Delving into the Latest Updates on TBO-Filgrastim with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Biograstim (Teva), filgrastim, Filgrastim biosimilar

+ [14]

Target

CSF-3R

Action

agonists

Mechanism

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

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesOther Diseases

Active Indication

Acute Myeloid LeukemiaStem cell mobilisationChemotherapy-Induced Febrile Neutropenia+ [2]

Inactive Indication-

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization

ratiopharm GmbHNichi-Iko Gifu Plant Co., Ltd.Teva Baltics UAB

+ [1]

Inactive Organization

AbZ-Pharma GmbH

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (15 Sep 2008),

Chemotherapy-Induced Febrile NeutropeniaCyclic NeutropeniaNeutropenia

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.

Start Date07 Sep 2021

Sponsor / Collaborator

Stanford University

[+1]

NCT05573386

/ CompletedNot ApplicableIIT

A Single Center, Prospective Study to Compare the Quality and Quantity of the Cellular Content of M-PRP Harvested After Peripheral Mobilization of Progenitor Cells Using Filgrastim Versus Pegfilgrastim

The goal of this prospective, observational study is to compare the quality and quantity of the cellular content of platelet-rich plasma harvested after administering one of two cell-stimulating proteins, filgrastim and pegfilgrastim. The main question it aims to answer is:
• Will participants have a similar cellular content when comparing a 4-day filgrastim treatment to a one-day pegfilgrastim treatment?
Participants will have the following intervention administered:
* 130mL of blood will be drawn on the first visit after consent and in followup visits after administering treatment (4 days for filgrastim, 7 days for pegfilgrastim)
* Half of all participants will receive filgrastim first, followed by pegfilgrastim 8 weeks after filgrastim treatment concludes. The other half will receive the treatments in reverse order
Researchers will compare the quality and quantity of cell content after each treatment administration as well as comparing differences in data dependent on which order treatment was given.

Start Date09 Aug 2021

Sponsor / Collaborator

Andrews Research & Education Foundation, Inc.

NCT03029000

/ TerminatedPhase 3

A Single-Arm Study of the Effect of a 5-day Regimen of Tbo-Filgrastim 10 mcg/kg of Body Weight Administered Subcutaneously on Peripheral Stem Cell Mobilization in Healthy Donors

A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.

Start Date02 Aug 2017

Sponsor / Collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

100 Clinical Results associated with TBO-Filgrastim

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100 Translational Medicine associated with TBO-Filgrastim

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100 Patents (Medical) associated with TBO-Filgrastim

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47

Literatures (Medical) associated with TBO-Filgrastim

01 Jan 2024·Journal of managed care & specialty pharmacy

Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019

Article

Author: Anderson, Gerard ; Socal, Mariana ; Xuan, Andrew ; Anderson, Kelly E ; Liu, Angela

BACKGROUND:

Medicare Advantage (MA) and Traditional Medicare face different financing structures and incentives and may implement different strategies to encourage biosimilar uptake. Strategies used by health insurers can influence biosimilar uptake, which can in turn promote savings to insurers and patients.

OBJECTIVE:

To compare filgrastim and infliximab biosimilar uptake between MA and Traditional Medicare from 2016 to 2019 and examine biosimilar uptake by different MA carriers and plan types (Health Maintenance Organization [HMO] or Preferred Provider Organization).

METHODS:

We use a 2016-2019 nationally representative random 20% sample of the carrier (physician) and outpatient paid claims for Traditional Medicare data and final-action carrier and outpatient records for MA data. We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis).

RESULTS:

From their introduction, there was consistently greater uptake of filgrastim and infliximab biosimilars in MA compared with Traditional Medicare. By Q4 2019, filgrastim biosimilar uptake was 7.6 percentage points higher in MA (80.3%) than Traditional Medicare (72.7%). By Q4 2019, infliximab biosimilar uptake was 28.7% and 15.4% in MA and Traditional Medicare, respectively. Kaiser HMO plans were primarily responsible for the higher uptake of biosimilars in MA; in Q4 2019, filgrastim and infliximab biosimilar uptake was 98.8% and 78.8%, respectively.

CONCLUSIONS:

Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs.

24 Feb 2023·Cureus

The Impact of Granulocyte Colony-Stimulating Factor Administration in a Neutropenic Cancer Patient With COVID-19-Related Acute Respiratory Distress Syndrome

Author: Mahmood, Rabia ; Zavoshi, Shirin ; Gidda, Harish ; Mohamed, Ayman

Chemotherapy-induced neutropenia is a serious adverse effect found in cancer patients treated with chemotherapy. As these patients are at risk of infections, granulocyte colony-stimulating factors (G-CSF) are commonly used in these patients to increase neutrophil counts. This report describes a case of a 73-year-old female with metastatic breast cancer treated with letrozole and palbociclib who presented to the hospital with flu-like symptoms and a positive SARS-CoV-2 test. She was saturating well on room air without the need for supplemental oxygen initially, however, she was febrile and lab work revealed neutropenia. Subsequently, she was given two doses of Tbo-filgrastim. Her respiratory status deteriorated shortly afterward and she required supplemental oxygen. The chest X-ray obtained at that time revealed increased atelectasis or infiltration in the middle and lower lung fields, and computed tomography angiography of the chest revealed bilateral patchy airspace and ground glass opacities. The timeline from symptom onset along with her imaging findings suggested COVID-19-related acute respiratory distress syndrome (ARDS) as a possible explanation for her respiratory status decline. Interestingly, her neutrophil-to-lymphocyte ratio (NLR) had consistently increased, along with her respiratory status deterioration, after the completion of the two doses of G-CSF. The patient was treated with dexamethasone. Her respiratory status eventually improved prior to discharge.

01 Oct 2022·Journal of clinical apheresis

Is split‐dose better than single‐dose? Results of Turkish Stem Cell Coordination Center (TURKOK) donors in the era of rising biosimilar G‐CSF

Article

Author: Orhan, Bedrettin ; Durgut, Himmet ; Ersal, Tuba ; Özkocaman, Vildan ; Gürsoy, Vildan ; Dakiki, Bahar ; Yalçın, Cumali ; Özkalemkaş, Fahir ; Candar, Ömer ; Pınar, İbrahim Ethem ; Ali, Rıdvan

Abstract:

Background:

Turkish Stem Cell Coordination Center (TURKOK) carries out the procurement process of unrelated allogeneic hematopoietic stem cells in Turkey. This study aims to compare the efficacy of both once‐daily and divided‐dose G‐CSF administration and the original and biosimilar G‐CSF use and the frequency and severity of adverse events in TURKOK donors.

Method:

The study was conducted retrospectively with 142 healthy TURKOK donors. For PBSC mobilization, two different subcutaneous G‐CSF programs were used as 10 μ/kg/day single‐dose and 5 μ/kg/12 h. Neupogen (Amgen, Puerto Rico) and Tevagrastim (Teva, Kfar Saba, Israel) were used as G‐CSF. All donors started apheresis on the fifth day, and all side effects were recorded during the procedure.

Results:

Stem cell yield was similar between single‐dose and divided‐doses based on donor weight, favoring the split‐dose based on recipient weight (P = .506 and P = .023, respectively). Both G‐CSF posologies were comparable if the target CD34+ cell yield was ≥4 × 106/kg. CD34+ cell yield was equivalent when evaluated against recipient weight, significantly favoring Tevagrastim vs Neupogen by donor weight (P = .740 and P = .021, respectively). Side effects, duration of pain, and need for analgesia favor Tevagratim over Neupogen.

Conclusion:

Split‐dose may be recommended for cases where the need for large numbers of CD34+ cells to be harvested is anticipated due to significant cell yield relative to recipient weight. However, sufficient hematopoietic stem cells can be collected with both posology. Tevagrastim is non‐inferiority effective to Neupogen. Side effects during administration are both low‐grade and temporary.

2

News (Medical) associated with TBO-Filgrastim

13 Feb 2024

·www.businesswire.com

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study. Evolution in Therapeutic Care Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant. The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance. What You Will Learn Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors. Assesses key markets, market dynamics, and market demographics. Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments. Provides market data and forecasts. Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations Assesses the importance of alliances and partnerships on drug product commercialization. Evaluates the impact of economic, technology, and regulatory factors Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/bktosb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ASH

09 Feb 2024

·www.prnewswire.com

Injectable Hematology Growth Factors Report: Shift in As-Supplied Packaging from Single and Multi-use Vials to Prefilled Injection Devices will Accelerate over the Next Five Years

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration. The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change. Key Highlights from the Report: An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems. Insight into market dynamics and demographics, underpinning industry growth. An evaluation of therapeutic demand drivers across pivotal segments in healthcare. Comprehensive market data and forecast trends to inform strategic decisions. Profiles of sector participants including business strategies and corporate associations. An assessment of how alliances and partnerships affect the commercialization of drug products. Insights into the economic, technological, and regulatory factors impacting the market. Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment. The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods. Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care. Discover the Future of Injectable Hematology Treatments As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward. Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them. Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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100 Deals associated with TBO-Filgrastim

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External Link

KEGG	Wiki	ATC	Drug Bank
D03235	-	L03AA02	DB00099

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	Japan	Nichi-Iko Gifu Plant Co., Ltd.	28 Feb 2013
Stem cell mobilisation	Japan	Nichi-Iko Gifu Plant Co., Ltd.	28 Feb 2013
Chemotherapy-Induced Febrile Neutropenia	European Union	ratiopharm GmbH	15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia	Iceland	ratiopharm GmbH	15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia	Liechtenstein	ratiopharm GmbH	15 Sep 2008
Chemotherapy-Induced Febrile Neutropenia	Norway	ratiopharm GmbH	15 Sep 2008
Cyclic Neutropenia	European Union	Teva GmbH	15 Sep 2008
Cyclic Neutropenia	Iceland	Teva GmbH	15 Sep 2008
Cyclic Neutropenia	Liechtenstein	Teva GmbH	15 Sep 2008
Cyclic Neutropenia	Norway	Teva GmbH	15 Sep 2008
Neutropenia	European Union	Teva GmbH	15 Sep 2008
Neutropenia	European Union	AbZ-Pharma GmbH	15 Sep 2008
Neutropenia	European Union	ratiopharm GmbH	15 Sep 2008
Neutropenia	Iceland	AbZ-Pharma GmbH	15 Sep 2008
Neutropenia	Iceland	ratiopharm GmbH	15 Sep 2008
Neutropenia	Iceland	Teva GmbH	15 Sep 2008
Neutropenia	Liechtenstein	ratiopharm GmbH	15 Sep 2008
Neutropenia	Liechtenstein	AbZ-Pharma GmbH	15 Sep 2008
Neutropenia	Liechtenstein	Teva GmbH	15 Sep 2008
Neutropenia	Norway	Teva GmbH	15 Sep 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02112045 (CTgov)	Phase 2	Multiple Myeloma	90	Autologous Stem Cell Transplant (ASCT)+melphalan+Granix (Experimental: Granix and High Dose Melphalan (HDM))	zujpxvqudn = lolvhgpurv nvgtwopzff (wncunygbyl, zhpkaqpcuj - ihxukbjbxp) View more	-	07 Jan 2019
				Autologous Stem Cell Transplant (ASCT)+melphalan (Control: High Dose Melphalan (HDM))	zujpxvqudn = qosetujrdg nvgtwopzff (wncunygbyl, jznieqhmqx - tumqzjkvlv) View more
NCT03029000 (GRANIX, CTgov)	Phase 3	-	1	Tbo-filgrastim	vzxcigkqcl = lsfamhsbot zlvdeyfekx (aqgmoonbbt, patkvfjglb - mhfkvdqqns) View more	-	14 Dec 2018
NCT02190721 (CTgov)	Phase 2	Solid tumor \| Neutropenia	50	Tbo-filgrastim+CTX (Infants (1 Month to <2 Years))	hhvtixadwh = byifdclsjj zfoqcosjzx (htyjzzshrh, rjhtmnkvko - teyedibmlj) View more	-	31 Jul 2018
				Tbo-filgrastim+CTX (Children (2 to <12 Years))	hhvtixadwh = mwzvmcngma zfoqcosjzx (htyjzzshrh, hqajyyizvp - xhmnfxjpjw) View more
NCT02098109 (Pubmed \| Biol Blood Marrow Transplant)	Phase 2	Multiple Myeloma \| Non-Hodgkin Lymphoma	97	Tbo-Filgrastim	pgdukdfqcs(exwwqkjjgs) = siclrmflhx jagjdmdgsp (ngsgyopsdu )	Positive	01 Dec 2017
				Filgrastim	pgdukdfqcs(exwwqkjjgs) = hjgluvmaiq jagjdmdgsp (ngsgyopsdu )
NCT02098109 (CTgov)	Phase 2	Multiple Myeloma	100	Stem Cell Transplant+Plerixafor+XM02 Filgrastim (XM02 Filgrastim (Granix) and Plerixafor)	woyibshtvh(gefkebskha) = xnbmhyjeau owzqhwqhuh (vbapfmrnwh, 6.7) View more	-	18 Jul 2017
				Stem Cell Transplant+Filgrastim+Plerixafor (Filgrastim (Neupogen) and Plerixafor)	woyibshtvh(gefkebskha) = xjmuwpveqq owzqhwqhuh (vbapfmrnwh, 6.8) View more
Phase II Trial (Tandem Meetings ASTCT and CIBMTR2017)	Phase 2	Stem cell mobilisation	97	Tbo-Filgrastim	jqkvxmatkm(akrveihako) = ssfnnxltzr exzizdrodu (uebdbbppem, 10.3 - 12.9) View more	Positive	01 Mar 2017
				Filgrastim	jqkvxmatkm(akrveihako) = ymtcolaozh exzizdrodu (uebdbbppem, 8.8 - 11.3) View more
Tandem Meetings ASTCT and CIBMTR2015	Not Applicable	Hematopoietic stem cell transplantation	148	Tbo-filgrastim	osmhztydxd(grmktyzqkn) = kqcrhaqjgs nodeqrtroy (mctnstcojt ) View more	Positive	01 Feb 2015
				Filgrastim	osmhztydxd(grmktyzqkn) = wruykowcft nodeqrtroy (mctnstcojt ) View more
EUCTR2004-001452-36-LT \| EUCTR2004-001450-84-HU \| EUCTR2004-001449-13-LT (ASCO2013)	Phase 3	Chemotherapy-Induced Febrile Neutropenia	677	tbo-filgrastim	czaooqxlzq(pupcyzekmx) = yjfsvmxzpc mmhiefbqmx (gkaboqwnqy ) View more	-	20 May 2013

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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.

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