[Edaily Reporter NA EUN-KYUNG ] Radiopharmaceutical developer DuChemBio Co.,LTD.(176750)announced on the 4th that it has completed the establishment of a supply chain for “Prostasic” (active ingredient: 18F-flutopolastat), a PSMA (prostate-specific membrane antigen)-targeted radiopharmaceutical for prostate cancer diagnosis, in the Yeongnam and Jeolla regions.

Through this expansion of the supply chain, the company can now supply the product to all tertiary general hospitals in the Yeongnam and Jeolla regions that operate positron emission tomography (PET-CT) for the diagnosis and treatment of prostate cancer. The company expects this to serve as an opportunity to strengthen the regional diagnostic infrastructure, noting that, given the nature of radiopharmaceuticals, the supply chain between manufacturing hubs and medical institutions directly determines patients’ access to testing.

According to the Central Cancer Registry of the Ministry of Health and Welfare, there were 22,640 new prostate cancer cases in South Korea in 2023, accounting for 7.8% of all cancers and making it the most common cancer among Namsung. With the recent expansion of PSMA-targeted therapy, the importance of PSMA PET diagnostics for pre-treatment patient selection is also growing.

The PSMA PET scan is a key test for determining whether to proceed with targeted therapy, as both the diagnostic agent and the therapeutic agent target the same PSMA. Novartis’ PSMA-targeted therapy, Flubicto, has been approved in South Korea for the treatment of metastatic castration-resistant prostate cancer, and the National Comprehensive Cancer Network (NCCN) guidelines in the United States also recommend a pre-treatment PSMA PET scan. Currently, Prostasic is the only PSMA-targeted PET diagnostic agent approved by the Ministry of Food and Drug Safety in South Korea, excluding in-house compounded formulations.

Prostasic is an F-18-based PET diagnostic agent that targets PSMA, which is overexpressed in prostate cancer cells. It is approved for use in diagnosing patients suspected of having metastases prior to their first curative treatment for prostate cancer, as well as patients suspected of recurrence due to elevated prostate-specific antigen (PSA) levels following treatment.

According to the company, the Phase 3 SPOTLIGHT clinical trial confirmed a 64% lesion detection rate in patients with early recurrence and PSA levels below 0.5 ng/mL, and last year, the product passed the Health Insurance Review and Assessment Service’s (HIRA) reimbursement evaluation for PET-CT procedures.

Kim Sang-woo, CEO of DuChemBio Co, LTD, stated, “Prostate cancer is a critical disease in which precise pre-treatment diagnostic results determine the treatment strategy.” He added, “Since radiopharmaceuticals have a short half-life, the distance between manufacturing facilities and hospitals directly determines whether testing is possible; therefore, we have established a foundation that allows patients in the Yeongnam and Jeolla regions to receive everything from diagnosis to treatment coordination near their homes.”

Meanwhile, the U.S. Food and Drug Administration (FDA) recently expanded the indications for Flubicto to include metastatic hormone-sensitive prostate cancer (mHSPC). The company anticipates that demand for PSMA PET diagnostics will also increase if the indications are expanded in South Korea in the future.