A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases – SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), is pleased to announce that an Investigational New Drug application (“IND”) for SM17, a humanised anti-IL-17RB monoclonal antibody for injection, for atopic dermatitis (“AD”) , has been filed with and accepted by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of China (“NMPA”). The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of AD.
SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB, which is a global first-in-class monoclonal antibody drug targeting IL-17BR with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological disorders. The IND is mainly for the treatment of AD, and the Company will initiate a Phase I clinical study in China upon approval of the present IND.
SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s) and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by interleukin-25 (IL-25). 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 for AD. Around the globe, about one-fifth of the population were affected by AD at a certain stage of life, especially during the period of children. The condition is extremely volatile and can be difficult to be totally cured. It significantly reduces the quality of life of patients, and requires highly effective products to make up for 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, and 30% of which will be moderate-to-severe patients. China’s AD medicine market was US$600 million in 2019, and is expected to grow to US$1.5 billion in 2024, and is expected to increase to US$4.3 billion in 2030, indicating a considerable market size. We expect that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB, will have a broad effect on skin inflammation. Coupled with the vast market potential of AD market and the lack of effective treatment methods, it is believed that the research and development of its treatment has market potential.
The Company is also committed to advancing multiple indications studies for SM17, laying a foundation for proof of concept and drug launches. In the United States, as early as March 2022, SM17’s IND application for the treatment of asthma was approved by the U.S. Food and Drug Administration (“FDA”), and the first healthy subject had been successfully dosed in a Phase I clinical First-in-Human(“FIH”) clinical trial in June 2022. Since then, none of the subjects reported a serious adverse event. At present, we are in full steam ahead to accelerate the progress of our clinical study, and expect the Phase I clinical study can be completed by the end of this year, six months ahead of the original anticipated completion date. In China, in addition to the acceptance of the application of SM17 for the treatment of AD, the new drug application for the treatment of asthma was also accepted by NMPA CDE on May 19 this year. If approved, the phase I clinical trial will be accelerated.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that, “As a global first-in-class humanised IgG4-k monoclonal antibody targeting IL-17RB, SM17 has made good progress in several new drug research with the Company’s proactive progress. The acceptance of the new drug application for SM17 not only helps the Company to carry out the clinical research and development project for the treatment of AD in China, but also reflects the high efficiency of the research and development of new drugs. The Company is confident in the significant clinical trial and commercial development prospects of the new drug of SM17, and expects that the new treatment option will benefit more Chinese patients in the future, to jointly write a new chapter in the treatment of AD. In addition, the Company will continue to insist on independent innovation, strive to improve the research of new drugs, continuously expand the indication population, and provide more effective treatment solutions for patients in China and worldwide with no efforts, with an aim to become a global leader in innovative therapies for immunological diseases.”
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 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. Cita Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842
Topic: Press release summary