AI assistant
SinoMab BioScience Limited — Regulatory Filings 2021
Jul 23, 2021
50863_rns_2021-07-23_37205d56-58df-46c1-b6fe-a4c52620b259.pdf
Regulatory Filings
Open in viewerOpens in your device viewer
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.
==> picture [29 x 43] intentionally omitted <==
==> picture [29 x 43] intentionally omitted <==
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 COMPLETION OF SN1011 PHASE I LAST SUBJECT LAST VISIT IN CHINA
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, 29 January 2020, 29 June 2020, 1 September 2020, 15 January 2021 and 24 June 2021 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 SN1011 has completed last subject last visit on 23 July 2021 in a Phase I dose-escalation study in China, in which 71 healthy subjects were enrolled. The highest dosage was ascended to 800 mg, and none of the subjects reported serious adverse event (SAE). This product showed well tolerability and safety. Clinical study report is expected to be released by the end of third quarter of this year. This Phase I clinical trial is to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in the treatment for autoimmune disease.
Following the approval of Investigational New Drug (IND) application for pemphigus vulgaris (“ PV ”) and systemic lupus erythematous (“ SLE ”) indication of SN1011, the Company is initiating the Phase II clinical study targeting on PV in China. The Company also plans to initiate Phase II clinical study targeting on SLE in the near future.
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 SLE, PV, 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.
By Order of the Board SinoMab BioScience Limited Dr. Shui On LEUNG Executive Director, Chairman and Chief Executive Officer
Hong Kong, 23 July 2021
As at the date of this announcement, the executive director of the Company is Dr. Shui On LEUNG, the non-executive directors of the Company are Dr. Haigang CHEN, Mr. Xun DONG, Mr. Senlin LIU, Ms. Wenyi LIU, Mr. Huiyuan MA and Mr. Jing QIANG, and the independent non-executive directors of the Company are Mr. George William Hunter CAUTHERLEY, Mr. Ping Cho Terence HON, Dr. Chi Ming LEE and Mr. Dylan Carlo TINKER.