预约演示
更新于：2025-01-25
Vunakizumab
夫那奇珠单抗
更新于：2025-01-25
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-08-20), |
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 319922229H
来源: *****
Sequence Code 319922230L
来源: *****
关联
31
项与 夫那奇珠单抗 相关的临床试验NCT06779097
A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Converted From Other Biologics
NCT06770088
A Prospective, Single-arm, Multicenter Study to Explore the Efficacy and Safety of Vunakizumab in Adults with Active Spondyloarthritis
CTR20243791
在成人活动性银屑病关节炎患者中评价SHR-1314注射液疗效和安全性的多中心、随机、双盲、安慰剂对照的III期临床试验
100 项与 夫那奇珠单抗 相关的临床结果
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100 项与 夫那奇珠单抗 相关的转化医学
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100 项与 夫那奇珠单抗 相关的专利（医药）
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5
项与 夫那奇珠单抗 相关的文献（医药）2025-01-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial
Article
作者: Meng, Zudong ; Chen, Rixin ; Li, Fuqiu ; Bai, Xiaoyan ; Li, Yuye ; Chen, Aijun ; Bi, Xiaodong ; Li, Shanshan ; Li, Yanlin ; Zhang, Litao ; Sun, Jianfang ; Li, Zhiming ; Lu, Yan ; Liu, Donghua ; Li, Yanling ; Cui, Xiaojing ; Xu, Ai'e ; Lu, Jianyun ; Zhang, Siping ; Zhang, Chunlei ; Ji, Chao ; Dong, Guangchao ; Wang, Wenqing ; Yan, Kexiang ; Yang, Sen ; Yao, Xiaoyan ; Wang, Wenqin ; Wang, Xiaohua ; Han, Ling ; Li, Xin ; Xu, Jinhua ; Zhang, Zhenghua ; Jiang, Meiying ; Wang, Yu ; Mou, Kuanhou ; Cheng, Hao ; Li, Hongyi ; Zhu, Xiaohong ; Han, Xiuping ; Li, Linfeng
BACKGROUND:
Vunakizumab, a novel anti-interleukin-17A antibody, has shown promising efficacy for moderate-to-severe plaque psoriasis in a phase 2 trial.
OBJECTIVE:
We conducted a double-blind, randomized phase 3 trial (NCT04839016) to further evaluate vunakizumab in this population.
METHODS:
Six hundred ninety subjects were randomized (2:1) to receive vunakizumab 240 mg or placebo at weeks 0, 2, 4, and 8. At week 12, subjects on placebo were switched to vunakizumab 240 mg (weeks 12, 14, 16, and every 4 weeks thereafter). The co-primary endpoints were ≥90% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 90) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.
RESULTS:
At week 12, the vunakizumab group showed higher PASI 90 (76.8% vs 0.9%) and sPGA 0/1 (71.8% vs 0.4%) response rates, as well as higher PASI 75 (93.6% vs 4.0%), PASI 100 (36.6% vs 0.0%), and sPGA 0 (38.2% vs 0.0%) response rates (all two-sided P < .0001 vs placebo). Efficacy was maintained through week 52 with continuous vunakizumab. Possible treatment-related serious adverse events occurred in 0.9% of vunakizumab-treated subjects.
LIMITATIONS:
Chinese subjects only; no active comparator.
CONCLUSION:
Vunakizumab demonstrated robust clinical response at week 12 and through week 52, with good tolerability in moderate-to-severe plaque psoriasis.
2024-11-01DRUGS
Vunakizumab: First Approval
Review
作者: Keam, Susan J
Vunakizumab (®) is a subcutaneous (SC) recombinant anti-interleukin (IL)-17A humanized monoclonal IgG1/κ antibody being developed by Suzhou Suncadia Biopharmaceutical Co., Ltd (a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd) for the systemic treatment of autoimmune diseases related to the IL-17 pathway, including psoriasis, ankylosing spondylitis and psoriatic arthritis. In August 2024, vunakizumab was approved in China for the treatment of adult patients with moderate-to-severe plaque psoriasis who are suitable for systemic treatment or phototherapy. This article summarizes the milestones in the development of vunakizumab leading to this first approval for the systemic treatment of moderate-to-severe plaque psoriasis.
2022-07-01Journal of the American Academy of Dermatology1区 · 医学
A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis
1区 · 医学
Article
作者: Zhu, Yi ; Yan, Kexiang ; Gao, Xinghua ; Chen, Xiang ; Xu, Qian ; Sinclair, Rodney ; Lei, Tiechi ; Xu, Jinhua ; Guo, Qing ; Yang, Sen ; Zhang, Chunlei ; Yu, Hong ; Zheng, Min ; Jin, Hongzhong ; Diao, Qingchun ; Wu, Jianhua
BACKGROUND:
Vunakizumab (SHR-1314) is a novel interleukin 17A monoclonal antibody that has shown preliminary efficacy and tolerability in phase I trials.
OBJECTIVE:
To evaluate the efficacy and safety of vunakizumab in moderate-to-severe plaque psoriasis.
METHODS:
In this 36-week, multicenter, double-blinded, phase II study (NCT03463187), 187 eligible patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive vunakizumab (40, 80, 160, or 240 mg) or placebo subcutaneously, every 4 weeks, until week 12 (2 more drug administrations for the vunakizumab groups on weeks 16 and 20). The primary end point was at least 75% improvement in the Psoriasis Area and Severity Index at week 12.
RESULTS:
At week 12, there were significantly greater proportions of responders with at least 75% improvement in the Psoriasis Area and Severity Index in all vunakizumab groups compared to placebo (40, 80, 160, and 240 mg: 56.8%, 65.8%, 81.6%, and 86.5%, respectively, vs 5.4%; P < .001 for all); the proportions of patients achieving Physician's Global Assessment responses of 0 or 1 were also higher with vunakizumab (45.9%, 47.4%, 60.5%, and 73.0%, respectively, vs 8.1%). No unexpected adverse effects were observed.
LIMITATIONS:
The study was relatively short in duration and included no active control.
CONCLUSION:
Vunakizumab showed promising efficacy for moderate-to-severe plaque psoriasis, with good tolerability, warranting further investigation in larger and longer-term studies.
100 项与 夫那奇珠单抗 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 斑块状银屑病 | 中国 | 2024-08-20 |
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 |
|---|---|---|---|---|
| 强直性脊柱炎 | 申请上市 | 中国 | 2024-02-08 | |
| 银屑病关节炎 | 临床3期 | 中国 | 2024-11-04 | |
| 格雷夫斯眼病 | 临床2期 | 中国 | 2022-09-13 | |
| 狼疮性肾炎 | 临床2期 | 中国 | 2021-06-08 | |
| 中轴性脊柱关节炎 | 临床1期 | 中国 | 2018-04-19 | |
| 银屑病 | 临床1期 | 澳大利亚 | 2016-08-22 |
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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 | 112 | 範願衊膚願觸觸齋醖壓(鹹醖膚齋膚艱願選網觸) = 願蓋淵製顧壓鹹願獵蓋 獵繭蓋製築襯鑰鏇齋憲 (選鹽餘醖網鏇網選鹹淵 ) 更多 | 积极 | 2024-11-18 | |||
範願衊膚願觸觸齋醖壓(鹹醖膚齋膚艱願選網觸) = 衊憲醖襯選夢觸壓簾構 獵繭蓋製築襯鑰鏇齋憲 (選鹽餘醖網鏇網選鹹淵 ) 更多 | |||||||
临床2/3期 | 548 | 餘鬱簾簾繭簾積觸膚蓋(觸範鹽窪膚簾襯鹹淵醖) = 醖範艱遞艱糧鬱構衊繭 築築膚構築積醖築餘蓋 (齋夢廠廠獵夢構鹹廠積 ) 更多 | 积极 | 2024-06-14 | |||
Placebo | 餘鬱簾簾繭簾積觸膚蓋(觸範鹽窪膚簾襯鹹淵醖) = 餘廠鹹餘蓋鹹範鏇鏇構 築築膚構築積醖築餘蓋 (齋夢廠廠獵夢構鹹廠積 ) 更多 | ||||||
临床2/3期 | 548 | 獵襯顧願製遞鹹繭醖顧(鹹壓廠網齋廠製廠積願) = 与安慰剂相比，SHR-1314对活动性强直性脊柱炎具有统计学显著性和临床意义的改善。 築積艱鹽築構餘糧網蓋 (艱願糧簾選廠餘夢夢製 ) 达到 更多 | 积极 | 2024-02-18 | |||
安慰剂 | |||||||
临床3期 | 690 | 願積艱襯鹽選製網鹽鬱(顧觸網鬱蓋鏇觸鹹鹽獵) = 蓋膚鏇鏇網窪鑰糧顧遞 鬱製鑰願鏇衊積糧繭鹽 (襯蓋觸鏇網選積觸衊獵, 72.7 ~ 80.5) 达到 更多 | 积极 | 2023-10-11 | |||
Placebo | 願積艱襯鹽選製網鹽鬱(顧觸網鬱蓋鏇觸鹹鹽獵) = 窪艱網顧觸構顧膚鏇鬱 鬱製鑰願鏇衊積糧繭鹽 (襯蓋觸鏇網選積觸衊獵, 0.2 ~ 3.1) 达到 更多 | ||||||
临床2期 | 187 | 淵餘築繭遞糧艱廠齋遞(蓋網艱築範觸獵選構鹽) = 膚艱鹹蓋範顧糧膚憲窪 夢襯襯製鹹鹽膚遞願簾 (餘襯齋憲範齋廠餘餘鹽 ) | 积极 | 2022-01-10 | |||
淵餘築繭遞糧艱廠齋遞(蓋網艱築範觸獵選構鹽) = 製鏇淵糧壓餘夢築憲築 夢襯襯製鹹鹽膚遞願簾 (餘襯齋憲範齋廠餘餘鹽 ) |
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