邦耀生物通用型UCAR-T细胞疗法获批临床，开启自身免疫疾病治疗新范式

Core Viewpoint - Shanghai Bangyao Biotechnology Co., Ltd. has made significant progress in the field of autoimmune disease treatment with the approval of its new drug clinical trial application for BRL-303, a universal CAR-T product targeting CD19, marking a milestone in the expansion of its innovative cell therapy technology from hematological tumors to complex autoimmune diseases [3][11]. Group 1: Product Development and Approval - BRL-303 is the world's first universal CAR-T product showing efficacy in treating autoimmune diseases in investigator-initiated clinical trials, receiving implied approval from the National Medical Products Administration (NMPA) [3][6]. - The product is based on Bangyao's proprietary universal cell platform (TyUCell) and represents a key advancement in the treatment of moderate to severe refractory systemic lupus erythematosus (rSLE) [3][6]. Group 2: Clinical Research and Efficacy - Previous clinical studies have demonstrated significant clinical efficacy of BRL-303 in treating SLE, with results published in prestigious journals such as Cell Research and Med [6][7]. - The product has shown the ability to precisely eliminate or inhibit pathogenic cells in SLE patients while promoting immune homeostasis, potentially leading to long-term disease control [10]. Group 3: Advantages of BRL-303 - The product overcomes accessibility barriers by being a "ready-to-use" CAR-T therapy, significantly reducing production costs and treatment waiting times for patients [8]. - BRL-303 enhances safety by avoiding excessive immunosuppression, with clinical trial data indicating a lower incidence of severe cytokine release syndrome (CRS) and neurotoxicity compared to similar products [9]. - The product's design allows for a stronger proliferation capacity and long-lasting persistence of T cells in patients, contributing to its effectiveness in managing SLE [10]. Group 4: Future Prospects and Industry Position - The approval of BRL-303 is expected to accelerate the clinical translation and industrialization of Bangyao's universal CAR-T technology, with plans to expand its application to more autoimmune diseases and solid tumors [11]. - Bangyao aims to leverage its dual-track strategy in hematological tumors and autoimmune diseases to maintain a leading position in China's innovative cell therapy market [11].