Biosino Achieves Milestone as China's First Off-the-Shelf UCAR-Vδ1 T-Cell Therapy UTAA09 Receives IND Approval

Apr 25, 2025 07:04 CST Updated 07:04

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On April 24, according to the official website of CDE, Bo sheng ji medicine science and technology (suzhou) co., LTD, and Bo sheng ji Anke Cell Technology Co., Ltd. jointly applied for the drug "UTAA09 Injection," obtaining the tacit approval for clinical trials, with the acceptance number CXSL2500075.

UTAA09 Injection is the first generic off-the-shelf CAR-T cell product submitted by Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD. This product is a UCAR-Vδ1T cell product prepared using healthy donor apheresis as the starting raw material. It is reported that this is also the first off-the-shelf generic UCAR-Vδ1T cell product in China accepted by the CDE.

Vδ1 T cells are a subset of γδ T cells, primarily distributed in tissues such as intestinal epithelium, skin, spleen, and liver. They are natural resident immune cells in human tissues, possessing strong active homing and infiltration capabilities. This characteristic of active homing distinguishes them from αβ T cells, NK cells, and other immune cells, making them an ideal platform for treating hematological tumors, solid tumors, and autoimmune diseases.

UTAA09 Injection not only retains its strong tissue and organ homing ability but also leads globally in CMC manufacturing processes, significantly reducing the cost of cell-based drugs. This creates opportunities for UTAA09 Injection to expand its indications to autoimmune diseases and other conditions in the future.

In addition to the UTAA09 injection recently approved for clinical trials, Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD's other multiple UCAR-Vδ1T cell drugs covering solid tumors, hematological tumors, and autoimmune diseases have also made significant progress in preclinical research. Some products were presented at the 2024 American AACR conference, receiving positive feedback from peers.

Source of the article: Bo Sheng Ji Cell Research