[Hot Stock] FutureChem Rises on Approval for Multiple Doses of Prostate Cancer Treatment Use

FutureChem is showing strong performance. This is interpreted as being influenced by the news that the prostate cancer treatment FC705 has received additional approval from the Ministry of Food and Drug Safety (MFDS) for therapeutic use of investigational drugs in clinical trials.

As of 3:13 PM on the 28th, FutureChem is trading at 16,660 KRW, up 5.98% from the previous day.

On this day, FutureChem announced that the prostate cancer treatment FC705 had received additional approval from the MFDS for therapeutic use of investigational drugs in clinical trials. The therapeutic use approval system is a system where the MFDS permits the use of investigational drugs that have not yet been approved for patients with no other treatment options or those with life-threatening severe conditions.

Since 2022, FutureChem’s FC705 has been used under therapeutic use approval for a total of 45 prostate cancer patients. In this recent approval, the previous restriction allowing only a single administration has been relaxed, enabling repeated administration up to six times per patient. This allows for more active treatment opportunities for patients with castration-resistant metastatic prostate cancer.

A FutureChem representative stated, “This approval reflects a comprehensive consideration of the prognosis of previously treated patients and recent Phase 2 clinical trial results,” adding, “Following the interim results of the Phase 2 trial presented at the European Association of Nuclear Medicine in October this year, we are currently compiling additional efficacy indicators such as the Objective Response Rate (ORR).” The company plans to apply for Phase 3 clinical trials within the first quarter after receiving the Clinical Study Report (CSR) in January next year.

In the Phase 3 trial, the primary evaluation will focus on progression-free survival (PFS) compared to the existing standard hormone therapy, followed by confirmation of key indicators such as overall survival (OS). The goal is to expand indications through combination therapy with existing treatments or monotherapy, enhancing the potential as a first- and second-line treatment.

Meanwhile, based on the advantages and safety of FC705 confirmed in the Phase 2 trial compared to competing drugs, FutureChem is also pursuing technology transfer agreements in the United States, Europe, and Asia.