On August 9th, the website of China National Medical Products Administration's Drug Evaluation Center announced that SYS6020 injection, a Class 1 new drug declared by CSPC Pharma, has been approved for clinical use and is intended for the treatment of refractory active systemic lupus erythematosus.
It was announced on August 9th that SYS6020 injection, a Class 1 new drug declared by CSPC Pharma, has been approved for clinical use and is intended for the treatment of refractory active systemic lupus erythematosus. With this clinical approval, it will also become CSPC Pharma's first cell therapy in development for its own autoimmune diseases.
According to the data, SYS6020 is a cell therapy product based on mRNA-LNP. It can target and kill cells in the patient's body that are BCMA positive by expressing chimeric antigen receptor (CAR) with specific recognition. Compared with traditional CAR-T products, SYS6020 has the advantages of high cell activity rate, high CAR positive rate, low risk of tumorigenesis caused by genome integration, and low side effects such as cytokine storms (CRS).
In June of this year, SYS6020 was approved for clinical testing for the first time in China, and is intended to develop treatment for recurrent or refractory multiple myeloma. Preclinical studies have shown that it significantly kills BCMA-positive myeloma cells and has good safety and efficacy. At the time, CSPC Pharma announced that in addition to multiple myeloma indications, SYS6020 also has potential for use in treating autoimmune diseases such as systemic lupus erythematosus and myasthenia gravis.