By Fineline Cube 
China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received market approval for its Category 1 drug firsekibart from the National Medical Products Administration (NMPA). The drug is indicated for adult patients with acute gouty arthritis attacks who are contraindicated for, intolerant of, or unresponsive to NSAIDs and/or colchicine, and are unsuitable for repeated corticosteroid use. This marks the first IL-1β monoclonal antibody (mAb) approved in China for this condition.
Clinical Advantages
Firsekibart demonstrates three key clinical advantages: long-term control, rapid and potent efficacy, and high safety. By precisely blocking IL-1β, the key inflammatory mediator in gout, the drug shows outstanding therapeutic effects.
Phase III Trial Results
Results from Phase III multicenter, randomized, double-blind, active-controlled clinical trials indicate that firsekibart provides rapid relief after a single dose. The analgesic effects are comparable to corticosteroids within 6-72 hours, and the drug reduces the risk of first recurrence within 6 months by 87%. Additionally, no drug-related serious adverse reactions were observed.-Fineline Info & Tech