Huahai subsidiary gets US FDA nod for drug clinical trial

Zhejiang Huahai Pharmaceutical Co., Ltd. announced its subsidiary, Shanghai Huaaotai Biopharmaceutical Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) to initiate Phase I clinical trials for injectable HB0043 in the United States. The drug, intended for the treatment of hidradenitis suppurativa, is a recombinant humanized IgG1 bispecific antibody targeting IL-17A and IL-36R. This follows approvals in New Zealand and by China's National Medical Products Administration earlier this year for clinical trials of HB0043.

The company has invested approximately RMB 71.11 million in the HB0043 project to date. HB0043 is described as a first-in-class dual-antibody drug globally, designed to overcome limitations of existing single-target therapies for inflammatory and fibrotic diseases. It has demonstrated superior efficacy compared to single antibodies in various animal models for conditions like atopic dermatitis and idiopathic pulmonary fibrosis.

The company cautions investors that drug development involves numerous uncertainties, from technical challenges to regulatory approvals and commercialization. Zhejiang Huahai Pharmaceutical commits to closely monitoring the progress of drug research, development, and registration, and will fulfill its information disclosure obligations promptly.