huahaipharm(SH:600521) Zheng Quan Zhi Xing·2025-07-31 16:15Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its drug HB0043, which targets pyogenic hidradenitis and represents a significant advancement in the treatment of autoimmune diseases [1][2]. Group 1: Drug Information - The drug HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [2]. - HB0043 has shown superior efficacy compared to monoclonal antibodies in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [2]. - The drug is expected to provide new therapeutic strategies for immune-mediated inflammatory skin diseases and fibrotic diseases, addressing the limitations of single-factor blocking therapies [2][3]. Group 2: Clinical Trial Approval - The drug has received approval for clinical trials, with the first phase set to take place in New Zealand, as approved by the Ethics Committee [1]. - The company has invested approximately RMB 69.09 million in the research and development of HB0043 to date [2]. Group 3: Competitive Advantage - HB0043 is the first bispecific antibody globally targeting both IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [3]. - The drug is positioned to be widely applicable in various Th17/IL-36 related immune-mediated diseases, showcasing a first-in-class advantage in its mechanism and potential [3].