huahaipharm(SH:600521) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-07-31 23:13Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of its drug HB0043, which targets pyogenic hidradenitis [1][2]. Drug Basic Information - Drug Name: Injectable HB0043 - Indication: Pyogenic Hidradenitis - Dosage Form: Injectable Sterile Powder - Application: Clinical Trial - Applicants: Shanghai Huatai Biopharmaceutical Co., Ltd. and Huabo Biopharmaceutical Technology (Shanghai) Co., Ltd. [1] Additional Drug Information - In May 2025, Huatai received approval from New Zealand's Medicines and Medical Devices Safety Authority to conduct Phase I clinical trials for HB0043 in New Zealand [1]. - The total R&D investment in the project has reached approximately RMB 69.09 million [3]. Drug Mechanism and Advantages - HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [3]. - Compared to monoclonal antibodies, HB0043 shows stronger efficacy in inhibiting cytokine-induced inflammation and fibrosis through dual blockade of IL-17A and IL-36R [3]. - It has proven superior efficacy in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [3]. - HB0043 is the first bispecific drug targeting IL-17A and IL-36R globally, potentially overcoming the limitations of existing single-target therapies [4].