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更新于：2025-08-07
Mecapegfilgrastim
硫培非格司亭
更新于：2025-08-07
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-05-08), |
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 4190
来源: *****
关联
17
项与 硫培非格司亭 相关的临床试验NCT07018271
A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients
NCT06684158
Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC: A Prospective, Randomized, Multicenter, Phase 2 Study.
CTR20243969
HHPG-19K注射液（通过预充针手动给药）与Auto-HHPG-19K注射液（通过 贴敷式自动给药装置递送）在健康受试者中单次给药后的随机、开放、双 周期交叉、PK/PD对比研究
100 项与 硫培非格司亭 相关的临床结果
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100 项与 硫培非格司亭 相关的转化医学
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100 项与 硫培非格司亭 相关的专利（医药）
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27
项与 硫培非格司亭 相关的文献（医药）2025-01-01HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK
Mecapegfilgrastim for the prophylaxis of chemotherapy‐induced neutropenia in locally advanced nasopharyngeal carcinoma: A prospective phase II clinical study
Article
作者: Chen, Xiaozhong ; Hua, Yonghong ; Huang, Shuang ; Tao, Changjuan ; Qin, Weifeng ; Wang, Lei ; Jin, Ting ; Jin, Qifeng
Abstract:
Background:
Induction chemotherapy of docetaxel plus cisplatin (TP) is myelosuppressive, leading to severe neutropenia and febrile neutropenia (FN). Herein, we aimed to investigate the efficacy and safety of mecapegfilgrastim in the prevention of neutropenia in patients with locally advanced nasopharyngeal carcinoma who received the TP regimen.
Methods:
A total of 30 treatment‐naive patients with locally advanced nasopharyngeal carcinoma were included in this study. Mecapegfilgrastim 6 mg was injected 24–48 h after the completion of induction chemotherapy with the TP regimen.
Results:
The incidence of grade ≥3 neutropenia during the three induction chemotherapy cycles was 6.7% (95% CI, 0.8%–22.1%). In the first cycle of chemotherapy, the incidence of grade ≥3 neutropenia was 3.3% (95% CI, 0.1%–17.2%). No FN or antibiotic usage was reported. All 30 patients completed the induction chemotherapy cycles.
Conclusion:
Mecapegfilgrastim effectively reduced the incidence of chemotherapy‐induced neutropenia and FN in patients with locally advanced nasopharyngeal carcinoma.
2024-12-01Translational Cancer Research
Safety and efficacy of mecapegfilgrastim in preventing neutropenia in patients with head and neck cancer: a multicenter, prospective, observational, real-world study
Article
作者: Qin, Shukui ; Yan, Jun ; Yan, Haijiao ; Mao, Chenyu ; Yang, Zhe ; Zhang, Ningling ; Ding, Lifang ; Chen, Minbin ; Xu, Nong ; Cheng, Gang ; Bie, Jun ; Chen, Yong ; Wang, Zhanggui ; Cariati, Paolo
Background:
Mecapegfilgrastim, a long-acting granulocyte colony-stimulating factor, is approved in China for neutropenia prevention. However, data on its safety and efficacy in patients with head and neck cancer remain limited. This study aimed to evaluate the safety and efficacy of mecapegfilgrastim in preventing neutropenia among these patients undergoing chemotherapy, particularly those receiving chemoradiotherapy or chemoimmunotherapy.
Methods:
This prospective, non-interventional, real-world study enrolled patients aged ≥18 years with pathologically or cytohistologically confirmed head and neck cancer who were deemed tolerable to mecapegfilgrastim. The administration of mecapegfilgrastim was determined by the local physicians. Patients were observed for up to four chemotherapy cycles, with follow-up 30±2 days post-final administration. The primary outcome was the incidence of adverse events following mecapegfilgrastim administration. Secondary outcomes included the incidence of grade ≥3 and grade 4 neutropenia [defined as absolute neutrophil count (ANC) <1.0×109/L and ANC <0.5×109/L, respectively], febrile neutropenia (FN), and infections across all chemotherapy cycles.
Results:
Between May 2019 and November 2021, 197 patients were enrolled from 24 sites across China. The median age was 53 years, and 76.6% were male. Among them, 25.9% underwent chemoradiotherapy and 38.6% received chemoimmunotherapy. Treatment-related adverse events (TRAEs) of any grade occurred in 18 (9.1%) of all patients, 6 (11.8%) of the 51 patients who underwent chemoradiotherapy, and 4 (5.3%) of the 76 patients who received chemoimmunotherapy. The most common TRAEs of any grade were increased (n=10, 5.1%) and decreased (n=5, 2.5%) white blood cell count. When mecapegfilgrastim was administered prophylactically during the initial chemotherapy cycle, grade ≥3 neutropenia occurred in 5.1% of 178 cycles with combined immunotherapy and 6.4% of 267 cycles without immunotherapy. No FN cases were observed in the immunotherapy group. Among 119 cycles with radiotherapy, grade ≥3 neutropenia occurred in 5.0%, compared to 6.1% in the 326 cycles without radiotherapy, with one FN case reported. Across 445 chemotherapy cycles with prophylactic mecapegfilgrastim, grade ≥3 neutropenia occurred in 26 cycles (5.8%), grade 4 neutropenia in 16 cycles (3.6%), FN in 1 cycle (0.2%), and infections in 7 cycles (1.6%).
Conclusions:
Mecapegfilgrastim demonstrated promising efficacy and safety in preventing neutropenia in patients with head and neck cancer, particularly those undergoing chemoradiotherapy or chemoimmunotherapy. Mecapegfilgrastim was well tolerated, with no new safety signals identified. These real-world findings support its continued use for neutropenia prevention in patients with head and neck cancer.
2024-08-01Immunity Inflammation and Disease
A multicenter, prospective, non‐interventional real‐world study to assess the effectiveness of mecapegfilgrastim in preventing neutropenia in patients with gastrointestinal cancer
Article
作者: Yan, Haijiao ; Yan, Jun ; He, Ye ; Gu, Yulan ; Han, Zhengxiang ; Ding, Lifang ; Shen, Peng ; Qin, Shukui ; Wang, Xiaoguang ; Mao, Chenyu ; Zhang, Ningling ; Yang, Zhe ; Chen, Minbin ; Chen, Yong ; Wang, Zhanggui ; Cheng, Gang ; Zhang, Guifang ; Zheng, Weie ; Xu, Nong ; Jiang, Hua ; Wang, Jufeng ; Zhang, Junqi
Abstract:
Background:
Mecapegfilgrastim, a long‐acting granulocyte‐colony stimulating factor has been approved for reducing the incidence of infection, particularly febrile neutropenia (FN), in China.
Objective:
We conducted a multicenter prospective observational study to examine the safety and effectiveness of mecapegfilgrastim in preventing neutropenia in gastrointestinal patients receiving the chemotherapy, including S‐1/capecitabine‐based regimens or the fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI)/fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) regimens.
Method:
Five hundred and sixty‐one gastrointestinal patients from 40 sites across China, between May 2019 and November 2021, were included. The administration of mecapegfilgrastim was prescribed at the discretion of local physicians.
Results:
The most common adverse drug reactions (ADRs) of any grade for all patients was increased white blood cells (2.9%). Grade 3/4 ADRs were observed for anemia (0.2%), decreased white blood cells (0.2%), and decreased neutrophil count (0.2%). Among the 116 patients who received S‐1/capecitabine‐based chemotherapy throughout all cycles, ADRs of any grade included anemia (1.7%), myalgia (0.9%), and increased alanine aminotransferase (0.9%). No grade 3/4 ADRs were observed. In 414 cycles of patients who underwent S‐1/capecitabine‐based regimens, only one (0.2%) cycle experienced grade 4 neutropenia. In the FOLFIRINOX, FOLFOXIRI, and FOLFOX chemotherapy regimens, grade 4 neutropenia occurred in one (2.7%) of 37 cycles, four (4.7%) of 85 cycles, and two (1.2%) of 167 cycles, respectively.
Conclusion:
In a real‐world setting, mecapegfilgrastim has proven effective in preventing severe neutropenia in gastrointestinal patients following chemotherapy. This includes commonly used moderate or high‐risk FN regimens or regimens containing S1/capecitabine, all of which have demonstrated favorable efficacy and safety profiles.
100 项与 硫培非格司亭 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 中性粒细胞减少 | 中国 | 2018-05-08 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 粒细胞减少性发热 | 临床3期 | 中国 | 2012-03-01 |
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临床结果
临床结果
适应症
分期
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临床4期 | 97 | 鏇壓餘憲鹽壓願遞構廠(遞糧蓋鏇鹹遞構簾蓋簾) = 鬱製鑰觸鏇獵鹹鏇衊艱 鏇鹹簾積鹹網糧齋鹹壓 (顧醖鏇製窪餘鏇鏇範構 ) 更多 | 积极 | 2024-05-24 | |||
(Control (no prophylaxis)) | 鏇壓餘憲鹽壓願遞構廠(遞糧蓋鏇鹹遞構簾蓋簾) = 繭積憲廠鏇廠膚製願壓 鏇鹹簾積鹹網糧齋鹹壓 (顧醖鏇製窪餘鏇鏇範構 ) 更多 | ||||||
EHA2024 人工标引  | 临床3期 | 35 | 鹽願鑰鹽窪獵願築淵獵(醖網憲蓋鏇簾淵衊網觸) = 簾簾鏇鹹艱壓糧獵網齋 淵壓廠窪選獵鑰積範鏇 (繭餘鹹積鹹製繭獵獵觸, 16.4 ~ 57.3) 更多 | 积极 | 2024-05-14 | ||
control | 鹽願鑰鹽窪獵願築淵獵(醖網憲蓋鏇簾淵衊網觸) = 窪淵鏇範積鑰糧顧鏇襯 淵壓廠窪選獵鑰積範鏇 (繭餘鹹積鹹製繭獵獵觸, 34.9 ~ 90.1) 更多 | ||||||
临床2期 | 63 | Mecapegfilgrastim on day 2 (D2 group) | 廠鹹範淵夢膚願積糧觸(範憲餘構膚廠選築顧遞) = 壓壓鹽壓齋範衊醖鏇繭 窪蓋齋糧餘淵夢鏇願獵 (選淵鹽構淵醖餘獵選顧 ) 更多 | 积极 | 2024-05-14 | ||
Mecapegfilgrastim on day 5 (D5 group) | 廠鹹範淵夢膚願積糧觸(範憲餘構膚廠選築顧遞) = 衊繭壓顧襯壓衊齋簾艱 窪蓋齋糧餘淵夢鏇願獵 (選淵鹽構淵醖餘獵選顧 ) 更多 | ||||||
N/A | 180 | 構淵憲鏇繭簾鹹鹽鬱憲(淵憲製製壓鹽遞糧淵鹹) = 27 pts (15.0%) reported adverse drug reaction 窪顧鏇餘鹽壓選鹹顧築 (窪觸鏇齋餘鏇衊選鬱夢 ) 更多 | - | 2021-09-16 | |||
N/A | 322 | 鏇製憲廠鬱鬱襯窪廠繭(衊鹽鬱遞簾遞壓獵顧壓) = 繭蓋襯窪願願餘衊選艱 糧鹹淵構願網襯廠衊壓 (選膚鬱艱網積憲範淵醖 ) 更多 | - | 2021-05-28 | |||
N/A | 151 | 齋構壓齋鬱蓋範廠膚餘(構壓構蓋壓膚鏇繭襯淵) = 16.44% vs 1.28% 襯觸鏇糧遞廠鬱艱齋鬱 (積遞夢膚鑰顧製觸襯鑰 ) 更多 | 积极 | 2020-09-17 | |||
(Un-prevention) | |||||||
临床3期 | 151 | CONTROL (saline) | 簾衊壓選網蓋齋鹹鏇餘(顧簾餘遞壓範製蓋願鬱) = 衊簾遞壓積窪築窪鏇糧 製繭齋夢鏇鹹夢夢鹹廠 (廠艱淵廠廠淵齋鑰選窪 ) | 积极 | 2014-05-20 |
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