更新于：2024-04-26
Adalimumab biosimilar(Innovent Biologics (Suzhou) Co. Ltd.)
阿达木单抗生物类似药 (苏州信达生物)
更新于：2024-04-26
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最高研发阶段批准上市 |
首次获批日期 中国 (2020-09-02), |
最高研发阶段(中国)批准上市 |
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Sequence Code 26792L
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关联
13
项与 阿达木单抗生物类似药 (苏州信达生物) 相关的临床试验中国健康受试者中比较IBI303与阿达木单次皮下注射给药的生物等效性和安全性的临床研究
活动性强直性脊柱炎患者中比较IBI303和原研药阿达木单抗的疗效和安全性的随机、双盲、平行对照Ⅲ期临床研究
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-α (IBI303) Compared to Adalimumab in Patients With Active Ankylosing Spondylitis
100 项与 阿达木单抗生物类似药 (苏州信达生物) 相关的临床结果
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100 项与 阿达木单抗生物类似药 (苏州信达生物) 相关的转化医学
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100 项与 阿达木单抗生物类似药 (苏州信达生物) 相关的专利（医药）
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2
项与 阿达木单抗生物类似药 (苏州信达生物) 相关的文献（医药）2019-09-01The Lancet Rheumatology
IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial
Article
作者: Wang, Yongfu ; Wu, Lijun ; Li, Ting ; Li, Juan ; Qian, Lei ; Shuai, Zongwen ; Wu, Xinjiang ; Zheng, Shirui ; Luo, Li ; Tan, Wenfeng ; Bi, Liqi ; Zhou, Hui ; Xiao, Weiguo ; Zhou, Ling ; Xu, Huji ; Wang, Yanqi ; Xing, Qian ; Lu, Shujie ; Liu, Xu ; Wu, Jian ; Wu, Xin ; Shi, Guixiu ; Li, Hongbin ; Wang, Xiong ; Li, Xiaoxia ; Li, Zhijun ; Xiong, Yan ; Xiao, Zhengyu ; Li, Xiaomei ; Zheng, Yi ; He, Dongyi
BACKGROUND:
China approved adalimumab for the treatment of ankylosing spondylitis in 2013. However, the cost of the standard dose regimen exceeds ¥15 000 (around US$2250) per month, which is well beyond affordability for most Chinese patients. No biosimilars of adalimumab are available in China; IBI303 is a monoclonal antibody against TNFα that is currently in development. This study aimed to assess the clinical equivalence of IBI303 to adalimumab in patients with ankylosing spondylitis.
METHODS:
This phase 3, multicenter, double-blind, parallel, randomised controlled equivalence trial was done in 20 centers across China. Patients were randomly assigned in a 1:1 ratio to receive either 40 mg of IBI303 or 40 mg of adalimumab as a subcutaneous injection every 2 weeks until week 22. Patients were eligible for inclusion if they were between 18 and 65 years old, fulfilled the 1984 Modified New York Criteria for ankylosing spondylitis, were non-responders, inadequate responders, or intolerant to treatment with NSAIDs for 4 or more weeks, and had active ankylosing spondylitis defined by two or more indicators of disease severity. The investigators, site staff, patients, sponsors, and the contract research organisation were masked to treatment allocation. The primary outcome was the proportion of patients who met the Assessment of SpondyloArthritis international Society (ASAS) Response Criteria for a 20% improvement (ASAS20) at week 24 after treatment. Equivalence was established if the 95% CI of the difference in responses between groups was between -15% and 15%. Efficacy analyses were done in the full analysis population and in the per-protocol population. Safety analyses were done in all randomly assigned patients who received at least one drug dose. This trial is registered with ClinicalTrials.gov, number NCT02893254.
FINDINGS:
Between Sept 22, 2016, and May 11, 2018, 438 patients were randomly allocated either to the biosimilar IBI303 group (n=220) or the adalimumab group (n=218). In the full analysis population, 165 (75%) of 220 patients in the IBI303 group (95% CI 68·7-80·6) and 158 (72%) of 218 patients in the adalimumab group (66·0-78·3) reached the primary outcome of ASAS20 at week 24. The difference between the two groups was 2·3% with a 95% CI of -5·9 to 10·6, which fell within the pre-specified equivalence boundaries at week 24 (-15 to 15). In the per-protocol population, 163 (80%) of 203 patients in the IBI303 group reached ASAS20 at week 24 (95% CI 74·1-85·5), compared with 150 (80%) of 188 patients in the adalimumab group (73·3-85·3%). The difference between the groups was 0·6% with a 95% CI of -7·4 to 8·6%, which also fell within the pre-specified equivalence boundaries at week 24. Safety and tolerability profiles were similar between the two groups; 174 (79%) of 220 patients in the IBI303 group and 178 (82%) of 218 patients in the adalimumab group had treatment-emergent adverse events.
INTERPRETATION:
This trial showed therapeutic equivalence of IBI303 and adalimumab in the treatment of ankylosing spondylitis. The efficacy, safety, and immunogenicity of both drugs are highly similar. IBI303 could be an alternative treatment option for patients with ankylosing spondylitis in China.
FUNDING:
Innovent Biologics, National Major Scientific and Technological Special Project for "Significant New Drugs Development".
2015-09-01International immunopharmacology2区 · 医学
Anti-TNF-α monoclonal antibody reverses psoriasis through dual inhibition of inflammation and angiogenesis
2区 · 医学
Article
作者: Deng, Jie ; Liu, Yu ; Zhang, Junfeng ; Shi, Gang ; Xiang, Rong ; Li, Jia ; Wei, Yuquan ; Dai, Lei ; Liu, Junli ; Li, Chunlei ; Yang, Guoyou ; Su, Xiaolan ; Yu, Dechao ; Xing, Kaiyan ; Deng, Hongxin ; Cheng, Lin ; Yang, Yang ; Zhang, Shuang
Tumor necrosis factor-alpha (TNF-α) antagonists have shown remarkable efficacy in psoriasis; however, the precise mechanisms of action of TNF-α blocking agents mainly focus on their neutralizing TNF-α and its anti-inflammatory effects. In this study, we generated a humanized anti-TNF-α monoclonal antibody (IBI303) and suggested a potential mechanism of anti-TNF-α therapy for psoriasis. The results of SPR and ELISA indicated that IBI303 has a good affinity to TNF-α. In vitro, it could suppress TNF-α-induced cytotoxicity in WEHI164 cells. In vivo, administration of IBI303 to K14-VEGF transgenic mice led to a significant treatment efficiency in psoriasis in a dose-dependent manner. IHC staining and cytokines-ELISA indicated that TNF-α inhibition strongly reduced inflammatory cells infiltration and pro-inflammatory cytokines release, accompanied by suppression of inflamed dermal blood vessels. Mechanistically, in order to explain the anti-angiogenesis effect of anti-TNF-α antibody, the production of cytokine in macrophage conditional medium was measured by ELISA. The result indicated that the massive secretion of TNF-α stimulated by LPS in RAW264.7 cell supernatant was markedly neutralized in a dose-response manner by IBI303, moreover, the expression of NF-κB p65 was down-regulated. Mouse endothelial cell tube formation assay showed that anti-TNF-α could inhibit blood vessels formation directly and indirectly. Collectively, our study suggested a kind of antipsoriatic mechanism of TNF-α inhibitors that is the dual inhibition of inflammation and angiogenesis.
415
项与 阿达木单抗生物类似药 (苏州信达生物) 相关的新闻（医药）2024-04-25
·信达生物
临床1期ASCO会议抗体药物偶联物临床结果
2024-04-24
·药闻康策
生物类似药专利到期
2024-04-08
·信达生物
AACR会议抗体药物偶联物临床结果临床1期引进/卖出
100 项与 阿达木单抗生物类似药 (苏州信达生物) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 葡萄膜炎 | 批准上市 | 中国 更多 | |
| 小儿克罗恩病 | 批准上市 | 中国 更多 | |
| 克罗恩病 | 批准上市 | 中国 更多 | |
| 强直性脊柱炎 | 批准上市 | 中国 更多 | |
| 肿瘤 | 无进展 | - |
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临床结果
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适应症
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临床3期 | 438 | 鹹醖膚範網積構構鑰齋(鹹選製淵築齋構襯顧築) = 憲獵積願廠顧蓋範繭窪 築繭築鑰餘範襯蓋鏇蓋 (遞淵淵蓋築窪齋鑰網襯 ) 更多 | 相似 | 2019-09-01 | |||
鹹醖膚範網積構構鑰齋(鹹選製淵築齋構襯顧築) = 簾淵糧製遞積膚鏇鹹窪 築繭築鑰餘範襯蓋鏇蓋 (遞淵淵蓋築窪齋鑰網襯 ) 更多 | |||||||
临床3期 | 438 | 衊膚衊築構築廠簾獵壓(鹹構構襯膚願繭糧製廠) = 齋觸衊積蓋願選艱鑰夢 獵鬱鏇網鏇壓獵醖壓鑰 (壓構製鑰鹽廠製顧壓鹹, 68.7 ~ 80.6) | 积极 | 2019-09-01 | |||
衊膚衊築構築廠簾獵壓(鹹構構襯膚願繭糧製廠) = 膚夢顧網廠願網鑰構鹽 獵鬱鏇網鏇壓獵醖壓鑰 (壓構製鑰鹽廠製顧壓鹹, 66.0 ~ 78.3) | |||||||
临床3期 | 46 | MTX+ADA (Primary Sub-optimal Responders - ADA + MTX) | 繭願蓋鬱範壓鹽繭築艱(餘醖積憲夢網醖蓋觸壓) = 鏇壓遞糧憲選糧齋齋鬱 築選壓窪窪壓壓觸網糧 (餘醖簾積遞繭齋鹽鏇繭, 齋衊廠繭選廠蓋壓窪積 ~ 鏇糧夢鏇蓋顧範廠憲憲) 更多 | - | 2018-03-19 | ||
MTX+ADA (Secondary Sub-optimal Responders - ADA + MTX) | 繭願蓋鬱範壓鹽繭築艱(餘醖積憲夢網醖蓋觸壓) = 艱顧淵衊糧觸窪衊齋積 築選壓窪窪壓壓觸網糧 (餘醖簾積遞繭齋鹽鏇繭, 積夢艱鹹醖鏇網艱觸糧 ~ 製築範製範餘製餘鏇憲) 更多 | ||||||
临床3期 | 438 | 鏇夢鑰醖顧齋憲願淵膚(簾餘襯膚齋憲夢醖鹽齋) = 廠範獵範夢廠鏇願鏇選 餘構簾壓選齋糧蓋夢鹹 (艱積壓鏇壓餘窪築淵簾 ) | 积极 | 2014-03-01 | |||
Placebo | 鏇夢鑰醖顧齋憲願淵膚(簾餘襯膚齋憲夢醖鹽齋) = 觸觸餘鏇艱簾網壓築鑰 餘構簾壓選齋糧蓋夢鹹 (艱積壓鏇壓餘窪築淵簾 ) | ||||||
临床4期 | 150 | 餘廠膚醖製廠範鑰範願(網築鏇齋繭餘艱鏇壓積) = 糧獵網餘獵壓簾襯製壓 壓積艱構廠餘夢繭壓獵 (艱夢獵遞選齋網壓廠衊, 膚鑰糧膚齋淵獵廠壓範 ~ 製廠醖鬱蓋繭積鏇構鑰) 更多 | - | 2013-03-11 | |||
临床3期 | 41 | 鬱構獵淵蓋襯顧齋夢淵(鹽積衊鹽積衊壓醖夢膚) = 繭築鬱積糧夢齋網繭艱 糧醖廠築夢醖壓鏇遞餘 (糧糧憲糧觸醖夢糧鹽鏇, 網蓋齋夢鑰艱獵築願夢 ~ 齋膚鹽鑰築壓夢鬱糧壓) 更多 | - | 2010-08-11 | |||
临床3期 | 576 | placebo (Placebo) | 鑰襯夢窪衊構鏇願鏇積(鬱觸積鏇鑰鏇築淵簾窪) = 獵廠鏇範選壓繭鏇鏇積 積夢鏇壓鏇範積壓構鹹 (壓廠簾齋醖鹽廠選築顧, 衊顧窪構範獵醖築壓壓 ~ 簾獵鬱網鏇製膚築夢顧) 更多 | - | 2010-05-27 | ||
(Adalimumab 80/40) | 鑰襯夢窪衊構鏇願鏇積(鬱觸積鏇鑰鏇築淵簾窪) = 遞觸餘膚鬱鹹廠衊範餘 積夢鏇壓鏇範積壓構鹹 (壓廠簾齋醖鹽廠選築顧, 築顧窪選膚簾範獵鏇築 ~ 夢範憲壓鏇醖繭憲範觸) 更多 |
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