Curocell begins commercialization process for Korea's first CAR-T

Press Conference commemorates approval of 'Rimqarto'... "Expanding patient access through domestic production base"

Aims to launch Rimqarto as a reimbursed drug under the concurrent approval-eval-nego process in September…expansion of indications also underway

Curocell is pursuing market entry following the approval of South Korea's first domestically developed chimeric antigen receptor T-cell (CAR-T) therapy. Based on its domestic R&D and manufacturing infrastructure, the company aims to improve patient access to the CAR-T treatment landscape that has previously relied mostly on overseas facilities. Furthermore, the company plans to strengthen its next-generation pipeline through a strategy of expanding indications.

On May 14, Curocell held a press conference at the Four Seasons Hotel in Seoul to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' (ingredient name: anbalcabtagene autoleucel). The company unveiled Rimqarto's clinical value, domestic commercialization strategy, and directions for subsequent clinical development. The event was attended by Curocell CEO Gunsoo Kim, Professor Won Seog Kim of Hemato-oncology at Samsung Medical Center, Curocell Executive Director Seungwon Lee, and Su-hee Cho, Head of Curocell’s Clinical Development Center.

Rimqarto is an autologous CD19-targeting CAR-T therapy that uses a patient's own T cells. The process involves collecting T-cells from the patient's blood, introducing genes that allow them to recognize cancer cells, proliferating them ex vivo, and reintroducing them into the patient. It has been designed with Curocell's proprietary OVIS platform, designed to maximize therapeutic effects by simultaneously suppressing the expression of PD-1 and TIGIT, immune checkpoint receptors that inhibit the anticancer activity of T cells.

Previously, on April 29, the Ministry of Food and Drug Safety (MFDS) granted marketing authorization for Rimqarto as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. With this, Rimqarto has been listed as the 42nd novel drug developed in Korea and the first CAR-T therapy developed by a Korean company.

Curocell CEO Gunsoo Kim

CEO Kim shared in his opening remark that "The approval of Rimqarto is more than just one new drug entering the market. Curocell has step-by-step built a foundation that allows the entire process(from R&D to clinical trials, production, quality control, and licensing) to be performed domestically."

CEO Kim emphasized that Rimqarto is a treatment option that can expand patient access in the CAR-T treatment landscape, which has been highly dependent on overseas supply. "For patients with relapsed or refractory DLBCL, treatment options are limited and disease progression can be rapid, making timely treatment critical," and added, "While existing CAR-T therapies faced barriers before reaching Korean patients in clinical settings, we will do our best to improve treatment accessibility and establish a stable supply base through Rimqarto."

Professor Won Seog Kim, the first presenter, explained the unmet needs in DLBCL treatment and the clinical value of Rimqarto. According to Professor Kim, approximately 6,000-6,500 cases of malignant lymphoma occur annually in Korea, with DLBCL being the representative disease, accounting for 40% of cases. However, 35–40% of DLBCL patients experience recurrence after standard treatment, and patients reaching the third-line treatment stage number around 700 annually in Korea, carrying a poor prognosis.

CAR-T therapies are considered an option that has changed the treatment paradigm in this relapsed/refractory DLBCL field. Professor Kim said, "In a patient group where the possibility of long-term survival was previously around 10%, data showed that CAR-T treatment could offer another treatment opportunity. For this reason, we could proceed quickly to obtain reimbursement, and added, "However, even with current commercial CAR-T therapies, the expectation for a complete cure remains at about 40%, leaving room for further improvement."

Professor Kim presented Curocell's proprietary OVIS technology as Rimqarto’s distinguishment. One reason existing CAR-T therapies fail is that T-cells become exhausted or immune checkpoint mechanisms such as PD-1 or TIGIT become active, preventing the sufficient elimination of cancer cells.

​"Curocell’s OVIS technology works by loading small RNA fragments into the CAR-T to suppress the expression of immune checkpoints like PD-1 and TIGIT," Professor Kim explained, "Rimqarto is a differentiated, next-generation CAR-T product in that it can overcome treatment failure caused byover-expression of immune checkpoints."

On May 14, Curocell held a press conference to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' 

Clinical data also confirms Rimqarto’s competitiveness. In Phase 2 trial, Rimqarto demonstrated an objective response rate (ORR) of 75% and a complete response (CR) rate of 67% based on independent review committee evaluations. Regarding safety, the incidence of Grade 3 or higher cytokine release syndrome (CRS) was 9%, and neurotoxicity was 4%. Professor Kim said, "The response rate of over 75% and a CR rate of 67% as evaluated by the committee are highly encouraging results. It showed data that is manageable not only in terms of efficacy but also safety."

Starting with this approval, Curocell plans to accelerate the commercialization of Rimqarto. Related to the core pillars of the commercialization strategy, Executive Director Lee Seung-won presented ▲rapid insurance reimbursement listing ▲expanding patient accessibility. "As CAR-T therapies are perceived as high-priced treatments, the speed of reimbursement listing is directly linked to patient access," Lee explained, " Rimqarto was selected for the parallel 'Approval-Evaluation-Negotiation' pilot project, listed on a track that can shorten the time from approval to reimbursement by approximately 90 days." Curocell is currently responding to supplementary data requests for the drug reimbursement evaluation and designing price-negotiation scenarios to support a reimbursed launch as early as September.

The company will also pursue its domestic production base to build a supply chain and expand patient access. Lee stated, "Existing global CAR-T therapies involve a structure where a Korean patient’s cells are sent to an overseas manufacturing site and then brought back, which takes weeks and carries international transport risks. Rimqarto can achieve a fast 'vein-to-vein' time based on its domestic production facility." Curocell plans to establish a system within the year allowing Rimqarto treatment at 30 hospitals nationwide and will manage the entire process (from ordering to collection, manufacturing, delivery, and administration) through its online tracking platform, 'CuroLink.'

On May 14, Curocell held a press conference to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' 

The company is also strengthening its next-generation pipeline by expanding Rimqarto's indications. As a follow-up development strategy, Curocell is considering expanding indications to adult acute lymphoblastic leukemia (ALL), systemic lupus erythematosus (SLE), and second-line treatment for DLBCL. Director Cho Su-hee explained, "There are currently no clear treatment options after standard therapy for patients over the age of 25, who make up the majority of adult ALL patients," and added, "Curocell has been preparing to expand the indication to adult ALL since 2022 and is currently in the final stages of Phase 1." The company plans to enter Phase 2 shortly and is also pursuing an expansion of clinical trials in Japan to strengthen global capabilities.

The company is also pursuing expansion into autoimmune diseases and earlier lines of treatment. Director Cho stated, "To provide a better life for patients with lupus nephritis, we have started Korea's first autoimmune disease CAR-T clinical trial. Based on the experience of administering Rimqarto to lupus nephritis patients through "approval for use for therapeutic purposes," we expect encouraging results," and added, "Since Rimqarto showed a high response rate compared to other agents in third-line DLBCL, moving it up to second-line treatment would help even more patients."