聚乙二醇重组人生长激素 (长春金赛)(Polyethylene glycol recombinant human somatropin(Changchun Genescience)) - 药物靶点：GHR_在研适应症：特发性矮小症，生长激素缺乏症，特纳综合症_专利_临床

概要

基本信息

药物类型

激素

别名

JINTOPIN AQ、Jintrolong、Jintropin

+ [8]

靶点

GHR

作用机制

GHR激动剂(生长激素受体激动剂)

治疗领域

其他疾病神经系统疾病心血管疾病+ [4]

在研适应症

特发性矮小症生长激素缺乏症特纳综合症+ [3]

非在研适应症-

原研机构

长春金赛药业有限责任公司

在研机构

长春金赛药业有限责任公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2014-01-06),

生长障碍

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构/序列

Sequence Code 26401985

关联

52

项与聚乙二醇重组人生长激素 (长春金赛) 相关的临床试验

ChiCTR2400094243

/ SuspendedN/AIIT

The dosage exploration study of PEG-rhGH for treating short stature in prepubertal and pubertal children

开始日期2024-12-31

申办/合作机构-

ChiCTR2400093194

/ Suspended临床4期IIT

Real world study of PEG-rhGH treatment for growth hormone deficiency patients in Western China

开始日期2024-12-01

申办/合作机构-

CTR20241370

/ CompletedN/A

在中国健康成年受试者中皮下注射变更前后聚乙二醇重组人生长激素注射液的随机、开放、单剂量的生物利用度研究

中国健康男性受试者皮下注射4.2 mg 变更前后的聚乙二醇重组人生长激素注射液（PEG-rhGH），评价药代动力学特征和两制剂在人体内的相对生物利用度。

开始日期2024-05-13

申办/合作机构

长春金赛药业有限责任公司

100 项与聚乙二醇重组人生长激素 (长春金赛) 相关的临床结果

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100 项与聚乙二醇重组人生长激素 (长春金赛) 相关的转化医学

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100 项与聚乙二醇重组人生长激素 (长春金赛) 相关的专利（医药）

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2,324

项与聚乙二醇重组人生长激素 (长春金赛) 相关的文献（医药）

2025-03-01·Growth Hormone & IGF Research

Identification and differentiation of somapacitan, a long-acting growth hormone derivative, and recombinant human growth hormone in equine plasma by LC-HRMS for doping control purpose

Article

作者: Hirano-Kodaira, Misato ; Saito, Kazunobu ; Shimizu, Yoshibumi ; Sugai-Bannai, Michiko ; Leung, Gary Ngai-Wa

Somapacitan, a long-acting growth hormone derivative, and recombinant human growth hormone (rhGH) are protein-based drugs generally used to treat growth disorders and GH deficiency in humans. Due to their potential to enhance the horse performance, the use of these drugs is prohibited at-all-times by the International Federation of Horseracing Authorities for horseracing and the Fédération Equestre Internationale for equestrian sports. In this study, we developed a test method for the identification and differentiation of somapacitan and rhGH in equine plasma by using liquid chromatography high-resolution mass spectrometry (LC-HRMS). The method involved C4 solid-phase extraction after ammonium sulfate precipitation, followed by chloroform/methanol precipitation, trypsin digestion, and analysis by LC-HRMS. The discriminative identification of somapacitan and rhGH was successfully achieved through the detection of their respective unique T10 peptide fragments. Noteworthy, the T10 peptide fragment of somapacitan was detected with its side chain structure remaining intact. The limit of identification (confirmation) (LOI) was determined to be 5 ng/mL for somapacitan and 2 ng/mL for rhGH in equine plasma, while the limit of detection (LOD) was 5 ng/mL for somapacitan and 1 ng/mL for rhGH. Furthermore, using the peptide fragments T1, T8, and T9 (which are shared between somapacitan and rhGH), the presence of somapacitan in equine plasma could be confirmed with higher sensitivity, achieving down to LOIs of 2 ng/mL and LODs of 1 ng/mL. The method was validated with respect to specificity, identification capability, robustness, precision, and reproducibility, paving the way for the analysis of post-administration samples from our already planned administration trials and future potential positive cases.

2025-01-02·Expert Opinion on Drug Safety

Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial

Article

作者: Taghavi, Behnam ; Shahbazi, Majid ; Ghergherehchi, Robabeh ; Arefnia, Serajaddin ; Didban, Abdollah ; Amini, Hossein ; Zaeri, Hossein ; Eshraghi, Peyman ; Akhlaghi, Aliasghar ; Noorian, Shahab ; Ghaznavi, Sina ; Omidvar, Shahriar ; Ghasemi, Mahmoud ; Moravej, Hossein ; Hashemipour, Mahin ; Servatian, Nazli ; Maleki, Elham ; Soheilipour, Fahimeh ; Dalili, Setila ; Khademolreza, Nasrin ; Kharazmi, Hosseinali

OBJECTIVESThis study is designed in order to compare the efficacy and safety of recombinant human growth hormone (rhGH) with the reference brand.METHODSAccording to the inclusion criteria, 85 people in 13 Iranian centers were randomly selected to receive biosimilar Somatropin (Somatin®) (44 people) and reference Somatropin (Norditropin®) (41 people) at a dose of 35 µg/kg/d, seven days/week for 12 months. The primary outcomes included height velocity (HV) was measured during 12 months of treatment.RESULTSThe two intervention groups' Height changes were similar. The mean HV was 10.96 cm/year in the biosimilar group and 10.05 cm/year in the reference groups after 12 months. Estimates of the lower bounds of 95% CI for mean height differences in the biosimilar intervention group compared to the reference intervention group did not exceed the 2 cm margin. Therefore, the non-inferiority of biosimilar intervention compared to the brand product is verified. Common ADRs in both groups were nausea in two patients (2.4%), diarrhea in two patients (2.4%), increased body temperature in one patient (1.2%), and headache in one patient (1.2%).CONCLUSIONSThe finding of this study indicated that Somatin® and Norditropin® have comparable efficacy and safety profiles.CLINICAL TRIAL REGISTRATIONwww.IRCT.irIRCT20171122037571N1.

2024-11-15·Medicine

A retrospective study of recombinant human growth hormone in the treatment of school-aged pediatric patients with idiopathic short stature

Article

作者: Chen, Yao ; Li, Yun-Hai ; Zhang, Xue-Rong

The present study aims to investigate the clinical efficacy of recombinant human growth hormone (r-hGH) in the treatment of school-age pediatric patients with idiopathic short stature (ISS). Pediatric patients who were diagnosed with ISS and treated with r-hGH at our hospital were enrolled as research subjects. The main outcome indicators included the serum level of insulin-like growth factor-1, insulin-like growth factor binding protein-3, baseline height standard deviation scores, and posttreatment height standard deviation scores and retrospective analysis was performed. This study complies with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. A total of 42 pediatric patients with a diagnosis of ISS were enrolled in the present study (24 males and 18 females). Following treatment, the levels of insulin-like growth factor-1 and insulin-like growth factor binding protein-3 were significantly higher than the baseline level and the difference was statistically significant. The posttreatment height standard deviation scores was significantly higher than the baseline height standard deviation scores and the difference was statistically significant. There were no significant differences between male and female participants in height standard deviation scores, either before or following treatment. This study found that r-hGH therapy may increase height in school-age pediatric patients with ISS and is therefore worthy of clinical application.

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项与聚乙二醇重组人生长激素 (长春金赛) 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

2024-12-09

·药研网

天境生物/济川药业：长效生长激素申报上市

12月9日，天境生物官方宣布，伊坦生长激素（eftansomatropin alfa，TJ101）治疗儿童生长激素缺乏症(PGHD)的生物制品上市申请(BLA)已获得中国国家药品监督管理局(NMPA)受理。据其新闻稿，作为国内申报阶段和已上市产品中首款且唯一一款融合蛋白长效生长激素，该创新疗法有望为儿童生长激素缺乏症患者带来安全、有效且更具便利性的治疗方案在2023年半年报中，天境生物曾提到伊坦生长激素对比Norditropin（诺泽）治疗儿童生长激素缺乏症的III期研究达到非劣效性主要终点。伊坦生长激素是Genexine开发的一款长效生长激素，通过刺激肝脏中胰岛素样生长因子1（IGF-1）的产生，对各种细胞和组织发挥生长刺激作用。 2021年11月10日，天境生物与济川药业举行战略合作签约仪式，就前者的伊坦生长激素（eftansomatropin alfa，TJ101）达成产品开发、生产及商业化战略合作。据悉，此项合作总金额高达20.16亿人民币，交易金额创下了近年中国生物医药市场及全球儿科医药领域同类新高。此次完成的III期研究（代号：CTJ101PGHD301）是一项开放标签、阳性药物对照的临床试验，共纳入336例3-10岁儿童生长激素缺乏症患者，旨在对比伊坦生长激素（1.2mg/kg，每周1次）和诺泽（0.034mg/kg，每天1次）的有效性和安全性。研究的主要终点为第52周受试者的年化身高生长速率（AHV）。结果显示，伊坦生长激素组患者的AHV为10.76厘米/年，Norditropin组患者的AHV为10.28厘米/年，达到非劣效性要求（P<0.0001)。安全性方面，伊坦生长激素耐受性良好，未见报告治疗相关不良事件导致的停药事件。目前，国内已有多款生长激素获批上市，包括尤得盼（LG Chem）、安苏萌（安科生物）、诺泽（诺和诺德）和金赛增（金赛药业）等。金赛增是一种聚乙二醇重组人生长激素，注射频率为每周1次。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 10月 | 20家生物医药裁员汇总 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

临床3期优先审批疫苗临床结果上市批准

2024-12-07

·医药魔方Info

一年长高10.76厘米！天境生物长效生长激素申报上市

12月7日，CDE网站显示，天境生物的伊坦生长激素（eftansomatropin alfa，TJ101）申报上市。在2023年半年报中，天境生物曾提到伊坦生长激素对比Norditropin（诺泽）治疗儿童生长激素缺乏症的III期研究达到非劣效性主要终点。伊坦生长激素是Genexine开发的一款长效生长激素，通过刺激肝脏中胰岛素样生长因子1（IGF-1）的产生，对各种细胞和组织发挥生长刺激作用。2015年10月，天士力子公司Tasgen（后来被天境生物收购）与Genexine达成协议，获得伊坦生长激素的中国权益。2021年11月，天境生物将该产品的商业化权益授权给济川药业。来源：天境生物官网此次完成的III期研究（代号：CTJ101PGHD301）是一项开放标签、阳性药物对照的临床试验，共纳入336例3-10岁儿童生长激素缺乏症患者，旨在对比伊坦生长激素（1.2mg/kg，每周1次）和诺泽（0.034mg/kg，每天1次）的有效性和安全性。研究的主要终点为第52周受试者的年化身高生长速率（AHV）。结果显示，伊坦生长激素组患者的AHV为10.76厘米/年，Norditropin组患者的AHV为10.28厘米/年，达到非劣效性要求（P<0.0001)。安全性方面，伊坦生长激素耐受性良好，未见报告治疗相关不良事件导致的停药事件。目前，国内已有多款生长激素获批上市，包括尤得盼（LG Chem）、安苏萌（安科生物）、诺泽（诺和诺德）和金赛增（金赛药业）等。金赛增是一种聚乙二醇重组人生长激素，注射频率为每周1次。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线上直播 ↑点击扫码，直达直播间↑

临床3期并购上市批准引进/卖出

100 项与聚乙二醇重组人生长激素 (长春金赛) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	聚乙二醇重组人生长激素 (长春金赛)	H01AC01	DB15112

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
特发性矮小症	中国	长春金赛药业有限责任公司	2024-10-29
生长激素缺乏症	中国	长春金赛药业有限责任公司	2024-08-13
特纳综合症	中国	长春金赛药业有限责任公司	2024-08-13
生长障碍	中国	长春金赛药业有限责任公司	2014-01-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
生长激素缺乏症	临床3期	美国	长春金赛药业有限责任公司	2023-12-01
生长激素缺乏症	临床3期	-	长春金赛药业有限责任公司	2023-12-01
侏儒症	临床2期	中国	长春金赛药业有限责任公司	2014-10-01
小于胎龄儿	临床2期	中国	长春金赛药业有限责任公司	2009-12-01

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临床结果

适应症

分期

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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	侏儒症 IGF1R	-	Recombinant human growth hormone treatment	(窪鏇繭觸觸窪醖鬱膚蓋) = 鹹齋齋鬱鹹鹹顧觸獵顧願顧選醖簾鹹夢繭襯醖 (範範繭窪獵鬱網襯鏇糧 ) 更多	-	2023-09-21
PSAT108 (ENDO2022)	N/A	侏儒症	40	Prepubertal boys with significant short stature receiving rhGH	鹹衊艱艱淵淵築積襯獵(憲顧鹽範積築糧糧鏇艱) = 艱鬱醖襯範鑰築鹽鑰鑰築遞簾鹹鑰壓鬱窪選壓 (鑰齋網艱顧顧蓋壓蓋餘 ) 更多	积极	2022-11-01
				recombinant human growth hormone (Age-matched healthy controls growing normally)	鹹衊艱艱淵淵築積襯獵(憲顧鹽範積築糧糧鏇艱) = 壓窪壓齋餘獵簾襯網壓築遞簾鹹鑰壓鬱窪選壓 (鑰齋網艱顧顧蓋壓蓋餘 ) 更多
ESPE2022	N/A	神经纤维瘤病-努南综合征	1	Recombinant human growth hormone	(衊觸窪積廠網窪齋顧壓) = 鹽廠遞鏇築衊獵蓋餘廠壓繭築鹽憲築膚艱膚窪 (選壓製繭選鑰艱壓獵衊 )	-	2022-09-15
LG Growth Study (ESPE2022)	N/A	生长障碍 inulin like growth factor-1 (IGF-1)	-	recombinant human growth Hormone	壓艱鏇膚選齋壓鹹衊鹹(願襯憲獵艱繭積鹹窪鏇) = 鬱淵鏇膚願製製窪鬱製衊範廠遞襯廠壓築夢選 (積簾壓蓋範衊鹹鑰淵觸 )	-	2022-09-15
				recombinant human growth Hormone	壓艱鏇膚選齋壓鹹衊鹹(願襯憲獵艱繭積鹹窪鏇) = 鏇襯觸壓網廠糧構艱遞衊範廠遞襯廠壓築夢選 (積簾壓蓋範衊鹹鑰淵觸 )
IAS2002	N/A	脂肪萎缩性糖尿病	12	Recombinant human growth hormone (rhGH)	壓遞夢廠繭選願鹹積衊(膚壓廠襯壓艱遞鏇遞膚) = 築鹽衊淵選窪範鏇壓選鹽齋觸鹹構範鹽範繭繭 (願構構網顧鏇積繭醖壓 ) 更多	-	2002-01-01
				Placebo	顧膚鏇繭製構蓋願窪鏇(網夢衊鑰獵憲淵壓遞壓) = 鏇餘壓衊願衊淵醖繭夢齋繭壓醖窪窪築鏇鹽鹹 (齋簾觸憲鬱構鹹積衊築 )