AbClon's next-generation CAR-T therapy, 'Nespe-cel (AT101),' has been designated as a fast-track advanced biopharmaceutical by the Ministry of Food and Drug Safety (MFDS), the company announced on the 24th.

The MFDS granted the designation approximately two months after AbClon applied on July 23rd. The fast-track designation system allows the MFDS to prioritize the review of treatments for life-threatening or severe diseases that lack existing therapies or show significant potential for medical improvement. This designation provides AbClon with several benefits, including the assignment of a dedicated review team, a shortened review period, and the potential for partial exemption from clinical trial data requirements, which can significantly reduce the time needed to obtain product approval.

'Nespe-cel (AT101) is a domestically developed CAR-T therapy with a target of receiving product approval in 2026. It is being developed with support from the Korea Drug Development Fund (KDDF).