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更新于：2026-09-01
Recombinant human neuregulin-1 (Zensun (Shanghai))
重组人纽兰格林（上海泽生）
更新于：2026-09-01
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
18
项与 重组人纽兰格林（上海泽生） 相关的临床试验NCT05949801
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Based on Standard Treatment to Evaluate the Effect of Injectable Neucardin on Cardiac Function and Reverse Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
CTR20192276
随机、双盲、安慰剂平行对照评价注射用重组人纽兰格林对射血分数保留心力衰竭(HFpEF) 患者安全性和有效性临床试验
CTR20210419
重组人纽兰格林皮下给药和静脉给药在健康受试者体内药代动力学开放标签研究
100 项与 重组人纽兰格林（上海泽生） 相关的临床结果
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100 项与 重组人纽兰格林（上海泽生） 相关的转化医学
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100 项与 重组人纽兰格林（上海泽生） 相关的专利（医药）
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21
项与 重组人纽兰格林（上海泽生） 相关的文献（医药）2024-02-01Journal of molecular and cellular cardiology
RETRACTED: The novel antibody fusion protein rhNRG1-HER3i promotes heart regeneration by enhancing NRG1-ERBB4 signaling pathway
Article
作者: Wang, Wei Eric ; Wu, Hao ; Tang, Luxun ; Zeng, Chunyu ; Fu, Wenbin ; He, Yanji ; Wang, Xuemei
Stimulating cardiomyocyte proliferation in the adult heart has emerged as a promising strategy for cardiac regeneration following myocardial infarction (MI). The NRG1-ERBB4 signaling pathway has been implicated in the regulation of cardiomyocyte proliferation. However, the therapeutic potential of recombinant human NRG1 (rhNRG1) has been limited due to the low expression of ERBB4 in adult cardiomyocytes. Here, we investigated whether a fusion protein of rhNRG1 and an ERBB3 inhibitor (rhNRG1-HER3i) could enhance the affinity of NRG1 for ERBB4 and promote adult cardiomyocyte proliferation. In vitro and in vivo experiments were conducted using postnatal day 1 (P1), P7, and adult cardiomyocytes. Western blot analysis was performed to assess the expression and activity of ERBB4. Cardiomyocyte proliferation was evaluated using Ki67 and pH 3 immunostaining, while fibrosis was assessed using Masson staining. Our results indicate that rhNRG1-HER3i, but not rhNRG1, promoted P7 and adult cardiomyocyte proliferation. Furthermore, rhNRG1-HER3i improved cardiac function and reduced cardiac fibrosis in post-MI hearts. Administration of rhNRG1-HER3i inhibited ERBB3 phosphorylation while increasing ERBB4 phosphorylation in adult mouse hearts. Additionally, rhNRG1-HER3i enhanced angiogenesis following MI compared to rhNRG1. In conclusion, our findings suggest that rhNRG1-HER3i is a viable therapeutic approach for promoting adult cardiomyocyte proliferation and treating MI by enhancing NRG1-ERBB4 signaling pathway.
2023-09-01JACC. Basic to translational science
Neuregulin-1β Improves Uremic Cardiomyopathy and Renal Dysfunction in Rats
Article
作者: Szabó, Petra Lujza ; Kiss, Attila ; Cserni, Gábor ; Földesi, Imre ; Fintha, Attila ; Krenács, Tibor ; Watzinger, Simon ; Zins, Karin ; Podesser, Bruno K ; Pokreisz, Peter ; Lauber, Gülsüm Yilmaz ; Siska, Andrea ; Márványkövi, Fanni ; Kővári, Bence ; Csont, Tamás ; Monostori, Péter ; Kovács, Ferenc ; Szűcs, Gergő ; Szabó, Gábor Tamás ; Abraham, Dietmar ; Acar, Eylem ; Galla, Zsolt ; Sárközy, Márta ; Kovács, Zsuzsanna Z A ; Kriston, András ; Horváth, Péter
Chronic kidney disease is a global health problem affecting 10% to 12% of the population. Uremic cardiomyopathy is often characterized by left ventricular hypertrophy, fibrosis, and diastolic dysfunction. Dysregulation of neuregulin-1β signaling in the heart is a known contributor to heart failure. The systemically administered recombinant human neuregulin-1β for 10 days in our 5/6 nephrectomy-induced model of chronic kidney disease alleviated the progression of uremic cardiomyopathy and kidney dysfunction in type 4 cardiorenal syndrome. The currently presented positive preclinical data warrant clinical studies to confirm the beneficial effects of recombinant human neuregulin-1β in patients with chronic kidney disease.
2023-07-01Archives of biochemistry and biophysics
Recombinant human neuregulin-1 alleviates immobilization-induced neuromuscular dysfunction via neuregulin-1/ErbB signaling pathway in rat
Article
作者: Min, Su ; Li, Ping ; Yang, Jun ; Ren, Li ; Lv, Feng ; Cao, Jun
Immobilization-induced Neuromuscular Dysfunction (NMD) increases morbidity and mortality of patients in Intensive Care Units. However, the underlying mechanism of NMD remain poorly elucidated which limited the development of therapeutic method for NMD. Here we developed an immobilization rat model and tested the hypothesis that decreased expression of NRG-1, abnormal expression and distribution of nicotinic acetylcholine receptors (nAChRs) in skeletal muscle caused by immobilization can lead to NMD. To investigate the role of NRG-1/ErbB pathway on immobilization-induced NMD, exogenous recombinant human neuregulin-1 (rhNRG-1) was used to increase the expression of NRG-1 in skeletal muscle during immobilization. It was observed rhNRG-1 significantly alleviated the muscle loss and enhanced the expression of ε-nAChR, while diminished the expression of γ- and α7-nAChR and NMD. Interestingly, ErbB inhibitor PD158780 blocked the protective effects of rhNRG-1. Collectively, the results of present study suggested that rhNRG-1 attenuated immobilization-induced muscle loss and NMD, suppressed γ- and α7-nAChR production, enhanced ε-nAChR synthesis via activating NRG-1/ErbB pathway. Taken together, our findings provide novel insights into NMD contribution, suggesting that the rhNRG-1 is a promising therapy to protect against immobilization-induced myopathy.
35
项与 重组人纽兰格林（上海泽生） 相关的新闻（医药）2026-09-01
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100 项与 重组人纽兰格林（上海泽生） 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 心脏衰竭 | 申请上市 | 中国 | 2012-04-17 | |
| 舒张期心力衰竭 | 临床3期 | 美国 | 2022-01-30 | |
| 慢性心力衰竭 | 临床3期 | 中国 | 2010-04-01 | |
| 慢性收缩性心力衰竭 | 临床3期 | 中国 | 2010-04-01 | |
| 射血分数保留型心力衰竭 | 临床2期 | 中国 | 2020-02-10 | |
| 心肌梗塞 | 临床申请 | 中国 | 2022-01-30 | |
| 神经鞘瘤 | 临床前 | 中国 | 2020-03-12 | |
| 脑卒中 | 临床前 | 中国 | 2018-12-17 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | 纽兰格林 | 鏇鹹糧鹹醖鏇獵糧願築(窪膚製餘糧鹹範淵繭糧): P-Value = >0.05 | 不佳 | 2022-06-30 | ||
Placebo | |||||||
临床3期 | 679 | 餘壓淵構餘選壓齋獵鏇(顧艱製願膚糧壓壓齋淵) = 窪積膚衊廠衊繭鏇築廠 觸齋鏇壓憲膚積膚餘選 (鹹觸憲築積構憲淵餘醖 ) 更多 | 积极 | 2018-03-08 | |||
Placebo | 餘壓淵構餘選壓齋獵鏇(顧艱製願膚糧壓壓齋淵) = 網鬱鹹繭鹹衊壓鹹醖鑰 觸齋鏇壓憲膚積膚餘選 (鹹觸憲築積構憲淵餘醖 ) 更多 |
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