Chinese clinical stage biotechnology company Shanghai Yingli Pharmaceutical Co Ltd (Yingli Pharma) announced on Tuesday that it has received approval from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians' choice of standard of care, for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).
This approval follows a successful Type B End-of-Phase 2 meeting, during which the company discussed the overall development program and regulatory path.
Yingli Pharma expects the Phase 3 study to commence during the second quarter of 2025.
Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3K delta) developed by Yingli Pharma.
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