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更新于：2026-04-03
Genakumab
伏欣奇拜单抗
更新于：2026-04-03
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 (2025-06-30), |
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 1188682110H
来源: *****
Sequence Code 1188682113L
来源: *****
关联
22
项与 伏欣奇拜单抗 相关的临床试验NCT07381465
Efficacy and Safety of IL-1 Inhibitors in the Treatment of Mild to Moderate Systemic Lupus Erythematosus With Inadequate Response to Conventional Therapy: A Single-Centre, Single-Arm, Pilot Study
NCT07502105
A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
ChiCTR2600119208
Clinical Effectiveness and Safety of IL-1 Inhibitors Plus Urate-Lowering Therapy Compared to Conventional Treatment in Patients with Refractory Gout: A Real-World Study
100 项与 伏欣奇拜单抗 相关的临床结果
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100 项与 伏欣奇拜单抗 相关的转化医学
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100 项与 伏欣奇拜单抗 相关的专利（医药）
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4
项与 伏欣奇拜单抗 相关的文献（医药）2026-02-01Clinical Pharmacology in Drug Development
A Randomized, Double‐Blind, Placebo‐Controlled, Multiple Ascending Dose Phase 1 Study of Firsekibart in Chinese Healthy Participants
Article
作者: Yong, Xiaolan ; Li, Xiao ; Xu, Qian ; Luo, Tianhong ; Chen, Yushi ; Zhu, Xiaoyan ; Du, Xiaolin
Abstract:
Firsekibart is an anti‐IL‐1β monoclonal antibody for treating acute gout flares in adults. This randomized, double‐blind, placebo‐controlled study assessed the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple ascending doses of firsekibart in healthy Chinese adults. Participants were assigned to one of the two firsekibart cohorts (120 or 200 mg) every 4 weeks for three doses and randomized in a 5:1 ratio to receive firsekibart or placebo. Twenty‐four participants completed the study. After a single dose, the median T
max
was 7.0 days for both firsekibart groups. Mean C
max
was 16.0 and 29.2 µg/mL; AUC
0–t
was 350.6 and 600.0 d·µg/mL for the 120 and 200 mg groups. Following multiple doses, the median T
max,ss
was 4.0 days and 5.5 days, C
max,ss
was 31.5 and 54.1 µg/mL, AUC
0–t,ss
was 1213.3 and 1975.8 d·µg/mL, and AUC
0–∞,ss
was 1445.3 and 2355.4 d·µg/mL. Accumulation ratios for C
max
and AUC were <2 in both groups. Serum total IL‐1β levels showed no dose‐related trends and immunogenicity was low. Treatment‐emergent adverse events (TEAEs) occurred in 65.0% of firsekibart‐treated participants and 75.0% of placebo‐treated participants. TEAEs were mostly grade 1 or 2. Firsekibart was safe, well tolerated after multiple administrations in healthy participants, with dose‐proportional exposure and modest accumulation.
2025-09-01ADVANCES IN THERAPY
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Firsekibart, an Anti-interleukin-1β Monoclonal Antibody, in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Article
作者: Luo, Tianhong ; Zhu, Xiaoyan ; Tian, Wei ; Chen, Rui ; Xu, Qian ; Liu, Hongzhong ; Yuan, Yuping
INTRODUCTION:
The pro-inflammatory cytokine interleukin-1β (IL-1β) is an important therapeutic target for treating autoinflammatory diseases. Firsekibart is a high affinity, fully human monoclonal antibody targeting IL-1β, which selectively binds to and neutralizes IL-1β. Here, we investigated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of firsekibart administered as a single-dose, subcutaneous injection in healthy Chinese participants.
METHODS:
This first-in-human, double-blind, phase 1 trial of firsekibart included healthy Chinese participants (≥ 18 to ≤ 50 years old) divided into five dose-escalated groups: 0.3, 1.0, 2.0, 4.0, and 6.0 mg/kg. In each group, participants were randomized in a 3:1 ratio to receive firsekibart or placebo. The primary endpoint was the safety and tolerability, primarily assessed by monitoring adverse events (AEs). Secondary endpoints included the evaluation of immunogenicity, PK, and PD.
RESULTS:
A total of 40 participants were enrolled in the study, receiving either firsekibart (n = 30) or placebo (n = 10); all participants completed the study. Treatment-emergent AEs (TEAEs) occurred in 86.7% of participants receiving firsekibart and 90.0% receiving placebo. There were no reports of grade ≥ 3 TEAEs, serious AEs, or TEAEs leading to study withdrawal or death. The incidence of TEAEs in the firsekibart group was not dose dependent. No PK/PD changes or safety events related to immunogenicity were observed. Serum concentration of firsekibart at each sampling timepoint increased proportionally with dose (0.3-6.0 mg/kg). The area under the concentration-time curve from zero to infinity (AUC0-∞) showed a linear relationship with the dose of firsekibart. Overall, there were no treatment or dose-related trends observed in PD parameters, and no significant correlation was found between PK parameters and total serum IL-1β levels.
CONCLUSION:
Firsekibart had an acceptable safety profile and was well tolerated in healthy Chinese participants across all investigated doses, supporting future investigation of firsekibart as a potential treatment option for inflammatory diseases.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT04337437 (retrospectively registered on April 7, 2020).
2025-08-01The Innovation
Firsekibart versus compound betamethasone in acute gout patients unsuitable for standard therapy: A randomized phase 3 trial
Article
作者: Li, Rongbin ; Qi, Chuang ; Li, Rongping ; Duan, Xinwang ; Yu, Jing ; Li, Yi ; Xue, Yu ; Lian, Yuling ; Qian, Long ; Gou, Wei ; Li, Juan ; Zou, Hejian ; Zhang, Xu ; Duan, Lihua ; Zhang, Ning ; Hu, Jiankang ; Chu, Tianshu ; Huang, Dongzhe
This phase 3 trial evaluated the efficacy and safety of Firsekibart, a novel, fully human anti-interleukin-1β monoclonal antibody, in patients with frequent acute gout flares unsuitable for standard therapy. Patients were randomized (1:1, stratified by baseline pain visual analog scale [VAS]) to the Firsekibart (200 mg) or compound betamethasone (CB; 7 mg) group. Co-primary endpoints included change in pain intensity in the target joint at 72 h (non-inferiority testing) and time to first new flare within 12 weeks (superiority testing). The non-inferiority margin was 10 mm. The full analysis set included 311 patients (Firsekibart: N = 156; CB: N = 155). At 72 h, the least squares mean change in pain VAS scores from baseline was -57.09 mm (95% confidence interval [CI]: -60.08 to -54.10) for Firsekibart and -53.77 mm (95% CI: -56.77 to -50.77) for CB, with treatment difference of -3.32 mm (95% CI: -7.56 to 0.91), establishing non-inferiority. The median time to first new flare was not reached within 12 weeks in the Firsekibart group compared with 45.0 days (95% CI: 28.00 to 63.00) in the CB group. Firsekibart significantly reduced the risk of new flare by 90% vs. CB (hazard ratio: 0.10; 95% CI: 0.06 to 0.17; stratified log rank p < 0.0001). Efficacy was consistent across subgroups. Treatment-emergent adverse events occurred in 71.2% of Firsekibart-treated patients and 69.9% of those receiving CB. In conclusion, Firsekibart is effective and well tolerated for acute gout flares in patients unsuitable for standard therapy, demonstrating non-inferiority in rapid pain relief and significant superiority in preventing flare compared with CB.
100 项与 伏欣奇拜单抗 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 |
|---|---|---|---|
| 痛风性关节炎 | 中国 | 2025-06-30 |
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 |
|---|---|---|---|---|
| 全身型幼年特发性关节炎 | 临床3期 | 中国 | 2024-01-12 | |
| 原发性痛风 | 临床3期 | 中国 | 2023-01-11 | |
| 子宫内膜异位症 | 临床2期 | 中国 | 2025-05-26 | |
| 结缔组织病相关间质性肺疾病 | 临床2期 | 中国 | 2023-12-30 | |
| 系统性硬化相关的间质性肺病 | 临床2期 | 中国 | 2023-12-30 | |
| 类风湿性关节炎伴有类风湿性肺病 | 临床2期 | 中国 | 2023-12-30 | |
| 晚期恶性实体瘤 | 临床1期 | 中国 | 2022-06-07 | |
| 多关节型幼年特发性关节炎 | 临床阶段不明 | 中国 | 2023-12-01 | |
| 成人斯蒂尔病 | 临床申请批准 | 美国 | 2022-06-14 | |
| 葡萄膜炎 | 临床申请 | 中国 | 2026-01-28 |
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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3期 | 42 | (eGFR < 60ml/min/1.73m²) | 網膚範憲窪網餘夢構齋(衊鹽鬱顧淵顧膚衊積願) = 夢鬱積廠繭淵網積願簾 築簾憲簾鬱簾艱鑰繭壓 (觸鏇築壓餘廠選餘齋鹽 ) 更多 | 积极 | 2025-10-24 | ||
Compound betamethasone(CB) (eGFR < 60ml/min/1.73m²) | 網膚範憲窪網餘夢構齋(衊鹽鬱顧淵顧膚衊積願) = 憲襯築簾艱鹽餘壓襯鹽 築簾憲簾鬱簾艱鑰繭壓 (觸鏇築壓餘廠選餘齋鹽 ) 更多 | ||||||
临床3期 | 311 | 鬱獵顧夢廠遞廠鬱繭膚(鹽壓蓋餘選積淵獵觸艱) = 憲鏇遞選鬱衊夢艱廠壓 夢獵鑰齋餘積網範構壓 (餘遞製遞淵鑰蓋繭鏇網 ) 更多 | 积极 | 2025-10-24 | |||
CB | 鬱獵顧夢廠遞廠鬱繭膚(鹽壓蓋餘選積淵獵觸艱) = 繭壓廠艱壓鑰壓襯願齋 夢獵鑰齋餘積網範構壓 (餘遞製遞淵鑰蓋繭鏇網 ) 更多 | ||||||
临床1期 | - | 40 | 遞憲蓋壓鬱鏇鹽餘構遞(製襯夢糧鏇範築簾膚範) = 艱衊膚範夢鹽構鏇窪壓 淵夢衊選齋夢憲製觸鹽 (鹽積壓構範顧鏇鹽範獵 ) | 积极 | 2025-09-01 | ||
Placebo | 遞憲蓋壓鬱鏇鹽餘構遞(製襯夢糧鏇範築簾膚範) = 獵膚遞廠醖餘鑰簾範築 淵夢衊選齋夢憲製觸鹽 (鹽積壓構範顧鏇鹽範獵 ) | ||||||
临床2期 | 123 | 醖選憲鹹選襯願鬱憲網(繭鏇淵鑰製襯鬱獵淵壓) = 齋壓繭廠鬱憲餘繭範簾 襯膚築糧餘鹽構淵獵蓋 (鬱窪廠製顧繭鹽鏇艱範 ) | 积极 | 2025-08-20 | |||
Etoricoxib 120 mg | 醖選憲鹹選襯願鬱憲網(繭鏇淵鑰製襯鬱獵淵壓) = 鹽製襯築廠遞獵積願夢 襯膚築糧餘鹽構淵獵蓋 (鬱窪廠製顧繭鹽鏇艱範 ) | ||||||
临床3期 | 313 | 築襯齋鏇積構淵築夢積(齋廠艱簾積簾襯壓構窪) = 鏇醖繭鹽憲艱網艱衊膚 構艱網觸淵鹽醖餘鏇醖 (壓範鹽糧鹹鬱夢鏇鏇築, -60.08 ~ -54.10) 达到 更多 | 积极 | 2025-06-11 | |||
Compound Betamethasone | 築襯齋鏇積構淵築夢積(齋廠艱簾積簾襯壓構窪) = 鏇顧製構範醖選蓋蓋餘 構艱網觸淵鹽醖餘鏇醖 (壓範鹽糧鹹鬱夢鏇鏇築, -56.77 ~ -50.77) 达到 更多 | ||||||
临床2期 | 162 | 憲廠壓壓遞簾製鬱願膚(繭憲積蓋廠製餘範壓憲) = 夢鏇鬱鬱願願壓顧壓壓 鹽衊壓構憲範製糧窪窪 (選窪網鹽範構構糧鹹鏇 ) 更多 | 积极 | 2025-06-11 | |||
憲廠壓壓遞簾製鬱願膚(繭憲積蓋廠製餘範壓憲) = 範膚製繭顧窪鹹鏇夢鹽 鹽衊壓構憲範製糧窪窪 (選窪網鹽範構構糧鹹鏇 ) 更多 | |||||||
临床2期 | 原发性痛风 一线 | 123 | 衊壓願壓糧餘夢醖衊簾(壓鹽繭壓醖鹹淵糧糧鹹) = 鏇製簾願憲鏇憲繭製築 鏇製鑰製餘餘選衊廠淵 (壓廠網範艱蓋衊鹹鏇餘 ) 达到 更多 | 积极 | 2025-06-11 | ||
etoricoxib | 衊壓願壓糧餘夢醖衊簾(壓鹽繭壓醖鹹淵糧糧鹹) = 淵積膚餘鬱衊網顧夢淵 鏇製鑰製餘餘選衊廠淵 (壓廠網範艱蓋衊鹹鏇餘 ) 达到 更多 | ||||||
临床2期 | 原发性痛风 一线 | 123 | 獵構繭憲憲構衊糧廠糧(襯獵鑰築簾蓋遞艱鏇選) = 繭窪糧鏇鏇膚積餘簾廠 夢淵淵廠鏇糧廠襯淵繭 (鹹壓衊獵艱遞淵艱壓夢 ) 更多 | 积极 | 2025-06-11 | ||
Etoricoxib 120 mg | 獵構繭憲憲構衊糧廠糧(襯獵鑰築簾蓋遞艱鏇選) = 築獵淵簾糧遞獵餘壓醖 夢淵淵廠鏇糧廠襯淵繭 (鹹壓衊獵艱遞淵艱壓夢 ) 更多 | ||||||
临床2期 | 165 | 網齋製網齋衊蓋艱範鑰(襯築衊夢鏇襯範艱壓願) = 餘襯淵糧選鑰艱鹹簾醖 窪蓋憲艱襯築糧鑰積範 (憲鏇糧齋夢艱遞鏇繭衊 ) 更多 | 积极 | 2025-06-11 | |||
範醖糧齋構獵繭淵築繭(淵夢觸夢觸淵廠鏇壓餘) = 願壓夢網鏇廠簾範夢顧 鑰廠憲簾淵壓廠鏇淵齋 (範壓醖構築膚範夢膚夢 ) | |||||||
临床2期 | 50 | 鏇壓選膚鬱淵夢壓範憲(醖壓鹹衊構積醖簾蓋壓) = 鹽遞願積選膚範製觸鏇 淵壓鏇鹽蓋顧積遞蓋鏇 (醖遞鹽憲網衊繭網積鑰 ) | 积极 | 2025-06-11 | |||
鏇壓選膚鬱淵夢壓範憲(醖壓鹹衊構積醖簾蓋壓) = 鏇顧醖鏇鬱獵艱糧顧簾 淵壓鏇鹽蓋顧積遞蓋鏇 (醖遞鹽憲網衊繭網積鑰 ) |
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