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First-in-Class Potential! FDA Clears IND Application for LBL-047, an Anti-BDCA2/TACI Bispecific Fusion Protein Developed by Leads Biolabs
Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) announced that the U.S. Food and Drug Administration (FDA) has approved its first-in-human Investigational New Drug (IND) application for LBL-047 on September 19, 2025. 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 independently developed by Leads Biolabs. There
About this update from Nanjing Leads Biolabs Co., Ltd. Class H
[{"type":"text","content":"NANJING, China, Sept. 22, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) announced that the U.S. Food and Drug Administration (FDA) has approved its first-in-human Investigational New Drug (IND) application for LBL-047 on September 19, 2025. 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 independently developed by Leads Biolabs. There are currently no approved clinical trials of drugs targeting both BDCA2 and TACI worldwide. With this unique mechanism of action, LBL-047 holds strong first-in-class potential.","length":749,"tagName":"p"},{"type":"text","content":"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 our pipeline beyond oncology into autoimmune diseases."","length":574,"tagName":"p"},{"type":"text","content":"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.".","length":616,"tagName":"p"},{"type":"text","content":"About LBL-047","length":13,"tagName":"p"},{"type":"text","content":"B cells and plasmacytoid dendritic cells (pDCs) are both central drivers of autoimmune disease pathogenesis. BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand) are key cy...