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The FDA classified Epitalon as a Category 2 bulk drug substance under Section 503A guidance in September 2023, confirmed in September 2024

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The icariin and P815AB peptide combination notably enhances the activity index of CTLs in mastocytoma (P815)-bearing mouse model, boosts CD8 + T cell cytotoxicity against prostate cancer (PC-3, DU 145, and RM-1) cells, upregulates immune-related proteins for lymphoma protection, and inhibits autophagy in ovarian cancer (SKVCR) cells, sensitizing it to cisplatin [720, 753]