Hua Medicine Subsidiary Huaota Biopharma Receives Approval to Initiate Phase I Clinical Trial of HB0043, a First-in-Class Bispecific Antibody Targeting IL-17A and IL-36R, in New Zealand

Abstract

Recently, Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota"), a subsidiary of Zhejiang Huahai Pharmaceutical Co., Ltd., has received approval from the New Zealand Medicines and Medical Devices Safety Authority (hereinafter referred to as "MEDSAFE") and the Health and Disability Ethics Committee (hereinafter referred to as "HDEC") to conduct a Phase I clinical trial of injectable HB0043 locally.

About HB0043

HB0043 is a recombinant humanized IgG1 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 conditions where single-factor blockade therapies have limitations.

Market Competition Situation

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 remains insufficient in some patients. HB0043 innovatively combines dual targets of IL-17A and IL-36R, showing potential for broad application in various IL-17/IL-36-related immune-mediated diseases, demonstrating a leading mechanism and first-in-class (FIC) advantages with wide-ranging potential.

About Huaota

Huaota Bio is a biopharmaceutical company focused on independent research and development with a global perspective. It specializes in the R&D of novel biologics for oncology and autoimmune diseases. Currently, the company has 11 projects in clinical stages, including: the IL-36R monoclonal antibody, which has completed pivotal clinical trials with all endpoints achieved, marking it as China’s first self-developed treatment for generalized pustular psoriasis; the PD-L1/VEGF bispecific antibody currently in Phase II clinical trials, showing promising signals in multiple cancers such as endometrial cancer and non-small cell lung cancer; and the CD73-ADC, the first dual-mechanism cytotoxic agent targeting refractory tumors, among other key projects.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, aiming to provide high-quality, advanced biopharmaceuticals to the global market. The goal is to meet the widespread patient demand for accessible and affordable biologics, committed to changing the world through innovation!