Curocell's CAR-T therapy wins fast-track designation

Curocell, a chimeric antigen receptor-T (CAR-T) developer, said its CAR-T therapy Anbal-Cel has won the advanced biomedicine expedited approval from the Ministry of Food and Drug Safety.

In clinical phase 2 trials targeting patients with relapsed or refractory large B-cell lymphoma (LBCL), Anbal-Cel demonstrated a complete remission rate (CRR) of 67.1 percent, surpassing the existing results of globally marketed CAR-T therapies.

As the first homegrown CAR-T therapy employing next-generation technology, Curocell expects to file for new drug approval for Anbal-Cel this year, and a market launch in the latter half of next year.

The advanced biomedicine expedited approval system is a regulatory mechanism to accelerate the market release and patient access to innovative therapies for life-threatening or severe diseases. Anbal-Cel’s designation enables a dedicated review team to prioritize its evaluation over other products.

The process will also include a tailored review of prepared materials and exemption from certain clinical trial data requirements.

Under the system, the MFDS reduces the processing period for obtaining marketing from 90 to 120 business days.

"We are very pleased that Anbal-Cel has won the advanced biomedicine expedited approval, crucial in addressing unmet medical needs," Curocell CEO Kim Gun-soo said. "We will strive to expedite the approval process and bring Anbal-Cel to market as swiftly as possible."