Novartis Pharmaceuticals (NVS.US) Class 1 New Drug Approved for Clinical Use in Rheumatoid Arthritis

Zhitongcaijing · 05/09 06:25

The Zhitong Finance App learned that on May 8, the CDE official website showed that Novartis Pharmaceuticals (NVS.US)'s new Class 1 drug PIT565 was clinically approved for use in rheumatoid arthritis. PIT565 is a first-of-its-kind CD3/CD19/CD2 triple antibody. Compared with the CD3 double antibody, CD2 co-stimulation through PIT565 can overcome T cell depletion and increase the depth and duration of the patient's response.

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Screenshot source: CDE official website

The drug was first applied for clinical use in China in November '24, and was first approved for clinical use in recurrent and/or refractory B-cell malignancies in January '25. In February '25, it was approved clinically again for systemic lupus erythematosus to achieve a boundary between cancer and self-immunity. Currently, clinical phase I has been initiated for both of the above indications, and patient recruitment is ongoing.

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Screenshot source: Insight database