Sanofi's (SNY.US) new drug lunsekimig injection has been approved for clinical trials in China again, this time for the treatment of asthma.

The National Medical Products Administration's (NMPA) Center for Drug Evaluation and Research (CDE) recently announced on its website that Sanofi (SNY.US) has received a new clinical trial approval for its new drug lunsekimig injection, which is intended to treat high-risk asthma in adults. The product has already been approved for an IND in China, targeting the indication of moderate to severe asthma in adults. According to public information, lunsekimig (previously known as SAR443765) is a nanobody that connects the heavy chain variable region (VHH) targeting IL-13 and TSLP. Sanofi said at its R&D day that the product has the potential to become a blockbuster drug. The image below is from the CDE's website. Lunsekimig is a dual inhibitor of TSLP and IL-13. Both IL-13 and TSLP are validated targets in the field of immunology and inflammation, and are also key mediators in the pathophysiology of asthma. Simultaneously blocking these two signaling pathways may produce synergistic effects and stronger efficacy. In a phase 1b clinical trial in asthma patients, lunsekimig significantly improved the exhaled nitric oxide fraction (FeNO), a marker of airway inflammation, compared to monotherapy targeting IL-13 or TSLP. This result demonstrates the potential synergistic effect of blocking these two signaling pathways. According to the China Drug Clinical Trial and Information Disclosure Platform's website, Sanofi is conducting two phase 2 clinical studies in adult patients with moderate to severe asthma to explore the dose range of lunsekimig and evaluate its long-term safety and efficacy. Source: CDE's website