---
title: "Huahaipharm: Huaotai has received FDA approval to conduct Phase I clinical trials of injectable HB0043 in the United States"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/257698115.md"
description: "Huahaipharm's subsidiary Huaotai has received FDA approval to conduct Phase I clinical trials of injectable HB0043 in the United States. HB0043 is a bispecific antibody targeting IL-17A and IL-36R, with high binding and blocking activity, aimed at treating various autoimmune diseases. Compared to monoclonal antibodies, HB0043 demonstrates stronger performance in suppressing inflammation and fibrotic responses, potentially providing new treatment ideas for immune-mediated inflammatory skin diseases and fibrotic diseases"
datetime: "2025-09-17T10:03:10.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/257698115.md)
  - [en](https://longbridge.com/en/news/257698115.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/257698115.md)
---

# Huahaipharm: Huaotai has received FDA approval to conduct Phase I clinical trials of injectable HB0043 in the United States

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

HB0043 is a recombinant humanized IgG1 bispecific antibody that simultaneously targets human interleukin-17A (IL-17A) and human interleukin-36 receptor (IL-36R), exhibiting high binding and blocking activity, and is developed for the treatment of various difficult-to-treat autoimmune diseases. Compared to monoclonal antibodies, HB0043 has a stronger inhibitory effect on cytokine-induced inflammation and fibrosis response. Through dual blockade of IL-17A and IL-36R, it has demonstrated superior efficacy to monoclonal antibodies in various animal disease models such as atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), diabetic nephropathy (DN), and neutrophilic asthma. HB0043 will provide new ideas for targeted therapy of immune-mediated inflammatory skin diseases and fibrotic diseases, which have limitations in single-factor blockade therapy.

HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, expected to break through the limitations of existing single-target therapies. Currently, IL-17A inhibitors (such as secukinumab), dual inhibitors of IL-17A/F (such as bimekizumab), and anti-IL-36R monoclonal antibodies (such as spesolimab) have achieved positive efficacy in multiple indications, but their single-dimensional intervention on inflammation still has shortcomings in some patients. HB0043 innovatively integrates the dual targets of IL-17A and IL-36R, with the potential for broad application in various T helper 17 (Th17) and interleukin-36 related immune-mediated diseases, demonstrating a leading mechanism and extensive potential as a first-in-class (FIC) advantage

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