By Fineline Cube 
China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), announced that its recombinant IL-1β monoclonal antibody (mAb) SSGJ-613 has achieved dual primary efficacy endpoints in a Phase III study for acute gouty arthritis. Additionally, a New Drug Application (NDA) for the drug has been accepted for review by China’s Center for Drug Evaluation (CDE).
Drug Mechanism and Differentiation
SSGJ-613 is a fully proprietary anti-IL-1β antibody with a distinct variable region sequence. It targets unique epitopes compared to marketed IL-1β inhibitors such as Novartis’ canakinumab and gevokizumab. This differentiation positions SSGJ-613 as a novel therapeutic option in the treatment of acute gouty arthritis.
Clinical Trial Results
In the Phase III study, SSGJ-613 demonstrated comparable efficacy to betamethasone compound injection in acute pain relief. It also showed superiority in preventing acute gout recurrence when compared to the active comparator. The drug maintained a favorable safety and tolerability profile, with no new safety signals identified versus class benchmarks.-Fineline Info & Tech