重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1803注射液附条件上市申请获得受理的公告

Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for the conditional approval of the drug registration application for GR1803 injection, which is intended for adult patients with relapsed or refractory multiple myeloma who have previously received at least three lines of treatment [1] Group 1: Drug Information - Drug Name: GR1803 Injection [1] - Application Type: Domestic drug registration application [1] - Applicant: Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. [1] - Acceptance Number: CXSS2600003 [1] - Approval Conclusion: The application has been accepted based on the review [1] Group 2: Disease Context - Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells, primarily affecting the elderly [2] - Common symptoms include organ dysfunction related to myeloma, such as elevated blood calcium, kidney damage, anemia, and bone diseases [2] - MM is the second most common malignant tumor in the blood system, with an increasing incidence rate in recent years, particularly among individuals aged 60 and above [2] Group 3: Drug Characteristics - GR1803 Injection is a bispecific antibody drug developed by the company, targeting BCMA and CD3, classified as a Class 1 therapeutic biological product [3] - The drug is based on a common light chain structure, which is similar to normal monoclonal antibody structures, facilitating its production and reducing potential immunogenicity [3] - GR1803 Injection has a higher affinity for BCMA (10^-10 M) compared to CD3 (10^-8 M), designed to activate T cells to kill tumor cells while minimizing non-specific T cell activation and reducing toxicity [3] - As of the announcement date, two imported BCMA×CD3 targeted antibody drugs have been conditionally approved for market in China [3]