Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received acceptance from the National Medical Products Administration (NMPA) for its cell immunotherapy product, Brexucabtagene Autoleucel (Ruxolitinib Injection), for a new indication in the second-line treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) patients [1][2] Group 1 - The application for Brexucabtagene Autoleucel is the fourth submission for this product by WuXi Biologics [1] - The NMPA granted breakthrough therapy designation for Brexucabtagene Autoleucel in January 2025 for the second-line treatment of r/r LBCL [1] - LBCL is a highly aggressive form of non-Hodgkin lymphoma and is the most common subtype of lymphoma in adults, with 30-40% of patients experiencing relapse or refractory disease after first-line treatment [1] Group 2 - The sBLA is based on a pivotal, single-arm, multi-center clinical study that evaluated Brexucabtagene Autoleucel in adult r/r LBCL patients who were not suitable for autologous stem cell transplantation (ASCT) after first-line treatment failure [2] - The Phase II open-label study in China included patients who had failed prior treatment with targeted CD20 antibodies and anthracycline-based regimens [2] - As of January 21, 2025, 49 patients had undergone cell infusion with at least 3 months of follow-up, showing significant clinical efficacy with an overall response rate (ORR) of 81.3% and a complete response rate (CRR) of 54.2% [2]
药明巨诺-B(02126.HK)：倍诺达®针对二线不适合自体造血干细胞移植成人复发或难治性大B细胞淋巴瘤的新适应症上市许可申请获中国药监局受理