GC Cell's immune cell therapy "Immuncell-LC injection" will be listed as an anticancer cell and gene therapy in the World Health Organization (WHO) drug classification system. As a product previously classified as an immunostimulant is reclassified as an anticancer therapy in the international pharmaceutical standard system, its utility is expected to increase in the process of entering overseas markets.
GC Cell said on the 9th that it has been confirmed that Immuncell-LC injection will be included in the "antineoplastic cell and gene therapy (L01XL)" category of the WHO Anatomical Therapeutic Chemical (ATC) classification system.
Immuncell-LC injection had been classified as "other immunostimulants (L03AX)" because there was no clear separate classification standard for cell therapies. After the WHO updated the ATC system to reflect the cell and gene therapy field, it was incorporated into the antineoplastic cell and gene therapy classification following a review. The detailed code (L01XL17) is scheduled to take effect starting in January next year.
The WHO ATC classification system is an international standard that classifies drugs according to therapeutic purpose and mechanism of action, and is used for national drug statistics and market analysis.
GC Cell explained that the classification change clarified the therapeutic area of Immuncell-LC injection under international standards, creating a basis that can be used in overseas approvals and technology export negotiations.
Immuncell-LC injection is an immune cell therapy in which immune cells are separated and cultured from a patient's blood and then reinfused. It is approved as a liver cancer treatment and is used in Korea.
GC Cell is also pursuing overseas market expansion. In May, the company administered the first dose of Immuncell-LC injection to a patient in Indonesia and, based on this, is continuing discussions on technology exports with other countries.