智翔金泰GR1803附条件上市申请获受理

Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has announced that its self-developed innovative drug GR1803 injection has received acceptance for conditional marketing authorization from the National Medical Products Administration, focusing on the urgent clinical need in the treatment of relapsed refractory multiple myeloma [1][2] Group 1: Product Development - GR1803 injection is a dual-target bispecific antibody targeting BCMA and CD3, designed to enhance safety by reducing non-specific T cell activation while effectively recruiting and activating T cells to kill tumor cells [2] - The drug's affinity for BCMA is significantly higher than for CD3, with a two-order magnitude difference, which contributes to its therapeutic efficacy [2] - GR1803 injection was previously included in the National Medical Products Administration's list of breakthrough therapies in August 2024 [2] Group 2: Market Context - Multiple myeloma is the second most common hematological malignancy, with increasing incidence rates, particularly among the aging population in China [1] - The targeted patient population for GR1803 includes adults with relapsed or refractory multiple myeloma who have undergone at least three lines of treatment, indicating a significant unmet medical need [1]