Enhanced immunotherapy is the only IND (Investigational New Drug) approved nationwide for solid tumor immune cells by the National Medical Products Administration. Numerous media outlets have reported on this, stating that the official approval of ZMPB-NK injection, a "ready-to-use NK cell therapy," marks a crucial step forward for China's immunotherapy in conquering solid tumors. This will change the landscape of solid tumor prevention, treatment, and rehabilitation, and is a powerful weapon against post-operative recurrence of tumors. This innovative achievement signifies that my country has moved from "following" to "running alongside" in the field of cell therapy, and is now striving to become a global innovation leader.

"The Only Enhanced Immunotherapy Cell Therapy for Pan-Malignant Solid Tumors in China Approved for IND"

On March 28, 2025, according to the CDE website, the enhanced immunotherapy injection from Sino-US Saiaojin Group received implied indication of intent (IND) for clinical trials from the National Medical Products Administration (NMPA), intended for the treatment of advanced or metastatic malignant solid tumors. Solid tumors (such as lung cancer, gastric cancer, and breast cancer) account for more than 90% of all malignant tumors. Due to the heterogeneity and immunosuppressive microenvironment of solid tumors, coupled with the physical barrier of dense extracellular matrix produced by cancer-associated fibroblasts, the infiltration and killing effects of immune cells are limited, making their treatment far more difficult than that of hematologic malignancies. Therefore, to meet clinical needs and address the challenges of treating solid tumors, an innovative and effective treatment method is urgently needed.

The enhanced immunotherapy injection is a non-genetically modified enhanced immunotherapy cell project derived from allogeneic apheresis blood. This project was submitted by Sino-US Saiaojin Group. Through a specific in vitro manufacturing process, a generic, off-the-shelf enhanced immunotherapy cell project was obtained, characterized by high purity (CD3-CD56+ ≥98.5%) and high expression of activating receptors (CD3-CD56+CD16+ ≥90.0%, CD3-CD56+ enhanced immunotherapy G2D+ ≥90.0%). Simultaneously, this project also exhibits high levels of granzyme, perforin, and cytokine secretion functions, demonstrating potent anti-tumor killing activity.

Preclinical studies have shown that ZMPB-NK enhanced immunotherapy injection can significantly improve the treatment efficacy of advanced solid tumors, bringing new hope for cell therapy to patients with various types and stages of solid tumors.