PCI Biotech, a cancer focused biopharmaceutical company announced that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for combination treatment with gemcitabine in patients with inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma). No approved treatment alternatives exist today for the first-line treatment of patients with this disease and fimaChem (fimaporfin) has the potential to play a role in this area of high unmet medical need.
“The RELEASE trial has in general shown promise with good recruitment activity in South Korea despite the Covid-19 pandemic. Receiving orphan status from the South Korean authorities is a key step in the development of this important new medicine for Asian cancer patients in need of better local treatments. PCI Biotech’s fimaChem treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods.” said Dr. Per Walday, CEO of PCI Biotech. “Orphan designation in South Korea, in addition to the already granted orphan designations in EU and USA, are all significant regulatory milestones and recognises the therapeutic benefits we seek to bring to the patients.”