ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness
Anbalcabtagene autoleucel (Anbal-cel; code: CRC01) is a next-generation CD19-targeted CAR-T cell therapy developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The approval underscores Korea’s growing innovation capabilities in advanced therapies and reflects the accelerating global momentum of CAR-T and gene therapies.
Clinical data from Phase 1/2 studies 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 supported the entire journey from post-IND supplier change, phase 2 clinical manufacturing, BLA application and commercial production, built upon our global CDMO quality system and facility. Leveraging our deep expertise in change control, we worked closely with the client's strategy to secure rapid approval for major process and site changes. Driven by a profound understanding of lentivirus manufacturing process, we completed process characterization in just four months, identified critical process parameters, established a robust control strategy, and achieved first-time success across all three process validation batches. During the Korean pre-approval inspection, our comprehensive audit framework, fast and professional responsiveness, and mature GMP quality system received high recognition from both Korean authorities and the client. ProBio has successfully passed the GMP inspection by MFDS. This milestone marks the first-time the MFDS has issued a GMP certification for a lentiviral vector (LVV) manufacturing facility, establishing ProBio as a pioneer in the Korean 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.
“We are thrilled to witness this landmark achievement by Curocell,” said Allen GUO CEO from ProBio. “This approval not only represents a major step forward for patients in Korea but also reinforces the global potential of innovative CAR-T therapies. At ProBio, we remain committed to empowering our partners with integrated CDMO solutions to accelerate the development and commercialization of advanced therapies worldwide.”
“The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea’s first CAR-T therapy,” said Kim Gun-soo, CEO of Curocell. “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.”
He added, “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.”
About ProBio CDMO
ProBio is a global leader in enabling biotech and pharmaceutical companies to advance the development and manufacturing of next-generation biologics and advanced therapies. As a fully integrated end-to-end Contract Development and Manufacturing Organization (CDMO), ProBio supports partners in optimizing drug development, accelerating time-to-market, and providing comprehensive life-cycle support. Since October 2017, ProBio has supported customers across the United States, Europe, and Asia-Pacific and other regions in obtaining more than 150 IND approvals, demonstrating its strong global regulatory and development capabilities.
ProBio’s comprehensive Cell and Gene Therapy (CGT) solutions span IND-enabling services, clinical manufacturing, and commercial production for plasmids, viral vectors, mRNA vaccines, and nucleic acid therapeutics etc. The company provides integrated CMC solutions for plasmids and viral vectors, including cell banking, process development, characterization and validation, analytical method development and validation, as well as stability studies. With manufacturing facilities and supply chain systems established in both China and the United States, ProBio empowers cell and gene therapy innovators to accelerate global development and commercialization.
To learn more about ProBio services, please visit www.probiocdmo.com.
About Curocell
Curocell Inc. is a cell and gene therapy company specializing in the development of CAR-T cell therapies. The company successfully commercialized RIMQARTO® (anbalcabtagene autoleucel), Korea’s first CAR-T therapy, which was approved as Korea’s 42nd domestically developed new drug.:
RIMQARTO is a next-generation CD19-targeted CAR-T therapy incorporating Curocell’s proprietary OVIS™ (Overcome Immune Suppression) platform technology. OVIS™ is designed to simultaneously modulate PD-1 and TIGIT immune-suppressive signaling, improving T-cell exhaustion while enhancing anti-tumor activity and persistence.
Beyond hematologic malignancies, Curocell is advancing the development of next-generation cell and gene therapies for solid tumors, autoimmune diseases, and in vivo CAR-T applications, while accelerating global development and commercialization efforts with a focus on North America and Europe.
