drugset / Press release

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

2024-10-25 · 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 FURTHER 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) (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 for the indication of myasthenia gravis (MG ) in China. Previously, the Product has obtained clinical trial approval for the indication of m ultiple myeloma (MM) and systemic lupus erythematosus (SLE). By expressing a CAR that can specifically recognise BCMA ant igens, the Product targets and kills BCMA-positive B-cells and plasma cells in the pati ent’s body, thus preventing the production of harmful autoantibodies and achieving therap eutic goals. Compared with traditional CAR-T products, the Product has the advantages of high cell viability, high CAR- positive percentage, minimal side effects such as cytokine release syndrome (CRS), and no risk of tumorigenicity caused by genomic integration. Prec linical studies have demonstrated that the Product can significantly kill BCMA antigen-posit ive myeloma cells with good safety profile and efficacy. At present, there is no CAR-T ce ll therapy approved globally for the treatment of myasthenia gravis, while the Product is the world ’s first mRNA-LNP-based cell therapy product approved for clinical trials for myast henia gravis. Myasthenia gravis is an autoimmune disease caused by autoan tibodies directed against the neuromuscular junction. Pathogenic autoantibodies inclu de anti-acetylcholine receptor (anti- AChR) antibodies, anti-muscle-specific receptor tyrosin e kinase (anti-MuSK) antibodies, anti-LPR4 antibodies, etc. These autoantibodies bind and i nitiate the complement cascade reaction, leading to the formation of membrane attack compl ex (MAC), which causes – 1 – damage to neuromuscular junctions and symptoms of muscle we akness. Although various drugs are currently available to alleviate symptoms, some p atients who have undergone a full course of at least two conventional immunosuppressive drugs (both corticosteroids and non-steroidal immunosuppressants) still experience recu rrence symptoms of myasthenia gravis. These patients often require hospitalisation for s alvage therapy (e.g. plasmapheresis or intravenous immunoglobulin injections) and are in urgen t need of more effective and safer therapeutic drugs to save their lives. CAR-T cell ther apy can deeply deplete BCMA- positive B-cells and plasma cells in the patient ’s body, leading to a significant and long-term improvement in clinical symptoms. This can reduce or even di scontinue the use of immunosuppressants and cholinesterase inhibitors to sign ificantly improve the quality of life. The clinical trial approval for myasthenia gravis indicati on obtained for the Product marks another significant progress of the Group in the field of cel l therapy. The Group will further promote the development of the Product in the fields of oncol ogy, autoimmune connective tissue diseases and neuromuscular autoimmune diseases wit h the expectation of bringing clinical benefits to more patients. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 25 October 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 direct ors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –

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