Novartis' (NVS.US) new three-in-one drug has been approved for clinical trials in China for the treatment of systemic lupus erythematosus.

The National Medical Products Administration's (NMPA) Center for Drug Evaluation and Research (CDE) website has recently announced that Novartis (NVS.US) has been granted a new clinical trial approval for its new drug PIT565, which is intended to treat systemic lupus erythematosus (SLE). According to public information, it is a tri-specific antibody targeting CD3/CD19/CD2 on malignant B cells. It has previously been approved in China for the IND of B cell malignancies. PIT565 is currently in the international multi-center phase I study, targeting indications including relapsed or refractory B-NHL and R/R CD19 positive B-ALL, as well as systemic lupus erythematosus (SLE). This time, PIT565 has been approved for clinical trials in China for the indication of SLE, indicating that the drug will also enter the clinical development stage in China. According to public information, PIT565 can target CD19 on malignant B cells while binding to CD3 (a component of TCR signal transduction) and CD2 (a co-stimulatory receptor) on T cells. Compared with CD3 bispecific antibodies, co-stimulating CD2 through PIT565 may overcome T cell exhaustion and increase the depth and duration of patient responses. Studies have shown that CD2 signal transduction is associated with the non-exhausted T cell phenotype.