Core Viewpoint - The approval of LBL-047's IND application by the FDA indicates a significant advancement for the company, positioning LBL-047 as a first-in-class bispecific fusion protein targeting BDCA2 and TACI, with potential applications in various autoimmune diseases [1][2]. Group 1: Drug Development - The FDA approved the IND application for LBL-047 on September 19, 2025, marking a critical milestone for the company [1]. - LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 antibody and a modified TACI extracellular domain, with no other similar proteins currently approved or in clinical stages globally [1]. Group 2: Mechanism of Action - LBL-047 targets BAFF/APRIL and BDCA2 to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [2]. - The TACI domain binds to BAFF and APRIL, inhibiting downstream signaling, while BDCA2 specifically expressed on pDC can effectively suppress the release of type I interferons (IFN-I) [1][2]. Group 3: Therapeutic Potential - LBL-047 shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [2]. - The drug's glycosylation modification enhances its ability to broadly inhibit various abnormal immune responses, playing a critical role in the treatment of these diseases [2]. - The modification of the Fc region extends the half-life of LBL-047, potentially reducing dosing frequency and improving patient compliance [2].
维立志博-B(09887.HK)：LBL-047取得美国FDA的IND批 准