By Fineline Cube 
Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) announced that the New Drug Application (NDA) for its Category 1 drug deutenzalutamide (HC-1119) has been approved by the National Medical Products Administration (NMPA). The drug is now available for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with abiraterone acetate and chemotherapy, and who have not previously received novel androgen receptor inhibitors.
Clinical Trial Success and Regulatory Milestone
Deutenzalutamide is a second-generation androgen receptor (AR) inhibitor independently developed by Hinova Pharmaceuticals for the treatment of mCRPC. The drug’s Phase III trial in China met its primary endpoint, demonstrating a significant extension in progression-free survival (PFS) compared to the control group and a 42% reduction in the risk of disease progression or death. These results highlight the drug’s potential to improve outcomes for patients with advanced prostate cancer.
Safety Profile and Patient Benefits
In addition to its efficacy, deutenzalutamide exhibited a favorable safety profile in clinical trials. The drug had a lower incidence of central nervous system adverse events such as seizures and falls, no rash-related adverse reactions, and reduced risk of common complications in elderly patients. These safety attributes make deutenzalutamide a promising treatment option for patients with mCRPC, particularly those who have exhausted other treatment options.-Fineline Info & Tech