Hangzhou Qihan Biotech Co., Ltd., a leading specialist in xenotransplantation based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its product QN-019a. This marks the first Investigational New Drug (IND) approval in China for a gene-edited induced pluripotent stem cell (iPSC)-derived cell therapy product.
QN-019a: A Breakthrough in CD19-Targeted Cell Therapy
Qihan Biotech employs state-of-the-art genome editing technology to modify human iPSCs, which are then differentiated into the natural killer (NK) cell therapy product QN-019a. This innovative therapy targets CD19-positive B-cell lymphoma and is clinically indicated for the treatment of CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.
Advantages of iPSC-Derived NK Cell Therapy
The NK cell therapy derived from induced pluripotent stem cells (iPSCs) is considered a potentially safe and effective treatment option. It has shown potential efficacy in targeting solid tumors, exhibits broad-spectrum anticancer activity, and does not significantly inhibit the Major Histocompatibility Complex (MHC). The therapy is also noted for its safety and stability. However, the effectiveness of NK cells can be limited due to reflux damage, which is where CAR-NK cells offer an advantage by reducing damage to NK cells. CAR-NK cells also present benefits such as lower costs and reduced toxicity.-Fineline Info & Tech
