Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer

Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC).

The Category 1 innovative drug candidate, HP518, is an androgen receptor-targeted PROteolysis TArgeting Chimera (PROTAC) under development for the treatment of advanced metastatic castration-resistant prostate cancer (mCRPC) and AR-positive TNBC. Currently, there is no similar product on the market globally. HP518 works by leveraging the intracellular ubiquitin proteasome system to facilitate the degradation of AR, thereby reducing AR protein expression levels. This mechanism inhibits the growth of AR-dependent cancer cells, offering a potential new treatment approach for cancer.- Flcube.com

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