GC Cell Applies for Domestic Marketing Authorization for Multiple Myeloma CAR-T Therapy 'Fucaso'

Full-Scale Entry into the CAR-T Market Backed by Cell Therapy Commercialization Experience

GC Cell announced on the 27th that it has submitted an application to the Ministry of Food and Drug Safety for domestic marketing authorization of the CAR-T therapy Fucaso for the treatment of multiple myeloma, which it introduced from IASO Biotechnology (IASO Bio) in Nanjing, China.

Fucaso is a BCMA (B-cell maturation antigen)-targeted CAR-T cell therapy developed by IASO Bio. It received marketing authorization in China in June 2023 and is currently being used there as a fourth-line treatment for multiple myeloma. GC Cell signed a domestic introduction agreement with IASO Bio in October last year and has since been carrying out the procedures required for approval.

The company stated that Fucaso demonstrated a high response rate in clinical trials and that the application of a fully human antibody reduced immunogenicity. It also reported that the incidence rate of representative side effects associated with CAR-T therapies is relatively low. According to the company, Fucaso has a competitive pricing structure compared with CAR-T therapies from existing global pharmaceutical companies, which can help improve treatment accessibility.

For its introduction into Korea, Fucaso was designated as an orphan drug by the Ministry of Food and Drug Safety in July 2025 and, in August of the same year, was designated as an advanced biopharmaceutical subject to expedited review.

GC Cell has accumulated clinical and commercialization experience in the cell therapy field through domestic marketing authorization and commercialization of Immunecell-LC injection, an immunotherapy for liver cancer. Another strength of the company is that it has established a full-cycle value chain covering everything from GMP-based manufacturing to commercialization and distribution. Based on this, the company plans to swiftly promote the introduction of CAR-T therapies into Korea and their establishment in the market.

GC Cell CEO Won Sungyong said, "Based on our accumulated experience in commercializing cell therapies and our business capabilities built through operating a pharmaceutical supply chain, we will steadily push forward with obtaining domestic approval for Fucaso and securing its position in the market," adding, "We will do our utmost to expand treatment accessibility so that patients in Korea can receive treatment at more reasonable costs."

This content was produced with the assistance of AI translation services.