Bioray Biotech's Next-Gen Allogeneic UCAR-T Therapy BRL-303 Receives IND Approval in China for Treatment of Refractory Systemic Lupus Erythematosus

CDE Clinical Trial Implied Permission Publicity Information

Systemic Lupus Erythematosus (SLE)It is a systemic autoimmune disease characterized by abnormal B-cell activation and the production of autoantibodies, with traditional immunosuppressants showing limited efficacy in some patients.Although early IIT research has shown preliminary efficacy of autologous CAR-T therapy for systemic lupus erythematosus,However, it faces challenges such as long individualized preparation cycles and high costs. Therefore, allogeneic CAR-T cells, with advantages like homogeneity and immediate availability, have become a highly promising alternative solution.

BRL-303 is based on BRL Medicine's proprietary universal cell platform (TyUCell).^®) A next-generation CD19-targeted allogeneic universal CAR-T product developed by BRL Medicine, aimed at the field of autoimmune diseases.The UCAR-T technology isDeveloped by a team of scientists led by Professor Mingyao Liu and Professor Bing Du, the founder & chairman of BRL Medicine, after 8 years of research and multiple iterations.It mainly achieves immune escape and functional optimization of allogeneic T cells through multiple gene-editing technologies, which not only avoids the risks of graft-versus-host disease (GVHD) and host versus graft (HVG) from the source, but also precisely targets and regulates abnormally activated immune cells in SLE patients, rebuilding immune balance. This perfectly overcomes the core technical barriers of allogeneic CAR-T in the treatment of autoimmune diseases, marking another innovative transformation of universal cell therapy technology in the autoimmune field.Previously,BRL MedicineBRL-303 UCAR-T for the Treatment of SLE Has Been Conducted in TwoIITSignificant clinical efficacy was demonstrated in clinical research, and the relevant research results have been published.Published in internationally renowned journals in 2025, respectivelyCell ResearchAndMed。

It is worth mentioning at the same time that this product treatsResearch findings on 3 patients with refractory autoimmune diseases published in a top journal in July 2024Cell, becoming the world's first reported application in clinical practice and successful treatment of autoimmune diseases with an allogeneic universal typeCAR-T Products in Clinical Research.This research achievement has successively been awarded important honors such as "Top Ten Science and Technology Progress News in China in 2024, Selected by the Two Academies of Sciences and Engineering," "Top Ten Advances in China's Pharmaceutical and Biotechnology in 2024," and "Top Ten Scientific Advances in China in 2024.""Father of CAR-T" Professor Carl June inCellHighly Commented Document:"Expected to reshape the treatment landscape of autoimmune diseases"It can be said that the existing clinical research has fully validated the application potential of BRL Medicine's allogeneic UCAR-T in the treatment of multiple indications, including tumors and autoimmune diseases.Showcased Three Core Advantages：

As an "off-the-shelf" universal CAR-T product, this allogeneic UCAR-T does not require the collection of patient autologous cells or customized production. A single batch can meet the treatment needs of more than 200 cases, significantly reducing production costs. Meanwhile, its HLA-matching-free feature enables "instant use," greatly shortening the treatment waiting period for patients. It is especially suitable for cancer patients with rapid disease progression and dysfunctional autologous immune cells, as well as refractory autoimmune patients, providing a convenient and accessible new treatment option for a broader patient population.

Unlike traditional treatment regimens with strong immunosuppression, this product does not require additional lymphodepletion or immunosuppression for patients. It can achieve complete clearance of target cells with only conventional or even lower lymphodepletion protocols while effectively avoiding risks such as infection, agranulocytosis, and slow lymphocyte recovery caused by excessive immunosuppression. Previous clinical trial data showed that patients treated with this product did not experience cytokine release syndrome (CRS) or neurotoxicity (ICANS) of grade 3 or higher, and the incidence of infection was lower than that of similar products, demonstrating its excellent clinical safety.

This product, by selecting healthy donor T cells and optimizing the expansion process, exhibits stronger proliferation ability and long-term persistence in patients. In earlier clinical studies, the product has demonstrated the capability to precisely eliminate or suppress pathogenic cells in SLE patients while promoting the reconstruction of immune homeostasis, achieving long-term disease control. This provides patients with the possibility of breaking free from recurring symptoms and attaining high-quality survival.

It is worth mentioning that the approval of BRL-303's IND in China not only opens up a new treatment pathway for patients with moderate to severe refractory SLE, but also marks that BRL Medicine’s universal cell therapy technology has established a dual-track layout of "hematological tumors + autoimmune diseases," which will further strengthen China’s innovative cell therapy technology in maintaining an international leading position. In the future, BRL Medicine will rapidly advance the multi-center clinical trials of BRL-303 UCAR-T in China, while actively exploring the application of UCAR-T technology in hematological tumors, solid tumors, and autoimmune diseases, benefiting a wide range of patients.