SinoMab BioScience Limited announced that on 11 August 2023, the Investigational New Drug application (IND), for the treatment of patients with asthma for the Company's First-in-Class (FIC) therapeutic product SM17, was approved by the National Medical Products Administration of China (the NMPA). The IND approval would enable the Company to conduct comprehensive clinical development program in China which lead to the indication for treatment of asthma. The Company plans to conduct a Phase I clinical study in China soon to investigate the safety profile of SM17 in Chinese population and to initiate the clinical development program of SM17 for the treatment of allergic diseases.

SM17 is a novel, First-in-Class (FIC), humanized, IgG4-k monoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical ''alarmin' molecule interleukin 25 (IL-25). SM17 could suppress Th2 immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s), and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by IL-25, and suppressing the release of the downstream Th2 cytokines such asIL-4, IL-5 and IL-13. IL-25 is a critical cytokine classified as 'alarmin'', which has shown to be implicated in the pathogenesis of multiple airway viral responses and allergic diseases, such as asthma.

Patients with severe, uncontrolled asthma are at risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures. Current approved therapies for severe asthma, including biologics, can reduce asthma exacerbations to a certain extent. However, there is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments.

The company expects that targeting upstream mediators of the Th2 inflammatory cascade, such as the receptor for IL-25, will have a broad effect on airway inflammation.