Full Press Release Details
Tzield approved in China as first disease-modifying therapy for adult and pediatric
patients with stage 2 type 1 diabetes
Paris, September 10, 2025- 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.
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.
(teplizumab) is a CD3-directed monoclonal antibody. Tzield is the first and only disease modifying therapy in autoimmune T1D; it was first approved in the US in November 2022 to delay the onset of stage 3 T1D
in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in China, the UK, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Regulatory reviews are
ongoing in the EU and other jurisdictions around the world.
About autoimmune T1D
T1D is a progressive autoimmune condition where the body's ability to regulate blood sugar levels is impacted due to the gradual destruction of
insulin producing beta cells by one's own immune system. There are four stages to the progression of T1D:
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