Tzield (teplizumab) has received approval from the Chinese National Medical Products Administration (NMPA) as the first disease-modifying therapy for autoimmune type 1 diabetes (T1D), specifically indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 T1D. The NMPA conducted a priority review, citing the innovative profile of Tzield and its benefits for pediatric patients.
The decision is based on results from the TN-10 phase 2 study, which showed that a single 14-day course of Tzield delayed progression to stage 3 T1D by a median of 48.4 months compared to 24.4 months with placebo.
“This approval represents the beginning of a new era of care for stage 2 type 1 diabetes patients in China, one focused on the potential of Tzield to prevent the natural progression of T1D by its unique beta-cell function preserving capabilities,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “Tzield is the first approved advanced therapy that slows down the loss of beta cell function, potentially giving people living with stage 2 T1D more time without the daily treatment burden. We are proud to bring this innovative medicine to China, and we remain committed to working with local stakeholders to advance diabetes care.”
This regulatory move follows recent updates in Chinese expert consensus guidelines released in November 2024, which highlighted protecting beta-cell function as central in managing autoimmune T1D and noted Tzield’s potential value. With this approval, China joins countries such as the United States, United Kingdom, Canada, Israel, Saudi Arabia, United Arab Emirates, and Kuwait where Tzield is already authorized for use in adults and children aged eight or older with stage 2 type 1 diabetes.
Tzield is described as a CD3-directed monoclonal antibody and was initially approved in November 2022 in the US for delaying onset of clinical-stage (stage 3) type 1 diabetes.
Type 1 diabetes progresses through four stages: Stage 1 involves an autoimmune attack on insulin-producing beta cells but normal blood sugar; Stage 2 shows abnormal blood sugar levels due to further loss of beta cell function but remains presymptomatic; Stage 3 presents clinical symptoms requiring daily insulin replacement; Stage 4 is marked by chronic complications after significant destruction of beta cells.
Sanofi states it continues efforts toward advancing treatments for autoimmune conditions globally. Regulatory reviews for Tzield are ongoing in other jurisdictions including those within Europe.
Sanofi describes itself as an R&D-driven biopharma company listed on EURONEXT: SAN and NASDAQ: SNY.
