Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb), for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).
SSGJ-611’s Mechanism of Action and Indications
SSGJ-611 is designed to block the signal transduction of IL-4 and IL-13 by specifically binding to IL-4Rα, thereby regulating immune function and alleviating diseases such as atopic dermatitis (AD), chronic sinusitis with nasal polyps, and COPD. The drug has already achieved its primary endpoint in a Phase II study for moderate to severe AD in China and is currently enrolling patients for a Phase II study in chronic sinusitis with nasal polyps.
Global Market and Competitive Landscape
Globally, commercially available IL-4R antibodies include Regeneron/Sanofi’s Dupixent (dupilumab), which is approved to treat moderate to severe AD, asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. SSGJ-611 shows high similarity with dupilumab in mechanism of action, preclinical, and clinical trial data. Sunshine Guojian is also exploring a superior clinical medication regimen compared to dupilumab’s current regimen (Q4W), aiming to enhance treatment efficacy and patient compliance.-Fineline Info & Tech
