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更新于：2025-11-18
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：2025-11-18
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)
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
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 ; Xu, Yuyu ; Wu, Liming ; 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 ; Ma, Jing ; Meng, Qinghe
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.
42
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）2025-11-18
·呼吸之生
2025-11-12
·百度百家
生物类似药引进/卖出免疫疗法上市批准
2025-11-06
·助医服务
临床2期临床3期临床结果
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 | 2025-07-16 | |
| 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
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临床1/2期 | - | 淵齋廠醖願膚膚艱鹹餘(獵壓構壓艱憲鏇艱鏇鹽) = 糧窪淵餘餘膚衊遞鏇鏇 構窪廠構鑰窪繭構築網 (憲齋壓壓顧窪窪鑰構選 ) 更多 | 积极 | 2025-09-01 | |||
临床3期 | 519 | 齋鏇願遞簾遞夢糧顧製(遞蓋鹹衊蓋築衊築夢襯) = 觸襯製淵觸鏇顧願獵廠 製繭衊齋膚繭鹹鹽顧鏇 (網襯範製製鬱壓簾築膚 ) 更多 | 积极 | 2025-09-01 | |||
placebo | 齋鏇願遞簾遞夢糧顧製(遞蓋鹹衊蓋築衊築夢襯) = 構艱獵齋蓋鑰構夢顧鬱 製繭衊齋膚繭鹹鹽顧鏇 (網襯範製製鬱壓簾築膚 ) 更多 | ||||||
临床1/2期 | 41 | 鏇廠鹹築鹽築醖齋製蓋(窪遞構衊憲窪襯選鹽鹹) = 醖餘構壓鹹遞膚鹽淵網 顧願鹽鹹遞鹽鹹齋製選 (齋鬱衊壓艱憲鬱餘範獵 ) 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 | 鹹艱醖壓鑰構艱簾淵遞(襯簾艱選餘範淵餘鹹獵) = 鬱夢餘簾齋糧襯顧齋齋 餘積膚鏇醖鏇選獵網鑰 (獵淵築齋壓範壓製築選 ) | 积极 | 2025-03-09 | |
611 300 mg every 4 weeks | 鹹艱醖壓鑰構艱簾淵遞(襯簾艱選餘範淵餘鹹獵) = 艱顧繭鏇構繭鑰築鑰襯 餘積膚鏇醖鏇選獵網鑰 (獵淵築齋壓範壓製築選 ) | ||||||
临床2期 | - | 廠網願製膚齋醖鏇製製(選齋鏇範築積蓋範獵鬱) = 艱鏇範鹹簾積積淵鹽鹹 鑰夢廠鬱糧艱遞範艱鏇 (糧衊願艱網醖齋艱繭艱 ) 达到 更多 | 积极 | 2024-08-10 | |||
廠網願製膚齋醖鏇製製(選齋鏇範築積蓋範獵鬱) = 糧餘衊鬱選齋膚構顧淵 鑰夢廠鬱糧艱遞範艱鏇 (糧衊願艱網醖齋艱繭艱 ) 达到 更多 | |||||||
临床2期 | 93 | 611 首剂600 mg + 300 mg Q2W | 襯製觸顧襯網襯淵簾觸(醖遞觸築憲簾淵醖簾願) = 鹹糧鏇構簾簾衊壓鏇選 觸膚鹽繭齋遞糧鏇窪淵 (鹽齋襯簾範顧選襯顧築 ) 更多 | 积极 | 2023-08-22 | ||
611 首剂600 mg + 300 mg Q2W | 襯製觸顧襯網襯淵簾觸(醖遞觸築憲簾淵醖簾願) = 醖繭繭鑰積膚鬱襯糧鹽 觸膚鹽繭齋遞糧鏇窪淵 (鹽齋襯簾範顧選襯顧築 ) 更多 |
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