Boryeong's Lymphoma Treatment Candidate Designated as Orphan Drug by US FDA
[Asia Economy Reporter Lee Gwan-ju] Boryung announced on the 12th that its lymphoma treatment candidate substance 'BR101801' has been designated as an orphan drug by the U.S. Food and Drug Administration (FDA).
BR101801 is a 'First-In-Class' lymphoma treatment substance that simultaneously inhibits PI3K gamma (γ), PI3K delta (δ), and DNA-PK, which are major growth and regulatory factors of cancer cells.
It passed clinical phase 1a last year, and among a total of 9 peripheral T-cell lymphoma (PTCL) patients in phase 1a, 'complete remission' was confirmed in 1 patient and 'partial remission' in 2 patients.
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Based on the efficacy and safety of BR101801 confirmed through phase 1a, Boryung is currently conducting clinical phases 1b and 2 simultaneously in South Korea targeting PTCL patient groups.
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