CSPC Group (01093): Application for marketing of usinumab injection biopharmaceuticals accepted

According to Zhitong Finance App, Shiyao Group (01093) announced that the biopharmaceutical marketing application for usinumab injection (this product) developed by the company's subsidiary Shiyao Group Jushi Biopharmaceutical Co., Ltd. has been officially accepted by the China National Drug Administration.

This product is an all-human IgG1kappa monoclonal antibody, an IL-12/IL-23p40 inhibitor. Usinumab binds specifically to the p40 protein subunit of IL-12 and IL-23 with high affinity to block the interaction of IL-12 and IL-23 with the cell surface receptor IL-12rB1, thereby inhibiting IL-12 and IL-23 mediated signaling and cytokine cascading reactions, thereby inhibiting keratinocyte proliferation and exerting pharmacological effects in the treatment of psoriasis.

This product is declared according to Class 3.3 of therapeutic biological products. The indications are plaque-like psoriasis in adults and children. The application was mainly based on a key phase III clinical trial. The enrolled patients were adults with moderate to severe plaque psoriasis who did not respond to, were contraindicated, or were intolerable to any systemic treatment (including cyclosporine, methotrexate (MTX), PUVA (copolipin and ultraviolet A), and Avi A capsules). Clinical trial results showed that the efficacy of this product and Starano® in treating subjects with moderate to severe plaque psoriasis were highly consistent, and the safety was good. The product has good curative efficacy in treating plaque psoriasis. The stable administration interval is once every 12 weeks, and it has significant clinical application advantages.