Drugs / Genakumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | gout | 2024-04-11 | “received the "Acceptance Notice" from the National Medical Products Administration (NMPA), signaling the acceptance of their marketing application for GenSci's Genakumab.” genscigroup.com ↗ |
Trials 9
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci's Firsekibart Injection Receives Approval by NMPA genscigroup.com ↗
Recently, GenSci's Firsekibart Injection(liquid formulation) has officially received approval from National Medical Products Administration (NMPA). |
| 2025-05-20 | Changchun GeneScience Pharmaceutical Co., Ltd. | Results GenSci 2025 R&D Day: The Next Growth Frontier for a Billion-Dollar Growth Hormone Leader genscigroup.com ↗
Meanwhile, Genakumab (anti-IL-1β monoclonal antibody), a long-acting biologic for acute gouty arthritis, is nearing commercialization with dual benefits of rapid pain relief within 6 hours and 87% reduction in recurrence risk within 6 months (HR=0.10, *p*<0.001), positioning it as a potential best-in-class therapy. |
| 2024-11-20 | Changchun GeneScience Pharmaceutical Co., Ltd. | Results Chinese Monoclonal Anti-IL-1β Breakthrough: Acute Gout Arthritis Treatment Impresses at ACR 2024 genscigroup.com ↗
At this prestigious event, the latest Phase III clinical trial results for Genakumab, now rebranded as Firsekibart, a novel fully humanized monoclonal anti-IL-1β antibody developed in-house by GenSci, was reported. |
| 2024-05-26 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory NMPA Approves Genakumab Injection for Clinical Trial Commencement genscigroup.com ↗
GenSci recently received the Approval Notice from the National Medical Products Administration (NMPA) to initiate the Genakumab Injection(liquid form) clinical trial, which marks the initiation of bioequivalence studies for the new formulation of Genakumab Injection. |
| 2024-04-11 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory R&D Progress: NMPA Approves Genakumab to the Market genscigroup.com ↗
Changchun GeneScience Pharmaceuticals Co., Ltd. (GenSci) received the "Acceptance Notice" from the National Medical Products Administration (NMPA), signaling the acceptance of their marketing application for GenSci's Genakumab. |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Genakumab | “All subjects received one dose of Genakumab injection every 4 weeks according to their group.” NCT06189495 ↗ |
| Known as | firsekibart | “This study evaluated the efficacy and safety of firsekibart, a fully human anti-IL-1β monoclonal antibody, in children with active sJIA.” PMID 41814037 ↗ Mar 2026 |
| Action | Inhibit | “fully human anti-IL-1β monoclonal antibody” PMID 41814037 ↗ Mar 2026 |
| Modality | Monoclonal antibody | “a fully human anti-IL-1β monoclonal antibody” PMID 41814037 ↗ Mar 2026 |
| Route | Subcutaneous | “single subcutaneous injection of Genakumab for Injection” NCT05328531 ↗ |
| Target | IL1B | “a fully human anti-IL-1β monoclonal antibody” PMID 41814037 ↗ Mar 2026 |