On November 26, GLONGHUI (300765.SZ) announced that the company's holding subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd. (hereinafter referred to as “Jushi Biotech”), recently received the “Notice of Acceptance” approved and issued by the State Drug Administration, and the marketing application for usinumab injections was accepted.
Usinumab injection is an all-human IgG1kappa monoclonal antibody. It is an IL-12/IL-23p40 inhibitor. Usinumab binds specifically with IL-12 and IL-23 p40 protein subunits to block the interaction of IL-12 and IL-23 with the cell surface receptor IL-12Rβ1, thereby inhibiting IL-12 and IL-23 mediated signaling and cytokine cascading reactions, thereby inhibiting IL-12 and IL-23 mediated signal transmission and cytokine cascading reactions, thereby inhibiting the proliferation of keratinocytes and exerting therapeutic effects on 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 is 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 usinumab injection and the original drug starnol in treating subjects with moderate to severe plaque psoriasis were highly consistent, and the safety was good. Usinumab injections are effective in treating psoriasis. The stable dosing interval is once every 12 weeks, which has significant clinical application advantages.