Nanjing Leads Biolabs Achieves Milestone with FDA Approval for Innovative Bispecific Antibody IND

Nanjing Leads Biolabs Co., Ltd. (9887.HK) has reached a significant breakthrough in biopharmaceutical innovation. On September 22, 2025, the company announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for LBL-047, marking a crucial step forward in the development of a novel bispecific antibody.

LBL-047 represents a cutting-edge approach in immunotherapy, combining two independently developed components:

1. A humanized antibody targeting blood dendritic cell antigen 2 (BDCA2)
2. An engineered ectodomain of the transmembrane activator and CAML interactor (TACI)

This bispecific fusion protein is the first of its kind to simultaneously target both BDCA2 and TACI, positioning LBL-047 as a potential first-in-class therapeutic agent. The dual-targeting mechanism of LBL-047 is designed to enhance immune system modulation, potentially offering new treatment options for autoimmune diseases and certain cancers.

Significance of the FDA Approval

The FDA's approval of the IND application for LBL-047 is a pivotal moment for Nanjing Leads Biolabs and the broader biotech industry:

• It validates the company's innovative approach to drug development
• Allows for the initiation of first-in-human clinical trials in the United States
• Positions LBL-047 at the forefront of bispecific antibody research

Market Implications

The advancement of LBL-047 could have far-reaching implications for both the biotechnology sector and related investment markets:

• Biotech Industry Impact: Success in clinical trials could accelerate interest in bispecific antibodies, potentially leading to increased research and development in this field.

• Investment Landscape: As the first company to receive FDA approval for a BDCA2 and TACI targeting bispecific antibody, Nanjing Leads Biolabs may attract increased attention from investors interested in innovative biotech companies.

• Potential for Partnerships: The unique mechanism of action of LBL-047 could make Nanjing Leads Biolabs an attractive partner for larger pharmaceutical companies looking to expand their immunotherapy portfolios.

As the biotech sector continues to evolve, developments like LBL-047 underscore the importance of staying informed about cutting-edge research and its potential impact on various markets, including those related to digital assets and biotechnology investments.