Cell therapy company Curocell (KOSDAQ:372320) announced on Thursday that RIMQARTO Inj. (anbalcabtagene autoleucel) has received full regulatory approval from South Korea's Ministry of Food and Drug Safety, marking the first commercialisation of CAR T-cell therapy by a Korean company.

The therapy becomes the 42nd locally developed drug approved under advanced biopharmaceutical regulations, transitioning from an initial conditional submission to full approval.

RIMQARTO is a personalised autologous T-cell immunotherapy targeting cancer cells, supported by the company's proprietary OVIS technology designed to mitigate immune suppression and improve sustained anticancer activity. It is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma following at least two prior treatments.

In a pivotal Phase 2 trial, the therapy demonstrated an objective response rate of 75.3% and a complete response rate of 67.1%, with cytokine release syndrome reported in 10% of patients and neurotoxicity in 5%. The regulator waived Phase 3 data requirements, citing the therapy's classification and third-line treatment use, while maintaining obligations for long-term follow-up and risk management.

The approval was supported by expedited regulatory pathways and government-backed R&D programmes, including initiatives from the Ministry of Health and Welfare and the Korea Drug Development Fund. Curocell plans to leverage the approval to expand indications, pursue global market entry, and advance next-generation pipelines, including applications in solid tumours and autoimmune diseases.