CSPC PHARMA (01093): SYS6055 injection approved for clinical trials in China.

CSPC PHARMA (01093) announced that the group's developed SYS6055 injection has been approved by the National Medical Products Administration (NMPA) of the People's Republic of China for clinical trials in China. This product is the first domestically approved intracellular CAR-T product, which generates CD19-targeting CAR-T cells directly in the body through a lentivirus vector, enabling the specific recognition and elimination of target cells to achieve therapeutic purposes. Compared to traditional CAR-T products, this product has potential advantages in terms of cost, accessibility, and immediacy. Preclinical studies have shown that the product can generate CAR-T cells in vivo with specific antitumor effects and good safety, along with cost and time advantages, offering better treatment options for B-cell lymphoma patients. The approved indication for this clinical trial is recurrent/refractory aggressive B-cell lymphoma. In addition, the product also has the potential to be used for the treatment of other CD19-positive B-cell malignancies and autoimmune diseases, with high clinical development value.