UNITED LAB (03933) announced that its wholly-owned subsidiary, Zhuhai United Laboratories Biopharmaceuticals Co., Ltd., has obtained implied approval from the National Medical Products Administration for clinical trials of its dupilumab biosimilar for the treatment of atopic dermatitis. The application acceptance number is CXSL2600180.
Dupilumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody used to treat atopic dermatitis, particularly moderate-to-severe cases where topical treatments are ineffective or not recommended. The drug specifically binds to the interleukin-4 receptor alpha subunit (IL-4Rα), blocking the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13). This action inhibits type 2 inflammatory responses, reduces the secretion of inflammation-related cytokines, lowers immunoglobulin E (IgE) levels, and improves skin and mucosal barrier function. It is currently a key targeted therapy for type 2 inflammatory diseases, including atopic dermatitis.
This approval marks another significant milestone in the company's innovative research and development efforts in the field of inflammatory and autoimmune diseases. Moving forward, UNITED LAB will continue to focus on the development of new products, with an emphasis on enhancing its competitiveness and innovation in the biopharmaceutical industry. This is expected to generate greater returns for the company and its shareholders.
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