• Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older, with stage 2 T1D compared to placebo
• Additional regulatory reviews are ongoing across different disease stages by regulatory authorities around the world

The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the first disease-modifying therapy in autoimmune type 1 diabetes (T1D) indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 T1D. The review was completed under priority review, following the recognition by NMPA of Tzield’s innovative profile and the benefit it brings to pediatric patients.

The approval is based on the positive results from the TN-10 phase 2 study, which demonstrated Tzield's ability to delay the onset of stage 3 T1D, compared to placebo. The pivotal study demonstrated that a once-daily, single and consecutive 14-day course of Tzield delayed the median onset of stage 3 T1D by 48.4 months vs 24.4 months observed in the placebo group.

“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.”

The approval aligns with recent Chinese expert consensus guidelines that recognize the importance of protecting beta-cell function as a pivotal component in the management of autoimmune T1D. These guidelines, published in November 2024, highlighted Tzield’s potential therapeutic value, which has now been validated by this approval, demonstrating Tzield’s relevance in addressing this significant clinical unmet need in the treatment of autoimmune T1D.

Tzield is approved for the treatment of adult and pediatric individuals aged eight years and older, living with stage 2 type 1 diabetes, in the US, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait. Regulatory reviews are ongoing in the EU and other jurisdictions around the world.