SinoMab BioScience Limited (“SinoMab” or the “Company”, stock code: 3681.HK), 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 the first healthy subject was successfully dosed in the Phase I clinical trial of SN1011, an innovative third-generation covalent reversible Bruton’s tyrosine kinase (“BTK”) inhibitor drug candidate, today in Shuguan Hospital in Shanghai, China. The subject is currently in a normal condition.
Medical staff from Shuguan Hospital in Shanghai conducted the Phase I clinical trial of SN1011.
SN1011 is the third generation, covalent reversible Bruton’s tyrosine kinase (“BTK”) inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of systemic lupus erythematosus, rheumatoid arthritis, pemphigus, multiple sclerosis and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of selectivity and affinity. The Phase I clinical trial was conducted in Shuguan Hospital in Shanghai, aiming to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in treatment for autoimmune diseases. SinoMab received the approval of SN1011’s Investigational New Drug application (“IND”) from the National Medical Products Administration of China on 27 August 2020, taking less than 5 months to progress into the current dosing stage, which utterly proves the Company’s efficient implementation of new drug R&D programs.
Dr. Weian YUAN, Principal Investigator from Shuguan Hospital in Shanghai for this Phase I Study, said, “So far, there are a number of BTK inhibitors that have been approved, but there is no third-generation BTK inhibitor that is yet approved. Since the third generation BTK inhibitor has much lower effective dose and a better safety profile, it makes SN1011 a promising product to bring patients a much better treatment.”
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab, said, “SN1011 successfully completed its first dose, representing another key R&D asset entering the stage of clinical trial following our flagship product, SM03. This is a prominent milestone along SinoMab’s progress in the R&D of various products for autoimmune diseases. Last year we launched the multiple ascending dose cohorts for SN1011 in Australia. SN1011, which shows great safety in clinical trials, possesses advantages of working just in a small dose and continuously benefitting patients, outperforming other BTK inhibitors in the market. We are absolutely confident in the enormous prospects of SN1011’s clinical development. We will accelerate the program in the future, hoping to provide safe, effective and affordable drugs for patients suffering from autoimmune diseases around the world.”
Bruton tyrosine kinase is a key kinase in the BCR signaling pathway in the B cell. Owing to the fact that loss of BTK exerts great impact on B cell development, targeting BTK becomes an attractive therapeutic means for autoimmune disease. SN1011 is a third generation BTK inhibitor which is covalent reversible in binding nature. It has unique chemical structure which renders it high binding affinity and selectivity towards BTK and excellent bioavailability in animal model. SN1011 has better efficacy and safety than other BTK inhibitors in pre-clinical studies. These data support the long-term usage for the treatment of autoimmune diseases in human.
About SinoMab BioScience Limited
SinoMab BioScience Limited (“SinoMab” or the “Company”, stock code: 3681.HK) 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 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, systemic lupus erythematosus, non-Hodgkin’s lymphoma, asthma, and other diseases with major unmet clinical needs.