Group 1 - The company Valiant Biopharma-B (09887) announced that its self-developed candidate drug LBL-047 has received approval for clinical trials (IND) from the National Medical Products Administration (NMPA) of China on November 25, 2025 [1] - LBL-047 is the world's first bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with a unique mechanism of action that positions it as a first-in-class and best-in-class potential therapy [1] - The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2 - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to develop transformative therapies for severe autoimmune diseases, granting Dianthus exclusive global rights for the research, production, and commercialization of LBL-047 outside Greater China [2] - The collaboration aims to advance the global development of LBL-047 and maximize its clinical value and commercial potential [2]
维立志博-B：LBL-047取得NMPA的IND批准