DuChemBio Completes Supply Chain for Prostate Cancer Radiopharmaceutical

DuChemBio, a Korean radiopharmaceutical company, announced on August 4 that it has completed the supply chain for ProstaSeek (active ingredient: 18F-plotupolastat), a radiopharmaceutical for prostate cancer diagnosis, in the Yeongnam and Honam regions. The drug targets prostate-specific membrane antigen (PSMA), and all tertiary general hospitals in both regions that perform PET-CT scans and provide prostate cancer diagnosis and treatment have been included in its supply scope.

According to data from the National Cancer Registry of the Korean Ministry of Health and Welfare, new prostate cancer cases reached 22,640 in 2023, accounting for 7.8% of all cancer cases and ranking sixth in male cancer incidence; with the increasing adoption of PSMA-targeted therapy, the demand for precise diagnosis before prostate cancer treatment is also growing rapidly.

PSMA-targeted diagnosis is closely linked to subsequent treatment, as both diagnostic and therapeutic agents target the same PSMA molecule. Novartis's PSMA-targeted therapeutic agent "Fluvicto" (active ingredient: lutetium (177Lu) vipivotide tetraxetan) received Korean approval in May 2024 for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer. The National Comprehensive Cancer Network (NCCN) guidelines recommend PSMA PET diagnosis prior to targeted therapy. "ProstaSeek" is currently the only PSMA-targeted diagnostic agent approved by the Korean Ministry of Food and Drug Safety, while 68Ga-PSMA-11 is an in-house preparation.

"ProstaSeek" is a PSMA-targeted PET diagnostic agent based on the radioisotope F-18 that tracks PSMA proteins overexpressed in prostate cancer cells. Its indications include: cases with suspected metastasis before initial curative prostate cancer treatment, and cases with suspected recurrence due to elevated serum PSA (prostate-specific antigen) levels after prior treatment.

The "SPOTLIGHT" Phase 3 clinical trial (391 patients) showed that for early recurrence patients with PSA levels below 0.5 ng/mL, "ProstaSeek" achieved a PET-CT detection rate of 64%, significantly higher than the 20% for MRI and CT. Additionally, the examination time was reduced from the previous 3-4 hours to 80 minutes. The drug passed the reimbursement review of the Health Insurance Review and Assessment Service in November last year.

DuChemBio CEO Kim Sang-woo noted: "For prostate cancer, the precise diagnostic results before treatment directly determine the treatment plan." He added: "Patients have had to travel across regions for diagnosis, which undoubtedly adds to their burden. Radiopharmaceuticals have short half-lives, and the distance between production facilities and hospitals directly affects diagnostic feasibility." Kim stated that the company has established a foundation enabling patients in the Yeongnam and Honam regions to conveniently access one-stop services from diagnosis to treatment locally.

In addition, the U.S. FDA approved the expanded indication of Fluvicto on July 31 to include metastatic hormone-sensitive prostate cancer (mHSPC), which means the number of eligible patients is expected to double. PSMA PET examination is also required before receiving Fluvicto treatment.