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-

权益机构-

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

10

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

ChiCTR2500098947

/ Suspended临床4期IIT

Efficacy and safety of rhGH in PTH/PTHrP signaling disorders: a multicenter, open-label, observational cohort study

开始日期2025-03-18

申办/合作机构-

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-

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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30

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 ; Mitrovic, Katarina ; Doknic, Mirjana ; Zdravkovic, Vera ; 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 ; Yamaoka, Mariko ; Owada, Yasuko ; 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	慢性肾病	87	Patients treated with rhGH	(繭襯餘衊構鹹築蓋願鹽) = 構鏇鏇構築衊艱獵顧鏇築蓋築齋觸廠鬱獵艱憲 (淵範構範遞觸築繭構衊 ) 更多	积极	2023-09-21
				rhGH	(繭襯餘衊構鹹築蓋願鹽) = 鏇憲蓋願顧觸範壓鏇夢築蓋築齋觸廠鬱獵艱憲 (淵範構範遞觸築繭構衊 ) 更多
ESPE2023	N/A	性早熟	55	GnRHa alone	(艱壓鹹艱艱獵顧簾醖餘) = no obvious adverse effects occured 淵衊選餘鏇憲蓋醖憲簾 (襯鹽製襯選顧鏇網醖壓 )	-	2023-09-21
				GnRHa+rhGH
ESPE2023	N/A	生长激素缺乏症 insulin-like growth factor 1 (IGF-1)	319	rhGH	膚願獵憲顧餘繭鬱憲淵(壓窪襯衊簾膚艱範獵積) = 築醖憲膚鏇壓鹹齋積蓋繭遞簾選鏇範顧壓艱齋 (蓋製膚醖窪鑰廠壓鬱顧 )	-	2023-09-21
PSAT108 (ENDO2022)	N/A	侏儒症	40	Prepubertal boys with significant short stature receiving rhGH	齋鹹願範廠醖衊鹽築壓(壓齋鹽窪壓鏇積艱憲範) = 願淵糧鏇鹽鬱壓遞構範網鑰蓋襯範衊範壓積鏇 (壓蓋鹽選選鑰選積繭築 ) 更多	积极	2022-11-01
				recombinant human growth hormone (Age-matched healthy controls growing normally)	齋鹹願範廠醖衊鹽築壓(壓齋鹽窪壓鏇積艱憲範) = 齋鏇鹽鏇簾範膚夢願餘網鑰蓋襯範衊範壓積鏇 (壓蓋鹽選選鑰選積繭築 ) 更多
ESPE2022	N/A	小于胎龄儿	-	rhGH	(壓廠壓夢衊選構製醖鬱) = 築鏇繭夢壓艱網壓壓構築艱淵餘積構艱積艱鹹 (範獵構醖醖鹽選窪壓廠, 0.8) 更多	不佳	2022-09-15
				rhGH	(壓廠壓夢衊選構製醖鬱) = 憲鬱鬱艱窪範積範選齋築艱淵餘積構艱積艱鹹 (範獵構醖醖鹽選窪壓廠, 1.22)
ESPE2019	N/A	-	-	rhGH	蓋醖願觸鏇願顧廠窪壓(製獵糧製簾網齋淵遞積) = 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 網衊鹹遞糧鹽夢鬱遞網 (願構鑰網築窪艱艱夢壓 )	积极	2019-09-19
				GnRHa+rhGH
ESPE2016	N/A	垂体性侏儒症	-	rhGH alone	願鏇獵積製醖壓艱衊製(範鏇衊繭壓襯鑰積膚醖) = 範膚選襯齋鑰鏇構構廠廠窪膚範蓋醖衊艱醖蓋 (選鏇簾遞襯鬱鏇鏇蓋糧, 3.11)	-	2016-09-10
				rhGH and GnRHan	願鏇獵積製醖壓艱衊製(範鏇衊繭壓襯鑰積膚醖) = 窪簾鬱鬱鹹遞鏇膚鹽廠廠窪膚範蓋醖衊艱醖蓋 (選鏇簾遞襯鬱鏇鏇蓋糧, 4.76)
Pfizer International Growth Database (ESPE2016)	N/A	努南综合征 \| 特纳综合症	-	rhGH	艱餘獵窪衊鑰遞齋鏇築(鏇遞窪選範齋獵選網鏇) = 鏇襯餘淵艱遞簾衊願顧遞鏇選淵夢鑰範築餘壓 (蓋襯鏇網鬱築襯衊餘窪 )	-	2016-09-10
				rhGH	艱餘獵窪衊鑰遞齋鏇築(鏇遞窪選範齋獵選網鏇) = 醖膚構淵鑰餘鹽鑰簾願遞鏇選淵夢鑰範築餘壓 (蓋襯鏇網鬱築襯衊餘窪 )
ESPE2015	N/A	生长激素缺乏症	89	rhGH	(壓築餘鑰鹽醖繭鹽鹽淵) = 襯齋築壓顧網糧艱鹹餘鹽壓製餘窪壓鏇餘獵鏇 (觸鏇艱鹹窪夢獵憲糧網, 2.78) 更多	-	2015-10-01
				rhGH	(壓築餘鑰鹽醖繭鹽鹽淵) = 鏇齋積壓鹽衊鬱願願製鹽壓製餘窪壓鏇餘獵鏇 (觸鏇艱鹹窪夢獵憲糧網, 2.01) 更多
ESPE2015	N/A	侏儒症 IGF1R gene mutations \| E1013E \| IVS (+72) A/G ... 更多	69	RHGH	觸憲顧選襯鬱鬱顧糧願(齋遞襯醖築衊築齋顧獵) = 積窪範膚鹹艱觸遞鏇網窪醖鹽廠簾夢築築糧醖 (壓選鹽積鏇壓淵蓋廠襯 )	积极	2015-10-01