Curocell Inc.
Founded in 2016, Curocell develops OVIS™ CAR-T therapies and filed for Korean approval of its CD19 therapy Limkato (CRC01) in December 2024.
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Business overview
Source: DART corporate disclosureCurocell, founded in 2016 and listed on KOSDAQ in 2023, is a cell and gene therapy company developing multiple CAR-T pipelines. Its lead product is Limkato (generic name anbalcabtagene autoleucel, development code CRC01), a next-generation CD19 CAR-T therapy built on Curocell's proprietary OVIS™ CAR-T technology, alongside pipelines in hematologic, solid tumor, and allogeneic CAR-T. Curocell plans direct production and sales in Korea and licensing or partnering overseas; for Limkato's DLBCL indication it filed for marketing approval with Korea's MFDS in December 2024 and for drug reimbursement review with HIRA in February 2025, targeting a 2026 launch, while its adult ALL indication is in Phase 1 targeting a 2027 launch.
Products & technology
- LimkatoCD19 CAR-T cell therapy (generic name anbalcabtagene autoleucel, code CRC01) for relapsed/refractory large B-cell lymphoma including DLBCL, HGBL, and PMBCL
Regulatory approvals
data.go.kr1 Orphan Drug designations · 2024 / 1 Korean MFDS drug approvals · 2026
- Orphan주사제2024-12-24Orphan Drug designation · in development20240221453
- MFDS drugRIMQARTO (anbalcabtagene autoleucel)2026-04-29Drug · Prescription · Approval202601287
Clinical trials
data.go.kr2 MFDS clinical trial authorisations · 2021–2025 (Phase 1/2 2)
- Phase 1/2CRC012025-07-31
1 trial site
- Phase 1/2CRC012021-02-18
10 trial sites
R&D and key agreements
Source: DART corporate disclosureCRC01 (anbalcabtagene autoleucel, 림카토주) · 거대B세포림프종(DLBCL·HGBL·PMBCL 포함) 등 재발성·불응성 B세포 림프종 성인 환자 · 품목허가 심사 중 · Last patient dosed Oct 2023; final clinical study report (CSR) received May 2024; MFDS fast-track and customized review designation Aug 2024; marketing authorization filed Dec 2024; drug reimbursement review filed with HIRA Feb 2025; targeting 2026 launch. Trials conducted at Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, National Cancer Center, Pusan National University Hospital, and Chonnam National University Hwasun Hospital.
CRC01 (anbalcabtagene autoleucel) · 재발성 또는 불응성 급성림프모구성백혈병(B-cell ALL) 성인 환자 · 임상 1상 (2상 전환 가능) · In Phase 1 under MFDS IND approval; a 2025 IND amendment approved initiation of Phase 2. Targeting 2027 launch.
CRC01 (anbalcabtagene autoleucel) · 심각한 불응성 자가면역질환(전신홍반성루푸스, SLE) 환자 · Listed as a target patient population; the specific clinical stage is not disclosed in the source text.
혈액암·고형암·동종유래 CAR-T 파이프라인 · Disclosed as holding additional pipelines in hematologic, solid tumor, and allogeneic CAR-T beyond CD19 CAR-T, but no specific program names, indications, or clinical stages are given in the source text.
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Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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