China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced the completion of patient enrollment in a China-based Phase II clinical study for its SSGJ-611, an IL-4Rα monoclonal antibody (mAb). The drug is being evaluated as a treatment for moderate to severe atopic dermatitis (AD).
Study Design and Previous Results
The multicenter, randomized, double-blind, placebo-controlled Phase II study is designed to assess the efficacy and safety of SSGJ-611 subcutaneous injection in three dose groups: first dose 600 mg+300 mg Q2W, first dose 600 mg+300 mg Q4W, and a placebo group. Previous Phase Ia and Ib studies conducted in the United States and China, respectively, have shown strong indications of good safety, tolerability, and clinical efficacy.
Mechanism of Action and Global Context
SSGJ-611 works by blocking the signal transduction of IL-4 and IL-13 through specific binding to IL-4Rα, thereby regulating immune function and alleviating diseases such as atopic dermatitis. Globally, commercially available IL-4R antibodies include Regeneron/Sanofi’s Dupixent (dupilumab), which is approved for moderate to severe AD, asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. SSGJ-611 demonstrates high similarity with dupilumab in terms of mechanism of action and preclinical and clinical trial data. Sunshine Guojian is actively exploring a more effective clinical medication regimen than dupilumab (Q4W).-Fineline Info & Tech
