CSPC PHARMA (01093): The Phase III clinical trial of Sintilimab Injection obtained top-line analysis data.

CSPC PHARMA (01093) announced that its subsidiary CSPC PHARMA Jushi Biotechnology Co., Ltd. has obtained top-line analysis data from the Phase III clinical trial of Sikkurixou monoclonal antibody injection developed for the treatment of moderate to severe plaque psoriasis. Psoriasis is an immune-related chronic, inflammatory, and systemic disease. Currently, there are over 7 million psoriasis patients in China. Interleukin (IL)-17A, mainly produced by activated T cells, is a key molecule in the pathogenesis of psoriasis. Sikkurixou monoclonal antibody specifically binds to IL-17A, blocking the signal transmission of IL-17 receptor, thereby suppressing psoriasis inflammation. This product is a fully human IgG1 monoclonal antibody drug developed by the Group, which is a biosimilar to Sikkurixou monoclonal antibody injection (Kesunte). Kesunte has been approved in China for the treatment of plaque psoriasis in patients aged 6 and above, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa, with its efficacy and safety widely recognized. Following the research principles of biosimilars, the Group conducted the development of this product and conducted a "head-to-head" equivalence study with Kesunte. The study is a multicenter, randomized, double-blind, parallel, positive-controlled equivalence Phase III clinical trial, aimed at verifying the consistency of efficacy between this product and Kesunte in treating patients with moderate to severe plaque psoriasis. The study population consists of patients with moderate to severe plaque psoriasis, randomized in a 1:1 ratio to the study group (this product) and the control group (Kesunte), with the main endpoint being the proportion of patients achieving a 75% improvement in Psoriasis Area and Severity Index (PASI-75) from baseline at week 12. This key study has achieved the pre-defined primary endpoint and obtained positive top-line results. Statistical analysis indicates that this product is clinically equivalent to Kesunte, with good safety and no new or unexpected safety signals, promising to meet the safety needs for long-term medication for patients. Detailed data from this study will be published in upcoming academic conferences and journals.