Huahai Pharmaceutical's Subsidiary Receives Approval to Initiate Phase I Clinical Trial of HB0043, a First-in-Class Bispecific Antibody Targeting IL-17A and IL-36R

Huahai Pharmaceutical (600521.SH) announced that its subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd. ("Huaota"), has recently received approval from New Zealand's Medicines and Medical Devices Safety Authority ("MEDSAFE") and the Health and Disability Ethics Committee ("HDEC") to conduct a Phase I clinical trial of injectable HB0043 in the region.

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-dimension 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 Th17/IL-36-related immune-mediated diseases, demonstrating a first-in-class (FIC) advantage with leading mechanisms and wide-ranging potential.