Press Release: Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes

Core Viewpoint - Tzield (teplizumab) has been approved in China as the first disease-modifying therapy for stage 2 type 1 diabetes (T1D), aimed at delaying the onset of stage 3 T1D in both adult and pediatric patients aged eight years and older [1][3] Group 1: Approval and Study Results - The approval by the Chinese National Medical Products Administration (NMPA) was based on positive results from the TN-10 phase 2 study, which showed that Tzield delayed the median onset of stage 3 T1D by 48.4 months compared to 24.4 months in the placebo group [2][6] - Tzield is already approved in several countries including the US, UK, Canada, Israel, Saudi Arabia, UAE, and Kuwait for the same indication, with ongoing regulatory reviews in the EU and other regions [4][5] Group 2: Significance and Impact - The approval signifies a new era of care for stage 2 T1D patients in China, focusing on Tzield's unique ability to preserve beta-cell function, potentially reducing the treatment burden for patients [3][5] - Recent expert consensus guidelines in China emphasize the importance of protecting beta-cell function in managing autoimmune T1D, validating Tzield's therapeutic value in addressing significant clinical needs [3][6] Group 3: About Tzield and T1D - Tzield is a CD3-directed monoclonal antibody and the first disease-modifying therapy for autoimmune T1D, initially approved in the US in November 2022 [5][6] - T1D is characterized by the autoimmune destruction of insulin-producing beta cells, progressing through four stages, with stage 2 marked by abnormal blood sugar levels due to beta-cell loss [6][7]