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pegfilgrastim (Peijin / Paijin)

✓ Approved

Xiamen Amoytop Biotech Co.ltd · CSF3R · 重组蛋白

什么是 pegfilgrastim？

pegfilgrastim 是一种重组蛋白，由Xiamen Amoytop Biotech Co.ltd研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名Peijin, Paijin
公司Xiamen Amoytop Biotech Co.ltd
药物类别重组蛋白
分子靶点CSF3R
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Xiamen Amoytop Biotech Co.ltd

作用机制

分子靶点

pegfilgrastim 作用于 1 个分子靶点：

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

pegfilgrastim 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Blood and lymphatic system disordersBone marrow disorder✓ Approved
Blood and lymphatic system disordersNeutropeniaPhase II

相关研究文献

PubMedEClinicalMedicine2026-08-02

Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China.

Guo Zihan Z, Hu Jinwei J, Mo Miao M, Wang Mengmeng M et al.

Long-acting granulocyte colony-stimulating factors (G-CSFs) are the standard of care for primary prophylaxis against chemotherapy-induced neutropenia in breast cancer, but comparative data remain limited. This prospective observational cohort study was conducted at a single center in Shanghai, China. Patients with breast cancer scheduled for high-febrile-neutropenia-risk chemotherapy and planned for long-acting G-CSF primary prophylaxis were eligible. Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice. The primary outcome was the incidence of grade 3/4 neutropenia (leukopenia), assessed during chemotherapy cycles and at follow-up visits. Safety was assessed via bone pain-related treatment-emergent adverse events (BPR TEAEs). Between March 25 and September 30, 2025, 407 patients were analyzed. Grade 3/4 neutropenia (leukopenia) occurred in 24.1%, varying numerically across agents (telpegfilgrastim 30.2%, mecapegfilgrastim 16.4%; overall P = 0.061). After multivariable adjustment, telpegfilgrastim was associated with a higher risk of grade 3/4 neutropenia (leukopenia) versus mecapegfilgrastim (OR = 2.46, P = 0.011). BPR TEAEs occurred in 62.4%, with similar incidence across groups (P = 0.32). Lower BPR TEAE risk was associated with ddEC chemotherapy (OR = 0.32, P = 0.0010) and postmenopausal status (OR = 0.53, P = 0.031). In exploratory analyses, administration at 24-48 h (versus <24 h) was associated with lower grade 4 neutropenia (leukopenia) (9.9% versus 27.3%, P = 0.011) and severe BPR TEAEs (0.5% versus 4.5%, P = 0.032), and a 3 mg pegfilgrastim dose was associated with comparable myeloprotection to 6 mg (29.4% versus 26.5%, P = 0.81) but fewer BPR TEAEs (29.4% versus 60.3%, P = 0.022). All four long-acting G-CSFs demonstrated clinical efficacy. Numerical variations and adjusted analyses indicated distinct clinical profiles, supporting tailored prophylaxis. Optimizing administration timing and considering dose reduction could improve benefit-risk balance. Larger prospective studies are needed to confirm these exploratory findings. None.

PMID 42541270
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PubMedHematology, transfusion and cell therapy2026-07-31

Improving engraftment in autologous hematopoietic stem cell transplantation: comparing pegfilgrastim with filgrastim in an outpatient setting.

Gutierrez-Aguirre Cesar Homero CH, la Garza-Salazar Fernando De F, Gómez-Almaguer David D, Jaime-Pérez José Carlos JC et al.

Febrile neutropenia, a frequent complication in patients undergoing autologous stem cell transplantation, increases morbidity and hospitalization costs. The aim of this study was to compare the efficacy of two formulations of pegylated filgrastim with filgrastim in patients who received autologous stem cell transplantation as outpatients for lymphoma or myeloma. Thirty patients were randomized to receive a single 6 mg dose of either reference or biosimilar pegfilgrastim on Day +1. A retrospective Control Group of fifty-three patients who received filgrastim was included. The median times to neutrophil engraftment were 10, 9 and 11 days for the innovator pegfilgrastim, biosimilar pegfilgrastim (p-value = 0.14), and filgrastim (p-value = 0.0001), respectively. The median times to platelet engraftment were 10 days for both of the pegfilgrastim groups and 12 days for the filgrastim group (p-value = 0.0001). Febrile neutropenia incidence was lower in the pegfilgrastim group (6.7%) than in the filgrastim group (24.5%; p-value = 0.04). Cost analysis showed higher costs for the innovator pegfilgrastim, with filgrastim having the lowest cost of the three formulations. The innovator and the biosimilar pegfilgrastim demonstrated similar efficacy in engraftment speed and febrile neutropenia incidence. Pegfilgrastim was associated with faster engraftment, a lower incidence of platelet transfusion, and a lower incidence of febrile neutropenia.

PMID 42531780
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PubMedImmunotherapy advances2026-07-25

Growth factor supportive care for chemotherapy-induced neutropenia suppresses antitumour immunity in checkpoint blockade-responsive pancreatic cancer.

Parent Brendan D BD, Kelly Anthony E AE, Hoffman Megan T MT, Dougan Michael M et al.

Growth factors, including granulocyte colony-stimulating factor (G-CSF; pegfilgrastim, filgrastim), are used for prophylaxis or treatment of chemotherapy-induced neutropenia, yet their effects on antitumour immunity remain incompletely understood. We previously found that serum from patients with pancreatic ductal adenocarcinoma (PDAC) treated with multiagent chemotherapy plus G-CSF drove differentiation of T cell-suppressive monocytes in vitro, suggesting that supportive care interventions may shape immune responses in this disease. We evaluated the immunologic and therapeutic impact of G-CSF in two murine PDAC models that differ in their baseline frequencies of infiltrating T cells and in their responsiveness to checkpoint blockade immunotherapy. In poorly immunogenic, T-cell-low tumours, use of G-CSF did not affect tumour growth or response to chemo- or immunotherapy, although neutrophil recovery was improved in mice receiving FOLFIRINOX and G-CSF compared to chemotherapy alone. In immunogenic tumours with a robust endogenous T-cell response, combination anti-PD1 and anti-CTLA-4 therapy resulted in durable tumour clearance. Combination with G-CSF diminished the effectiveness of checkpoint blockade and resulted in significantly fewer cured mice. G-CSF, commonly used for supportive care with FOLFIRINOX and other chemotherapy regimens, induces systemic immune suppression that can reduce the efficacy of T-cell-targeting immunotherapies.

PMID 42500327
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PubMedTransfusion medicine reviews2026-07-24

Efficacy and Safety of Pegfilgrastim for Hemopoietic Stem Cell Mobilization in Healthy Donors: A Systematic Review and Meta-Analysis.

Bennani Aymane A, Benmansour El Khalil EK, Sadki Ikram I, Aqodad Zahida Z et al.

Our study aims to determine the efficacy and the safety of pegfilgrastim for hematopoietic stem cell mobilization in healthy donors undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). PubMed, Scopus and CENTRAL (Cochrane Central Register of Controlled Trials) databases were systematically searched for eligible studies. Meta-analysis of proportions (for dichotomous outcomes) and meta-analysis of single means (for continuous data) were performed using a random-effects model. Heterogeneity was assessed using I2 statistics. A subgroup and leave-one-out sensitivity analyses were also conducted. The ROBINS-I tool was used for risk of bias assessment. R software (version 4.4.2) was used for all statistical analyses. PROSPERO registry number CRD420251015182. Seven studies were included. Following a single pegfilgrastim administration, 67% of donors achieved the target mobilization threshold of ≥4 × 10⁶ CD34⁺ cells/kg in one apheresis session (95% CI: 47%-85%). In the 12 mg subgroup, mobilization success increased to 76% (95% CI: 70%-81%). Circulating CD34+ progenitors reached a mean peak of 72.04/µL (95% CI: 50.69-102.37), increasing to 83.30/µL (95% CI: 73.11-94.91) with 12 mg dosing. The grafts yielded a mean of 6.75 × 10^6 CD34+ cells/kg recipient weight (95% CI: 5.12-8.89), rising to 7.95 × 10^6 CD34+ cells/kg (95% CI: 6.10-10.36) in the 12 mg dosing. Bone pain (76%; 95% CI: 51%-97%) and headaches (37%; 95% CI: 23%-53%) were the most reported side effects. Pegfilgrastim demonstrates favorable efficacy and tolerability for stem cell mobilization in healthy donors undergoing allo-HSCT. The 12 mg dose appears to be the most appropriate dose for achieving optimal mobilization outcomes.

PMID 42492155
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PubMedClinical and translational science2026-07-21

Anti-PEG Antibodies From mRNA COVID-19 Vaccines Affect In Vitro Measurements of Pegylated Drug Levels.

Svyatova Elizaveta A EA, Liu Zhuoming Z, Becker Robyn E RE, Sung Jungeun M JM et al.

The recent adoption of mRNA-based technology for vaccine development has led to widespread exposure to new vaccine components, such as polyethylene glycol (PEG), against which antibodies may be made. This study assesses the presence of anti-PEG antibodies in human serum following SARS-CoV-2 vaccination, and if these antibodies could interfere with drug level assessment of PEG containing drugs. Elevated anti-PEG antibody titers with prolonged prevalence were detected in individuals who received the mRNA-1273 vaccine as compared to control samples. Anti-PEG antibody levels were approximately 10-fold higher post-vaccination compared to pre-vaccination in approximately 33% of assessed mRNA-1273 vaccine recipients. Elevated anti-PEG antibody levels persisted for over 6 months. Serum from those who received the BNT162b2 or Ad26.COV2.S vaccines had anti-PEG antibody levels similar to control samples. Serum from individuals with elevated anti-PEG antibodies, regardless of study group, typically showed decreased detection of the pegylated drug, pegfilgrastim. This study demonstrates that anti-PEG antibodies have the potential to interfere with bioanalytical assays used for pharmacokinetic drug measurement during the development of pegylated pharmaceutical products, as well as during the establishment of comparability to pegylated reference products during development of biosimilar drug products.

PMID 42477513
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PubMedClinical and translational science2026-07-09

Advancing PEGylated Drug Evaluation: A Novel Approach to Pegfilgrastim Pharmacokinetic Assessment.

Svyatova Elizaveta E, Shi Da D, Shah Ankit A, Howard Kristina E KE

Addition of polyethylene glycol (PEG), or PEGylation, is a modification that extends the half-life of drug products, thereby reducing the frequency of dosing. However, PEGylation can pose challenges for biosimilar drug development, as replicating the reference product's PEG characteristics to achieve similarity to the reference product's pharmacokinetics (PK) can be difficult. A few biosimilar product submissions have highlighted issues with PK assays, potentially contributing to failures in PK similarity assessment. With many approved PEGylated protein therapeutics soon becoming eligible for biosimilar development, developing alternative methods for PK assessment that can be applied across multiple product categories may help to facilitate a more efficient biosimilar development program. We previously validated an ELISA-based method and observed significant variability even in samples prepared with known drug concentrations. We decided that a cell-based assay (CBA) might offer greater translatability to other PEGylated products. CBAs rely on cells with receptors for the drug product being tested, and the choice of cell line would vary depending on the specific drug product. In this study, we utilized pegfilgrastim, a PEGylated granulocyte-colony stimulating factor (G-CSF) product, for PK determination using the CBA method. This proof-of-concept study demonstrates that while the sensitivity of the CBA is lower than that of the validated ELISA, its ability to capture receptor-accessible drug provides an important advantage for pharmacokinetic assessment. Moreover, it exhibits good reproducibility and can be read using a 96-well platform. This CBA approach may be a viable option for the rapid development of PK assays for other PEGylated drug products.

PMID 42420781
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