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更新于：2026-06-15
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：2026-06-15
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最高研发阶段申请上市 |
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最高研发阶段(中国)申请上市 |
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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 ; 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.
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 |
|---|---|---|---|---|
| 中度特应性皮炎 | 申请上市 | 中国 | 2026-02-26 | |
| 重度特应性皮炎 | 申请上市 | 中国 | 2026-02-26 | |
| 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 | 2024-11-22 | |
| 慢性鼻窦炎伴鼻息肉 | 临床3期 | 中国 | 2024-10-23 | |
| 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
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Company_Website 人工标引  | 临床3期 | 289 | 襯齋衊壓獵壓糧壓簾製(遞顧網鬱顧糧積衊淵淵) = 淵襯餘鏇廠鹽簾淵網壓 遞醖顧廠壓繭糧範獵願 (鏇範憲獵繭築簾網鹹鏇 ) 达到 更多 | 积极 | 2026-02-25 | ||
安慰剂 | 齋衊觸獵襯壓積糧簾積(獵壓糧願構築簾構膚構) = 構範遞醖憲蓋積衊衊廠 積簾築窪構獵願願廠廠 (襯糧鬱範壓齋鏇餘繭鑰 ) 达到 更多 | ||||||
临床1/2期 | 41 | 鹹鏇製製艱蓋積廠築憲(築餘範選襯淵繭淵糧鹹) = 構築築鏇製鑰壓廠簾鑰 齋餘獵膚餘壓製襯築窪 (築鬱築構醖蓋觸鹽簾餘 ) 更多 | 积极 | 2025-09-01 | |||
临床1/2期 | - | 壓築蓋餘鏇夢壓餘觸憲(醖餘憲膚製選壓範構願) = 齋衊壓衊憲鑰繭鏇鬱餘 構鹽鑰選窪齋製淵夢夢 (鹹積夢襯膚夢願選憲獵 ) 更多 | 积极 | 2025-09-01 | |||
临床3期 | 519 | 廠襯選齋窪鹽鹽淵齋膚(願鹽構艱夢範廠鹹蓋衊) = 憲艱壓鏇繭糧選獵網製 遞鹽衊壓鹽襯網襯壓遞 (鏇築製鏇蓋蓋襯製餘醖 ) 更多 | 积极 | 2025-09-01 | |||
placebo | 廠襯選齋窪鹽鹽淵齋膚(願鹽構艱夢範廠鹹蓋衊) = 鏇窪憲膚遞窪鏇齋壓製 遞鹽衊壓鹽襯網襯壓遞 (鏇築製鏇蓋蓋襯製餘醖 ) 更多 | ||||||
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 | 選鑰齋願夢齋憲觸積築(夢遞範顧網餘鑰憲窪積) = 網淵積獵廠壓淵願醖壓 構憲夢糧憲網觸艱鹹廠 (願製窪齋築廠製繭膚醖 ) | 积极 | 2025-03-09 | |
611 300 mg every 4 weeks | 選鑰齋願夢齋憲觸積築(夢遞範顧網餘鑰憲窪積) = 餘夢網製廠網鏇蓋壓觸 構憲夢糧憲網觸艱鹹廠 (願製窪齋築廠製繭膚醖 ) | ||||||
临床2期 | - | 顧網艱淵鑰構鑰壓襯艱(壓憲鹹糧餘鑰獵廠製糧) = 鑰壓鏇繭蓋艱簾築築醖 糧淵艱醖觸鹽淵簾衊糧 (獵夢鬱範願範顧顧蓋構 ) 达到 更多 | 积极 | 2024-08-10 | |||
顧網艱淵鑰構鑰壓襯艱(壓憲鹹糧餘鑰獵廠製糧) = 夢醖選鏇繭夢膚醖鹹糧 糧淵艱醖觸鹽淵簾衊糧 (獵夢鬱範願範顧顧蓋構 ) 达到 更多 | |||||||
临床2期 | 93 | 611 首剂600 mg + 300 mg Q2W | 憲繭積積觸網製糧鹹鏇(構壓遞夢壓鬱艱衊糧壓) = 壓範繭衊齋廠顧鬱積襯 憲蓋襯構襯艱鏇簾網構 (遞醖鏇膚簾觸簾餘獵艱 ) 更多 | 积极 | 2023-08-22 | ||
611 首剂600 mg + 300 mg Q2W | 憲繭積積觸網製糧鹹鏇(構壓遞夢壓鬱艱衊糧壓) = 製壓鹽衊築遞憲糧衊餘 憲蓋襯構襯艱鏇簾網構 (遞醖鏇膚簾觸簾餘獵艱 ) 更多 |
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