FutureChem Receives MFDS Approval for Therapeutic Use of Prostate Cancer Drug 'FC705'

[Asia Economy Reporter Lee Gwan-ju] FutureChem announced on the 14th that its prostate cancer treatment drug 'FC705' has received approval from the Ministry of Food and Drug Safety for therapeutic use of an investigational drug.

Therapeutic use approval is a system where the Ministry of Food and Drug Safety permits the use of unapproved drugs or drugs under clinical trials solely for treatment purposes before official approval, for patients with no other treatment options or those with life-threatening severe conditions.

FC705, developed by FutureChem, is a prostate cancer treatment targeting metastatic castration-resistant prostate cancer (mCRPC) patients who are unresponsive to hormone therapy and chemotherapy.

FC705 received approval for therapeutic use through an application at Seoul St. Mary's Hospital after demonstrating safety and therapeutic efficacy in a Phase 1 clinical trial conducted domestically. This approval was granted for individual patients, and there are plans to apply for therapeutic use approval for an additional 20 patients.

A FutureChem representative stated, "FutureChem has already secured the production facilities and technical capabilities necessary for drug supply," adding, "Many mCRPC patients in Korea have no treatment options domestically and are undergoing costly overseas treatments. Through this therapeutic use approval, we aim to provide treatment opportunities to patients until the new drug is supplied domestically."

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