[Market Focus] FutureChem Rises on Announcement of Domestic Phase 3 Clinical Trial Results

As of 9:40 a.m. on July 10, shares of FutureChem were trading at 19,320 won on the KOSDAQ market, up 9.65% from the previous day's closing price. This increase appears to be due to the company’s announcement of domestic Phase 3 clinical trial results for its radiopharmaceutical for prostate cancer diagnosis the previous day.

FutureChem is engaged in the research and development of peptide compounds similar to proteins that are specifically expressed in certain diseases, labeling them with radioisotopes to develop new radiopharmaceuticals for the diagnosis or treatment of specific diseases.

On July 9, FutureChem announced through a disclosure that it had reported results from two domestic Phase 3 clinical trials of F-18 FC303 (ingredient name: F-18 Florastamine, hereafter referred to as FC303). The company emphasized that all primary efficacy endpoints were met. If approved by the Ministry of Food and Drug Safety, FC303 is expected to become the first domestically developed prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical for prostate cancer diagnosis in Korea.

In a trial involving 398 patients in the prostate cancer risk group, PET/CT using FC303 demonstrated a sensitivity of 75.58%, showing a statistically significant advantage over MRI (61.18%). However, in terms of specificity, MRI was statistically significantly higher at 90.45% compared to PET/CT at 55.28%. Regarding safety, 33 adverse events occurred in 28 out of 392 participants (7.14%).

In a separate trial involving 138 patients suspected of recurrent or metastatic prostate cancer, the positive predictive value (PPV) of FC303 PET/CT was 86.96%. Notably, the lower bound of the 95% confidence interval was 79.01%, exceeding the reference value of 60.6%, thereby demonstrating clinical efficacy. In terms of safety, 112 treatment-emergent adverse events (TEAEs) were reported in 47 patients (34.06%), and four adverse drug reactions (ADRs) were observed in four patients (2.9%).

FutureChem stated, "We plan to apply for domestic marketing authorization for this drug." Having completed domestic Phase 3 trials, FC303 is currently undergoing Phase 3 trials in Europe and China, and Phase 1 trials in the United States, as the company seeks entry into the global market.