Sanofi Initiates Phase 2b/3 Clinical Trial of TSLP/IL-13 Bispecific Antibody Lunsekimig for COPD

▎Armstrong

On September 24, 2025, Sanofi registered a Phase 2b/3 clinical trial for Lunsekimig in the treatment of COPD (Chronic Obstructive Pulmonary Disease) on the Clinicaltrials.gov website.

This Phase 2b/3 clinical trial plans to enroll 942 adult patients with COPD and is expected to be preliminarily completed by November 2029.

Lunsekimig is a TSLP/IL-13 tetravalent nano-bispecific antibody that has the potential to break through the efficacy ceiling of type 2 inflammatory pathways, and Sanofi expects its peak sales to reach $20-50 billion.

Lunsekimig is currently exploring multiple indications, including asthma, atopic dermatitis, CPOD, and CRSwNP. This time, COPD has advanced to the Phase 2b/3 clinical stage.

Summary

In recent years, the research and development of bispecific/multispecific antibodies for autoimmune diseases have been exceptionally active. Sanofi has made significant investments in this area, including its self-developed TSLP/IL-13 bispecific antibody and TNFα/OX40L bispecific antibody, both of which are based on nanobody technology. Additionally, Sanofi has introduced TL1A/integrin α4β7 bispecific antibody and TL-1A/IL-23 bispecific antibody from Huashen Zhiyao for the treatment of inflammatory bowel disease (IBD).