016-09-10
				rhGH	夢網鏇鹹觸膚觸鏇淵觸(積襯築餘鬱鏇製襯範艱) = 顧遞醖築窪夢願鬱鬱顧願壓鹽膚選構鑰構鹽鹽 (鏇觸範糧繭夢鏇餘襯糧 )
ESPE2016	N/A	垂体性侏儒症	-	rhGH alone	醖網願襯範鏇積觸選鹽(簾糧廠網顧憲範廠構繭) = 廠淵築網衊鏇鑰鹽鑰鹽獵糧鹽窪壓膚鏇餘繭構 (衊遞築願膚齋構衊觸鹹, 3.11)	-	2016-09-10
				rhGH and GnRHan	醖網願襯範鏇積觸選鹽(簾糧廠網顧憲範廠構繭) = 鏇願夢願鏇淵蓋夢餘糧獵糧鹽窪壓膚鏇餘繭構 (衊遞築願膚齋構衊觸鹹, 4.76)
ESPE2015	N/A	肾性尿崩症	-	rhGH treatment	蓋鹹衊餘鹽鏇窪醖淵願(觸鹹憲範膚艱襯鹽鹹網) = 構繭鹽製鏇糧餘繭鹹窪選膚選製廠構鑰壓選齋 (蓋範顧選醖窪夢壓鑰鏇 ) 更多	-	2015-10-01
ESPE2015	N/A	侏儒症 IGF1R gene mutations \| E1013E \| IVS (+72) A/G ... 更多	69	RHGH	淵構遞積繭廠蓋鑰鹹餘(齋網膚鏇觸遞夢鬱糧壓) = 齋鏇顧顧廠顧齋衊鑰範鬱選夢餘顧網鏇網鏇餘 (憲觸築鹹鬱範襯範醖獵 )	积极	2015-10-01