SinoMab Completes First Patient Dosed in a Phase 1b Clinical Trial of SM17 in China

中國抗體製藥有限公司 SinoMab BioScience Limited (Incorporated in Hong Kong with limited liability) (Stock Code: 3681) SinoMab Completes First Patient Dosed in a Phase 1b Clinical Trial of SM17 in China (12 June 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 (Stock Code: 3681.HK, “SinoMab” or the “Company”) , is pleased to announce that, the first patient has been dosed in the Phase 1b clinical trial of SM17 (a humanised anti -IL- 17RB monoclonal antibody for injection) in China on 5th June 2024. The phase 1b trial aims to study safety, tolerability and pharmacokinetics (PK) profiles of SM17, as well as to explore the preliminary efficacy of SM17 in Atopic Dermatitis (“AD”) patients. SM17 is a novel, First -in-Class (FIC), humanized, IgG4 -κ monoclonal antibody, which is a global first-in-class monoclonal antibody drug targeting IL -17RB with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological disorders. SM17 could suppress Type 2 helper T (Th2) immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s) and Th2 cells, to block a cascade of responses induced by IL -25 and suppress the release of the downstream Th2 cytokines such as IL -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 autoimmune and inflammatory skin diseases, especially in AD. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient’s quality of life, but patients showing irresponsiveness to those approved therapies still need effective products to make up for the unmet medical needs. As a long-standing chronic disease, new cases of AD are growing rapidly in China with broad market potential. According to Frost & Sullivan, there were approximately 65.7 million AD patients in China in 2019 and is expected to grow to 81.7 million in 2030, with 30% of them being moderate-to-severe patients. The AD medicine market in China was valued at US$600 million in 2019, and is expected to reach US$1.5 billion in 2024, further increasing to US$4.3 billion in 203 0. These figures indicate a considerable market size. The Company believes that therapies targeting upstream of the Th2 inflammatory cytokine pathway, such as IL-25 receptor, will have broad effects on skin inflammation, implicating a great potential for SM17 to be a differentiating, safer and more effective product for the treatment of AD. Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “The clinical study of SM17 has been progressing steadily. Following the first -in-human phase I clinical trial (NCT05332834) performed in the US to evaluate the safety and tolerability of SM17 in healthy subjects and the phase 1a bridging study completed in China, the Company is now performing a phase 1b clinical trial to validate the comparable effectiveness of SM17 to JAK1 inhibitor in treating AD, which were the study results of preclinical studies published in an international scientific journal Allergy. Based on the data conducted from our US phase I and China phase 1a clinical studies, we believe that SM17 can demonstrate a satisfactory efficacy and safety profile in the phase 1b clinical trial in China. We are confident in the huge development prospects of SM17 and believe that with its first-in-class advantage, SM17 will become a new and effective treatment option for atopic dermatitis, benefiting more 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 cli nical 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), Sjogren’s syndrome (SS), systemic lupus erythematosus (SLE), atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), asthma, and other diseases with major unmet clinical needs.

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