Hengrun Dasheng's First CD19/CD22 Dual-Target CAR-T Therapy Receives IND Acceptance from NMPA

On October 20, Shanghai Hengrun Dasheng Biotechnology Co., Ltd. (hereinafter referred to as “Hengrun Dasheng”), a cell therapy enterprise in Zhangjiang Science City, had its investigational new drug application for the first CD19-CD22 dual-target CAR-T therapy accepted by the NMPA.

Shanghai Hengrun Dasheng Biotechnology Co., Ltd., established in 2015, specializes in the research, development, and application of tumor immunotherapy technologies. As one of the earliest companies in China to enter the cell therapy sector, it currently boasts a pipeline of more than ten CAR-T candidates targeting various oncology indications, with ongoing advancements in R&D programs for CAR-NK, TCR-T, and oncolytic viruses.

Currently, Shanghai Hengrun Dasheng Biotechnology Co., Ltd. has obtained three CAR-T clinical trial approvals, with targets involving CD19 and BCMA. These are respectively used for the treatment of relapsed/refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma, relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia, and BCMA-positive relapsed/refractory multiple myeloma. The registration clinical trials for these three approvals have been simultaneously conducted at well-known tertiary hospitals in China.

It is reported that Shanghai Hengrun Dasheng Biotechnology Co., Ltd.’s 11,000-square-meter large-scale CAR-T GMP manufacturing center, located in the Zhangjiang Jinshan Biopharmaceutical Base, is nearing completion. This facility will lay a solid foundation for the future large-scale industrial production of cell therapy products. Meanwhile, the RMB 200 million in Series B+ financing completed by the company this September will be used to support the further advancement of clinical trials for three CAR-T product approvals, accelerate the commercial development of CAR-T products, and promote the research and development of pipelines targeting new solid tumor antigens, including CAR-T, TCR-T, CAR-NK, and oncolytic virus therapies, thereby laying the groundwork for a subsequent initial public offering (IPO).