Results from Pre-clinical Models and Phase I Clinical Study of SinoMab SM17 on Asthma Had Been Published on Frontiers in Immunology

中國抗體製藥有限公司 SinoMab BioScience Limited (Incorporated in Hong Kong with limited liability) (Stock Code: 3681) Results from Pre-clinical Models and Phase I Clinical Study of SinoMab SM17 on Asthma Had Been Published on Frontiers in Immunology (12 December 2024 – Hong Kong) A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases- SinoMab BioScience Limited (“SinoMab” or the “Company”; Stock Code: 3681), is pleased to announce that the results from pre-clinical models and first-in-human (FIC) Phase 1 clinical trial of SM17, a humani sed monoclonal IgG4 antibody against IL -25 receptor, is published on Frontiers in Immunology (Impact Factor 5.7), a leading journal in the field of immunology, on 9 December, 2024. The article compared the effects of SM17 and dexamethasone (“DEX”) on asthma-related inflammatory factors in a preclinical setting, verifying that animals treated with SM17 showed similar or even better therapeutic responses than those treated with DEX. The article al so published the results of SM17 Phase I clinical trial (NCT05332834) performed in the US. SM17 showed a n outstanding profile in terms of safety, tolerability, and pharmacokinetic in healthy participants. Frontiers in Immunology is an international peer-reviewed and widely cited international journal. This publication established the scientific validity of SM17 on the treatment of asthma, and highlights the potential of SM17 as a revolutionary product in this field. SM17 is a global, first-in-class, humanised, IgG4-k mAb 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 T helper 2 (Th2) immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s) and Th2 cells, blocking a cascade of responses induced by IL- 25 and suppressing the release of the downstream Th2 cytokines such as IL-4, IL-5, IL-9 and IL- 13. IL-25 is classified as “alarmin” which is overexpressed in biopsy tissues of patients with asthma, atopic dermatitis (AD) and idiopathic pulmonary fibrosis (IPF). Our in vitro studies clearly demonstrated that SM17 can suppress IL-25 induced type 2 immunity and the underlying mechanism supports its potential benefits in treating allergic and autoimmune diseases, such as AD, asthma and IPF. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab , said “SinoMab focuses on the development of innovative products through scientific excellence, with the goal of identifying differentiating products that address immunological diseases of unmet medical needs. We are encouraged by the evidence demonstrating the advantageous therapeutic potential of SM17 for treating asthma is scientifically endorsed by publication in the renowned peer -reviewed journal Frontiers in Immunology. According to the latest report by Grand View Research, Inc. , 2024 global market size for asthma is estimated at US 26.41 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.30% from 2024 to 2030. According to our Phase I clinical study performed in the US, SM17 was well tolerated in healthy participants and demonstrated a favourable safety profile, revealing that SM17 to be a potential global first -in-class product. Currently, SM17 proof-of-concept clinical study for the treatment of AD had completed patient enrolment. Topline data readout is expected in March 2024 at the earliest time to verify the preliminary efficacy of SM17 in AD patients. The Company has also initiated its clinical validation work plan of SM17 on Asthma patients.” – END – About SinoMab BioScience Limited SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. SinoMab is headquartered in Hong Kong with its R&D base in Hong Kong and production base in mainland China. The Company's flagship product Suciraslimab (SM03) is a potential global first-in-class mAb against CD22 for the treatment of rheumatoid arthritis (RA) and other immunological diseases. SM03 (Suciraslimab) has completed the Phase III clinical trial for RA in China and is pending NMPA ’s marketing approval for RA in China. In addition, the Company possesses other potential first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), S jogren’s syndrome (SS), systemic lupus erythematosus (SLE), atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), asthma, and other diseases with major unmet clinical needs. About Frontiers in Immunology Frontiers in Immunology is a leading journal in its field, publishing rigorously peer-reviewed research across basic, translational and clinical immunology. This multidisciplinary open -access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. Frontiers in Immunology is the official journal of the International Union of Immunological Societies (IUIS). Encompassing the entire field of immunology, this journal welcomes papers that investigate basic mechanisms of immune system development and function, with a particular emphasis given to the description of the clinical and immunological phenotype of human immune disorders, and on the definition of their molecular basis. For more information about SM17, please read the published article on Frontiers in Immunology. Link：https://www.frontiersin.org/articles/10.3389/fimmu.2024.1495540 Media enquiries Strategic Financial Relations Limited Veron Ng Tel: +852 2864 4831 Email: [email protected] Phoenix Fung Tel: +852 2114 4939 Email: [email protected] Shannon Lei Tel: +852 2114 2881 Email: [email protected] Will Cheng Tel: +852 2864 4894 Email: [email protected]

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