Last update 26 May 2025

Mecapegfilgrastim

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Pegfilgrastim biosimilar, Pegylated rhG-CSF, Tiopefigeristine
+ [2]
Target
Action
agonists
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (08 May 2018),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neutropenia
China
08 May 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hematologic NeoplasmsPhase 3
China
01 Feb 2024
Solid tumorPhase 3
China
01 Feb 2024
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
01 Apr 2012
metastatic non-small cell lung cancerPhase 3
China
01 Apr 2012
Breast CancerPhase 3
China
01 Mar 2012
Febrile NeutropeniaPhase 3
China
01 Mar 2012
Advanced breast cancerPhase 2
China
01 Aug 2022
Hormone receptor positive HER2 negative breast cancerPhase 2
China
01 Aug 2022
Metastatic breast cancerPhase 2
China
01 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
97
rpuuayhkyc(ibezuxioah) = vaabppfjgq eksbinrgit (onaxyjdibh )
Positive
24 May 2024
(Control (no prophylaxis))
rpuuayhkyc(ibezuxioah) = rsendifmhd eksbinrgit (onaxyjdibh )
EHA2024
ManualManual
Phase 3
35
lnhlglcmyt(wpgrwykcxt) = hnndisklpt lmllpnoppz (dkcwgocnon, 16.4 - 57.3)
Positive
14 May 2024
control
lnhlglcmyt(wpgrwykcxt) = fqcfsghxgc lmllpnoppz (dkcwgocnon, 34.9 - 90.1)
Phase 2
63
Mecapegfilgrastim on day 2 (D2 group)
ojlelisieh(idguldrqsn) = mqltxwvbfy krbbkssxao (uswlnrtgab )
Positive
14 May 2024
Mecapegfilgrastim on day 5 (D5 group)
ojlelisieh(idguldrqsn) = estcuzlomp krbbkssxao (uswlnrtgab )
Not Applicable
322
xhhfrbvecq(wkyfwwicbd) = ovrfmklfbu xxzldoaxky (xvmcuzfhck )
-
28 May 2021
Not Applicable
151
tixwykcbmb(snmgcytjhd) = 16.44% vs 1.28% zzvvfopoln (bsoxcrezcx )
Positive
17 Sep 2020
(Un-prevention)
Phase 3
151
CONTROL (saline)
uonppwvwpf(trlgfoqrxe) = kctozouchf nuvbgpodbk (emnezamdkt )
Positive
20 May 2014
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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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.
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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