SinoMab Completes First Cohort of the Healthy Subjects Dosed in a Phase I Clinical Trial of SM17 in China

[For Immediate Release] 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 Cohort of the Healthy Subjects Dosed in a Phase I Clinical Trial of SM17 in China Adding Important Milestone in Clinical Development (27 November 2023 – Hong Kong), A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and com mercialisation 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 Company has successfully completed the first cohort of the healthy subjects in a phase I clinical trial of SM17(a humanised anti-IL-17RB monoclonal antibody for injection) in China on 25th November 2023. The phase I trial is aimed to establish safety, pharmacokinetics (PK) and immunogenicity profiles of SM17 in Chinese population, as well as to test the preliminary safety, efficacy and pharmacodynamic characteristic of SM17 in Atopic Dermatitis patients. As at present, no adverse event was observed. SM17 is a novel, First -in-Class (FIC), humanized, IgG4 -k monoclonal antibo dy, 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 implic ated in the pathogenesis of autoimmune and inflammatory skin diseases, especially in atopic dermatitis (“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. The Company is also committed to advancing multiple indication studies for SM17, laying a foundation for proof of concept and drug launches. In the United States, a Phase I study for SM17 had been completed, with the Last Subject Last Visit ( LPLV) completed in September 2023 . The clinical study report is expected to be released by the first quarter of 2024. As of today, no drug-related serious adverse event has been reported; In China, in addition to the approval of SM17 for the treatment of AD by the National Medical Products Administration of China (the ‘‘NMPA’’), the Investigational New Drug (‘‘IND’’) application for the treatment of patients with asthma was also approved by the NMPA on 11 August 2023. and the Phase I clinical trial in China will also be initiated shortly. Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “As a global first-in-class humani sed, IgG4 -k monoclonal antibody drug targeting IL -17BR, SM17 has been successfully administered to the first cohort of healthy subjects in China's Phase I clinical trial, marking another important milestone in the R &D of SM17’s product pipeline. At present, there is still a lack of effective treatment for atopic dermatitis (AD) in China, resulting in broad market potential. We are confident in the huge development prospects of SM17 and believe that with its first-in-class target, 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. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company's flagship product Suciraslimab (SM03) is a potential global first -in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first -in-target and first- in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer's disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non -Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact: Financial PR (HK) Limited Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Romy Hong Email: [email protected] Tel: (852) 2610 0846 Fax: (852) 2610 0842

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