huahaipharm(SH:600521) 智通财经网·2025-09-17 10:04Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HB0043 in the United States, marking a significant advancement in the treatment of autoimmune diseases [1] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug is developed for treating various difficult-to-treat autoimmune diseases, showing stronger efficacy in animal models compared to monoclonal antibodies [1] - HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [1] Group 2: Market Potential - Current IL-17A inhibitors and IL-36R monoclonal antibodies have shown positive effects in multiple indications, but there are still limitations in their single-dimensional intervention for some patients [1] - The dual-target approach of HB0043 is expected to provide new treatment strategies for immune-mediated inflammatory skin diseases and fibrotic diseases [1] - The innovative mechanism of HB0043 positions it as a first-in-class (FIC) product with broad potential applications in Th17 and IL-36 related immune-mediated diseases [1]