On July 30, 2025, the National Medical Products Administration formally approved the New Drug Application for Ranicabtagene Autoleucel Injection (HICARA^®) submitted by Shanghai Hengrun Dasheng Biotechnology Co., Ltd. (hereinafter referred to as “Harin Bio”).

As China's first entirely domestically developed CD19 CAR-T product for relapsed or refractory large B-cell lymphoma (r/r LBCL), this Class 1 innovative biological product has been granted market authorization. This approval not only fills the gap in domestically developed CAR-T products for this indication but also marks a new phase of self-reliance and control in China's immune cell therapy technology, providing solutions for more unmet clinical needs.

Image source: NMPA

Addressing critical clinical challenges, bringing hope to patients facing dire circumstances

HICARA^® is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more prior systemic therapies, including: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified， DLBCL arising from follicular lymphoma transformation， High-grade B-cell lymphoma with MYC and BCL2 rearrangements， High-grade B-cell lymphoma not otherwise specified.

Professor Liu Peng, Principal Investigator of the Chinese registration clinical trial for HICARA^® and Professor at Zhongshan Hospital stated: "As the lead institution for this project, the Department of Hematology at Zhongshan Hospital is honored to have participated in and witnessed the entire journey of China's first domestically developed CD19 CAR-T product for relapsed/refractory large B-cell lymphoma, from its development to market launch. This drug has demonstrated durable responses in patients with this type of lymphoma, coupled with an excellent overall safety profile. Its launch not only provides clinicians with a powerful weapon against this refractory disease but also brings new hope and vitality to countless patients and their families."

Full-chain independent innovation establishes a milestone for China's cell therapy solution

The development and production of HICARA^® rely entirely on Harin Bio's proprietary molecular design, independently established process quality system, and closed-loop, large-scale production platform. This achieves full domestically production of CAR-T cell therapy from R&D to manufacturing, breaking foreign technological monopolies. Notably, HICARA^® is the first domestically produced CAR-T product approved to utilize the stable-transfected cell-lines virus process. Harin Bio's proprietary viral vector platform achieved high-quality research project acceptance by Ministry of Industry and Information Technology in 2023. The platform's annual production capacity can meet CAR-T cell preparation demands for over 10,000 patients.