SLE是一种典型的系统性自身免疫性疾病，主要特征包括免疫系统的异常激活继而产生大量自身抗体，导致多个器官(如肾脏、心脏、肺和皮肤)出现急性或慢性炎症和功能损伤，大部分患者需要终生接受治疗。激素联合免疫抑制剂的治疗使SLE患者的长期生存有所改善，但不可避免的疾病复发及不可逆转的器官损伤仍是患者死亡的重要原因。因此急需新型治疗手段实现病症的持续缓解，控制器官损伤，改善患者长期生存，甚至实现彻底治愈。CSPC Pharma (01093) issued an announcement that the group's first mRNA-LNP technology-based product targeting B cells has been developed...
CSFC FinTech (01093) issued an announcement that the group's first mRNA-LNP technology-based product targeting B-cell maturation antigen (BCMA), chimeric antigen receptor (CAR)-T cell injection liquid (SYS6020) manufactured by the group, has been approved by the National Medical Products Administration of China and is eligible to conduct clinical trials for systemic lupus erythematosus (SLE) indications in China. Previously, this product had obtained clinical trial approval for multiple myeloma (MM) indications in China.
This product is currently the world's first mRNA-LNP-based cell therapy product approved for clinical trials of SLE. By expressing CAR that can specifically recognize the BCMA antigen and combine with the BCMA on the surface of mature B lymphocytes and plasma cells, it targets and kills immune cells, eliminates elevated autoantibodies, and provides new, safe, and effective potential treatment options for SLE patients. It is currently not approved for CAR-T therapy for SLE worldwide. Compared with traditional CAR-T products, this product has the advantages of high cell viability, high CAR-positive rate, low risk of tumorigenesis caused by genomic integration, and low side effects of cytokine storms (CRS). Preclinical studies have shown that the product can significantly kill BCMA-positive myeloma cells and has good safety. In terms of cost, using LNP transfection of T cells can reduce the expensive cost of using slow virus vectors and ease the burden on patients.
SLE is a typical systemic autoimmune disease, characterized by abnormal activation of the immune system, followed by the production of a large number of autoantibodies, which leads to acute or chronic inflammation and functional damage in multiple organs (such as the kidneys, heart, lungs and skin). Most patients need lifelong treatment. Treatment with immunosuppressive agents combined with steroids has improved long-term survival of SLE patients, but inevitable disease recurrence and irreversible organ damage are still important causes of patient death. Therefore, new treatment methods are urgently needed to achieve sustained relief of symptoms, control organ damage, improve long-term survival of patients, and even achieve complete cure.
The approval of the SLE clinical trial indications for this product is another important achievement of the Group's layout in the field of cell therapy, laying a good foundation for the development of other cell therapies, such as in vivo generated CAR-T.
