Delving into the Latest Updates on Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

PEG-G-CSF, PEG-filgrastim, Pegfilgrastim biosimilar

+ [5]

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Neutropenia

Inactive Indication-

Originator Organization

Dong-A Pharmaceutical Co., Ltd.

Active Organization

Dong-A Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (14 Aug 2014),

Neutropenia

Regulation-

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

* 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

Start Date16 Jan 2024

Sponsor / Collaborator

National Cancer Center Korea

[+1]

ChiCTR2000037800

/ SuspendedPhase 4IIT

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

Start Date01 Sep 2020

Sponsor / Collaborator-

100 Clinical Results associated with Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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100 Translational Medicine associated with Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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100 Patents (Medical) associated with Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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72

Literatures (Medical) associated with Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

01 Apr 2025·Supportive Care in Cancer

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

Article

Author: 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.

01 Feb 2025·Stem Cells and Development

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

Article

Author: 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.

02 Jan 2025·International Journal of Radiation Biology

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

Article

Author: 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 Deals associated with Pegfilgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	South Korea	Dong-A Pharmaceutical Co., Ltd.	14 Aug 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GI2019	Not Applicable	Pancreatic carcinoma non-resectable Neoadjuvant	40	PEG-G-CSF	(zentwpwszs) = nxyyecqbxh xldslsacfi (gzyltfsaln ) View more	Positive	29 Jan 2019
				No G-CSF	(zentwpwszs) = syszlbutvb xldslsacfi (gzyltfsaln ) View more
DSHNHL (ASCO2007)	Not Applicable	Diffuse Large B-Cell Lymphoma	109	Peg-filgrastim on day 2	spqyrzwvow(uzglfgzfat) = jnkqzbfizm ulmaxsrknd (fglefibuxn ) View more	-	20 Jun 2007
				Peg-filgrastim on day 4	spqyrzwvow(uzglfgzfat) = yjecfakbzb ulmaxsrknd (fglefibuxn ) View more

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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