更新于：2024-09-20
Vunakizumab
夫那奇珠单抗
更新于：2024-09-20
概要
基本信息
原研机构 |
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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序列信息
Sequence Code 319922229H
来源: *****
Sequence Code 319922230L
来源: *****
关联
26
项与 夫那奇珠单抗 相关的临床试验A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices
健康受试者皮下注射不同规格SHR-1314注射液的安全性和药代动力学研究
一项单臂、开放标签、前瞻性II期研究以评估皮下注射SHR-1314注射液在活动性中重度Graves 眼病患者中的疗效和安全性
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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3
项与 夫那奇珠单抗 相关的文献（医药）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 ; Xu, Jinhua ; Lei, Tiechi ; 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.
Frontiers in immunology2区 · 医学
A Novel Bifunctional Fusion Protein, Vunakizumab-IL22, for Protection Against Pulmonary Immune Injury Caused by Influenza Virus
2区 · 医学
ArticleOA
作者: Shi, Chenchen ; Han, Lei ; Zhu, Haiyan ; Zeng, Xian ; Fan, Jiajun ; Cen, Lifeng ; Mei, Xiaobin ; Ju, Dianwen
Influenza A virus infection is usually associated with acute lung injury, which is typically characterized by tracheal mucosal barrier damage and an interleukin 17A (IL-17A)-mediated inflammatory response in lung tissues. Although targeting IL-17A has been proven to be beneficial for attenuating inflammation around lung cells, it still has a limited effect on pulmonary tissue recovery after influenza A virus infection. In this research, interleukin 22 (IL-22), a cytokine involved in the repair of the pulmonary mucosal barrier, was fused to the C-terminus of the anti-IL-17A antibody vunakizumab to endow the antibody with a tissue recovery function. The vunakizumab-IL22 (vmab-IL-22) fusion protein exhibits favorable stability and retains the biological activities of both the anti-IL-17A antibody and IL-22 in vitro. Mice infected with lethal H1N1 influenza A virus and treated with vmab-mIL22 showed attenuation of lung index scores and edema when compared to those of mice treated with saline or vmab or mIL22 alone. Our results also illustrate that vmab-mIL22 triggers the upregulation of MUC2 and ZO1, as well as the modulation of cytokines such as IL-1β, HMGB1 and IL-10, indicating the recovery of pulmonary goblet cells and the suppression of excessive inflammation in mice after influenza A virus infection. Moreover, transcriptome profiling analysis suggest the downregulation of fibrosis-related genes and signaling pathways, including genes related to focal adhesion, the inflammatory response pathway, the TGF-β signaling pathway and lung fibrosis upon vmab-mIL22 treatment, which indicates that the probable mechanism of vmab-mIL22 in ameliorating H1N1 influenza A-induced lung injury. Our results reveal that the bifunctional fusion protein vmab-mIL22 can trigger potent therapeutic effects in H1N1-infected mice by enhancing lung tissue recovery and inhibiting pulmonary inflammation, which highlights a potential approach for treating influenza A virus infection by targeting IL-17A and IL-22 simultaneously.
Biomedicines
Vunakizumab-IL22, a Novel Fusion Protein, Promotes Intestinal Epithelial Repair and Protects against Gut Injury Induced by the Influenza Virus
Article
作者: Tang, Jianguo ; Cao, Yiou ; Shi, Chenchen ; Zhu, Haiyan ; Han, Lei ; Cen, Lifeng ; Wang, Zetian ; Su, Chang ; Shi, Xunlong ; Ju, Dianwen
Secondary immune damage to the intestinal mucosa due to an influenza virus infection has gained the attention of investigators. The protection of the intestinal barrier is an effective means of improving the survival rate in cases of severe pneumonia. We developed a fusion protein, Vunakizumab-IL22(vmab-IL22), by combining an anti-IL17A antibody with IL22. Our previous study showed that Vunakizumab-IL22 repairs the pulmonary epithelial barrier in influenza virus-infected mice. In this study, we investigated the protective effects against enteritis given its anti-inflammatory and tissue repair functions. The number of goblet cells and the expression of zonula occludens protein 1(ZO-1), Mucin-2, Ki67 and IL-22R were determined by immunohistochemistry (IHC) and quantitative RT-PCR in influenza A virus (H1N1)-infected mice. The expression of NOD-like receptor pyrin domain containing 3 (NLRP3) and toll- like-receptor-4 (TLR4) was assayed by IHC in the lungs and intestine in HIN1 virus-induced mice to evaluate the whole efficacy of the protective effects on lungs and intestines. Consequently, Cytochrome C, phosphorylation of nuclear factor NF-kappaB (p-NF-κB), IL-1β, NLRP3 and Caspase 3 were assayed by Western blotting in dextran sulfate sodium salt (DSS)-treated mice. Treatment with Vunakizumab-IL22 improved the shortened colon length, macroscopic and microscopic morphology of the small intestine (p < 0.001) significantly, and strengthened the tight junction proteins, which was accompanied with the upregulated expression of IL22R. Meanwhile, Vunakizumab-mIL22 inhibited the expression of inflammation-related protein in a mouse model of enteritis induced by H1N1 and DSS. These findings provide new evidence for the treatment strategy for severe viral pneumonia involved in gut barrier protection. The results suggest that Vunakizumab-IL22 is a promising biopharmaceutical drug and is a candidate for the treatment of direct and indirect intestinal injuries, including those induced by the influenza virus and DSS.
177
项与 夫那奇珠单抗 相关的新闻（医药）19 小时之前
临床3期临床结果上市批准申请上市
2024-09-19
·恒瑞医药
临床3期上市批准申请上市免疫疗法
2024-09-18
·恒瑞医药
临床结果临床1期抗体药物偶联物
100 项与 夫那奇珠单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
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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 |
|---|---|---|---|---|
| AS | 申请上市 | 中国 | 2024-02-08 | |
| TED | 临床2期 | - | 2022-06-13 | |
| 银屑病关节炎 | 临床2期 | 中国 | 2021-10-22 | |
| 狼疮性肾炎 | 临床2期 | 中国 | 2021-06-08 | |
| AxSpA | 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2/3期 | 548 | 遞繭獵夢鑰顧憲糧觸憲(範範憲鏇製網廠襯簾鹽) = 蓋顧膚鹽襯製範選鑰築 艱觸簾簾鬱窪衊艱艱範 (願齋襯範艱壓製網鏇網 ) 更多 | 积极 | 2024-06-14 | |||
Placebo | 遞繭獵夢鑰顧憲糧觸憲(範範憲鏇製網廠襯簾鹽) = 淵鹹艱願膚觸襯淵鹽獵 艱觸簾簾鬱窪衊艱艱範 (願齋襯範艱壓製網鏇網 ) 更多 | ||||||
临床2/3期 | 548 | 積艱積廠壓觸餘醖獵廠(網鏇鏇製齋鹹鹽衊繭糧) = 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。 糧夢構憲觸窪艱觸廠衊 (簾選壓淵願壓鑰膚積簾 ) 达到 更多 | 积极 | 2024-02-18 | |||
安慰剂 | |||||||
临床3期 | 690 | 膚網獵簾獵遞鹽願醖衊(積積簾簾獵簾衊範積鏇) = 鏇蓋餘餘窪構艱鹹範簾 餘憲簾窪淵製構網鏇網 (繭積膚願鬱積顧觸淵衊, 72.7 ~ 80.5) 更多 | 积极 | 2023-10-11 | |||
Placebo | 膚網獵簾獵遞鹽願醖衊(積積簾簾獵簾衊範積鏇) = 範鬱鏇製顧憲觸顧製築 餘憲簾窪淵製構網鏇網 (繭積膚願鬱積顧觸淵衊, 0.2 ~ 3.1) 更多 | ||||||
临床2期 | 187 | 網壓製製簾醖膚鹹製網(糧齋簾鑰網餘網夢積製) = 顧積簾繭艱蓋鏇鏇廠遞 窪網淵遞餘衊鏇齋壓膚 (顧鏇憲鏇壓製鬱獵鹹醖 ) | 积极 | 2022-01-10 | |||
網壓製製簾醖膚鹹製網(糧齋簾鑰網餘網夢積製) = 廠鏇醖醖醖鏇鏇積網鬱 窪網淵遞餘衊鏇齋壓膚 (顧鏇憲鏇壓製鬱獵鹹醖 ) |
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