康弘药业：度普利尤单抗KH816注射液药物临床试验获批

Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Chengdu Kanghong Biotechnology Co., has received approval from the National Medical Products Administration for the clinical trial of KH816 injection, a biosimilar of Dupilumab [1] Group 1: Product Development - KH816 injection is developed as a biosimilar to Dupilumab, which is a fully human monoclonal antibody (IgG4 type) [1] - The mechanism of action involves specific binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes, inhibiting the signaling pathways of IL-4 and IL-13 [1] Group 2: Therapeutic Indications - IL-4 and IL-13 mediated inflammation plays a crucial role in the pathogenesis of asthma, atopic dermatitis, nodular prurigo, and chronic obstructive pulmonary disease [1] - The inflammatory response involves various cell types expressing IL-4Rα, including mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, and goblet cells, as well as inflammatory mediators such as histamine, leukotrienes, cytokines, and chemokines [1] Group 3: Mechanism of Action - By blocking IL-4Rα, Dupilumab can inhibit the inflammatory responses induced by IL-4 and IL-13 cytokines, including the release of pro-inflammatory cytokines, chemokines, nitric oxide, and IgE [1]