SinoMab BioScience Limited (SinoMab or the Company, together with its subsidiaries, the Group, HKG: 3681), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 23 August 2022, an Investigational New Drug application (IND, for neuromyelitis optica spectrum disorder (NMOSD)) for SN1011 was approved by the National Medical Products Administration of China (the NMPA). The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China. The planned first patient enrollment is in the first quarter of 2023.
SN1011 is the Company’s third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy, and improved safety for the long-term treatment of systemic lupus erythematous (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder(NMOSD) and other rheumatoid or immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile.
Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively. At the same time, the Company is planning an IND submission for MS in the U.S.
NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “The IND application of SN1011 for the treatment of NMOSD was accepted by the NMPA at the beginning of June, and approved within three months, fully reflecting the potential of SN1011 as well as the efficient execution of the Company’s new drug R&D program. The clinical study for the treatment of NMOSD is the fourth indication of SN1011 approved in China following the approval of IND application for SLE, PV and MS, fully demonstrating the great potential of the innovative BTK inhibitor for multiple indications in the field of the treatment of autoimmune diseases. Currently, numerous of the Company’s main candidate products, covering indications in the field of autoimmune diseases, have entered the clinical stage gradually. Among these, our flagship product SM03 (Suciraslimab) is approaching the endpoint in its Phase III clinical study for rheumatoid arthritis. As the clinical studies of our key candidates move forward, we will continue to expand the potential indications of the products, promote the global R&D progress and constantly improve our production facility and expand capacity to enhance our commercialization capability. SinoMab is devoted to becoming a biopharmaceutical company, with R&D headquartered in Hong Kong and production based in Mainland China, with a whole industry chain layout from R&D to production as well as a global leader in the innovation of therapeutics for immunological and other debilitating diseases.
About SinoMab BioScience Limited
SinoMab BioScience Limited (HKG: 3681) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in 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), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with the major unmet clinical need.