On July 30, 2025, the National Medical Products Administration (NMPA) officially approved the new drug application for HICARA, a CD19 CAR-T cell therapy. As China’s first fully independently developed CD19 CAR-T product for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL), this approval not only fills a domestic gap in CAR-T therapies for this indication but also marks a significant step forward in China’s capabilities for self-reliant immunocellular therapy. It offers new solutions for urgent unmet clinical needs.
Addressing Critical Clinical Needs, Bringing Light to Patients in Despair
HICARA is indicated for adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who have received two or more prior lines of systemic therapy. This includes diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), follicular lymphoma transformed into DLBCL, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified.
Professor Peng Liu from the Department of Hematology at Zhongshan Hospital, Fudan University, and the lead investigator of the China registration clinical trial, stated: “It has been an honor to be fully involved in and witness the development of the first domestically developed CD19 CAR-T therapy for relapsed and refractory large B-cell lymphoma—from initial research through to regulatory approval. The product has demonstrated durable remission in this patient population and has shown an excellent safety profile. Its approval not only offers clinicians a powerful new weapon against this challenging disease but also brings renewed hope to patients and their families.”
Fully Independent Innovation: A Milestone in China’s Cellular Therapy Development
HICARA was developed and manufactured using a fully localized process, supported by proprietary molecular design, a self-built quality and production system, and a closed, large-scale manufacturing platform. This end-to-end autonomy breaks reliance on foreign technologies. Notably, it is the first approved domestic CAR-T product using a stable producer cell line-based viral vector system. The viral vector platform passed national evaluation in 2023 and has the production capacity to meet the CAR-T therapy needs of over 10,000 patients annually.
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