FutureChem said Wednesday that its radiopharmaceutical candidate FC705 for treating prostate cancer has been granted Global Innovative Products on Fast Track (GIFT) designation by the Ministry of Food and Drug Safety.

GIFT is a support system to bring highly innovative drugs, such as treatments for life-threatening or serious diseases, to the market and patients quickly.

Once designated, corporate applications are reviewed within a maximum of 90 days and are eligible for accelerated review, with dossiers prioritized for review and on-call companion review. The program also supports rapid commercialization, including expert consulting with one-on-one support from reviewers and developers.

FC705 is a therapy that combines a peptide that binds to prostate-specific membrane antigen (PSMA) expressed exclusively in prostate cancer with the therapeutic isotope LU-177.

FutureChem expects FC705 to reach cancer cells through blood vessels and kill them with the energy released from LU-177. Phase 2 clinical trials of FC705 are underway in Korea and the U.S., and all patients in the Korean phase 2 trial have completed at least one dose.

"We plan to complete all repeat doses within the year," a FutureChem official said, "We will strive for rapid commercialization with the designation of the GIFT program."