Drugs / GUMOKIMAB
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | ankylosing spondylitis | 2026-01-19 | “古莫奇单抗（AK111）用于治疗活动性强直性脊柱炎（AS）的新药上市申请（sNDA），已获得国家药品监督管理局药品审评中心（NMPA CDE）受理” akesobio.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05504317 | May 2020 → Mar 2021 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 1 | NCT03622021 | Aug 2018 → Sep 2019 | psoriasis | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06061471 | Sep 2023 → Dec 2024 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05467995 | Jun 2021 → Apr 2022 | ankylosing spondylitis | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05096364 | Apr 2021 → Feb 2023 | psoriasis | Akeso | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06378697 | Nov 2023 → Feb 2025 | ankylosing spondylitis | Akeso | Completed | Met primary |
| Phase 3 | NCT06066125 | Mar 2023 → Aug 2024 | psoriasis | Akeso | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06947109 Comparator | May 2025 → Jan 2026 overdue | — | Akeso | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Akeso | Regulatory 古莫奇单抗(IL-17)获批上市，治疗中重度银屑病，康方生物自免领域再添重磅新药 akesobio.com ↗
康方生物(9926.HK)欣然宣布，公司独立自主研发的靶向IL-17的单克隆抗体奇佑康®(古莫奇单抗，AK111)，已获得国家药品监督管理局(NMPA)批准上市，用于中重度斑块状银屑病成人患者的治疗. |
| 2026-01-19 | Akeso | Regulatory 古莫奇单抗第2项NDA，治疗强直性脊柱炎新药上市申请获受理 akesobio.com ↗ |
| 2025-08-21 | Akeso | Results 康方生物古莫奇单抗治疗强直性脊柱炎Ⅲ期临床研究达到全部疗效终点 akesobio.com ↗
康方生物（9926.HK）今日宣布，其自主研发的新型人源化抗IL-17A单克隆抗体古莫奇（研发代号：AK111），在治疗活动性强直性脊柱炎（AS）的关键注册性Ⅲ期临床研究中取得阳性结果，主要疗效终点ASAS20及亚组分析、关键次要终点ASAS40，及其他预先选定的多个次要终点均均获得成功，具有统计学显著性和临床意义的改善. |
| 2025-01-27 | Akeso | Regulatory 康方生物古莫奇（IL-17）单抗新药上市申请获NMPA受理 akesobio.com ↗ |
| 2024-10-28 | Akeso | Results 长期疗效卓越疗效！康方古莫奇（IL-17）中重度斑块型银屑病III期完整数据发布：充分满足患者更高的治疗需求 akesobio.com ↗ |
| 2024-10-02 | Akeso | Results EADV 2024 | 古莫奇（IL-17）治疗中重度斑块型银屑病的优异II期临床结果发表 akesobio.com ↗ |
| 2023-12-01 | Akeso | Results 康方生物古莫奇单抗（IL-17）治疗中重度斑块型银屑病Ⅲ期研究达到全部疗效终点 akesobio.com ↗ |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Akeso | 古莫奇单抗(IL-17)获批上市，治疗中重度银屑病，康方生物自免领域再添重磅新药 akesobio.com ↗ |
| 2026-01-19 | Akeso | 古莫奇单抗第2项NDA，治疗强直性脊柱炎新药上市申请获受理 akesobio.com ↗ |
| 2025-08-21 | Akeso | 康方生物古莫奇单抗治疗强直性脊柱炎Ⅲ期临床研究达到全部疗效终点 akesobio.com ↗ |
| 2025-01-27 | Akeso | 康方生物古莫奇（IL-17）单抗新药上市申请获NMPA受理 akesobio.com ↗ |
| 2024-10-28 | Akeso | 长期疗效卓越疗效！康方古莫奇（IL-17）中重度斑块型银屑病III期完整数据发布：充分满足患者更高的治疗需求 akesobio.com ↗ |
| 2024-10-02 | Akeso | EADV 2024 | 古莫奇（IL-17）治疗中重度斑块型银屑病的优异II期临床结果发表 akesobio.com ↗ |
| 2023-12-01 | Akeso | 康方生物古莫奇单抗（IL-17）治疗中重度斑块型银屑病Ⅲ期研究达到全部疗效终点 akesobio.com ↗ |
| 2021-12-28 | Akeso | 康方生物IL-17A单抗（AK111）治疗强直性脊柱炎Ⅱ期临床试验完成受试者入组 akesobio.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GUMOKIMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095302 ↗ |
| Known as | AK111 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06066125 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5095302 ↗ |
| Route | Subcutaneous | “administered subcutaneously” NCT03622021 ↗ |