Tzield Approved in China as First Disease-Modifying Therapy for Stage 2 Type 1 Diabetes

The Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the country’s first disease-modifying therapy for autoimmune type 1 diabetes (T1D). The treatment is now authorized for use in adult and pediatric patients aged eight and older with stage 2 T1D, aiming to delay the onset of stage 3, insulin-dependent T1D.

The approval follows a priority review, underscoring the NMPA’s recognition of Tzield’s innovative therapeutic potential, particularly for pediatric patients at risk of progressing to full-blown diabetes.

Backed by Strong Clinical Data

Tzield’s approval is based on the TN-10 Phase 2 trial, which demonstrated that a 14-day course of Tzield significantly delayed disease progression. Patients receiving Tzield had a median delay of 48.4 months before progressing to stage 3 T1D, compared to 24.4 months in the placebo group.

“This approval represents the beginning of a new era of care for stage 2 type 1 diabetes patients in China,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “Tzield is the first approved advanced therapy that slows down the loss of beta-cell function, potentially giving people more time without the burden of daily treatment.”

Shifting the Standard of Care in China

Tzield’s approval aligns with the November 2024 Chinese expert consensus guidelines, which emphasized the importance of preserving pancreatic beta-cell function in managing autoimmune T1D. The new guidance highlighted Tzield as a promising intervention to meet this clinical need—a position now validated by formal regulatory approval.

With this milestone, China joins a growing list of countries—including the U.S., U.K., Canada, Israel, Saudi Arabia, UAE, and Kuwait—that have approved Tzield for delaying T1D progression. Regulatory reviews are ongoing in the EU and other jurisdictions.

As the first therapy to target the underlying autoimmune process in early-stage T1D, Tzield is poised to change how the disease is managed globally, offering patients and families a longer window of insulin-free life.