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

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Filgrastim biosimilar, Leucostim, Leukopoeitin

+ [4]

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

Diabetic peripheral neuropathic pain

Originator Organization

Dong-A Pharmaceutical Co., Ltd.

Active Organization

Dong-A Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

South Korea (07 Jun 1995),

Neutropenia

Regulation-

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

PURPOSERecombinant human granulocyte colony-stimulating factor (rhG-CSF) is widespread in the prevention and treatment of blood-related toxic effects associated with chemotherapy. This study aimed to explore the correlation between rhG-CSF and the recurrence of non-small cell lung cancer (NSCLC) in patients who have undergone postoperative chemotherapy.METHODSOur study encompassed 517 NSCLC patients at pathological stage I-III, who underwent surgical removal and subsequent chemotherapy from January 2012 to December 2019 at the First Affiliated Hospital of Nanchang University. The research focused on evaluating the separate impact of rhG-CSF on the likelihood of postoperative recurrence. The analysis employed both univariate and multivariate Cox regression models.RESULTSOf 517 NSCLC patients, 123 patients did not receive rhG-CSF, while 394 patients received rhG-CSF. Unexpectedly, it was discovered that rhG-CSF usage correlated with the emergence of distant metastasis (HR: 1.8, 95 %CI 1.2-2.7, p = 0.005), though not with local recurrence (HR: 1.4, 95 %CI 0.9-2.3, p = 0.142). By multifactorial Cox analysis, rhG-CSF was an independent risk factor for distant metastasis (adjusted HR: 1.7, 95 %CI 1.0-2.6, p = 0.033). We additionally discovered that rhG-CSF could increase the risk of brain metastasis (adjusted HR: 3.9, 95 %CI 1.5-9.8, p = 0.005) and bone metastasis (adjusted HR: 3.1, 95 %CI 1.2-8.2, p = 0.02).CONCLUSIONOur findings indicate that rhG-CSF independently contributes to the risk of distant metastasis, yet it shows no correlation with local recurrence. Furthermore, employing rhG-CSF played a crucial role in predicting brain metastasis and bone metastasis after postoperative chemotherapy in NSCLC patients.

01 Oct 2024·Zhongguo shi yan xue ye xue za zhi

[Effect and Influencing Factors of Peripheral Blood Hematopoietic Stem Cells Collection from Unrelated Donors].

Article

Author: Yang, Huan ; Sun, Hua ; Xiang, Hong-Xia ; Tang, Yu

OBJECTIVETo analyze the effect of peripheral blood hematopoietic stem cells (PBSC) collection from unrelated donors and its influencing factors.METHODSA retrospective analysis was conducted on the mobilization and collection of PBSC from 113 unrelated donors at Yueyang Central Hospital from January 2021 to December 2023.RESULTS113 donors were successfully mobilized. The average count of PBSC mononuclear cells (MNC) and CD34⁺ cells were (12.40±7.41)×10⁸/kg and (10.64±8.07)×10⁶/kg, respectively. Univariate analysis showed that the PBSC CD34⁺ cells ratio of male donors was significantly higher than that in female donors (P =0.015). The peripheral blood (PB) white blood cell (WBC) count before collection was positively correlated with the PBSC nucleated cells count (r =0.388), and the donor's body weight, the PB CD34⁺ cell ratio before collection were positively correlated with the PBSC CD34⁺ cell ratio (r =0.259, r =0.780). The daily dose of rhG-CSF was negatively correlated with the PBSC CD34⁺ cell ratio (r =-0.285). Both rhG-CSF agents achieved successful mobilization. Multivariate analysis showed that PB WBC count before collection was a factor affecting the count of PBSC nucleated cells (P <0.001), while the PB CD34⁺cell ratio before collection was a factor affecting the PBSC CD34⁺ cell ratio (P <0.001).CONCLUSIONThe mobilization and collection of PBSC from unrelated donors are good, and the PB WBC count and CD34⁺ cell ratio before collection are reliable indicators for predicting the collection effect.

01 Jun 2024·Molecular Therapy

CRISPR-Cas9n-mediated ELANE promoter editing for gene therapy of severe congenital neutropenia

Article

Author: Mir, Perihan ; Borbaran-Bravo, Natalia ; Dannenmann, Benjamin ; Xu, Yun ; Skokowa, Julia ; Ritter, Malte U ; Cathomen, Toni ; Lengerke, Claudia ; Kaufmann, Masako M ; Klimiankou, Maksim ; Arreba-Tutusaus, Patricia ; Zeidler, Cornelia ; Nasri, Masoud ; Welte, Karl

Severe congenital neutropenia (CN) is an inherited pre-leukemia bone marrow failure syndrome commonly caused by autosomal-dominant ELANE mutations (ELANE-CN). ELANE-CN patients are treated with daily injections of recombinant human granulocyte colony-stimulating factor (rhG-CSF). However, some patients do not respond to rhG-CSF, and approximately 15% of ELANE-CN patients develop myelodysplasia or acute myeloid leukemia. Here, we report the development of a curative therapy for ELANE-CN through inhibition of ELANE mRNA expression by introducing two single-strand DNA breaks at the opposing DNA strands of the ELANE promoter TATA box using CRISPR-Cas9D10A nickases-termed MILESTONE. This editing effectively restored defective neutrophil differentiation of ELANE-CN CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in vitro and in vivo, without affecting the functions of the edited neutrophils. CRISPResso analysis of the edited ELANE-CN CD34⁺ HSPCs revealed on-target efficiencies of over 90%. Simultaneously, GUIDE-seq, CAST-Seq, and rhAmpSeq indicated a safe off-target profile with no off-target sites or chromosomal translocations. Taken together, ex vivo gene editing of ELANE-CN HSPCs using MILESTONE in the setting of autologous stem cell transplantation could be a universal, safe, and efficient gene therapy approach for ELANE-CN patients.

100 Deals associated with Filgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA02	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	South Korea	Dong-A Pharmaceutical Co., Ltd.	07 Jun 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	Discovery	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Jun 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P304 (EBMT2023)	Not Applicable	Myeloid Tumor Maintenance	24	rhG-CSF+Decitabine	(fqwgfhbaxu) = yhrqirbzlu xxlzmqlawf (hsbyxfkoxh, 9.57 - NA)	-	23 Apr 2023
EHA2015	Not Applicable	-	29	Biosimilar filgrastim (Leucostim®)	mljadzlvsk(pnxociuyrb) = laeatxpuuy wvaievngma (qkynsqogll ) View more	-	21 May 2015
EHA2015	Not Applicable	-	29	Lenograstim (Granocyte®)	mljadzlvsk(pnxociuyrb) = mamstpycip wvaievngma (qkynsqogll ) View more	-	21 May 2015
ASCO2006	Phase 2	Non-small cell lung cancer stage III	22	Induction docetaxel/cisplatin with rhG-CSF	rpztnyioxj(smgodmwlhj) = iaravrhoje lsmioyvtuj (owrexvrhok ) View more	-	20 Jun 2006
ASCO2006	Phase 2	Non-small cell lung cancer stage III	22	Concurrent pulsed docetaxel chemoradiation	rpztnyioxj(smgodmwlhj) = oqbjycayvn lsmioyvtuj (owrexvrhok )	-	20 Jun 2006
ASCO2004	Phase 2	Non-small cell lung cancer stage III	15	Induction Docetaxel/Cisplatin with rhG-CSF	(vwlfccsaig) = ybwaqpjfyl huxmylpawn (hdesaexeqg )	-	15 Jul 2004

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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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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.

Regulation

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Filgrastim biosimilar(Dong-A Pharmaceutical Co., Ltd.)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation