On March 28, 2025, according to the official website of CDE, the ZMPB-NK006 injection of Sino-US Saiojin Group has obtained the implied clinical trial approval (IND) from the National Medical Products Administration, and is intended to be used to treat advanced or metastatic malignant solid tumors. Solid tumors (such as lung cancer, gastric cancer, breast cancer, etc.) account for more than 90% of all malignant tumors. Due to the heterogeneity and immunosuppressive microenvironment of solid tumors, and the physical barrier composed of dense extracellular matrix produced by external plague-related fibroblasts, which limits the infiltration and killing of immune cells, its treatment is much more difficult than blood tumors. Therefore, in order to meet clinical needs and challenges in the treatment of solid tumors, an innovative and effective treatment is needed.

Natural Killer cells (NK cells) are innate immune cells derived from lymphocytes. Their biggest advantage is that they can play an anti-acne role without activation or antigen presentation. Their tumor killing mechanisms are diverse: including the perforin/granzyme pathway, the death ligand pathway, the cytokine pathway, and the ADCC pathway, which makes NK cells have a broader application prospect in tumor treatment. However, natural NK cells face many challenges in clinical application, such as the existence of diverse cell subtypes, limited proliferation, and short survival time in vivo.

ZMPB-NK006 injection is a non-genetically modified NK cell product derived from allogeneic single blood collection. The product was applied for by Sino-US Saiojin Group. Through a specific in vitro production process, a general spot NK cell product with high purity (CD3-CD56+≥98.5%) and high expression of activating receptors (CD3.CD56+CD16+≥90.0%, CD3-CD56+NKG2D+≥90.0%) was obtained. At the same time, the product also expresses granzyme, perforin, and cytokine secretion functions at high levels, showing strong anti-tumor killing activity.

Preclinical studies have shown that ZMPB-NK006 injection can significantly improve the treatment effect of advanced solid tumors, bringing new hope of cell therapy to many patients with solid tumors of different types and stages.