RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This follows the company’s August announcement of reaching the primary endpoints in its phase 3 clinical trial for Taitaxipu in the treatment of generalized myasthenia gravis (gMG) in China. The current application is speculated to be for the treatment of gMG .
Taitaxipu, an ADCC-enhanced monoclonal antibody developed by RemeGen, targets CLDN18.2 and is the first of its kind with no similar product approved globally. Tislelizumab, a programmed death-1 (PD-1) inhibitor developed by BeiGene, is approved for 12 indications in China. Myasthenia gravis currently lacks satisfactory treatment options, and B-cell targeted therapies have shown promising results with a significant reduction in relapse rates compared to traditional immunotherapy regimens .
Taitaxipu is a dual-target antibody fusion protein that targets both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), addressing the source of pathogenic antibody production—B cells and plasma cells. The product was approved for systemic lupus erythematosus (SLE) in China in March 2021 and for rheumatoid arthritis in July this year .
RemeGen has garnered significant recognition for Taitaxipu in the field of myasthenia gravis, including inclusion in the breakthrough therapy program by China’s NMPA, orphan drug designation, and fast track designation from the US FDA . In August, the company announced the enrollment of the first patient in the US for the global multicenter phase 3 clinical trial for this indication. The phase 3 clinical study of Taitaxipu for the treatment of gMG in China has also achieved its primary endpoints, with clinical research results demonstrating sustained and effective improvement in the clinical condition of patients with gMG, showing good efficacy and safety .- Flcube.com
