FutureChem's Prostaview Approved as Korea's 43rd Homegrown New Drug

FutureChem’s radiopharmaceutical for prostate cancer diagnosis has been approved as South Korea’s 43rd domestically developed new drug.

The Ministry of Food and Drug Safety (MFDS), led by Commissioner Yu-kyung Oh, announced on May 4 that it has approved FutureChem’s Prostaview Injection (florastamin F-18).

Prostaview Injection is a PET diagnostic radiopharmaceutical that selectively binds to prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells, helping identify lesions.

The product is indicated for patients with recurrent or metastatic prostate cancer who have shown abnormal findings in previous imaging tests.

For the approval, the MFDS formed a dedicated review team and carried out a tailored review process, prioritizing assessments of clinical trial compliance (GCP) and manufacturing and quality control standards (GMP). The agency also held in-person meetings before and after the application to accelerate the review.

FutureChem expects Prostaview Injection to improve the diagnostic accuracy of prostate cancer lesions and support treatment decision-making.