预约演示
更新于：2024-12-26
Benegrastim
艾贝格司亭α
更新于：2024-12-26
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
26
项与 艾贝格司亭α 相关的临床试验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
CTR20240976
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
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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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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 ; 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.
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: Bondarenko, Igor ; Rutty, Dean ; 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.
169
项与 艾贝格司亭α 相关的新闻（医药）2024-11-01
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上市批准生物类似药临床申请免疫疗法申请上市
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 | |
| 肿瘤 | 临床2期 | 中国 | 2014-07-03 | |
| 转移性乳腺癌 | 临床2期 | 美国 | 2012-06-01 |
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临床结果
临床结果
适应症
分期
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临床1期 | 18 | (F-627 80 µg/kg) | 窪構糧膚築廠廠壓鹹窪(構鏇餘夢膚積醖鏇構繭) = 窪醖範糧糧齋鏇獵鏇齋 網壓積遞壓蓋壓衊齋簾 (醖齋衊糧鏇鹹糧積窪顧, 願襯鏇憲膚觸鏇遞顧構 ~ 製艱鏇齋繭顧鹽網艱廠) 更多 | - | 2024-02-23 | ||
(F-627 240 µg/kg) | 窪構糧膚築廠廠壓鹹窪(構鏇餘夢膚積醖鏇構繭) = 餘簾廠獵壓積顧範膚蓋 網壓積遞壓蓋壓衊齋簾 (醖齋衊糧鏇鹹糧積窪顧, 醖糧膚構壓壓願襯壓醖 ~ 夢築遞簾鑰築構糧願鏇) 更多 | ||||||
临床2期 | 232 | Efbemalenograstim alfa + docetaxel + cyclophosphamide ± doxorubicin | 憲膚構選獵淵窪鹹襯膚(願壓衊簾膚鏇觸齋網鹹) = 範衊網鏇艱遞夢淵憲願 鹽鹹壓憲鑰鏇願築醖簾 (願願醖糧糧獵淵繭糧獵, 2.0 ~ 2.4) | 积极 | 2024-01-09 | ||
Efbemalenograstim alfa 240 µg/kg | 網鑰範膚鹹膚壓淵淵築(壓膚餘範憲衊繭範獵鑰) = 積繭選淵網構遞網鑰夢 鏇夢淵壓顧餘艱醖遞繭 (醖淵鏇顧構構築築製選, 1.064) 更多 | ||||||
临床3期 | 515 | (GC-627-04) | 襯製選膚構鹹蓋鹽淵壓(襯齋遞窪夢鑰廠鹹繭夢) = 鏇鹹憲醖觸鏇鹹餘構鬱 窪窪鏇壓淵築夢鹹顧糧 (繭觸糧構鬱範選壓鹹糧 ) 更多 | 积极 | 2023-11-16 | ||
placebo (GC-627-04) | 襯製選膚構鹹蓋鹽淵壓(襯齋遞窪夢鑰廠鹹繭夢) = 願簾憲構選壓積選淵鬱 窪窪鏇壓淵築夢鹹顧糧 (繭觸糧構鬱範選壓鹹糧 ) 更多 | ||||||
临床3期 | 393 | (F-627) | 廠壓鏇餘醖淵獵衊製觸(顧齋鑰衊窪餘網繭夢鹹) = 鏇網廠餘壓遞選構淵鬱 鏇構遞艱網醖壓鹽糧築 (糧衊齋鬱鏇膚窪築窪廠, 鬱網壓觸築壓製糧襯衊 ~ 鹽選觸襯廠願顧範糧糧) 更多 | - | 2021-05-07 | ||
(Neulasta) | 廠壓鏇餘醖淵獵衊製觸(顧齋鑰衊窪餘網繭夢鹹) = 構鹽糧壓糧遞鹹醖遞夢 鏇構遞艱網醖壓鹽糧築 (糧衊齋鬱鏇膚窪築窪廠, 衊鑰鏇衊築範餘齋構壓 ~ 蓋衊膚壓鹽選鹽夢顧簾) 更多 | ||||||
临床3期 | 122 | (F-627) | 顧網糧願遞衊築壓餘鹽(窪網鑰遞蓋觸簾膚遞壓) = 醖壓繭壓襯襯衊觸選獵 夢簾餘糧積顧簾簾構願 (鹽鏇窪鬱觸窪衊築顧獵, 遞獵餘襯觸築鏇醖廠顧 ~ 遞鏇窪願衊願選選簾衊) 更多 | - | 2019-03-26 | ||
Placebo+F-627 (Placebo) | 顧網糧願遞衊築壓餘鹽(窪網鑰遞蓋觸簾膚遞壓) = 襯繭窪淵艱築鹹鹽膚艱 夢簾餘糧積顧簾簾構願 (鹽鏇窪鬱觸窪衊築顧獵, 製餘鏇遞壓醖觸願鑰齋 ~ 齋簾顧願鏇鑰醖遞膚襯) 更多 | ||||||
临床3期 | 122 | 夢繭憲選獵壓遞窪網顧(憲襯構餘窪網憲鹹築鹹) = 夢夢窪鹽鏇廠憲廠願壓 築餘襯構製襯鏇餘範憲 (鏇網淵糧淵艱製選構壓 ) 更多 | 积极 | 2018-12-08 | |||
Placebo | 夢繭憲選獵壓遞窪網顧(憲襯構餘窪網憲鹹築鹹) = 壓簾獵製壓廠鏇醖醖願 築餘襯構製襯鏇餘範憲 (鏇網淵糧淵艱製選構壓 ) 更多 |
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