Shanghai Pharmaceuticals Gets NMPA Approval for Phase I Clinical Study of B019 CAR-T Cell Injection

Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for its proprietary B019 injection. B019 is a chimeric antigen receptor (CAR) autologous T cell injection that targets CD19 and CD22, developed for the treatment of recurrent or refractory B-lymphocyte tumors.

B019’s Innovative CAR Structure
The CAR structure of B019 features a double cis trans carrier structure, which allows for the expression of two independent CARs on T cells. These CARs can bind to CD19 or CD22 proteins expressed on the surface of B lymphocytes without interfering with each other, thereby exerting synergistic anti-tumor effects. This innovative approach has the potential to enhance the efficacy of T cell therapies in targeting and eliminating cancer cells.

Clinical Study Significance
The initiation of the Phase I clinical study marks a significant step forward in the development of B019, as it will evaluate the safety, tolerability, and preliminary efficacy of the therapy in patients with B-lymphocyte tumors. This study is crucial for advancing the understanding of B019’s potential role in cancer treatment and bringing this novel therapy closer to patients in need.-Fineline Info & Tech

Fineline Info & Tech