VOLUNTARY ANNOUNCEMENT - FIRST mRNA-LNP-BASED CAR-T CELL INJECTION (SYS6020) OBTAINS CLINICAL TRIAL APPROVAL
2024-06-25 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
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. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT FIRST mRNA-LNP-BASED CAR-T CELL INJECTION (SYS6020) OBTAINS CLINICAL TRIAL APPROVAL 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 Antigen Receptor (CAR)-T Cell Injection (SYS6020) (the “Product”), developed by the Group, has obtained approval from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. The Product is the world’s first mRNA-LNP-based cell therapy product approved for clinical trials. By expressing a CAR that can specifically recognise the BCMA antigens, it can then target and kill BCMA-positive cells in patient’s body to achieve therapeutic purposes. Compared to conventional CAR-T products, the Product has the advantage of high cell viability, high CAR-positive percentage, no risk of tumorigenicity due to genomic integration, and minimal side effects such as cytokine release syndrome (CRS). Preclinical studies have demonstrated that the Product can significantly kill BCMA antigen-positive myeloma cells and has a good safety and efficacy profile. The indication for this clinical trial approval ismultiple myeloma (MM). Inaddition, the Product has the potential to be used for the treatment of autoimmune diseases such as systemic lupus erythematosus (SLE) andmyasthenia gravis (MG), providing apromising clinical development value. The clinical trial approval obtained for the Product marks the first significant achievement of the Group in the field of cell therapy, which lays a solid foundation for the development of other cell therapy products, such as in vivo-generated CAR-T. - 1 - By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 25 June 2024 As at the date of this announcement, the Board comprises Mr. CAI 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. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors. - 2 -
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