Zhongzheng Intelligent Finance & Research Leads Biolabs(09887) announced on December 1st evening that the company's independently developed candidate drug LBL-047's new drug clinical trial (IND) application was approved by the National Medical Products Administration (NMPA) on November 25th.
According to the announcement, LBL-047 is the world's first dual-specific fusion protein to achieve dual submissions and dual approvals in China and the United States. It is composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and calcineurin binding molecule (TACI) extracellular domain. Currently, there are no drugs globally that simultaneously target plasma cell-like dendritic cells (pDC) and B cells and have been approved for clinical trials. This drug, with its unique mechanism of action, has the potential to be the first and the best among its kind.
LBL-047 selectively eliminates pDC to reduce the production of type 1 interferons and inhibits the B cell activation factor (BAFF) and proliferation-inducing ligand (APRIL) signaling pathways to block B cell activation, differentiation, and antibody production. It has the potential to treat various autoimmune indications and has been further optimized by extending its half-life through Fc region modification.
The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation I phase study, which will be conducted simultaneously in healthy adults and patients with systemic lupus erythematosus (SLE). The core purpose is to evaluate the safety, tolerability, and initial clinical efficacy of LBL-047 in SLE patients. The healthy volunteer trial is led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, and the SLE patient trial is led by Professor Ye Shuang and Professor Chen Sheng from Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital.
In addition, the company reached an exclusive global partnership with clinical-stage biotechnology company Dianthus Therapeutics (NASDAQ: DNTH) on October 16th, granting the company the exclusive rights to research, produce, and commercialize LBL-047 (DNTH212 outside the Greater China region) outside of the Greater China region. Both parties will jointly advance the global research and development process of this drug.

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