Curocell, a chimeric antigen receptor-T (CAR-T) developer, has applied for Anbal-cel, its CAR-T candidate, to be included in the Ministry of Food and Drug Safety (MFDS)’s Advanced Biomedicine Expedited Approval System.

The system is designed to facilitate the rapid market entry of innovative medicines that address serious or life-threatening conditions, thereby enabling quicker patient access, according to the company.

Under the expedited approval system, the MFDS allocates dedicated staff to expedite the review of designated products, streamlining the drug approval process.

Curocell said the program also allows for a tailored review process based on the preparedness of the applicant's data and may permit exemptions from some clinical trial requirements under certain conditions.

The company aims to secure expedited designation for Anbal-cel by the third quarter of this year and plans to pursue formal drug approval subsequently.

“With this application for the expedited approval system, we expect to accelerate the approval of Anbal-cel and supply the first homegrown CAR-T treatment to patients in Korea,” Curocell CEO Kim Gun-soo said. “We also hope that Anbal-cel, which has demonstrated high therapeutic effectiveness and safety in clinical trials, will give many patients hope for a cure.”

In a phase 2 clinical trial, Anbal-cel achieved a complete response rate (CRR) of 67.1 percent among patients with relapsed or refractory large B-cell lymphoma (LBCL).