Drugs / COMEKIBART
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | atopic eczema | 2025-10-30 | “2025年10月30日， 由麦济生物提交的1类创新药柯美奇拜单抗注射液（研发代号：MG-K10）的中国上市许可申请获得中国国家药品监督管理局（NMPA）受理，受理号为CXSS2500116，产品拟用于治疗成人中重度特应性皮炎” mabgeek.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06765005 | Jul 2024 → May 2025 overdue | atopic eczema | Shanghai Mabgeek Biotech.Co.Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05382910 | Jul 2022 → Dec 2023 | asthma | Shanghai Mabgeek Biotech.Co.Ltd | Unknown | Met primary |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05466877 | Aug 2022 → Sep 2023 | atopic eczema | Shanghai Mabgeek Biotech.Co.Ltd | Unknown | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06846385 | Mar → May 2025 overdue | seasonal allergic rhinitis | Shanghai Mabgeek Biotech.Co.Ltd | Recruiting | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT07479615 | May 2026 → Jan 2029 expected | atopic eczema | Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07540442 | Apr 2026 → Jan 2027 expected | atopic eczema | Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07546487 | Apr 2026 → Mar 2028 expected | chronic idiopathic urticaria | Shanghai Mabgeek Biotech.Co.Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06837922 | Mar 2025 → Nov 2027 expected | asthma | Shanghai Mabgeek Biotech.Co.Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06026891 | Jan 2024 → Jun 2025 | atopic eczema | Shanghai Mabgeek Biotech.Co.Ltd | Unknown | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT06277284 | Oct 2023 → Jan 2024 | — | Shanghai Mabgeek Biotech.Co.Ltd | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Shanghai Mabgeek Biotech.Co.Ltd | Results 柯美奇拜单抗每八周给药潜力初显 mabgeek.com ↗
主要终点方面，第24周，MG-K10 300mg Q4W组和MG-K10 600mg Q8W组达到EASI-75的受试者比例分别为83.3%和88.5%，达到IGA评分达到0或1分且较基线下降≥2分的受试者比例分别为70.0%和73.1%。 |
| 2026-04-30 | Shanghai Mabgeek Biotech.Co.Ltd | Regulatory 麦济生物柯美奇拜单抗（MG-K10）序列及用途专利维持专利权有效 mabgeek.com ↗
并于近日做出无效宣告请求审查决定： 维持专利权有效 。 |
| 2026-03-30 | Shanghai Mabgeek Biotech.Co.Ltd | Results MG-K10重磅亮相美国AAD大会：52周EASI-75达94.3%，长效抗IL-4Rα开启中重度AD便捷高效治疗新篇章 mabgeek.com ↗
第52周时MG-K10组的EASI‑90达标率进一步提升至79.1% 。 |
| 2025-12-05 | Shanghai Mabgeek Biotech.Co.Ltd | Results 麦济生物长效抗IL-4Rα单抗 MG-K10 Ⅱ期临床结果发表于《Dermatitis》 mabgeek.com ↗ |
| 2025-10-31 | Shanghai Mabgeek Biotech.Co.Ltd | Regulatory 全球首个长效IL-4Rα单抗MG-K10中重度特应性皮炎适应症上市申请获受理 mabgeek.com ↗
2025年10月30日， 由麦济生物提交的1类创新药柯美奇拜单抗注射液（研发代号：MG-K10）的中国上市许可申请获得中国国家药品监督管理局（NMPA）受理，受理号为CXSS2500116，产品拟用于治疗成人中重度特应性皮炎。 |
| 2023-11-21 | Shanghai Mabgeek Biotech.Co.Ltd | Results 麦济生物长效IL-4R单抗治疗中重度哮喘II期试验结果积极 mabgeek.com ↗
期中分析显示，主要疗效 终点治疗12周时 支气管扩张剂 使用前FEV 1 较基线的绝对值变化，MG-K10 300mg Q4W组和MG-K10 300mg Q2W组与安慰剂组差异均达到统计学显著差异，安全性良好。 |
| 2023-06-29 | Shanghai Mabgeek Biotech.Co.Ltd | Results MG-K10治疗中重度特应性皮炎的II期临床研究达到主要终点 mabgeek.com ↗
2023年6月29日，麦济生物宣布，其MG-K10（comekibart）人源化单抗注射液用于治疗中重度特应性皮炎患者的 II期临床研究达到主要临床终点，安全性优秀，眼部及注射部位的反应不良反应低于同类产品 。 |
All press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Shanghai Mabgeek Biotech.Co.Ltd | 麦济生物柯美奇拜单抗（MG-K10）特应性皮炎全球多中心 III 期临床试验完成首例受试者随机入组 mabgeek.com ↗ |
| 2026-07-15 | Shanghai Mabgeek Biotech.Co.Ltd | 柯美奇拜单抗每八周给药潜力初显 mabgeek.com ↗ |
| 2026-05-29 | Shanghai Mabgeek Biotech.Co.Ltd | 快讯 | 麦济生物柯美奇拜单抗（MG-K10）结节性痒疹III期临床试验获阳性顶线结果 mabgeek.com ↗ |
| 2026-04-30 | Shanghai Mabgeek Biotech.Co.Ltd | 麦济生物柯美奇拜单抗（MG-K10）序列及用途专利维持专利权有效 mabgeek.com ↗ |
| 2026-04-24 | Shanghai Mabgeek Biotech.Co.Ltd | 一次给药，长效覆盖季节性过敏全程——麦济生物1类新药柯美奇拜单抗（MG-K10）季节性过敏性鼻炎适应症NDA获受理 mabgeek.com ↗ |
| 2026-03-30 | Shanghai Mabgeek Biotech.Co.Ltd | MG-K10重磅亮相美国AAD大会：52周EASI-75达94.3%，长效抗IL-4Rα开启中重度AD便捷高效治疗新篇章 mabgeek.com ↗ |
| 2025-12-05 | Shanghai Mabgeek Biotech.Co.Ltd | 麦济生物长效抗IL-4Rα单抗 MG-K10 Ⅱ期临床结果发表于《Dermatitis》 mabgeek.com ↗ |
| 2025-10-31 | Shanghai Mabgeek Biotech.Co.Ltd | 全球首个长效IL-4Rα单抗MG-K10中重度特应性皮炎适应症上市申请获受理 mabgeek.com ↗ |
| 2023-11-21 | Shanghai Mabgeek Biotech.Co.Ltd | 麦济生物长效IL-4R单抗治疗中重度哮喘II期试验结果积极 mabgeek.com ↗ |
| 2023-06-29 | Shanghai Mabgeek Biotech.Co.Ltd | MG-K10治疗中重度特应性皮炎的II期临床研究达到主要终点 mabgeek.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | COMEKIBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068104 ↗ |
| Known as | MG-K10 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06026891 ↗ |
| Action | Inhibit | “which inhibits IL-4 and IL-13-mediated signalling to reduce type 2 inflammation in asthma” PMID 42212541 ↗ May 2026 |
| Modality | Monoclonal antibody | “MG-K10 is a long-acting, humanised monoclonal antibody against interleukin-4 receptor alpha (IL-4Rα)” PMID 42212541 ↗ May 2026 |
| Route | Subcutaneous | “Received MG-K10 300 mg subcutaneous injection every 2 weeks” NCT05382910 ↗ |
| Target | IL4R | “MG-K10 is a long-acting, humanised monoclonal antibody against interleukin-4 receptor alpha (IL-4Rα)” PMID 42212541 ↗ May 2026 |