Core Insights - The company Valiant Biopharma-B (09887) has received approval from the National Medical Products Administration (NMPA) in China for the clinical trial application of its candidate drug LBL-047, marking it as the first bispecific fusion protein to achieve dual reporting and approval in both China and the U.S. [1] - LBL-047 targets both plasmacytoid dendritic cells (pDC) and B cells, with no other drug currently approved for clinical trials that simultaneously targets these cells, indicating its potential as a first-in-class and best-in-class 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] Collaboration and Commercialization - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to grant Dianthus exclusive global rights for the research, development, production, and commercialization of LBL-047 outside of Greater China, aiming to maximize its clinical value and commercial potential [2]
维立志博-B(09887)：LBL-047取得NMPA的IND批准