The board of directors of SinoMab BioScience Limited announced that on 19 May 2023, an Investigational New Drug application (IND'', for asthma) for SM17 has been filed with and accepted by the Center for Drug Evaluation (theCDE) of the National Medical Products Administration of China (the NMPA). Upon approval of the present IND, the Company plans to initiate a Phase I clinical study in China to bridge between Chinese (Asian) and American (CAsian/Black) populations, as well as to investigate the safety profile of SM17 in Chinese population. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma.

SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB. SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as 'alarmin'', which has shown to be implicated in the pathogenesis of airway viral responses and allergic disease, such as asthma.

Patients with severe, uncontrolled asthma are at a 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 annual 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 IL-17RB, will have a broad effect on airway inflammation.