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SinoMab BioScience Limited — Regulatory Filings 2019
Nov 14, 2019
50863_rns_2019-11-14_c083c96f-b2d3-4d97-8b3b-6054242b897a.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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Stock Code: 3681
VOLUNTARY ANNOUNCEMENT – UPDATE ON SN1011
The Board of SinoMab BioScience Limited (the " Company ") wishes to provide an update on the progress of the clinical trial of one of the Group's key products, SN1011.
The Board is pleased to announce that with regards to SN1011's Phase I clinical trial for immunological diseases in Australia, as at 13 November 2019, 24 subjects have completed dosing in three cohorts, and no SAE has been reported. The current safety is in line with expectations. The Company is expecting to commence dosing for the fourth cohort next week.
SN1011 is our third-generation, covalent reversible BTK inhibitor designed for higher selectivity and superior efficacy for the treatment of RA, pemphigus and SLE for long term administration. Traditional BTK inhibitors, limited by their mechanism of action, are inappropriate in treating chronic diseases as a result of insufficient target affinity and lack of selectivity, and are mostly relegated to treatments in oncology. SN1011 is a third-generation, covalent reversible NCE developed via the approach of rational drug design where the NCE is conferred with properties favorable for the long term use of the BTK inhibitors. It selectively inhibits B cell activity, and has been shown to effectively suppress inflammatory responses in CIA (collagen induced arthritis) and CAIA (collagen antibody induced arthritis) murine arthritis model and murine MRL/lpr Lupus model.
Definition and glossary of technical terms
Unless the context otherwise requires, the terms used in this announcement shall have the following meanings:
"Board" the board of directors of the Company "BTK" or "Bruton's tyrosine an enzyme that in humans is encoded by the BTK gene. kinase" BTK is a kinase that plays a crucial role in B-cell development
"CAIA" collagen antibody induced arthritis, a simple mouse model of RA that can be used for the fast preclinical efficacy evaluation of candidate therapeutic agents targeting pathogenic mechanisms and inflammatory processes of arthritis
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"CIA" collagen induced arthritis, a condition induced in mice (or rats) to study RA
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"Group" the Company and its subsidiaries
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"MRL/lpr" MRL-lpr Mice are homozygous for the lymphoproliferation spontaneous mutation (Faslpr), and show systemic autoimmunity, massive lymphadenopathy associated with proliferation of aberrant T cells, arthritis, and immune complex glomerulonephrosis. It is used as a model to study lupus
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"NCE" new chemical entity, is a compound without any precedent among the regulated and approved drug products
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"RA" or "rheumatoid arthritis" an autoimmune disease where the body’s immune system attacks normal joint tissues, causing inflammation of the joints and surrounding tissues; it can also affect other organs
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"SAE" serious adverse event, any untoward medical occurrence in a patient during clinical trials that results in death, is life-threatening, requires impatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
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"SLE" or "systemic lupus erythematosus"
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a systemic immunological disease in which the body’s immune system attacks normal, healthy tissue and can result in symptoms such as inflammation and swelling
By order of the Board of Directors
SinoMab BioScience Limited
Dr. Shui On LEUNG
Executive Director, Chairman and Chief Executive Officer
Hong Kong, 14 November 2019
As at the date of this announcement, the executive Director is Dr. Shui On LEUNG, the nonexecutive Directors are Ms. Wenyi LIU, Dr. Haigang CHEN, Mr. Senlin LIU, Mr. Chang LIU and Mr. Huiyuan MA, and the independent non-executive Directors are Mr. Dylan Carlo TINKER, Mr. Michael James Connolly HOGAN and Mr. Ping Cho Terence HON.