LEADS BIOLABS-B (09887.HK): LBL-047 completes first SLE patient dosing in Phase I Part B

NewTimeSpace News: According to the HKEX on October 30, Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs", 09887.HK) announced that LBL-047 (known as DNTH212 outside Greater China), its independently developed novel bispecific fusion protein targeting BDCA2 and TACI, has completed first dosing of a systemic lupus erythematosus (SLE) patient in Part B of its Phase I clinical study, marking LBL-047's first entry into autoimmune disease patients.

According to the announcement, LBL-047 acts on both innate and adaptive immunity, two clinically validated pathogenic pathways, with a complementary and differentiated dual-target design. Part B of the study mainly evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics as well as preliminary efficacy of LBL-047 in SLE patients, led by Professor Ye Shuang and Professor Chen Sheng of Renji Hospital.

The company said SLE is a highly heterogeneous systemic autoimmune disease, with about 107,000 and 34,000 new cases in China and the US each year respectively. On October 16, 2025, the company entered into an exclusive global partnership with Nasdaq-listed Dianthus Therapeutics, with a total deal value of up to USD1 billion, under which Dianthus will develop, manufacture and commercialize LBL-047 outside Greater China.