China's First Self-Developed CD19 CAR-T Therapy HICARA® (Relnigocel Injection) by Hengrun DaSheng Approved for r/r LBCL

On July 30, 2025, the National Medical Products Administration officially approved Shanghai Hengrun Dasheng Biotechnology Co., Ltd.(hereinafter referred to as "Hengrun")AchieveShanghai Hengrun Dasheng Biotechnology Co., LtdDeclared Class 1 Innovative Biological Product - Ranikioluzen Injection(Product Name: Hengkailai^®, English Product Name: HICARA^®）New drug marketing application,As China's first completely self-developed treatment for relapsed or refractory large B-cell lymphoma（r/r LBCL）CD19 CAR-T Product, its approval not only fills the gap in the field of domestically produced CAR-T in China, but also marks that China's immune cell therapy technology has entered a new stage of independent control, providing solutions for more unmet clinical needs.

Source of the image: National Medical Products Administration

Heng Kai Lai^®For the treatment of adult relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified.

Heng Kai Lai^®Professor Liu Peng, the principal investigator of the registered clinical trial in China and from Zhongshan Hospital Affiliated to Fudan University, stated: "As the leading unit of this project, the Hematology Department of Zhongshan Hospital is honored to have participated in and witnessed the breakthrough journey of the first domestically produced CD19 CAR-T product for treating relapsed or refractory large B-cell lymphoma, from research and development to market launch. This drug has demonstrated durable remission effects in patients with this type of lymphoma and has shown excellent overall safety. Its introduction not only provides clinicians with a powerful weapon against this difficult-to-treat disease but also brings new hope and vitality to countless patients and their families."

The research, development, and production of Hengkailai® are fully supported by Shanghai Hengrun Dasheng Biotechnology Co., Ltd.Molecular design with independent intellectual property rights, independently constructed process quality system, and a closed, large-scale production platform, achieving the full-process localization of CAR-T cell from research and development to production in China, breaking the foreign technical monopoly. Particularly noteworthy is Hengkailai.^®YesThe First Approved Chinese-produced CAR-T Product Using a Stable Cell Line Virus ProcessIn 2023, the achievements of Shanghai Hengrun Dasheng Biotechnology Co., Ltd's proprietary viral vector platform passed the acceptance of high-quality research projects by China's Ministry of Industry and Information Technology. The platform's annual production capacity can meet the CAR-T cell preparation needs of more than 10,000 patients.

Shanghai Hengrun Dasheng Biotechnology Co., Ltd. is an innovative biopharmaceutical company focused on the research and production of breakthrough immunotherapy drugs, primarily targeting treatment areas such as malignant hematological diseases and solid tumors. The company leads with its independent R&D of CAR-T products while simultaneously advancing international cutting-edge technologies like CAR-NK, forming a product pipeline that spans from early-stage research to mature clinical trial phases. This pipeline demonstrates both diversity and technical foresight. The company has five Class 1 innovative biological products.(CAR-T Cell Therapy Products)An innovative pharmaceutical company with registered clinical approval and simultaneous progress.

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