FutureChem's radiopharmaceutical (RPT) for diagnosing prostate cancer has received product approval from the Ministery of Food and Drug Safety.
The company said on the 4th that its radiopharmaceutical for diagnosing prostate cancer, "ProstaView injection (ingredient name: Florastamine)," has been approved by the Ministery of Food and Drug Safety as the 43rd new drug in Korea.
Radiopharmaceuticals (RPTs) are medicines that use radiation emitted by radioisotopes to diagnose targets or destroy altered cells. They work by binding to proteins that are overexpressed in prostate cancer, and the concept is similar to antibody-drug conjugates (ADCs). While ADCs are drugs conjugated to antibodies, RPTs conjugate radioisotopes to target substances.
With these characteristics, they are considered to have shorter development periods and relatively fewer side effects than existing new drugs. They can also be used for both diagnosis and treatment depending on the type of isotope.
The RPT market is growing rapidly amid expanded investment by global pharmaceutical companies. In particular, interest in the field has increased as Novartis of Switzerland surpassed 1 trillion won in annual sales with "Pluvicto," a metastatic prostate cancer treatment launched in 2022.
ProstaView injection is a diagnostic agent that combines the positron-emitting isotope "F-18" with a peptide targeting the prostate-specific membrane antigen (PSMA). After intravenous administration to a patient and performing positron emission tomography-computed tomography (PET-CT), the signal from the radiopharmaceutical bound to cancer cells enables a more precise assessment of the cancer's location and status.
Clinical results also showed improved diagnostic accuracy. In a domestic phase 3 trial of patients with suspected recurrent or metastatic prostate cancer, the primary efficacy endpoint, positive predictive value (PPV), was 86.96%. The lower limit of the 95% confidence interval was 79.01%, exceeding the prespecified threshold (60.6%) and demonstrating clinical efficacy.
Compared with the positive predictive value of existing imaging tests (CT, MRI, bone scan), which was about 60.16%, ProstaView injection recorded a figure about 26.79 percentage points higher. This is evaluated as securing a clinical advantage as a PSMA-PET–based diagnostic radiopharmaceutical by significantly improving diagnostic accuracy over existing tests and reducing the false-positive rate.
This product approval is the result of demonstrating safety and efficacy through a phase 3 trial conducted at a total of 11 domestic institutions. FutureChem, with this approval, has established its fourth diagnostic RPT portfolio following lung cancer (FLT), Parkinson's disease (Pidiview injection), and Alzheimer's disease (AlzaView injection).
Using this approval as a springboard, the company plans to ramp up supply to the domestic market while accelerating entry into overseas markets such as China. It also established a foundation for production and supply optimization through collaboration with Trasis, a company specializing in automated synthesis equipment.
Prostate cancer has the highest incidence among men's cancers in Korea, and the related diagnostic market is projected to grow to about $13.16 billion (about 19.3 trillion won) by 2030.
A company official said, "In the United States, more than 400,000 PET-CT–based prostate cancer diagnoses are performed annually, and the market is expanding rapidly," adding, "Accordingly, ProstaView injection is expected to become a core revenue source for FutureChem going forward."