预约演示
更新于：2025-11-21
Benegrastim
艾贝格司亭α
更新于：2025-11-21
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-05-06), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 140357
来源: *****
关联
25
项与 艾贝格司亭α 相关的临床试验NCT07187908
A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
NCT06649448
A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.
NCT06251947
A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial
100 项与 艾贝格司亭α 相关的临床结果
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100 项与 艾贝格司亭α 相关的转化医学
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100 项与 艾贝格司亭α 相关的专利（医药）
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7
项与 艾贝格司亭α 相关的文献（医药）2025-11-01Clinical Drug Investigation
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Efbemalenograstim Alfa (F-627), a Novel Long-Acting rhG-CSF, in Healthy Chinese Participants: An Open-Label, Single-Center Phase I Study
Article
作者: Yao, Wei ; Hou, Denny ; Chen, Jianmin ; Song, Linda ; Wang, Xiaoyan ; Zhao, Xingna ; Wang, Shufang ; Li, Renshu ; Cao, Zhihai ; Chu, Xiaoxiang ; Tang, Zhengwei ; Hu, Wei ; Li, Yao ; Zhang, Gaochong
BACKGROUND AND OBJECTIVES:
In clinical practice, granulocyte colony-stimulating factor (G-CSF) is often used to lower infection risk and avoid poor outcomes from chemotherapy dose reduction or delay. Efbemalenograstim alfa (also known as F-627) is a non-pegylated but long-acting (once-per-cycle) recombinant human granulocyte colony-stimulating factor (rhG-CSF) compared with pegfilgrastim. This study was designed to obtain pharmacokinetic (PK)/pharmacodynamic (PD), safety, and tolerability data for F-627 in healthy Chinese participants.
METHODS:
This was a single-center, open-label phase I clinical study involving 24 healthy Chinese volunteers (sex ratio = 1:1). All the participants were administered a single subcutaneous injection of 20 mg F-627 into the abdomen.
RESULTS:
In this study, 15 (62.5%) participants reported 28 treatment-related adverse events. PK/PD data showed that after a single 20 mg subcutaneous (SC) F-627 abdominal injection in healthy Chinese participants, serum concentrations peaked at 36 h post dose, while the absolute neutrophil count (ANC) peaked at 96 h. After peaking, F-627 serum levels decreased rapidly to low concentrations by 120 h, while ANC declined gradually to near baseline by day 15. Similar trends in serum concentration and ANC kinetics were seen between sex.
CONCLUSIONS:
This phase I study showed that 20 mg F-627 was well tolerated and exhibited a favorable safety profile in a healthy Chinese population. The PK and PD data correlated well and were consistent across sex.
TRIAL REGISTRATION:
This trial was registered at the Chinese Clinical Trial Registry (chictr.org.cn) on 10 September 2024 (registration ID: ChiCTR2400089548).
2025-11-01Clinical Drug Investigation
Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial
Article
作者: Liu, Xiaoan ; Yao, Wei ; Yan, Xi ; Hou, Denny ; Cai, Dongyan ; Ye, Changsheng ; Xu, Xiaohong ; Wang, Haibo ; Li, Hongsheng ; Jiang, Hongchuan ; Wang, Shufang ; Cui, Shude ; Nie, Jianyun ; Lu, Jinsong ; Yang, Hongjian ; Ji, Dongmei ; Wang, Xiaoyan ; Cao, Junning ; Yi, Jilin
BACKGROUND AND OBJECTIVES:
Neutropenia is the most severe hematologic toxicity of myelosuppressive chemotherapy. The objective of this study was to evaluate the safety and efficacy of efbemalenograstim alfa versus filgrastim for neutropenia support in patients with breast cancer receiving myelosuppressive chemotherapy and find the recommended dose for phase III clinical trials.
METHODS:
This was an open-label, dose-finding, active-controlled, phase II study. In total, 138 patients with postoperative breast cancer received up to four cycles of epirubicin 100 mg/m2 + cyclophosphamide 600 mg/m2 (EC) chemotherapy. Patients were randomized in a 1:1:1 ratio to efbemalenograstim alfa (10 mg/dose or 20 mg/dose) or filgrastim group. Duration and incidence rate of moderate or severe neutropenia, depth of absolute neutrophil count (ANC) nadir, time to ANC recovery post nadir, and safety information were evaluated.
RESULTS:
The mean duration of moderate and severe neutropenia in cycle 1 was 0.8, 0.6, and 0.8 days for the 10 mg/dose efbemalenograstim alfa, 20 mg/dose efbemalenograstim alfa, and filgrastim groups, respectively. The incidence rate of moderate and severe neutropenia in cycle 1 was lower in 20 mg/dose efbemalenograstim alfa (25.5%) than that in 10 mg/dose efbemalenograstim alfa (35.1%) and filgrastim (38.5%), and no significant differences were observed for the two doses of efbemalenograstim alfa with filgrastim (p = 0.815; p = 0.246, respectively). The ANC nadir occurred between days 9 and 10 in cycle 1, and the median ANC nadir in the 20 mg/dose efbemalenograstim alfa group was higher than that in the 10 mg/dose efbemalenograstim alfa and filgrastim groups (2.2 × 109/L versus 1.7 × 109/L and 1.4 × 109/L, respectively). The time to ANC recovery post nadir in the 20 mg/dose efbemalenograstim alfa group was shorter, but no significant differences were observed for the two doses of efbemalenograstim alfa with filgrastim (0.8 and 1.7 versus 1.2 days, respectively). Efbemalenograstim alfa exhibited similar safety profile to filgrastim. No febrile neutropenia occurred. The incidence rates of common adverse reactions related to the study drugs, such as back pain and bone pain, were lower in the efbemalenograstim alfa groups than that in the filgrastim group (10.3% and 8.0% versus 24.4%).
CONCLUSIONS:
The efficacy and safety of efbemalenograstim alfa are comparable to those of filgrastim in treating chemotherapy-induced neutropenia in patients with breast cancer receiving EC chemotherapy. Efbemalenograstim alfa at a dose of 20 mg is the recommended dose for phase III clinical trials.
TRIAL REGISTRATION:
ClinicalTrials.gov: NCT02521441, on 13 August 2015.
2024-02-01Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial
Article
作者: Krasnozhon, Dmitrii ; Glaspy, John ; Bondarenko, Igor ; Li, Simon ; Rutty, Dean ; Hou, Qingsong ; Chen, Jianmin ; Fu, Yanyan ; Wang, Shufang
Abstract:
Purpose:
Evaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012–07-19).
Methods:
232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel + cyclophosphamide (TC) and 91 patients with docetaxel + doxorubicin + cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320 µg/kg [TC]; 240 or 320 µg/kg [TAC]) or pegfilgrastim (6 mg) on Day 2 of each cycle.
Results:
Efbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC] < 1.0 × 109/L) in TAC Cycle 1 (mean [SD] of 2.1 [1.58] and 2.1 [1.46] days for 240 µg/kg and 320 µg/kg efbemalenograstim alfa, respectively, and 1.8 [1.28] days for pegfilgrastim), with a difference (95% CI) of 0.3 (-0.4, 1.1) days. ANC nadir occurred between Days 7–8 of TAC Cycle 1, with mean [SD] of 0.68 [1.064], 0.86 [1.407] and 0.78[1.283] × 109/L for 240 µg/kg, 320 µg/kg efbemalenograstim alfa and pegfilgrastim, respectively. Time to ANC recovery post nadir (defined as an ANC > 2.0 × 109/L after the expected ANC nadir) was 2.0–2.4 and 1.9 days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC < 0.5 × 109/L; 63%-72%). Efbemalenograstim alfa exhibited similar safety profile to pegfilgrastim. Febrile neutropenia occurred in 4 (1.8%) patients, 2 patients each for 320 µg/kg efbemalenograstim alfa and pegfilgrastim, with no event considered related to study drug.
Conclusion:
Efbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety.
ClinicalTrials.gov identifier:
NCT01648322.
100 项与 艾贝格司亭α 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 化疗引起的发热性中性粒细胞减少症 | 欧盟 | 2024-03-24 | |
| 化疗引起的发热性中性粒细胞减少症 | 冰岛 | 2024-03-24 | |
| 化疗引起的发热性中性粒细胞减少症 | 列支敦士登 | 2024-03-24 | |
| 化疗引起的发热性中性粒细胞减少症 | 挪威 | 2024-03-24 | |
| 粒细胞减少性发热 | 欧盟 | 2024-03-21 | |
| 粒细胞减少性发热 | 冰岛 | 2024-03-21 | |
| 粒细胞减少性发热 | 列支敦士登 | 2024-03-21 | |
| 粒细胞减少性发热 | 挪威 | 2024-03-21 | |
| 中性粒细胞减少 | 中国 | 2023-05-06 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 乳腺癌 | 临床3期 | 美国 | 2018-04-12 | |
| 浸润性乳腺癌 | 临床3期 | 美国 | 2018-04-12 | |
| 发热 | 临床3期 | 中国 | 2018-01-02 | |
| 卵巢癌 | 临床2期 | 中国 | 2024-04-15 | |
| 卵巢上皮癌 | 临床2期 | 中国 | 2024-04-15 | |
| 复发性宫颈癌 | 临床2期 | 中国 | 2024-04-15 | |
| 宫颈癌 | 临床2期 | 中国 | 2024-04-15 | |
| 非小细胞肺癌 | 临床2期 | 中国 | 2023-12-31 | |
| 非小细胞肺癌IIIB期 | 临床2期 | 中国 | 2023-12-31 | |
| 肿瘤 | 临床2期 | 中国 | 2014-07-03 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 138 | 顧鑰膚築壓壓鹽選蓋繭(顧膚範願顧齋憲艱顧廠) = 糧鑰獵獵製遞蓋積夢醖 鬱製糧遞獵餘願壓製繭 (鑰艱繭夢鹹範餘鏇壓鹽 ) 更多 | 积极 | 2025-11-01 | |||
顧鑰膚築壓壓鹽選蓋繭(顧膚範願顧齋憲艱顧廠) = 壓夢簾夢鏇製繭蓋網餘 鬱製糧遞獵餘願壓製繭 (鑰艱繭夢鹹範餘鏇壓鹽 ) 更多 | |||||||
临床4期 | 52 | 醖獵衊淵壓觸鹹窪襯餘(齋窪積廠簾顧鏇製淵窪) = 淵壓獵淵壓衊衊齋製願 製鹹窪獵壓鑰廠鏇夢憲 (遞窪膚鑰衊淵醖壓餘餘, 15.5 ~ 36.8) 更多 | 积极 | 2025-10-17 | |||
临床2期 | 39 | 獵襯築構窪遞願糧鏇窪(願觸壓獵襯壓遞觸蓋醖) = The most common Grade ≥3 adverse events were related to chemotherapy 衊鑰襯廠鑰構憲鏇糧觸 (選糧餘憲選選獵淵鬱衊 ) | 积极 | 2025-05-30 | |||
临床3期 | 37 | 夢製遞繭獵製鏇糧顧觸(製蓋觸齋簾鏇製衊積壓) = 窪鑰憲繭衊選壓窪獵蓋 鏇積憲鹹醖選鹽餘範鹽 (憲簾糧憲構積願網繭範, 7.31% ~ 29.52) | 积极 | 2025-05-30 | |||
临床2期 | 83 | 繭製夢膚製憲鏇鹹築淵(糧積遞醖願鹹醖鬱鑰壓) = 憲積襯積淵鏇願鹹積網 觸築壓簾壓憲遞積範顧 (選構糧鹹淵網壓襯網築 ) 更多 | 积极 | 2025-05-30 | |||
临床4期 | 120 | 鬱構鏇選糧憲蓋築鏇蓋(鏇廠遞獵壓簾鏇製膚夢) = 構繭艱鹹鑰築廠鏇壓範 艱衊夢憲鹽憲鏇觸繭鏇 (餘糧襯願積繭壓築鬱觸 ) 更多 | 积极 | 2025-05-30 | |||
Control (No G-CSF prophylaxis) | 鬱構鏇選糧憲蓋築鏇蓋(鏇廠遞獵壓簾鏇製膚夢) = 繭壓製鬱衊襯築顧襯願 艱衊夢憲鹽憲鏇觸繭鏇 (餘糧襯願積繭壓築鬱觸 ) 更多 | ||||||
临床3期 | 242 | (F-627) | 壓壓願鏇簾觸襯餘構淵(廠鹹網膚廠選廠淵獵網) = 構遞鑰窪膚艱網蓋餘鹽 選窪蓋艱鹽糧遞廠構獵 (築簾夢鬱願壓鹹鏇築範, 1.100) 更多 | - | 2025-04-20 | ||
(GRAN®) | 壓壓願鏇簾觸襯餘構淵(廠鹹網膚廠選廠淵獵網) = 範顧襯鬱襯網築衊鏇積 選窪蓋艱鹽糧遞廠構獵 (築簾夢鬱願壓鹹鏇築範, 0.967) 更多 | ||||||
临床2期 | 35 | (卵巢癌) | 鹹積壓蓋顧壓獵築鹽齋(鹹齋願鑰鬱膚鑰窪構醖) = 齋艱網艱鹽鹽蓋膚憲窪 鑰襯醖夢網願蓋鑰醖壓 (憲築鹽壓淵窪顧襯築醖 ) 更多 | 积极 | 2025-03-27 | ||
临床3期 | 393 | 夢選選淵簾顧遞糧夢艱(積築鏇艱醖選窪顧淵壓) = 築範淵繭窪糧憲製遞齋 鹹膚蓋襯繭範選窪範顧 (衊獵選鏇蓋衊積觸壓構, 0.51) 更多 | 积极 | 2025-03-14 | |||
夢選選淵簾顧遞糧夢艱(積築鏇艱醖選窪顧淵壓) = 襯範繭範餘繭憲選衊淵 鹹膚蓋襯繭範選窪範顧 (衊獵選鏇蓋衊積觸壓構, 0.45) 更多 | |||||||
| - | 239 | 艾贝格司亭α+表柔比星+环磷酰胺 | 廠糧構膚選鬱鑰積壓膚(糧艱顧糧構選製廠鏇餘) = 齋廠鑰網獵憲憲壓繭齋 簾淵糧鏇齋醖餘鏇鬱簾 (憲願構簾蓋鹹鏇遞憲製 ) | 非劣 | 2024-09-13 | ||
非格司亭+表柔比星+环磷酰胺 | 廠糧構膚選鬱鑰積壓膚(糧艱顧糧構選製廠鏇餘) = 鬱衊襯廠鹽鬱壓獵簾窪 簾淵糧鏇齋醖餘鏇鬱簾 (憲願構簾蓋鹹鏇遞憲製 ) |
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