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SinoMab BioScience Limited Regulatory Filings 2021

Jun 24, 2021

50863_rns_2021-06-24_00973828-65ca-44d9-bf09-75c4bcc8ed3a.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 SN1011 OBTAINS APPROVAL FOR NEW INDICATION

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 and 15 January 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, on 23 June 2021, the China National Medical Products Administration of China (the “ NMPA ”) has approved the Investigational New Drug (“ IND ”) application of SN1011 for pemphigus vulgaris (“ PV ”). SN1011 is the first Bruton’s tyrosine kinase (“ BTK ”) known for the treatment of PV in China with huge unmet clinical needs. The IND approval would enable the Company to conduct comprehensive clinical development programs for the treatment of PV in China. This would be the second targeted indication of SN1011, following the approval of systemic lupus erythematous (“ SLE” ) indication in August 2020. The first healthy subject had been successfully dosed in Phase I clinical trial for SLE in Shanghai, China on 15 January 2021, and Phase I clinical trial is in good progress.

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, 24 June 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.