Hua Hai Pharmaceutical's Subsidiary Huaaotai Receives FDA Approval to Initiate Phase I Clinical Trial of HB0043 Injection in the U.S.

Huahai Pharmaceutical (600521.SH) announced that recently, its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") has received approval from the U.S. Food and Drug Administration (hereinafter referred to as "FDA") to conduct a Phase I clinical trial of injectable HB0043 in the United States.

HB0043 is a recombinant humanized IgG1-type bispecific antibody that simultaneously targets human interleukin-17A (IL-17A) and human interleukin-36 receptor (IL-36R). It exhibits high binding and blocking activity and is being developed for the treatment of various difficult-to-treat autoimmune diseases. Compared with monoclonal antibodies, HB0043 demonstrates stronger inhibition of cytokine-induced inflammation and fibrotic responses. Through dual blockade of IL-17A and IL-36R, it has shown superior efficacy to monoclonal antibodies in multiple animal disease models, such as atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), diabetic nephropathy (DN), and neutrophilic asthma. HB0043 will provide new insights into targeted therapies for immune-mediated inflammatory skin diseases and fibrotic diseases where single-factor blockade therapy has limitations.

HB0043 is the world's first bispecific antibody drug targeting both IL-17A and IL-36R, with the potential to overcome the limitations of current single-target treatments. Although IL-17A inhibitors (secukinumab), IL-17A/F dual inhibitors (bimekizumab), and anti-IL-36R monoclonal antibodies (pepsolizumab) have shown positive efficacy in multiple indications, their single-dimensional intervention in inflammation still falls short in some patients. HB0043 innovatively combines dual targets of IL-17A and IL-36R, showing promise for broad application in various T-helper 17 (Th17) and interleukin-36-related immune-mediated diseases, demonstrating a mechanism-leading, widely potent First-in-Class (FIC) advantage.