培非格司亭生物类似药 (Dong-A Pharmaceutical)(Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)) - 药物靶点：CSF-3R_在研适应症：中性粒细胞减少_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

PEG-G-CSF、PEG-filgrastim、Pegfilgrastim biosimilar

+ [5]

靶点

CSF-3R

作用方式

激动剂

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

中性粒细胞减少

非在研适应症-

原研机构

Dong-A Pharmaceutical Co., Ltd.

在研机构

Dong-A Pharmaceutical 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

韩国 (2014-08-14),

中性粒细胞减少

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4190

当前序列信息引自: *****

关联

16

项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的临床试验

KCT0008772

/ Recruiting临床2期IIT

An open-label, randomized, multicentre, phase ? trial of Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers

开始日期2024-01-16

申办/合作机构

National Cancer Center Research Institute

NCT06135896

/ Recruiting临床2期IIT

An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

* Clinical trial phase: Phase 2
* Intervention model: Control group
* Group allocation: Randomized controlled trial
* Research perspective: Prospective study
* Participating centers: Multicenter study
* Definition of the intervention period: Based on the RECIST 1.1 guidelines, patients will receive treatment until dropout due to disease progression or unacceptable toxicity related to the trial drug. Patients will be followed up with to assess survival every 2 months until either death or the end of the trial, whichever is first.
* The intervention period is from the date of IRB approval to December 31st, 2025
* The follow-up duration is one year, and the statistical analysis duration is six months
* The total research period is from the date of IRB approval to June 30th, 2026

开始日期2024-01-16

申办/合作机构

National Cancer Center Korea

[+1]

ChiCTR2000037800

/ Suspended临床4期IIT

A prospective comparative study of pharmacoeconomics and patient compliance between short-acting G-CSF and PEG-CSF in primary prevention of neutropenia after adjuvant chemotherapy for breast cancer patients

开始日期2020-09-01

申办/合作机构-

100 项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的临床结果

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100 项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的转化医学

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100 项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的专利（医药）

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72

项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的文献（医药）

2025-04-01·Supportive Care in Cancer

Temporal trends in time toxicity of R-CHOP: a nationwide hospital-based database analysis in Japan

Article

作者: Kadowaki, Takashi ; Yamauchi, Takahiro ; Seki, Tomohisa ; Yamaguchi, Satoko ; Ohe, Kazuhiko ; Araie, Hiroaki ; Okada, Akira ; Nangaku, Masaomi ; Yamauchi, Toshimasa

AbstractPurposeWhile the prognosis of patients with cancer has improved, the time burden of treatment has recently been recognized as time toxicity; although, the actual clinical situation remains largely unexplored. This retrospective study aimed to elucidate the time toxicity of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with B-cell lymphoma and the factors influencing it.MethodsWe used a nationwide hospital-based database between January 2010 and November 2021 in Japan. We extracted the claims data of patients with diffuse large B-cell lymphoma and follicular lymphoma who were hospitalized and/or visited hospitals for chemotherapy.ResultsAmong the 7760 R-CHOP administered to 2006 patients, the rate of outpatient therapy increased over time (2010–2015: 17.9%; 2016–2021: 31.8%). In 2016, the median length of hospitalization was the shortest at 13 days (IQR 8–19), which coincided with the peak use of pegylated granulocyte colony-stimulating factor (Peg-G-CSF) during hospitalization in 2015–2016, likely driven by changes in the insurance system. In multivariate analysis, the factors associated with longer hospital stays were older age and poor activities of daily living, whereas the use of Peg-G-CSF, a reduced-dose regimen, and treatment at cancer-designated hospitals were associated with shorter stays.ConclusionThe time toxicity of R-CHOP has improved and may be influenced by the patient’s condition, adequate supportive care, changes in the insurance system, and center-specific treatment proficiency.

2025-02-01·Stem Cells and Development

PEGylated Granulocyte Colony-Stimulating Factor and Plerixafor Enhance Autologous Stem and Progenitor Cell Mobilization and Transplantation in Pediatric Patients

Article

作者: Voermans, Carlijn ; Dierselhuis, Miranda P. ; Tissing, Wim J.E. ; Kraal, Kathelijne C.J.M. ; Rozeman, Maria L. ; Westinga, Kasper ; Tytgat, Godelieve A.M. ; Kuijk, Carlijn ; Zwaan, Christian M. ; Jaspers-Bakker, Antoinette ; Zsiros, József ; Timmerman, Ilse ; Kunze, Nina ; Slager, Tirza J.E. ; Fiocco, Marta ; Hochheuser, Caroline ; van den Bos, Cor ; Gelineau, Nina U.

Autologous hematopoietic stem cell transplantation is used to restore bone marrow function after high-dose chemotherapy. For apheresis, granulocyte colony-stimulating factor (G-CSF) is standard of care, but obtaining sufficient stem cells can be challenging. Other mobilization agents include plerixafor and PEGylated G-CSF (PEG-G-CSF). While efficacy of these is established in adults, limited data for their use in pediatric patients are available. Here, we compare Good versus Poor Mobilizers and study success of different mobilization regimens in regard to CD34⁺cell-collection, -quality, -phenotype and hematologic reconstitution in pediatric patients. In this multi-center retrospective study, we analyzed data of 278 patients with solid tumors and lymphoma, mobilized with either G-CSF (n = 224), PEG-G-CSF (n = 34), or G-CSF/PEG-G-CSF with additional plerixafor (n = 20). In Poor Mobilizers (13.7% of all patients), addition of plerixafor to G-CSF augmented CD34⁺cell collection, without adverse effects on hematologic reconstitution and CD34⁺cell quality. PEG-G-CSF-aided mobilization was successful as first-line treatment in two-thirds of patients and did not impair hematological reconstitution, compared to G-CSF-only. Within the Poor Mobilizer group, G-CSF+plerixafor increased primitive (CD45RA^-CD38^-CD90⁺CD49f⁺) and CXCR4-expressing CD34⁺cells in apheresis products compared to G-CSF-only, without exceeding levels of Good Mobilizers. No plerixafor-related increase in tumor cells was observed in apheresis products. In conclusion, our comprehensive study supports the use of plerixafor and furthermore demonstrates the potential of patient-friendly PEG-G-CSF for mobilization of pediatric patients.

2025-01-02·International Journal of Radiation Biology

IEPA, a novel radiation countermeasure, alleviates acute radiation syndrome in rodents

Article

作者: Asang, Corinna ; Fish, Brian L. ; Bähr, Stella ; Munjal Mehta, Srishti ; Gasperetti, Tracy ; Czajkowski, Maciej T. ; Eibl, Michael ; Wesolowski, Radoslaw ; Orschell, Christie M. ; Himburg, Heather A. ; Pleimes, Dirk ; Singh, Nikita

Repurposing therapeutic agents with existing clinical data is a common strategy for developing radiation countermeasures. IEPA (imidazolyl ethanamide pentandioic acid) is an orally bioavailable small molecule pseudopeptide with myeloprotective properties, a good clinical safety profile, and stable chemical characteristics facilitating stockpiling. Here, we evaluated IEPA's radiomitigative efficacy in the hematopoietic subsyndrome of acute radiation syndrome (H-ARS) using total-body irradiation (TBI) models in C57BL/6J mice and WAG/RijCmcr rats, applying various posology schemes and introducing syringe feeding of the IEPA formulation in the pudding. Additionally, we assessed IEPA in the delayed effects of acute radiation exposure (DEARE) model after partial-body irradiation (PBI) in WAG/RijCmcr rats. Endpoints included survival, body weight, hematology, and pulmonary parameters, depending on the model. Results from mouse and rat TBI models demonstrated survival improvements with repeated IEPA dosing at 10 mg/kg, with the largest benefits observed in the bi-daily (BID) treatment over the 30-day ARS phase in female rats. Survival across PBI-DEARE subsyndromes was comparable between IEPA and vehicle groups, though IEPA improved pulmonary parameters in female rats during the lung-DEARE phase. Sex-related differences in response to irradiation and IEPA were noted, with females showing a survival advantage. IEPA treatment is compatible with Neulasta® (Pegfilgrastim; PEG-G-CSF); adequately powered studies are needed to confirm the trend toward improved survival over standard care alone. IEPA is a promising development candidate as a medical countermeasure against the effects of acute radiation syndrome. Further confirmatory studies in small and large animal models should validate the robustness and translatability of preliminary rodent data on IEPA's radiomitigative efficacy.

100 项与培非格司亭生物类似药 (Dong-A Pharmaceutical) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中性粒细胞减少	韩国	Dong-A Pharmaceutical Co., Ltd.	2014-08-14

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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


ASCO_GI2019	N/A	不能切除性胰腺癌新辅助	40	PEG-G-CSF	(窪餘窪蓋鏇範積糧膚鹹) = 淵範簾鏇艱艱淵網壓糧蓋窪衊繭夢繭範艱鹹餘 (壓選餘獵夢夢餘鑰窪壓 ) 更多	积极	2019-01-29
				No G-CSF	(窪餘窪蓋鏇範積糧膚鹹) = 構選鬱範醖糧夢製範鬱蓋窪衊繭夢繭範艱鹹餘 (壓選餘獵夢夢餘鑰窪壓 ) 更多
DSHNHL (ASCO2007)	N/A	弥漫性大B细胞淋巴瘤	109	Peg-filgrastim on day 2	積選餘獵積壓鹹積鑰願(壓鬱壓觸鑰夢鏇鏇積顧) = 積遞簾憲積選廠壓憲醖選醖餘餘夢遞衊鬱遞網 (獵鏇糧獵築簾衊製獵鏇 ) 更多	-	2007-06-20
				Peg-filgrastim on day 4	積選餘獵積壓鹹積鑰願(壓鬱壓觸鑰夢鏇鏇積顧) = 網網淵蓋憲鹹願觸醖壓選醖餘餘夢遞衊鬱遞網 (獵鏇糧獵築簾衊製獵鏇 ) 更多