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SinoMab BioScience Limited — Regulatory Filings 2020
Jun 29, 2020
50863_rns_2020-06-29_dfe0e500-bbcb-46e7-8b13-9d3fbc016758.pdf
Regulatory Filings
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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
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SinoMab BioScience Limited 中國抗體製藥有限公司
(Incorporated in Hong Kong with limited liability)
(Stock code: 3681)
VOLUNTARY ANNOUNCEMENT IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE
Reference is made to the announcements of SinoMab BioScience Limited (中國抗體製藥有限公 司) (the “ Company ”, together with its subsidiaries, the “ Group ”) on 14 November 2019 and 29 January 2020 in relation to the latest research and development progress of one of the Group’s key products, SN1011.
The board of directors (the “ Board ”) of the Company is pleased to announce that, on 22 June 2020, an Investigational New Drug application (“ IND ”, for autoimmune disease) for SN1011 has been filed with and accepted, on 25 June 2020, 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 I 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 systemic lupus erythematosus (“ SLE ”) and rheumatoid arthritis (“ RA ”).
SN1011 is our third generation, covalent reversible Bruton’s tyrosine kinase (“ BTK ”) inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of SLE, RA, 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.
By Order of the Board SinoMab BioScience Limited Dr. Shui On LEUNG Executive Director, Chairman and Chief Executive Director
Hong Kong, 29 June 2020
As at the date of this announcement, the executive directors of the Company are Dr. Shui On LEUNG and Mr. Jing QIANG, the non-executive directors of the Company are Ms. Wenyi LIU, Dr. Haigang CHEN, Mr. Senlin LIU, Mr. Huiyuan MA and Mr. Xun DONG, and the independent non-executive directors of the Company are Mr. Dylan Carlo TINKER, Mr. Michael James Connolly HOGAN, Mr. Ping Cho Terence HON and Mr. George William Hunter CAUTHERLEY.