FutureChem Receives First Domestic Product Approval from MFDS for New Prostate Cancer Diagnostic Agent

FutureChem is intensifying its efforts to enter the precision diagnostics market after obtaining product approval from the Ministry of Food and Drug Safety for its radiopharmaceutical for prostate cancer diagnosis.

On May 4, FutureChem announced via a public disclosure that it had received product approval for its new radiopharmaceutical diagnostic agent for prostate cancer, Prostavu Injection (Florastamin (18F)).

The newly approved Florastamin (18F) demonstrated safety and efficacy through a Phase 3 clinical trial conducted at a total of 11 institutions within Korea. With this approval, FutureChem has established its fourth lineup of diagnostic radiopharmaceuticals, following FLT (for lung cancer), PDBU Injection (for Parkinson’s disease), and Alzaview Solution (for Alzheimer’s disease).

Florastamin (18F) is a product that combines the positron-emitting isotope ‘F-18’ with a peptide targeting the prostate-specific membrane antigen (PSMA). After intravenous administration to the patient, a PET-CT scan can precisely identify the location and status of cancer cells by visualizing where the radiopharmaceutical has bound to tumor tissue.

In particular, Prostavu Injection (Florastamin (18F)) is notable for significantly improving diagnostic accuracy compared to conventional imaging methods. In a domestic Phase 3 clinical trial targeting prostate cancer patients suspected of recurrence or metastasis, the primary efficacy endpoint, positive predictive value (PPV), reached 86.96%. The lower bound of the 95% confidence interval was 79.01%, exceeding the reference value of 60.6%, thereby sufficiently demonstrating clinical efficacy.

FutureChem plans to accelerate not only domestic market supply but also expansion into overseas markets such as China, using this product approval as a starting point. The PET-CT-based prostate cancer diagnostic agent has grown into a blockbuster market, with more than 400,000 procedures performed annually in the United States, and rapid growth is also expected in the Korean market. The company has also completed product optimization through collaboration with Trasis, a specialist in automated synthesizer equipment, thereby establishing a foundation for global expansion.

This content was produced with the assistance of AI translation services.