预约演示
更新于：2026-06-29
Manfidokimab
曼多奇单抗
更新于：2026-06-29
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评- |
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结构/序列
Sequence Code 616723267H
来源: *****
Sequence Code 616723268L
来源: *****
关联
12
项与 曼多奇单抗 相关的临床试验CTR20244937
一项评价AK120注射液治疗青少年中重度特应性皮炎患者的疗效与安全性的随机双盲、安慰剂平行对照、多中心Ⅲ期临床研究
NCT06756126
A Multicenter, Open Label Phase II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AK120 in Adolescents With Moderate-to-severe AD
NCT06700499
A Multicenter, Open Label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
100 项与 曼多奇单抗 相关的临床结果
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100 项与 曼多奇单抗 相关的转化医学
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100 项与 曼多奇单抗 相关的专利（医药）
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2
项与 曼多奇单抗 相关的文献（医药）2023-10-01Dermatology and therapy
Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Rα Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study
Article
作者: Chen, Benchao ; Zhang, Yu ; Cole, Alexandra ; Sinclair, Rodney ; Wang, Max ; Li, Baiyong ; Wang, Guoqin ; Lemech, Charlotte ; Wynne, Christopher John ; Xia, Michelle
INTRODUCTION:
Interleukin-4 (IL-4) and interleukin-13 (IL-13) are two essential cytokines involved in the T helper 2 (Th2)-mediated inflammatory response to diseases, such as atopic dermatitis (AD). AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. This mAb inhibits the signaling of the IL-4 and IL-13 cytokines.
METHODS:
The study consisted of two parts. Part 1 was a single ascending dose (SAD) study with five cohorts (receiving 15, 50, 150, 300 or 600 mg of AK120, respectively) of healthy subjects; part 2 was a multiple ascending dose (MAD) study with four cohorts (receiving AK120 at doses of 300 mg once every 2 weeks [Q2W], 300 mg once weekly [QW], 150 mg QW or 75 mg QW) of subjects with AD. A total of 81 subjects (40 in part 1, 41 in part 2) were enrolled in the study.
RESULTS:
The compound was safe and well tolerated in both a SAD up to 600 mg in healthy subjects and in a MAD from 75 to 600 mg in subjects with AD. The exposure of AK120 increased in an approximately dose-dependent manner upon subcutaneous dosing. The levels of the biomarkers serum thymus and activation-regulated chemokine ligand 17 (TARC/CCL17) and immunoglobulin E decreased from baseline after AK120 administration, indicating the inhibition of the IL-4/IL-13 signaling pathways. AK120 showed improved Eczema Area and Severity Index (EASI) scores, and the proportion of subjects with Investigator Global Assessment (IGA) score 0/1 increased after AK120 treatment.
CONCLUSIONS:
AK120 exhibited an acceptable safety profile in healthy and AD subjects, and showed preliminary efficacy. These findings support the continued investigation of AK120 for treating AD.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov identification number: NCT04256174.
AUSTRALASIAN JOURNAL OF DERMATOLOGY
Efficacy and Safety of
IL
‐
4Rα
Inhibitors for Atopic Dermatitis: A Systematic Review and Meta Analysis of Randomised Controlled Trials
Review
作者: Vieira, Ana Carolina Putini ; de Freitas Rezende, Ellen ; de Jesus, Ana Carolina Ventura Santana ; Baquião, Arianne Costa
ABSTRACT:
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting over 200 million people globally. Emerging IL‐4Rα–targeted monoclonal antibodies have demonstrated strong efficacy and safety in clinical trials, warranting comparison with dupilumab, the current systemic standard. This meta‐analysis synthesises available evidence on their efficacy and safety. PubMed, Embase and Cochrane Library were systematically searched in April 2025 for randomised controlled trials (RCTs) comparing IL‐4Rα–targeting monoclonal antibodies versus placebo in moderate‐to‐severe AD, with EASI‐75 as the primary outcome. Non‐RCTs and trials using concomitant corticosteroids were excluded. Risk of bias was assessed using the Cochrane RoB‐2 tool. Analyses were performed in R (v4.5.0), with heterogeneity evaluated by Cochran Q and
I2
statistics. Nineteen RCTs comprising 4465 patients met inclusion criteria. At week 16, IL‐4Rα inhibitors showed sustained efficacy across EASI‐50/75/90, IGA 0/1 and pruritus reduction. Dupilumab remained the most validated agent, with durable effects, low heterogeneity and favourable safety. Among novel biologics, stapokibart and rademikibart demonstrated the most promising results, achieving superior EASI‐90 and ≥ 4‐point PP‐NRS responses: stapokibart (OR 4.94; 95% CI 3.20–7.61) and rademikibart (OR 4.61; 95% CI 1.68–12.65), though the latter showed higher odds of adverse events. Other agents (MG‐K10, GR1802, 611, AK120) provided encouraging but limited data. IL‐4Rα inhibitors represent effective and safe therapies for moderate‐to‐severe AD. Dupilumab remains the reference standard, while stapokibart and rademikibart emerge as promising next‐generation options. Further large, long‐term, head‐to‐head RCTs are warranted to confirm their comparative performance.
PROSPERO Registration:
CRD420251129343.
100 项与 曼多奇单抗 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特应性皮炎 | 申请上市 | 中国 | 2026-02-25 | |
| 中度特应性皮炎 | 临床3期 | 中国 | 2024-04-30 | |
| 重度特应性皮炎 | 临床3期 | 中国 | 2024-04-30 | |
| 哮喘 | 临床2期 | 中国 | 2022-02-11 | |
| 慢性鼻窦炎伴鼻息肉 | 临床申请批准 | 中国 | 2024-01-02 |
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临床结果
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临床3期 | - | 獵膚網構壓製願襯鏇網(鏇網衊觸構範簾選鑰簾) = 成功 獵廠艱襯夢繭願窪簾簾 (鏇獵構築製鏇壓範憲構 ) 达到 更多 | 积极 | 2025-08-25 | |||
临床1期 | IL-4 | IL-13 | 40 | 醖鬱鏇壓窪鏇壓窪糧構(壓鏇鹹鹹醖艱繭繭鑰鑰) = A total of 28 (87.5%) subjects received AK120 treatment and 7 (77.8%) subjects received placebo experienced at least one treatment-emergent adverse event (TEAE). All TEAEs were mild and moderate in severity. 12 (37.5%) subjects experienced at least one treatment-related TEAEs in the AK120 treatment group, and 4 (44.4%) subjects in the placebo group. The most common TEAEs occurred in AK120 treatment group were skin infection (12.5%) and injection site pain (12.5%). There was no death, no serious adverse event (SAE) or treatment-related SAE in the study. 築鑰襯膚膚蓋觸餘淵壓 (鏇蓋製壓獵醖簾窪積範 ) | 积极 | 2023-10-11 | ||
Placebo | |||||||
临床1期 | IL-4 receptor alpha (IL-4Rα) | IL-4 | IL-13 | 40 | 獵網廠齋製積膚網淵選(顧淵鬱膚窪鬱窪蓋鹹窪) = 構醖襯顧壓淵築蓋鑰構 廠艱範醖鑰襯顧觸鹹鬱 (襯鏇齋憲餘襯鑰膚蓋壓 ) 更多 | 积极 | 2022-09-07 | ||
獵網廠齋製積膚網淵選(顧淵鬱膚窪鬱窪蓋鹹窪) = 淵憲鹽範遞獵憲鑰製願 廠艱範醖鑰襯顧觸鹹鬱 (襯鏇齋憲餘襯鑰膚蓋壓 ) 更多 |
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