Novartis' First-in-Class Trispecific Antibody PIT565 Granted IND Approval in China for Rheumatoid Arthritis

Intelligent Finance APP learned on May 8 that the CDE official website showed that Novartis (NVS.US) Class 1 new drug PIT565 has been approved for clinical use for rheumatoid arthritis. PIT565 is a first-in-class CD3/CD19/CD2 tri-specific antibody. Compared with CD3 bispecific antibodies, CD2 co-stimulation via PIT565 can overcome T-cell exhaustion and increase the depth and duration of patient response.

Screenshot source: CDE official website

The drug was first applied for clinical trials in China in November 2024, and received its initial clinical approval in January 2025 for relapsed and/or refractory B-cell malignancies. In February 2025, it received another clinical approval for systemic lupus erythematosus, marking a crossover from oncology to autoimmune diseases. Currently, Phase I clinical trials for both indications have been initiated and patient recruitment is underway.

Screenshot source: Insight database