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三生国健:GJ-613新药上市申请获受理
news flash· 2025-06-05 10:44
Core Viewpoint - The company has successfully completed the Phase III clinical trial for its innovative anti-IL-1β humanized monoclonal antibody injection (project code "GJ-613") for the treatment of acute gouty arthritis, achieving the primary efficacy endpoints and has submitted a new drug application to the National Medical Products Administration [1] Group 1 - The drug GJ-613 is developed independently by the company and possesses its own intellectual property rights, differentiating itself from existing products targeting the same pathway, such as Canakinumab and Gevokizumab, by having completely different binding epitopes [1] - The completed Phase III clinical study demonstrated that GJ-613 effectively alleviates pain in acute gouty arthritis and prevents recurrence, achieving dual primary efficacy endpoints comparable to the positive control drug, compound betamethasone injection, and significantly outperforming it [1]