CSPC biosimilar secukinumab achieves positive phase III results

CSPC Pharmaceutical Group Limited, through its subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., has obtained positive topline results from the Phase III equivalence clinical trial of its secukinumab injection. The product is a biosimilar to Cosentyx® and is intended for the treatment of moderate to severe plaque psoriasis.

The study, a multi-center, randomised, double-blinded, parallel, positive-controlled Phase III equivalence clinical trial, met its pre-specified primary endpoint. Statistical analyses demonstrated clinical equivalence to Cosentyx®, coupled with a favorable safety profile showing no new or unexpected safety signals. The primary endpoint measured the proportion of patients achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 12.

Psoriasis affects over 7 million patients in China, with IL-17A being a key mediator in its pathogenesis. Secukinumab specifically targets IL-17A, blocking signal transduction and inhibiting psoriatic inflammation. The company plans to present detailed data from this study at upcoming academic conferences and publish it in peer-reviewed journals.