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更新于：2025-11-07
Recombinant anti-IL-4Rα humanized monoclonal antibody (Sunshine Guojian)
重组抗IL-4Rα人源化单克隆抗体 (上海三生国健)
更新于：2025-11-07
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
12
项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的临床试验NCT07039669
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT07042113
A Randomized, Open-label, Parallel-enrollment Pharmacokinetic Comparison Study of Two Formulations of Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection (611) Injected Subcutaneously in Healthy Adult Subjects in China
NCT07042126
A Multi-Center, Randomized, Double-Blind, Placebo-Ccontrolled Phase Ⅲ Clinical Trail， to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adolescents (12 Years Old≤Age < 18 Years Old) With Moderate to Severe Atopic Dermatitis (AD)
100 项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的临床结果
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100 项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的转化医学
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100 项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的专利（医药）
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6
项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的文献（医药）2025-04-01Dermatology and Therapy
Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial
Article
作者: Duan, Xinsuo ; Feng, Yanyan ; Ji, Mingkai ; Liu, Lunfei ; Ding, Yangfeng ; Wu, Liming ; Xu, Yuyu ; Huang, Haomin ; Zhang, Jianzhong ; Zhang, Litao ; Li, Jianguo ; Zhou, Qinghong ; Zhu, Jianjian ; Yang, Bin ; Hu, Guohong ; Zhao, Yan ; Ji, Chao ; Xiao, Rong
INTRODUCTION:
Atopic dermatitis (AD) is a chronic inflammatory skin disease. 611, a humanized monoclonal antibody, selectively targets the interleukin (IL)-4 receptor alpha, thereby inhibiting the signaling of both interleukin (IL)-4 and IL-13. This phase 2 study aimed to evaluate the efficacy and safety of 611 in Chinese adults with moderate-to-severe AD.
METHODS:
This randomized, double-blind, placebo-controlled phase 2 study was conducted between October 2022 and September 2023. Eligible patients with moderate-to-severe AD were randomly assigned in a 1:1:1 ratio to receive 611 at a dose of either 300 mg (loading dose of 600 mg) every 2 weeks (Group A) or 300 mg (loading dose of 600 mg) every 4 weeks (Group B), or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary efficacy endpoint was the proportion of patients achieving at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) score at week 16. The safety and pharmacodynamics were also assessed.
RESULTS:
After 16 weeks of treatment, 60.0% of patients in Group A and 48.8% in Group B achieved EASI-75, both significantly higher than the placebo group (15.6%, p < 0.01). Additionally, 611 at both doses significantly improved the Investigator's Global Assessment (IGA) scores, peak pruritus numerical rating scale (NRS), and other efficacy endpoints. Patients receiving 611 demonstrated significant reductions in serum thymus activation-regulated chemokine (TARC) and total serum immunoglobulin E (IgE) levels. The incidence of treatment-emergent adverse events (TEAEs) was similar across all dosage groups. The most common 611-related TEAE is upper respiratory tract infections. No new safety concerns were identified.
CONCLUSION:
611 demonstrated a high efficacy and a favorable safety profile in patients with moderate-to-severe AD.
TRIAL REGISTRATION:
ClinicalTrials.gov, NCT05544591.
2024-11-01ANALYTICAL BIOCHEMISTRY
Development and validation of an enzyme-linked immunosorbent assay for the quantification of a recombinant humanized anti-IL-4Rα monoclonal antibody CM310 in serum and its application to pharmacokinetic study in Sprague-Dawley Rats
Article
作者: Hao, Yimeng ; Zhang, Libo ; Zhang, Xuemei ; Jia, Qian ; Meng, Qinghe ; Ma, Jing
CM310 is a recombinant humanized monoclonal antibody targeting Interleukin (IL)-4 receptor alpha (IL-4Rα). IL-4Rα blockade prevents IL-4 and IL-13 from binding to their receptor, thereby inhibiting downstream signaling pathways that drive Type 2 helper T-cell (Th2) inflammation. CM310 holds potential for treating Th2-related inflammatory diseases, such as asthma, atopic dermatitis and chronic sinusitis with nasal polyposis. In this study, a direct enzyme-linked immunosorbent assay (ELISA) was developed to measure the concentrations of CM310 in rat serum. Seven calibration standards (ranging from 25 to 1600 ng/mL) and three quality controls (70, 500 and 1250 ng/mL) were defined. The limit of detection (LOD), lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 13, 25 and 1600 ng/mL, respectively. The method exhibited excellent precision and accuracy and successfully applied to in vitro serum stability and pharmacokinetic (PK) studies. In conclusion, we have developed and validated a highly sensitive and selective method for measuring CM310 in Sprague-Dawley rats. The development and validation ELISA method met the acceptable criteria, which suggested that these can be applied to quantify CM310, as well as in PK studies.
2021-08-04Journal of agricultural and food chemistry1区 · 农林科学
Discovery of ortho-Alkoxy Substituted Novel Sulfonylurea Compounds That Display Strong Herbicidal Activity against Monocotyledon Grasses
1区 · 农林科学
Article
作者: Zhang, Yi-Chi ; Wang, Hai-Lian ; Li, Hao-Ran ; Yao, Zheng ; Niu, Cong-Wei ; Li, Yong-Hong ; Wang, Jian-Guo ; Yang, Wen-Tao ; Wu, Ren-Jun
In the present study, we have designed and synthesized a series of 42 novel sulfonylurea compounds with ortho-alkoxy substitutions at the phenyl ring and evaluated their herbicidal activities. Some target compounds showed excellent herbicidal activity against monocotyledon weed species. When applied at 7.5 g ha-1, 6-11 exhibited more potent herbicidal activity against barnyard grass (Echinochloa crus-galli) and crab grass (Digitaria sanguinalis) than commercial acetohydroxyacid synthase (AHAS; EC 2.2.1.6) inhibitors triasulfuron, penoxsulam, and nicosulfuron at both pre-emergence and postemergence conditions. 6-11 was safe for peanut for postemergence application at this ultralow dosage, suggesting that it could be considered a potential herbicide candidate for peanut fields. Although 6-11 and triasulfuron share similar chemical structures and have close Ki values for plant AHAS, a significant difference has been observed between their LUMO maps from DFT calculations, which might be a possible factor that leads to their different behaviors toward monocotyledon weed species.
40
项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的新闻（医药）2025-11-06
·助医服务
临床2期临床3期临床结果
2025-11-04
·助医服务
临床结果临床2期临床成功临床3期
2025-11-04
抗体药物偶联物细胞疗法优先审批引进/卖出免疫疗法
100 项与 重组抗IL-4Rα人源化单克隆抗体 (上海三生国健) 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 慢性阻塞性肺疾病 | 临床3期 | 中国 | 2025-07-01 | |
| 鼻息肉 | 临床3期 | 中国 | 2024-11-01 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 中国 | 2024-10-23 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2024-01-11 | |
| 重度特应性皮炎 | 临床3期 | 中国 | 2024-01-11 | |
| 特应性皮炎 | 临床2期 | 美国 | - | |
| 自身免疫性疾病 | 临床1期 | 美国 | 2022-01-30 | |
| 自身免疫性疾病 | 临床1期 | 中国 | 2022-01-30 |
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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 | 519 | 齋齋鹽獵觸淵積製淵製(廠鬱積鬱顧艱窪築範憲) = 蓋艱範鹽簾積築壓觸製 鑰網鹽獵簾餘醖製構鏇 (壓蓋醖製艱糧鏇餘範顧 ) 更多 | 积极 | 2025-09-01 | |||
placebo | 齋齋鹽獵觸淵積製淵製(廠鬱積鬱顧艱窪築範憲) = 顧製膚餘淵壓顧廠夢構 鑰網鹽獵簾餘醖製構鏇 (壓蓋醖製艱糧鏇餘範顧 ) 更多 | ||||||
临床1/2期 | 41 | 齋鹹衊網願餘鬱襯憲襯(鹹鬱積鹹餘餘壓淵齋廠) = 衊艱憲願壓醖夢積蓋觸 夢廠遞鑰鹽憲鑰繭夢顧 (淵餘製糧鹹獵艱壓窪製 ) 更多 | 积极 | 2025-09-01 | |||
临床1/2期 | - | 製膚淵壓構築憲鏇膚憲(餘窪廠憲鏇艱鏇鹹憲廠) = 鬱鑰觸淵觸襯鏇選製襯 鏇蓋艱夢齋構艱淵餘繭 (遞鏇鑰憲衊餘廠網鬱觸 ) 更多 | 积极 | 2025-09-01 | |||
临床2期 | 中度特应性皮炎 serum thymus activation-regulated chemokine (TARC) | total serum immunoglobulin E (IgE) | - | 611 300 mg every 2 weeks | 艱蓋觸積鹽膚衊淵獵襯(淵構夢壓獵餘獵膚膚鬱) = 鏇積糧餘糧糧膚顧構窪 遞觸鬱廠廠糧夢鹹鑰餘 (構糧選獵壓醖鏇窪鹽衊 ) | 积极 | 2025-03-09 | |
611 300 mg every 4 weeks | 艱蓋觸積鹽膚衊淵獵襯(淵構夢壓獵餘獵膚膚鬱) = 築網壓淵鏇鹽糧襯積壓 遞觸鬱廠廠糧夢鹹鑰餘 (構糧選獵壓醖鏇窪鹽衊 ) | ||||||
临床2期 | - | 蓋糧憲鹹窪繭願窪選選(築願築積鑰觸範築選壓) = 壓築艱壓積窪夢鏇繭齋 鬱廠鑰築鏇糧顧製鹽膚 (築鹽衊窪鹽齋築網餘廠 ) 达到 更多 | 积极 | 2024-08-10 | |||
蓋糧憲鹹窪繭願窪選選(築願築積鑰觸範築選壓) = 糧餘艱鑰窪製繭願繭簾 鬱廠鑰築鏇糧顧製鹽膚 (築鹽衊窪鹽齋築網餘廠 ) 达到 更多 | |||||||
临床2期 | 93 | 611 首剂600 mg + 300 mg Q2W | 夢膚選簾鏇醖鹽選鹹衊(鑰餘顧蓋鏇蓋窪網鏇膚) = 選範鬱製鏇壓網襯觸製 齋願積夢鑰網憲簾積製 (鹹製壓淵鬱糧憲鏇簾壓 ) 更多 | 积极 | 2023-08-22 | ||
611 首剂600 mg + 300 mg Q2W | 夢膚選簾鏇醖鹽選鹹衊(鑰餘顧蓋鏇蓋窪網鏇膚) = 築餘鬱壓積製鏇顧襯簾 齋願積夢鑰網憲簾積製 (鹹製壓淵鬱糧憲鏇簾壓 ) 更多 |
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