重组人血清白蛋白（北京普罗吉）(Recombinant Human Serum Albumin(Protgen Ltd.)) - 药物靶点：albumin_在研适应症：腹水，肝硬化，肝硬化性心肌病_专利_临床

概要

基本信息

药物类型

重组蛋白

别名

Recombinant human serum albumin biosimilar(Protgen)

靶点

albumin

作用方式

调节剂

作用机制

albumin调节剂(血清白蛋白调节剂)、免疫调节剂

治疗领域

在研适应症

非在研适应症

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

11

项与重组人血清白蛋白（北京普罗吉）相关的临床试验

NCT06553456

/ Not yet recruiting临床2/3期

Random, Double-blind, Parallel Group Phase II/III Clinical Trial to Evaluate the Effectiveness and Safety of Recombinant Human Serum Albumin Versus Human Serum Albumin in Hepatic Cirrhosis Patients With Ascites

This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.

开始日期2024-08-13

申办/合作机构

北京普罗吉生物科技发展有限公司

NCT06489015

/ Recruiting早期临床1期

An Open-label, Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild to Moderate Alzheimer's Disease

This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin (rHSA, hereafter referred to as the "investigational drug") in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.

开始日期2024-06-28

申办/合作机构

北京普罗吉生物科技发展有限公司

NCT05858853

/ Completed临床2/3期

To Evaluate the Effectiveness of Recombinant Human Serum Albumin Versus Human Serum Albumin in Patients With Hepatic Cirrhosis and Safety of Random, Double-blind, Parallel Grouping Phase II/III Clinical Trial

This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.

开始日期2023-05-25

申办/合作机构

北京普罗吉生物科技发展有限公司

100 项与重组人血清白蛋白（北京普罗吉）相关的临床结果

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100 项与重组人血清白蛋白（北京普罗吉）相关的转化医学

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100 项与重组人血清白蛋白（北京普罗吉）相关的专利（医药）

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5

项与重组人血清白蛋白（北京普罗吉）相关的文献（医药）

2017-08-14·ACS Biomaterials Science & Engineering3区 · 工程技术

Engineering Xeno-Free Microcarriers with Recombinant Vitronectin, Albumin and UV Irradiation for Human Pluripotent Stem Cell Bioprocessing

3区 · 工程技术

Article

作者: Fan, Yongjia ; Zhang, Fan ; Tzanakakis, Emmanuel S.

The development of platforms for the expansion and directed differentiation of human pluripotent stem cells (hPSCs) in large quantities under xeno-free conditions is a key step toward the realization of envisioned stem cell-based therapies. Microcarrier bioreactors afford great surface-to-volume ratio, scalability and customization with typical densities of 10⁶-10⁷ cells/ml or higher. In this study, a simple and inexpensive method was established for generating microcarriers without animal-derived components. While coating polystyrene beads with vitronectin alone did not support the culture of hPSCs in stirred suspension, the inclusion of recombinant human serum albumin and UV irradiation led to enhanced seeding efficiency and retention while cells grew more than 20-fold per passage for multiple successive passages and without loss of cell pluripotency. Human PSCs expanded on microcarriers were coaxed to tri-lineage differentiation demonstrating that this system can be used for the self-renewal and specification of hPSCs to therapeutically relevant cell types. Such systems will be critical for the envisioned use of stem cells in regenerative medicine and drug discovery.

2016-09-01·Applied Microbiology and Biotechnology3区 · 工程技术

Expression and bioactivity of recombinant human serum albumin and dTMP fusion proteins in CHO cells

3区 · 工程技术

Article

作者: Guo, Dingding ; Wang, Haiqing ; Wang, Na ; Che, Jingmin ; Li, Hongyu ; Wang, Yong ; Ru, Yi ; Wei, Suzhen ; Zhi, Dejuan ; Wang, Meizhu ; Li, Yang

The 14-amino acid (IEGPTLRQWLAARA) thrombopoietin mimetic peptide (TMP) shares no sequence homology with native thrombopoietin (TPO). When dimerized, it displays a high-binding affinity for the TPO receptor and has equipotent bioactivity with recombinant human TPO (rhTPO) in stimulating proliferation and maturation of megakaryocytes in vitro. However, TMP is limited for clinical usage because of its short half-life in vivo. In this study, fusion proteins that composed of tandem dimer of TMP (dTMP) genetically fused at the C- or N-terminus of human serum albumin (HSA) were separately expressed in Chinese hamster ovary (CHO) cells. In vitro bioactivity assays showed that purified fusion proteins promoted the proliferation of megakaryocytes in a dose-dependent manner and activated signal transducer and activator of transcription (STAT) pathway in TPO receptor-dependent manner. Following subcutaneous administration, both HSA-dTMP and dTMP-HSA significantly elevated peripheral platelet counts in normal mice in a dose-dependent manner. In addition, fusion with HSA successfully prolonged dTMP half-life in mice. However, when HSA was fused at the C-terminus of dTMP, the bioactivity of dTMP-HSA was about half of that of HSA-dTMP. In conclusion, these results suggested that HSA/dTMP fusion proteins might be potential drugs for thrombocytopenia and, when HSA was fused at the N-terminus of dTMP, the fusion protein had a higher activity.

2016-01-01·Journal of Reproduction and Development4区 · 生物学

Lipid-rich bovine serum albumin improves the viability and hatching ability of porcine blastocysts produced <i>in vitro</i>

4区 · 生物学

Article

作者: YOSHIOKA, Koji ; HOSHI, Hiroyoshi ; SUZUKI, Chie ; SAKAGUCHI, Yosuke

The effects of lipid-rich bovine serum albumin (LR-BSA) on the development of porcine blastocysts produced in vitro were examined. Addition of 0.5 to 5 mg/ml LR-BSA to porcine blastocyst medium (PBM) from Day 5 (Day 0 = in vitro fertilization) significantly increased the hatching rates of blastocysts on Day 7 and the total cell numbers in Day-7 blastocysts. When Day-5 blastocysts were cultured with PBM alone, PBM containing LR-BSA, recombinant human serum albumin or fatty acid-free BSA, addition of LR-BSA significantly enhanced hatching rates and the cell number in blastocysts that survived compared with other treatments. The diameter, ATP content and numbers of both inner cell mass and total cells in Day-6 and Day-7 blastocysts cultured with PBM containing LR-BSA were significantly higher than in blastocysts cultured with PBM alone, whereas LR-BSA had no effect on mitochondrial membrane potential. The mRNA levels of enzymes involved in fatty acid metabolism and β-oxidation (ACSL1, ACSL3, CPT1, CPT2 and KAT) in Day-7 blastocysts were significantly upregulated by the addition of LR-BSA. The results indicated that LR-BSA enhanced hatching ability and quality of porcine blastocysts produced in vitro, as determined by ATP content, blastocyst diameter and expression levels of the specific genes, suggesting that the stimulatory effects of LR-BSA arise from lipids bound to albumin.

100 项与重组人血清白蛋白（北京普罗吉）相关的药物交易

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研发状态

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
肝硬化性心肌病	临床3期	中国	北京普罗吉生物科技发展有限公司	2024-08-13
腹水	临床3期	中国	深圳普罗吉医药科技有限公司	2024-08-09
肝硬化	临床3期	中国	深圳普罗吉医药科技有限公司	2024-08-09
肝腹水症	临床3期	中国	北京普罗吉生物科技发展有限公司	2023-05-25
阿尔茨海默症	临床1期	中国	北京普罗吉生物科技发展有限公司	2024-06-28
晚期癌症	临床前	中国	北京普罗吉生物科技发展有限公司	2022-01-30
新生儿高胆红素血症	临床前	中国	北京普罗吉生物科技发展有限公司	2022-01-30
低蛋白血症	临床前	中国	北京普罗吉生物科技发展有限公司	2022-01-30
休克	临床前	中国	北京普罗吉生物科技发展有限公司	2022-01-30
纤维化	药物发现	中国	北京普罗吉生物科技发展有限公司	2021-10-14