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FDA approval
Hinova Pharmaceuticals receives FDA Fast Track Designation for HP518 breast cancer drug candidate
Precision Medicine
Jul 5, 2024
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Precision Medicine

Precision Medicine

Jul 5, 2024

Hinova Pharmaceuticals receives FDA Fast Track Designation for HP518 breast cancer drug candidate

FDA approval

  • Hinova Pharmaceuticals has received the US FDA Fast Track Designation for its drug candidate, HP518, for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC).

  • HP518 is an oral AR PROTAC protein degrader that degrades wild-type AR and clinically relevant AR ligand-binding domain (LBD) mutants, including L702H. It is currently in Phase I/II clinical trials conducted in China for patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). With the Fast Track Designation, the company plans to accelerate the development and commercialization of HP518 to improve patient outcomes.

  • Hinova Pharmaceuticals is a biopharmaceutical company based in China,  specializing in developing drugs using PROTAC (proteolysis-targeting chimera) and deuteration technology. The company focuses on creating therapeutics for oncology and metabolic diseases. Its pipeline includes several drug candidates, such as HC-1119 for castration-resistant prostate cancer, HP501 for hyperuricemia, and HP518, an androgen receptor degrader. Hinova's research platforms include targeted drug discovery and validation, as well as lead compound optimization screening​.

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