Health of the Nation: GJ-613 New Drug Market Application Accepted

San Sheng Guo Jian Announcement: The Phase III clinical trial of the company's recombinant humanized monoclonal antibody injection for acute gouty arthritis, targeting IL-1, has achieved the primary efficacy endpoints and has submitted a new drug application to the National Medical Products Administration. This drug, independently developed by the company, has proprietary rights to the anti-IL-1 antibody and has a completely different binding site from the marketed products Canakinumab and Gevokizumab targeting the same site. The completed Phase III clinical study shows that GJ-613 achieves dual primary efficacy endpoints in relieving pain and preventing recurrence in acute gouty arthritis and is comparable to the positive control drug compound betamethasone injection, significantly outperforming the positive control drug.