drugset / Press release

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

2022-02-07 · SinoMab BioScience Ltd · original sinomab.com ↗

1 To: Business Editor [For immediate release] 中國抗體製藥有限公司 SinoMab BioScience Limited SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE [7 February 2022, Hong Kong] SinoMab BioScience Limited ("SinoMab" or the " Company", together with its subsidiaries, the " Group", 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, on 21 January 2022, an Investigational New Drug application (‘‘IND’’, for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (the ‘‘CDE’’) of the National Medical Products Administration of China (the ‘‘NMPA’’). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. 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 multiple sclerosis. 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, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other 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. Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "after the Company announced earlier the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03, an IND application (for multiple sclerosis) for SN1011 has been filed with and accepted by the Center for the CDE of the NMPA, which will accelerate the progression of the Phase II clinical study and clinical development program related to indication for treatment of multiple sclerosis, fully reflecting the Company’s efficient implementation of new drug R&D programs. We are absolutely confident in the enormous prospects of SN1011’s clinical development. In the future, t he Company will accelerate the program to further expand its product pipeline and strive to bring benefits to patients." - END - About SinoMab BioScience Limited SinoMab BioScience Limited (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 (RA) and is currently in Phase III clinical trial for rheumatoid arthritis 2 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 vulgaris (PV), non -Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs. This press release is issued by Porda Havas International Finance Communications Group for and on behalf of SinoMab BioScience Limited. For further information, please contact: Porda Havas International Finance Communications Group Ms. Angela Shi +852 3150 6778 [email protected] Ms. Tia Wong +852 3150 6739 [email protected]

The release as fetched from its publisher. sinomab.com ↗