IND Application for SinoMab’s First-in-Class Asthma Therapeutic Product SM17 Accepted by FDA

HONG KONG, February 17, 2022 – (ACN Newswire) – – SinoMab BioScience Limited (“SinoMab” or the “Company”, together with its subsidiaries, the “Group”, stock code: 3681.HK), a hong kongbiopharmaceutical company specializing in the research, development, manufacturing and commercialization of therapeutic products for the treatment of immunological diseases, is pleased to announce that, the February 11, 2022 (EST local time), an Investigational New Drug (“IND”) application for the Company’s therapeutic product SM17 (humanized anti-IL17RB monoclonal antibody for injection) has been submitted and accepted by the US Food and Drug Administration (“FDA”). The Company plans to launch the First-In-Human study in the we in the first quarter of 2022, once the IND is approved by the FDA.

SM17 is the world’s first monoclonal antibody targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the UK). SM17 has a wide range of indications, including indications with large market volumes such as asthma and high mortality diseases such as idiopathic pulmonary fibrosis. Compared with other products on the market, SM17 enjoys differentiation advantages. With preclinical data and SM17’s unique mechanism of action, the Company believes that SM17 potentially has a broader and more beneficial effect on the treatment of asthma than other approved biologics.

In the global market, the number of asthma patients is gradually increasing and is expected to reach 247.5 million by 2023 and further increase to 267.7 million by 2030. The number of asthma patients in PRC is increasing at a faster rate than the global rate and is expected to reach 25.6 million by 2023 and further increase to 27.8 million by 2030. In terms of market size, the global asthma market is expected to reach US$25.1 billion by 2023 and US$34.6 billion by 2030. However, the asthma market in PRC is expected to reach 36.4 billion RMB by 2023 and RMB65.0 billion by 2030. In terms of treatment options, traditional asthma treatment relies on inhaled corticosteroids, but they are prone to serious adverse effects, especially in adolescents. Drug resistance can also develop if used for a long time. The introduction of SM17 should provide a better treatment option in terms of the balance between efficacy and safety.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said: “Following the acceptance of the IND application for SN1011 for the treatment of multiple sclerosis by NMPA, the acceptance of the IND application for SM17 by the FDA fully demonstrates the effective execution of the Company’s new drug R&D program. There continues to be an unmet medical need for additional effective therapies, particularly for patients which do not respond to current therapies, so we are confident in the enormous clinical development prospects of SM17 products, including SM03, SN1011 and SM17, are progressing smoothly through clinical R&D, leading the Company to gradually progress towards the Going forward, we will accelerate the implementation of our plans to deliver patient benefits and create shareholder value through innovation.

About SM17

SM17 is known to be the world’s first humanized IgG4-k monoclonal antibody for new drug development, which targets IL-17RB. And IL-17RB is a unique type I transmembrane glycoprotein belonging to the IL-17 receptor family. Binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a class of cytokines called “alarmine”, which has been shown to be involved in the pathogenesis of allergic diseases and viral airway responses. An alternative approach targeting mediators upstream of the Th2 inflammatory cascade, such as “alarmins”, should have a broader effect on airway inflammation and provide more effective asthma control than currently available therapies. and products with a mechanism of action similar to that of SM17 have been approved by the FDA.

On SinoMab BioScience Limited

SinoMab BioScience Limited (stock code: 3681.HK) is engaged in the research, development, manufacture and marketing of therapeutic products for the treatment of immunological diseases. The Company’s lead product, SM03, is a potential global first mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently undergoing a phase III clinical trial for rheumatoid arthritis in Chinawhich has been recognized as one of the important special projects of Significant development of new drugs the period of the twelfth five-year plan and the period of the thirteenth five-year plan. In addition, the Company has other potential first-in-target and first-in-class drug candidates, some of which are already in the clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE ), pemphigus vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma and other diseases with major unmet clinical needs.

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