drugset / Press release

VOLUNTARY ANNOUNCEMENT - FIRST mRNA-LNP-BASED CAR-T CELL INJECTION (SYS6020)OBTAINS CLINICAL TRIAL APPROVAL FOR NEW INDICATION

2024-08-09 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

Hong Kong Exchanges and Clearing Limited and The Stock Excha nge of Hong Kong Limited take no responsibility for the contents of this announcemen t, make no representation as to its accuracy or completeness and expressly disclaim any lia bility whatsoever for any loss howsoever arising from or in reliance upon the whole or any pa rt of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT FIRST mRNA-LNP-BASED CAR-T CELL INJECTION (SYS6020) OBTAINS CLINICAL TRIAL APPROVAL FOR NEW INDICATION The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the first mRNA-Lipid Nanoparticles (LNP)-based Chimeric Anti gen Receptor (CAR)-T Cell Injection (SYS6020) targeting B-cell maturation antigen ( BCMA) (the ‘‘Product ’’) developed by the Group has obtained approval from the Nation al Medical Products Administration of the People ’s Republic of China to conduct clinical trials for the indica tion of systemic lupus erythematosus (SLE) in China. Previously , the Product has obtained clinical trial approval in China for the indication of multi ple myeloma (MM). The Product is the world ’s first mRNA-LNP-based cell therapy product approved for cl inical trials for SLE. By expressing a CAR that can specifically rec ognise BCMA antigens and bind to BCMA on the surface of mature B lymphocytes and plasma cells, it targets and kills immune cells, thereby eliminating elevated autoantibodie s. This potentially offers a new, safe and effective treatment option for SLE patients. At pre sent, there is no CAR-T therapy approved globally for the treatment of SLE. Compared to conv entional CAR-T products, the Product has the advantage of high cell viability, high CAR-p ositive percentage, no risk of tumorigenicity due to genomic integration, and minimal sid e effects such as cytokine release syndrome (CRS). Preclinical studies have demonstrated tha t the Product can significantly kill BCMA antigen-positive myeloma cells and has a good safe ty profile. In terms of cost, using LNP transfection of T cells can lower the high costs ass ociated with using lentiviral vectors, thereby reducing the burden on patients. – 1 – SLE is a typical systemic autoimmune disease mainly charact erised by abnormal activation of the immune system, leading to the production of a large num ber of autoantibodies and resulting in acute or chronic inflammation and functional d amage in multiple organs such as the kidneys, heart, lungs, and skin. Most patients require l ifelong treatment. The treatment combining hormones and immunosuppressants has improved th e long-term survival of SLE patients. However, inevitable disease relapse and irrever sible organ damage remain major causes of patient mortality. Therefore, there is an urgent n eed for new treatment methods to achieve sustained remission of the condition, control orga n damage, improve long-term survival of patients, and even achieve complete cure. The clinical trial approval for SLE indication obtained for the Product marks another significant achievement of the Group in the field of cell the rapy, which lays a solid foundation for the development of other cell therapy produc ts, such as in vivo-generated CAR-T. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 9 August 2024 As at the date of this announcement, the Board comprises Mr. C AI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. JIANG Hao, Dr. YAO Bing and Mr. CAI Xin as executive directors ; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. L AW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –

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