CSPC Innovation Pharmaceutical (300765.SZ) subsidiary Siriuskiov monoclonal antibody injection III phase clinical trial obtained top-line analysis data.

CSPC Innovation Pharmaceutical (300765.SZ) announced that its subsidiary CSPC PHARMA's subsidiary Giantstone Biopharma Co., Ltd. ("Giantstone") has recently obtained top-line analysis data from Phase III clinical trials of Sitravatinib monoclonal antibody injection. This product is a fully human IgG1 monoclonal antibody developed by Giantstone, and is a biosimilar of Sitravatinib. Sitravatinib 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. The key research has met the pre-defined primary endpoint and achieved positive top-line results. Statistical analysis indicates that the product is clinically equivalent to Sitravatinib with good safety, and no new or unexpected safety signals were observed, suggesting it may meet the safety requirements for long-term use by patients. Detailed data will be released in subsequent academic conferences and publications.