Sanofi's new drug Lunsekimig injection has been approved for clinical trials in China again, intended for the treatment of asthma.

The China National Medical Products Administration's Center for Drug Evaluation (CDE) recently announced on its official website that Sanofi (SNY.US) has received a new clinical trial implied license for its Class 1 new drug lunsekimig injection, intended for the treatment of adult high-risk asthma. This product had previously received IND approval in China for the treatment of moderate to severe asthma in adults. Public information indicates that lunsekimig (previously known as SAR443765) is a nanobody that combines a heavy chain variable domain (VHH) targeting IL-13 and TSLP. Sanofi stated in a previous research and development day that this product has the potential to be a major drug. Lunsekimig is a dual inhibitor of thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13). IL-13 and TSLP are validated targets in the fields of immunology and inflammation, and are key mediators in the pathophysiology of asthma. Inhibiting both of these signaling pathways simultaneously may lead to a synergistic effect and enhanced therapeutic efficacy. In a Phase 1b clinical trial for asthma patients, lunsekimig significantly improved the fraction of exhaled nitric oxide (FeNO), a marker of airway inflammation, compared to single-target IL-13 or TSLP therapies. This result demonstrates the potential synergistic effect of blocking both signaling pathways. According to the official website of the Chinese Clinical Trial and Registration Platform for Drugs, Sanofi is conducting two Phase 2 clinical studies on adult patients with moderate to severe asthma to explore the dosing range of lunsekimig and evaluate its long-term safety and efficacy.