Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA) filing for its Category 1 drug HC-1119 has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed to undergo treatment with either abiraterone or docetaxel, and are intolerable or unsuitable for docetaxel treatment. HC-1119 is touted as the first of its kind for this patient population.
Characteristics and Development of HC-1119
HC-1119 is an innovative androgen receptor (AR) antagonist currently under development in both China and the US for mCRPC. The drug features deuterium substitution, which slows drug metabolism and increases exposure to the active ingredient. The proposed clinical dose is half that of enzalutamide, resulting in better drug compliance. Additionally, no epileptic events have been observed in clinical studies, indicating superior safety compared to enzalutamide.
Clinical Trial Results and Regulatory Progress
HC-1119 has completed six Phase I and one Phase III clinical studies. The statistical results of the confirmatory clinical trial data showed that the drug reached the main therapeutic endpoint, with statistically significant results. The safety statistical results also indicated that the overall safety profile is well controlled. This progress marks a significant step towards bringing HC-1119 to market for patients in need.-Fineline Info & Tech
