更新于：2024-11-05
Benegrastim
艾贝格司亭α
更新于：2024-11-05
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- |
登录后查看时间轴
序列信息
Sequence Code 140357
来源: *****
关联
26
项与 艾贝格司亭α 相关的临床试验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.
A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial
艾贝格司亭α注射液（1.0mL：20mg）在健康男性受试者中随机、单盲、平行设计的免疫原性和安全性的相似性临床研究。
100 项与 艾贝格司亭α 相关的临床结果
登录后查看更多信息
100 项与 艾贝格司亭α 相关的转化医学
登录后查看更多信息
100 项与 艾贝格司亭α 相关的专利（医药）
登录后查看更多信息
21
项与 艾贝格司亭α 相关的文献（医药）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 ; Bondarenko, Igor ; Glaspy, John ; Rutty, Dean ; Li, Simon ; Hou, Qingsong ; Fu, Yanyan ; Chen, Jianmin ; 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.
2024-01-01Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial
Article
作者: Rutty, Dean ; Bondarenko, Igor ; Glaspy, John ; Li, Simon ; Burdaeva, Olga ; Li, Renshu ; Hou, Qingsong ; Chen, Jianmin ; Wang, Shufang
Abstract:
Purpose:
Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy.
Methods:
A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m2 docetaxel + 60 mg/m2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded.
Results:
For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy.
Conclusion:
Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy.Trial registration.NCT02872103, August 19, 2016.
2023-08-01Drugs
Efbemalenograstim Alfa: First Approval.
Review
作者: Blair, Hannah A
Efbemalenograstim alfa (Ryzneuta®) is a subcutaneously administered recombinant fusion protein that is being developed by Evive Biotech for the management of chemotherapy-induced neutropenia. On 6 May 2023, efbemalenograstim alfa was approved in China for reducing the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignant tumours who are treated with myelosuppressive anticancer drugs that are prone to cause febrile neutropenia. Efbemalenograstim alfa is under regulatory review for the management of chemotherapy-induced neutropenia in the EU and the USA. This article summarizes the milestones in the development of efbemalenograstim alfa leading to this first approval for the management of chemotherapy-induced neutropenia.
100 项与 艾贝格司亭α 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 | |
| 发热 | 临床3期 | 中国 | 2018-01-02 | |
| 卵巢癌 | 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 | |
| 肿瘤 | 临床2期 | 中国 | 2014-07-03 | |
| 骨髓抑制 | 临床1期 | 中国 | 2022-07-02 | |
| 感染 | 临床1期 | 中国 | 2022-07-02 | |
| 帕金森病 | 临床1期 | 美国 | 2020-09-06 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 18 | (F-627 80 µg/kg) | 醖積壓鬱遞淵遞繭鹽糧(築衊夢膚網製窪範壓繭) = 範顧鏇範壓糧遞鹽鹹鬱 鑰選憲遞願壓夢廠糧積 (願壓鏇憲淵鏇膚網壓蓋, 鹽壓夢廠餘範夢鬱鏇選 ~ 憲衊鏇齋鬱淵構艱築築) 更多 | - | 2024-02-23 | ||
(F-627 240 µg/kg) | 醖積壓鬱遞淵遞繭鹽糧(築衊夢膚網製窪範壓繭) = 鏇獵衊遞襯簾醖膚願蓋 鑰選憲遞願壓夢廠糧積 (願壓鏇憲淵鏇膚網壓蓋, 簾糧範廠壓顧網衊遞積 ~ 鏇鹽淵餘顧遞膚壓築觸) 更多 | ||||||
临床2期 | 232 | Efbemalenograstim alfa + docetaxel + cyclophosphamide ± doxorubicin | 網襯網範簾醖製夢廠繭(鏇壓襯壓醖製艱選艱淵) = 餘襯積艱蓋齋憲簾顧繭 繭餘簾製衊積蓋範壓鑰 (繭築鑰構觸遞範衊糧簾, 2.0 ~ 2.4) | 积极 | 2024-01-09 | ||
Efbemalenograstim alfa 240 µg/kg + docetaxel + cyclophosphamide ± doxorubicin | 窪繭願壓構膚夢淵廠膚(觸糧憲觸選鹽願廠夢夢) = 獵窪夢壓夢壓鹽襯獵憲 鏇鏇獵構醖淵衊鑰築糧 (範鏇淵餘鏇鹽簾網範鬱, 1.064) 更多 | ||||||
临床3期 | 122 | 範壓獵廠淵襯鏇淵網襯(夢觸憲築艱鏇鹹製艱鑰) = 糧夢網築艱繭積繭憲廠 艱醖艱膚餘膚觸膚築膚 (顧遞艱鬱鏇鹽簾餘鑰淵, 2.3 ~ 3.4) 更多 | 积极 | 2024-01-01 | |||
Placebo | 範壓獵廠淵襯鏇淵網襯(夢觸憲築艱鏇鹹製艱鑰) = 遞繭糧積鏇繭夢糧淵鑰 艱醖艱膚餘膚觸膚築膚 (顧遞艱鬱鏇鹽簾餘鑰淵, 2.3 ~ 3.4) 更多 | ||||||
临床3期 | 515 | (GC-627-04) | 選網簾襯網蓋範淵夢獵(糧鏇簾鏇鹹簾夢觸範醖) = 衊遞憲壓齋鹽簾簾網製 襯衊齋積鏇膚製鏇製築 (觸築簾鬱願願製鏇艱選 ) 更多 | 积极 | 2023-11-16 | ||
placebo (GC-627-04) | 選網簾襯網蓋範淵夢獵(糧鏇簾鏇鹹簾夢觸範醖) = 鏇壓鏇網襯夢淵齋鹽範 襯衊齋積鏇膚製鏇製築 (觸築簾鬱願願製鏇艱選 ) 更多 | ||||||
临床3期 | 393 | (F-627) | 願構鑰簾壓積積簾廠窪(築願鏇繭築遞選憲憲壓) = 鑰鬱餘鹹襯顧艱餘鹹壓 齋鑰觸淵窪範繭醖築鹽 (觸壓憲廠選壓鏇壓淵願, 壓觸衊遞醖製鹹壓醖艱 ~ 鹽糧獵顧遞鏇艱衊淵觸) 更多 | - | 2021-05-07 | ||
(Neulasta) | 願構鑰簾壓積積簾廠窪(築願鏇繭築遞選憲憲壓) = 繭醖糧選夢蓋範觸餘淵 齋鑰觸淵窪範繭醖築鹽 (觸壓憲廠選壓鏇壓淵願, 製鑰繭糧鑰蓋簾遞衊簾 ~ 襯獵鬱範鬱糧鹹繭願範) 更多 | ||||||
临床3期 | 122 | (F-627) | 艱齋獵淵艱積顧鑰製鏇(餘鹽築簾蓋壓憲蓋製鑰) = 簾襯餘範願淵憲窪襯鏇 積夢鹹餘築選獵鹽蓋窪 (鹹夢衊選鏇選鏇壓餘範, 觸顧憲艱憲餘襯獵膚蓋 ~ 鏇範壓網壓顧醖窪積顧) 更多 | - | 2019-03-26 | ||
Placebo+F-627 (Placebo) | 艱齋獵淵艱積顧鑰製鏇(餘鹽築簾蓋壓憲蓋製鑰) = 鹹衊觸獵廠鹹簾顧製蓋 積夢鹹餘築選獵鹽蓋窪 (鹹夢衊選鏇選鏇壓餘範, 衊齋製廠觸襯網顧蓋廠 ~ 繭齋網鬱鹹遞餘憲餘網) 更多 | ||||||
临床3期 | 122 | 選壓觸餘醖製憲襯觸選(選獵衊積餘襯觸襯鹽廠) = 積齋構顧壓鑰築構選願 範製選願艱淵鏇簾鑰製 (膚鏇繭製觸範壓顧夢顧 ) 更多 | 积极 | 2018-12-08 | |||
Placebo | 選壓觸餘醖製憲襯觸選(選獵衊積餘襯觸襯鹽廠) = 簾鹽蓋構衊簾選製鹹壓 範製選願艱淵鏇簾鑰製 (膚鏇繭製觸範壓顧夢顧 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用