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石藥集團：自願公告 - 首款基於mRNA-LNP的CAR-T細胞注射液(SYS6020)再獲新適應症臨床試驗批准

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

HKEX ·  Oct 25 18:45

Summary by Futu AI

石藥集團有限公司宣佈，其開發的首款基於mRNA-LNP的CAR-T細胞注射液（SYS6020）獲中國國家藥品監督管理局批准進行重症肌無力（MG）適應症的臨床試驗。此次批准為該產品在中國開展的第三項臨床試驗，前兩項分別針對多發性骨髓瘤（MM）和系統性紅斑狼瘡（SLE）。SYS6020通過特異性識別BCMA抗原，對BCMA陽性的B細胞和漿細胞進行殺滅，以治療相關疾病。該產品具有諸多優勢，包括高細胞活率、高CAR陽性率、低細胞因子風暴副作用，並無基因組整合引起的致瘤風險。臨床前研究顯示，SYS6020對BCMA抗原陽性的骨髓瘤細胞具有顯著殺傷力，並具良好的安全性和有效性。石藥集團表示，該產品的臨床試驗獲批是其在細胞治療領域的重要進展，將進一步推進該產品在腫瘤、自身免疫性結締組織疾病、神經肌肉自身免疫疾病領域的開發。公告日期為2024年10月25日。
石藥集團有限公司宣佈，其開發的首款基於mRNA-LNP的CAR-T細胞注射液（SYS6020）獲中國國家藥品監督管理局批准進行重症肌無力（MG）適應症的臨床試驗。此次批准為該產品在中國開展的第三項臨床試驗，前兩項分別針對多發性骨髓瘤（MM）和系統性紅斑狼瘡（SLE）。SYS6020通過特異性識別BCMA抗原，對BCMA陽性的B細胞和漿細胞進行殺滅，以治療相關疾病。該產品具有諸多優勢，包括高細胞活率、高CAR陽性率、低細胞因子風暴副作用，並無基因組整合引起的致瘤風險。臨床前研究顯示，SYS6020對BCMA抗原陽性的骨髓瘤細胞具有顯著殺傷力，並具良好的安全性和有效性。石藥集團表示，該產品的臨床試驗獲批是其在細胞治療領域的重要進展，將進一步推進該產品在腫瘤、自身免疫性結締組織疾病、神經肌肉自身免疫疾病領域的開發。公告日期為2024年10月25日。
CSPC Pharma announced that its first CAR-T cell injection based on mRNA-LNP (SYS6020) has been approved by the China National Medical Products Administration for clinical trials in the indication of myasthenia gravis (MG). This approval marks the third clinical trial of the product in China, with the first two focusing on multiple myeloma (MM) and systemic lupus erythematosus (SLE) respectively. SYS6020 targets the BCMA antigen specifically, targeting BCMA-positive B cells and plasma cells for treatment of related diseases. The product has many advantages, including high cell viability, high CAR positivity rate, low cytokine storm side effects, and no tumorigenic risk caused by genomic integration. Preclinical studies have shown that SYS6020 has significant cytotoxicity against BCMA-positive myeloma cells, with good safety and efficacy. CSPC Pharma stated that the approval of clinical trials for this product is a significant advancement in their cellular therapy field, further advancing the product's development in oncology, autoimmune connective tissue diseases, and neuromuscular autoimmune diseases sectors. The announcement was made on October 25, 2024.
CSPC Pharma announced that its first CAR-T cell injection based on mRNA-LNP (SYS6020) has been approved by the China National Medical Products Administration for clinical trials in the indication of myasthenia gravis (MG). This approval marks the third clinical trial of the product in China, with the first two focusing on multiple myeloma (MM) and systemic lupus erythematosus (SLE) respectively. SYS6020 targets the BCMA antigen specifically, targeting BCMA-positive B cells and plasma cells for treatment of related diseases. The product has many advantages, including high cell viability, high CAR positivity rate, low cytokine storm side effects, and no tumorigenic risk caused by genomic integration. Preclinical studies have shown that SYS6020 has significant cytotoxicity against BCMA-positive myeloma cells, with good safety and efficacy. CSPC Pharma stated that the approval of clinical trials for this product is a significant advancement in their cellular therapy field, further advancing the product's development in oncology, autoimmune connective tissue diseases, and neuromuscular autoimmune diseases sectors. The announcement was made on October 25, 2024.
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