The US Food and Drug Administration (FDA) has approved Leads Biolabs’ first-in-human Investigational New Drug (IND) application for LBL-047, a novel therapeutic candidate for the treatment of autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren's syndrome.

LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain. There are currently no approved clinical trials of drugs targeting both BDCA2 and TACI worldwide, positioning LBL-047 as a potential first-in-class therapy.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated, "Autoimmune diseases often require lifelong management and represent the third most common chronic illness after cardiovascular diseases and cancer, underscoring the urgent need for safe and effective long-term therapies. LBL-047, our first autoimmune therapeutic candidate to enter the clinic, represents a major milestone in translating foundational immunology research into clinical development.”

This achievement also marks the expansion of the company’s pipeline beyond oncology into autoimmune diseases.

Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "In addition to our leading focus on oncology, we are committed to leveraging our immunology expertise to address chronic, underserved diseases such as autoimmune disorders. Our approach to antibody-based therapeutics is guided by a deep understanding of disease pathogenesis and powered by our advanced engineering platforms. LBL-047, along with our other autoimmune candidate LBL-051, reflects our strategy of developing bi- and tri-specific antibody modalities to rapidly deliver meaningful clinical benefit to patients worldwide.”