The board of directors of SinoMab BioScience Limited announce that on 9 June 2023, an Investigational New Drug application ("IND'', for atopic dermatitis ("AD'') for SM17 has been filed with and accepted by the Center for Drug Evaluation (the "CDE'') of the National Medical Products Administration of China (the "NMPA''). The Company plans to initiate a Phase I clinical study in China upon approval of the present IND. 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 AD. 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) and Type 2 helper T (Th2) cells, 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 autoimmune and inflammatory skin diseases, such as AD. Patients with AD also have an increasing all-cause mortality rate and disease-specific mortality rate in the following diseases, which includes infections, respiratory diseases, gastrointestinal diseases and oncologic diseases. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life. However, there is still an unmet medical need for patients showing irresponsiveness to those approved therapies.