培非格司亭生物类似药（Cinfa Biotech SL）(Pegfilgrastim biosimilar (Cinfa Biotech SL)) - 药物靶点：CSF-3R_在研适应症：粒细胞减少性发热，中性粒细胞减少_专利_临床

概要

基本信息

药物类型

生物类似药、集落刺激因子

别名

Pegfilgrastim biosimilar、Pegfilgrastim biosimilar (Cinfa Biotech)、Pegylated granulocyte colony stimulating factor

+ [3]

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

粒细胞减少性发热中性粒细胞减少

非在研适应症-

原研机构

Cinfa Biotech SL

在研机构

Mundipharma International Ltd.

非在研机构

Purdue Pharma, Inc.

Cinfa Biotech SL

最高研发阶段批准上市

首次获批日期

欧盟 (2018-11-20),

粒细胞减少性发热中性粒细胞减少

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4190

当前序列信息引自: *****

关联

3

项与培非格司亭生物类似药（Cinfa Biotech SL）相关的临床试验

KCT0002985 / Not yet recruiting临床2期IIT

Open-labeled, multicenter phase II study of prophylactic administration of pegylated granulocyte colony-stimulating factor in relapsed or refractory multiple myeloma who received pomalidomide/dexamethasone-containing regimens

开始日期2018-08-01

申办/合作机构-

JPRN-jRCTs051180232 / Completed临床2期IIT

Docetaxel plus Ramucirumab with pegylated granulocyte-colony stimulating factor support for elderly patients with advanced non-small cell lung cancer: A multicenter prospective single arm phase II study (WJOG9416L) - DOC+RAM+PEG-G-CSF in elderly NSCLC (WJOG9416L)

开始日期2018-03-28

申办/合作机构-

NCT02912377 / Completed临床1期

Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects

Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects

开始日期2016-09-01

申办/合作机构

Cinfa Biotech SL

100 项与培非格司亭生物类似药（Cinfa Biotech SL）相关的临床结果

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100 项与培非格司亭生物类似药（Cinfa Biotech SL）相关的转化医学

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100 项与培非格司亭生物类似药（Cinfa Biotech SL）相关的专利（医药）

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36

项与培非格司亭生物类似药（Cinfa Biotech SL）相关的文献（医药）

2024-12-01·Current Research in Translational Medicine

The transplantation effect of pegylated granulocyte colony-stimulating factor mobilized hematopoietic stem cells may be superior to that of G-CSF mobilized hematopoietic stem cells in haploidentical allogeneic hematopoietic cell transplantation

Article

作者: Pei, Renzhi ; Zhuang, Xianxu ; Lu, Ying ; Li, Shuangyue ; Liu, Xuhui ; Chen, Dong ; Ye, Peipei ; Du, Xiaohong ; Cao, Junjie

Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells have become the preferred source of hematopoietic stem cells. We compared the effectiveness of G-CSF and pegylated G-CSF (peg-G-CSF) for hematopoietic stem cell mobilization in haploidentical hematopoietic stem cell transplantation (haplo-HSCT) donors, and evaluated the transplant outcomes. We conducted a matched retrospective cohort study. Donors mobilized with peg-G-CSF (n = 70) and G-CSF (n = 70). 140 consecutive patients diagnosed with acute leukemia who underwent haplo-HSCT were included in this study. The findings revealed that the peg-G-CSF cohort exhibited significantly elevated myeloid-derived suppressor cells (MDSCs) levels in their grafts when compared to the G-CSF cohort (P < 0.001). The 100-day cumulative incidence (CI) of grade III-IV acute graft-versus-host disease (GVHD) and 1-year CI of moderate-to-severe chronic GVHD were 4.3% vs 14.3 % (P = 0.047) and 11.2% vs 27.4 % (P = 0.023), in the peg-G-CSF group and G-CSF group. Patients reveiving mobilized stem cell with peg-G-CSF had a significantly greater likelihood of 1-year GVHD-free relapse-free survival (GRFS) compared to patients reveiving mobilized stem cell with G-CSF (74.9% vs 37.9 %, P < 0.001). The higher graft MDSCs proportion was associated with lower grade II-IV aGVHD, cGVHD (P < 0.05) and higher GRFS in the univariate analysis (P < 0.05). Multivariate analysis showed that MDSCs proportion higher than 11.36 % (HR, 0.305; 95 % CI, 0.154-0.606; P = 0.001) and peg-G-CSF for stem cell mobilization (HR, 0.466; 95 % CI, 0.251-0.865; P = 0.016) were independent prognostic factors of GRFS. The superior survival rates observed in recipients of peg-G-CSF-mobilized cells are likely due to reduced acute GVHD, potentially mediated by the increased MDSCs within the grafts.

2023-10-01·JTO clinical and research reports

Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L).

Article

作者: Ota, Keiichi ; Tachihara, Motoko ; Wakuda, Kazushige ; Nakamura, Atsushi ; Miura, Satoru ; Tokito, Takaaki ; Takayama, Yusuke ; Sato, Yuki ; Okada, Hideaki ; Toyozawa, Ryo ; Watanabe, Hiroshi ; Hata, Akito ; Yamamoto, Nobuyuki ; Nakagawa, Kazuhiko ; Tabata, Eriko ; Shimokawa, Mototsugu ; Hara, Satoshi

IntroductionDocetaxel plus ramucirumab could be a promising treatment for chemo-naive elderly patients with NSCLC, but high incidence of febrile neutropenia (FN) is a critical concern. We thus adopted a routine primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF) to reduce FN and maximize the efficacy of docetaxel plus ramucirumab in elderly patients.MethodsThis is a single arm phase 2 trial for chemo-naive elderly patients (aged ≥75 y) with advanced NSCLC. Docetaxel (60 mg/m², d 1) plus ramucirumab (10 mg/kg, d 1) with PEG-G-CSF (3.6 mg, d 2) was administered every 3 weeks until progression. The primary end point was overall response rate (ORR) (expected ORR: 35%).ResultsBetween February 2018 and January 2021, 54 patients were enrolled. Median age was 78 (range: 75-86). A total of 21 (38.9%) partial response, 22 (40.7%) stable disease, nine (16.7%) progressive disease, and two (3.7%) not assessable were confirmed, resulting in ORR of 38.9% (90% confidence interval [CI]: 27.7%-51.0%) and disease control rate of 79.6%. Median progression-free survival and overall survival were 5.2 (95% CI: 4.2-6.9) and 12.7 (95% CI: 10.2-18.9) months, respectively. There were one (1.9%) FN, two (3.7%) bleeding grade greater than or equal to 3, and one (1.9%) treatment-related death (pneumonitis). Pneumonitis occurred in five patients (9.3%). Main adverse events grade greater than or equal to 3 were observed: four (7%) thrombocytopenia; three (5.6%) neutropenia; six (11.1%) hyposodium; five (9.3%) infection; five (9.3%) hypertension; four (7.4%) anorexia; and three (5.6%) oral mucositis.ConclusionsDocetaxel plus ramucirumab with PEG-G-CSF revealed efficacy and safety for chemo-naive elderly patients with NSCLC. Primary prophylactic PEG-G-CSF highly prevented FN.

2023-08-01·Clinical Pharmacology in Drug Development

Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor

Article

作者: Taro, Shimizu ; Nakamura, Shingen ; Abe, Masahiro ; Goda, Mitsuhiro ; Kitahara, Takashi ; Ishizawa, Keisuke ; Ishida, Tatsuhiro ; Ando, Hidenori ; Okada, Naoto

AbstractPolyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half‐life and efficacy. We previously reported that the PEGylated granulocyte colony‐stimulating factor (PEG‐G‐CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti‐PEG antibody titers and the clinical impact of PEG‐G‐CSF in 19 hematological patients. A gradual decrease of anti‐PEG antibody titers from baseline was observed after PEG‐G‐CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG‐G‐CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut‐off values of pretreated anti‐PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6 U/mL, respectively. All patients who experienced noninfectious fever had anti‐PEG antibody titers above this cut‐off value (P = .033). An enzyme‐linked immunosorbent assay revealed that some anti‐PEG antibodies in patients with anti‐PEG antibody titers above the cut‐off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti‐PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti‐PEG antibodies and the development of adverse events after PEG‐G‐CSF administration.

100 项与培非格司亭生物类似药（Cinfa Biotech SL）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06889	-	L03AA13	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
粒细胞减少性发热	冰岛	Mundipharma International Ltd.	2018-11-20
粒细胞减少性发热	列支敦士登	Mundipharma International Ltd.	2018-11-20
粒细胞减少性发热	挪威	Mundipharma International Ltd.	2018-11-20
粒细胞减少性发热	欧盟	Mundipharma International Ltd.	2018-11-20
中性粒细胞减少	冰岛	Mundipharma International Ltd.	2018-11-20
中性粒细胞减少	欧盟	Mundipharma International Ltd.	2018-11-20
中性粒细胞减少	列支敦士登	Mundipharma International Ltd.	2018-11-20
中性粒细胞减少	挪威	Mundipharma International Ltd.	2018-11-20