SYS6012 (secukinumab biosimilar) / CSPC Pharma - LARVOL DELTA

CSPC Pharmaceutical Group announced that China’s National Medical Products Administration has accepted the marketing authorisation application for its Secukinumab Injection biosimilar, developed by subsidiary CSPC Megalith Biopharmaceutical. (TipRanks) - "The drug, a fully human IgG1 monoclonal antibody targeting IL-17A, is being registered as a Class 3.3 therapeutic biological product and is designed to treat inflammatory diseases such as psoriasis, psoriatic arthritis and axial spondyloarthritis."

China filing • Immunology • Psoriasis

TOPLINE RESULTS OBTAINED FROM PHASE III CLINICAL TRIAL OF SECUKINUMAB INJECTION (CSPC Press Release) - "This pivotal study met its pre-specified primary endpoint and delivered positive topline results. Statistical analyses demonstrated that the Product was clinically equivalent to Cosentyx , with a favorable safety profile and no new or unexpected safety signals observed, giving it potential to meet the long-term safety requirements for patients. Detailed data from this study will be presented at upcoming academic conferences and published in peer-reviewed journals."

P3 data: top line • Psoriasis

A Randomized, Double-blind, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of SYS6012 VS secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis (ChiCTR) - P3 | N=394 | Completed | Sponsor: Shanghai Skin Disease Hospital; Shanghai Skin Disease Hospital

New P3 trial • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis