Firsekibart is a recombinant human IgG4-λ2 monoclonal antibody that specifically targets human interleukin-1 beta (IL-1β). It is also known by the synonyms Genakumab, GenSci048, and Kinnazumab.
Firsekibart is an anti-IL-1β monoclonal antibody developed for inflammatory disease applications. Clinical development has included investigation in gouty arthritis and other inflammation-related conditions. The China NMPA granted its first approval in 2025 for gouty arthritis, according to the IUPHAR/BPS Guide to PHARMACOLOGY.
Firsekibart has a molecular weight of approximately 145.13 kDa and is identified by CAS No. 2981430-39-9. The substance is classified as a protein / monoclonal antibody, with a human IgG4 configuration.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |