FutureChem's FC303 meets phase 3 goals, setting stage for 1st Korean-developed PSMA PET imaging agent

FutureChem said it has received successful clinical study reports (CSRs) for two phase 3 trials of its prostate-specific membrane antigen (PSMA)-targeted diagnostic radiopharmaceutical candidate, F-18 Florastamin (development code: FC303).

The results raise expectations for the product’s approval in Korea and its potential commercialization as the country’s first PSMA-targeted PET imaging agent for prostate cancer.

Following the announcement, FutureChem shares rose 6.64 percent to 18,790 won ($13.82) as of 2:40 p.m. Thursday.

The company disclosed the results in two separate regulatory filings, detailing studies conducted in both high-risk prostate cancer patients and those with recurrent or metastatic disease.

FC303 combines the PSMA-targeting ligand florastamin with the radioisotope fluorine-18 (F-18), enabling PET/CT-based visualization of prostate cancer lesions with high precision.

In the trial targeting high-risk prostate cancer patients, conducted from April 2021 to December 2024 across five institutions, including Seoul St. Mary’s Hospital, 398 participants were evaluated.

The study compared the sensitivity and specificity of FC303 PET/CT imaging with standard magnetic resonance imaging (MRI). The FC303 group showed a sensitivity of 75.58 percent and specificity of 55.28 percent, while the MRI group recorded 61.18 percent sensitivity and 90.45 percent specificity.

The difference in sensitivity favored FC303 with statistical significance, demonstrating its superior ability to detect cancer, although MRI maintained significantly higher specificity.

On the safety front, among 392 participants, 28 individuals (7.14 percent) experienced 33 treatment-emergent adverse events (TEAEs), and 10 participants (2.55 percent) reported 11 serious adverse events (SAEs). There was one case (0.26 percent) of SAE leading to trial discontinuation. Notably, no adverse drug reactions (ADRs), deaths, or drug-related discontinuations occurred.

The second phase 3 trial evaluated 138 patients with suspected recurrent or metastatic prostate cancer across 11 institutions, including the National Cancer Center, from 2023 to March 2025. Here, the primary endpoint was the positive predictive value (PPV) of FC303 PET/CT scans. The trial reported a PPV of 86.96 percent, exceeding the predefined threshold of 60.6 percent, thus confirming clinical efficacy.

Safety data showed TEAEs in 47 patients (34.06 percent) with 112 events reported, while ADRs were observed in four patients (2.9 percent). SAEs were reported in five patients (3.62 percent), but all were judged unlikely to be related to the investigational product. No serious ADRs (SADRs) were recorded.

FutureChem emphasized that FC303 holds several advantages over conventional diagnostic methods, including non-invasive detection, superior early-stage identification compared to tissue biopsy or FDG PET, and reduced patient burden.

Also, the F-18 label offers a longer half-life than gallium-68–based agents, enabling mass production and broad distribution to multiple hospitals, along with improved imaging resolution that can better identify small lesions.

With the phase 3 studies complete, FutureChem plans to submit a marketing application to the Ministry of Food and Drug Safety. The company is also advancing late-phase clinical development overseas, including phase 3 trials in Europe and China and a phase 1 trial in the U.S., as part of its global expansion strategy.

“We are preparing to apply for product approval in Korea,” the company said in a statement. “We look forward to making FC303 Korea’s first domestically developed PSMA-targeted prostate cancer diagnostic agent.”