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Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of Waldenström macroglobulinemia (WM).

This is the first ODD granted to APG-2575, and the second ODD Ascentage Pharma received from the FDA, following the previous ODD granted to the company's third-generation BCR-ABL inhibitor HQP1351 in May 2020 for the treatment of chronic myeloid leukemia.

For more info, please visit:

https://www.biospace.com/article/releases/ascentage-pharma-s-bcl-2-inhibitor-apg-2575-granted-orphan-drug-designation-by-the-fda-for-the-treatment-of-waldenstrom-macroglobulinemia/

For info on clinical trials involving this drug, please visit:

https://clinicaltrials.gov/ct2/show/NCT04260217?term=APG-2575&draw=2&rank=4