French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that China's National Medical Products Administration has approved Tzield (teplizumab) for adult and paediatric patients aged eight years and older with stage 2 type 1 diabetes.

This decision, granted under priority review, makes Tzield the first disease-modifying therapy in this indication in China.

The approval is based on the TN-10 phase 2 study, which showed that a 14-day treatment course of Tzield delayed the median onset of stage 3 type 1 diabetes by 48.4 months compared to 24.4 months with placebo. Sanofi highlighted the therapy's ability to preserve beta-cell function, potentially extending the time patients can live without the daily treatment burden of stage 3 disease.

The decision follows Chinese expert consensus guidelines issued in 2024 that emphasised the importance of protecting beta-cell function in type 1 diabetes management. Sanofi said that the approval validates Tzield's therapeutic value and addresses a significant unmet medical need in the country.

Tzield is already approved in the US, UK, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait, with additional regulatory reviews ongoing in the EU and other jurisdictions.