Hengrunda Sheng's CD19 CAR-T Therapy Renikio-Oranlizumab Injection Approved in China for Relapsed/Refractory Large B-Cell Lymphoma

Jul 31, 2025 11:37 CST Updated 11:37

Hrain Biotechnology

Developer of Tumor Immunotherapy Technology R&D

On July 30, the National Medical Products Administration (NMPA) of China officially approved the new drug marketing application for Reni Carols Injection, a Class 1 innovative biologic product submitted by Shanghai Hengrun Dasheng Biotechnology Co., Ltd.This is a CD19 CAR-T product, which has been approved this time for the treatment of adult relapsed or refractory large B-cell lymphoma (r/r LBCL) 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, and associatedMYCAndBCL2High-grade B-cell lymphoma, not otherwise specified (NOS)。

According to the information disclosed in Hengrun Dasheng's previous prospectus,RanimilustIt is the companyThe product with the fastest progress in the R&D pipeline isA CAR-T product targeting CD19.It uses genetic engineering technology to express CAR on the surface of T cells, enabling them to specifically recognize the CD19 target antigen on the surface of malignant tumor cells.The intracellular region of the CAR molecule contains fragments that initiate an immune activation cascade signal, a structure that enables CAR-T cells to specifically recognize and kill tumor cells. Completed preclinical and clinical studies have shown that the product demonstrates good safety and efficacy.

Public information shows that 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 development of CAR-T products while simultaneously advancing international cutting-edge technologies like CAR-NK, establishing a product pipeline that ranges from early-stage research to mature clinical trial phases. Currently, it holds five Class 1 innovative biological product (CAR-T cell therapy) investigational new drug (IND) approvals in China, all of which are being advanced concurrently.

References:

[1]China's First! Hengrun Dasheng's Self-developed CD19 CAR-T Product Hengkailai® (Ranikiolun Injection) Approved for Marketing! From https://mp.weixin.qq.com/s/lJnK4lf2vLjqhxKVkbescg

[2] Shanghai Hengrun Dasheng Biotechnology Co., Ltd. Prospectus. Retrieved Oct 18, 2022, from http://static.sse.com.cn/stock/information/c/202210/6a2c552cb9f44f3a80cf3e5bde2d18a2.pdf

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