Announcement • May 11
ProBio Inc. And Curocell Announce BLA Regulatory Approval And Commercial Readiness Of Anbalcabtagene Autoleucel ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01). This next-generation CD19-targeted CAR-T cell therapy is developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval not only highlights Korea's growing innovation in advanced therapies but also marks a critical step towards bringing transformative treatment options to patients. Clinical data from Phase 1/2 studies has demonstrated compelling efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy also exhibited a manageable safety profile, with the most commonly reported grade 3/4 adverse events including neutropenia, anemia, and thrombocytopenia. A key differentiating feature of CRC01 lies in Curocell's proprietary OVIS™ platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This innovative mechanism is designed to address immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to conventional CAR-T approaches. As a strategic partner of Curocell, Probio has supported the journey from post-IND supplier change to BLA application and commercial production. Company partnered closely with the client to manage complex change control activities and secure rapid regulatory approval for major process and site changes. With deep expertise in lentiviral vector manufacturing, company completed process characterization within four months, defined critical process parameters, implemented a robust control strategy, and achieved first-pass success across all three validation batches. Company strong performance during the MFDS pre-approval inspection, from audit readiness to real-time responses, was recognized by both regulators and the client. Companies successfully obtained MFDS GMP certification, representing the first GMP approval for a lentiviral vector manufacturing facility in Korea and reinforcing role as a pioneer in the local cell and gene therapy supply chain. The program has now progressed into the commercial manufacturing phase. ProBio remains committed to delivering high-quality plasmid and viral products, supporting the broader adoption of CAR-T therapy, enabling patient access. The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea's first CAR-T therapy. ProBio has played a key role throughout the entire process, from the clinical stage to process development, quality management, regulatory response, and preparation for commercial production, serving as an important partner in supporting the successful approval and laying the foundation for commercialization. Moving forward, Curocell plans to improve treatment access for patients in Korea based on a stable global supply chain and quality competitiveness, while continuing to expand into global markets and advance the development of next-generation CAR-T therapies. Announcement • May 02
Curocell Secures Full Regulatory Approval for Rimqarto Injection Curocell said that RIMQARTO Inj. (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the Ministry of Food and Drug Safety (MFDS) on April 29. With this approval, RIMQARTO becomes the 42nd drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company. The CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient’s immune cells are genetically modified to selectively target cancer cells. RIMQARTO has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell’s proprietary OVIS (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing “T-cell exhaustion,” and enabling more sustained anticancer activity over the long term. RIMQARTO is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy. In the pivotal Phase 2 trial supporting the approval, RIMQARTO achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%. Although RIMQARTO was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy’s safety and efficacy. The approval reflects the combined impact of the MFDS’s expedited review framework and full-cycle support from government R&D programs. RIMQARTO was developed with support from the Ministry of Health and Welfare (MOHW) R&D program and the Korea Drug Development Fund. In addition, the MFDS’s “Bio-Challenger Program” for advanced biopharmaceuticals and RIMQARTO’s “Global Innovative Products on Fast Track” (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes. RIMQARTO was also selected for the MOHW’s “Concurrent Pilot Program for Approval-Evaluation-Negotiation,” which is expected to shorten the timeline from its approval to national health insurance reimbursement listing. Announcement • Mar 17
Curocell Inc., Annual General Meeting, Mar 31, 2026 Curocell Inc., Annual General Meeting, Mar 31, 2026, at 10:00 Tokyo Standard Time. Location: conference room, 11, gukjegwahak 16-ro, yuseong-gu, daejeon South Korea 
