IND,血霁生物 z-bio 2025-07-03 2665

　　On June 9, 2025, the new drug clinical trial application (IND) submitted by Suzhou Xueji Biotechnology Co., Ltd. (hereinafter referred to as "Xueji Biotechnology") was officially accepted by the National Drug Administration (NMPA). This is the world's first formal clinical trial application for megakaryocyte injection. It is an allogeneic megakaryocyte product independently developed by Xueji Bio. The indication is thrombocytopenia caused by tumors. This will be a huge supplement to the existing thrombocytopenia (TPO) treatment and platelet infusion. It is expected to bring new hope to the thrombocytopenia population of tens of millions of people each year and has important social and economic value. Xueji Bio's "megakaryocyte injection from umbilical cord blood" is a hematopoietic stem cell as the source cell. Without any gene editing, it produces high-quality, large-scale, stable and controllable megakaryocytes through a directionally induced differentiation system without serum, feeder layer, immortalization operation, and residual heterogeneous cells. This cell product is safe and stable, freezes and can be resuscitated, has no risk of infectious diseases, and has no risk of tumorigenesis. It meets the demands of blood infusion for different age groups and different diseases. It does not require many years of follow-up teratomas. It is an embodiment of Xueji Bio's philosophy of insisting on making the safest, cleanest and repeatable transfusion products. This injection will be expected to be used in the treatment of increasing platelet count in patients with thrombocytopenia to varying degrees in the future. This drug is also the world's first FDA-accredited megakaryocyte injection product to be recognized by RPDD and ODD. It can be used in the treatment of giant platelet syndrome and congenital azoresis thrombocytopenia in children and adults. In addition to these indications, megakaryocyte injection is also developing pipelines for several other related indications simultaneously. If this project can successfully complete the implied permission of NMPA, Xueji Biotech will launch official clinical trials as soon as possible. In the future, it is expected to provide patients with thrombocytopenia and related blood diseases with universal, spot type, controllable price, long duration and high clinical value with innovative drugs from the global First-in-Class, allowing my country to remain far ahead in the cell therapy track of megakaryocytes and platelets. About Bloody Biology

　　Xueji Bio was established in Suzhou Industrial Park in June 2021. It is a new cell therapy enterprise for the in vitro regeneration hematopoietic lineage (including blood cells and immune cells) founded by overseas returnees. It has unique stem cell reprogramming, editing and differentiation technology. It takes the in vitro regeneration of platelets as the priority and core development direction, and enters the cell therapy field of targeted differentiation of adult stem cells and iPSCs cells.