South Korea’s Ministry of Food and Drug Safety (MFDS) granted Orphan Drug Designation to equecabtagene autoleucel (Fucaso; eque-cel) for adults with relapsed or refractory multiple myeloma (MM) who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent.
Developed by IASO Biotherapeutics, eque-cel modifies a patient’s T cells using a lentiviral vector to target BCMA, a protein linked to multiple myeloma. The therapy shows quick results and lasting effects, helping patients achieve deep remission, according to the company’s press release.
In May 2025, eque-cel received a similar designation in Saudi Arabia.
“Equecabtagene autoleucel’s Orphan Drug Designation in South Korea brings us closer to delivering this advanced CAR-T therapy to patients with limited treatment options, expanding its global reach,” said Jinhua Zhang, who is the CEO of IASO Biotherapeutics.
