Nanjing Leads Biolabs (9887) Announces NMPA IND Approval for LBL-047 and Global Partnership with Dianthus Therapeutics

Bulletin Express12-01

Nanjing Leads Biolabs Co., Ltd. (Stock Code: 9887) announced that on November 25, 2025, the National Medical Products Administration approved the Investigational New Drug application for its self-developed drug candidate LBL-047. The compound is described as the first bispecific fusion protein composed of a humanized anti-BDCA2 antibody and an engineered TACI ectodomain to gain IND approval in both China and the United States. No approved clinical trials globally currently target both plasmacytoid dendritic cells and B cells, which indicates distinctive potential for LBL-047.

According to the announcement, a double-blind, randomized, placebo-controlled Phase I study will be conducted in healthy adults and patients with systemic lupus erythematosus (SLE). The portion involving healthy volunteers is led by Professor Meng Xianmin at Shanghai Public Health Clinical Center, while the SLE patient segment is led by Professors Ye Shuang and Chen Sheng at Renji Hospital, Shanghai Jiaotong University School of Medicine. On October 16, 2025, Nanjing Leads Biolabs Co., Ltd. entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to research, develop, manufacture, and commercialize LBL-047, known as DNTH212 outside Greater China. The announcement cautioned that there is no guarantee of successful development or marketing of LBL-047, and advised shareholders and potential investors to exercise due care when dealing in the company’s shares.

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