Drugs / AK120
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | atopic eczema | 2026-02-26 | “已受理康方生物（9926.HK）自主研发的曼多奇单抗（IL-4Rα单抗，AK120）用于治疗中重度特应性皮炎的新药上市申请（NDA）” akesobio.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04256174 | Jun 2020 → Oct 2021 | atopic eczema | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06035354 | Nov 2021 → Jun 2024 | atopic eczema | Akeso | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06756126 | Dec 2024 → Jun 2025 overdue | atopic eczema | Akeso | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06700499 | Jul 2024 → Jul 2025 | atopic eczema | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT06092762 | Nov 2023 → Nov 2024 | atopic eczema | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05155020 | Feb → Aug 2022 | asthma | Akeso | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05048056 | Sep 2021 → May 2023 | atopic eczema | Akeso Biopharma, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT06383468 | Apr 2024 → Jan 2025 | atopic eczema | Akeso | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-26 | Akeso | Regulatory 康方生物曼多奇单抗（IL-4Rα）新药上市申请 获受理，治疗中重度特应性皮炎 akesobio.com ↗
日前，国家药品监督管理局药品审评中心（NMPA CDE）官网显示，已受理康方生物（9926.HK）自主研发的曼多奇单抗（IL-4Rα单抗，AK120）用于治疗中重度特应性皮炎的新药上市申请（NDA）. |
| 2025-08-25 | Akeso | Results 康方生物曼多奇单抗（IL-4Rα）中重度特应性皮炎Ⅲ期临床研究达到全部疗效终点 akesobio.com ↗ |
| 2023-09-11 | Akeso | Results 康方生物IL-4Rα单抗治疗特应性皮炎研究成果在《Dermatology and Therapy》发表 akesobio.com ↗
结果显示，AK120治疗中重度特应性皮炎患者安全可耐受，且初步疗效提示良好的临床前景. |
| 2021-10-12 | Akeso | Regulatory 康方生物迅速推进IL-4Rα单抗（AK120）特应性皮炎和哮喘适应症的II期临床研究 akesobio.com ↗ |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-26 | Akeso | 康方生物曼多奇单抗（IL-4Rα）新药上市申请 获受理，治疗中重度特应性皮炎 akesobio.com ↗ |
| 2025-08-25 | Akeso | 康方生物曼多奇单抗（IL-4Rα）中重度特应性皮炎Ⅲ期临床研究达到全部疗效终点 akesobio.com ↗ |
| 2023-09-11 | Akeso | 康方生物IL-4Rα单抗治疗特应性皮炎研究成果在《Dermatology and Therapy》发表 akesobio.com ↗ |
| 2021-10-12 | Akeso | 康方生物迅速推进IL-4Rα单抗（AK120）特应性皮炎和哮喘适应症的II期临床研究 akesobio.com ↗ |
| 2021-09-27 | Akeso | IL-4Rα单抗（AK120）中度至重度特应性皮炎全球II期临床启动 akesobio.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AK120 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04256174 ↗ |
| Action | Inhibit | “This mAb inhibits the signaling of the IL-4 and IL-13 cytokines.” PMID 37668898 ↗ Sep 2023 |
| Modality | Monoclonal antibody | “AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb)” PMID 37668898 ↗ Sep 2023 |
| Route | Subcutaneous | “The exposure of AK120 increased in an approximately dose-dependent manner upon subcutaneous dosing.” PMID 37668898 ↗ Sep 2023 |
| Target | IL4R | “directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes” PMID 37668898 ↗ Sep 2023 |