SM17 is a novel, first-in-class, 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 and morbidity, diminished quality of life and increased health expenditures.
Meanwhile, the Company is also advancing the Phase I clinical study of SM17 in the
As a new pathway for asthma treatment, therapy targeting the upstream mediators of the Th2 inflammatory cascade pathway, such as "alarmin", is expected to have a broad effect on airway inflammation. This is expected to lead to more effective control of asthma symptoms and an improvement in disease conditions compared to existing therapies. This has also been validated in the clinical trial of SM17.
The potential first-in-target antibody of SM17 has demonstrated the potential efficacy for multiple indications, including asthma and IPF (Idiopathic Pulmonary Fibrosis). The above unique mechanism enables SM17 to cover more diversified indications, which can not only target indications with huge market size such as asthma and atopic dermatitis, but also treat diseases with high mortality rate such as IPF, and continuously expand its indication coverage. Compared with other currently approved therapeutic antibody drugs targeting ILC2s downstream pathway, SM17 has a differentiated advantage at the source.
As one of the global pandemics, asthma has caused social problems, with huge and urgent medical needs that cannot be ignored. The number of asthma patients worldwide is increasing year by year, and a large patient base is in urgent need of effective therapeutic drugs to alleviate unmet medical needs. According to the Frost & Sullivan Report, the number of asthma patients worldwide is expected to increase to approximately 860 million in 2030, of which the number of asthma patients in
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: "SM17's IND application for the treatment of asthma has been approved three months after it was accepted by the NMPA, which demonstrates that the efficient execution of the Company's new drug R&D program is well recognized by the NMPA, and also fully reflects the huge potential of SM17 in unmet medical needs for asthma treatment. We are confident in the huge clinical development and commercialization prospects of SM17, and will accelerate the progress of clinical trials and strive to achieve commercial business as soon as possible in the future. At the same time, we continue to expand the scope of indications so that new treatment options can benefit more Chinese patients in the future. The Company will continue to focus on autoimmune diseases, and spare no effort to provide more effective treatment options for Chinese and global patients with abundant technical reserves and strong innovation capabilities."
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