Teplizumab (Tzield), a CD3-Targeting Monoclonal Antibody by Sanofi, Approved in China to Delay Onset of Type 1 Diabetes by Nearly 3 Years

(Source: Antibody Circle)

Tilizumab（Teplizumab）It is a CD3-targeted monoclonal antibody that protects pancreatic β-cells from the root cause.。According to publicly available information from Sanofi,For patients with type 1 diabetes who receive at least 4 insulin injections daily, the total accumulates to as high as 4,380 times over 3 years.TilizumabMonoclonal AntibodyDelayed onset by nearly 3 years, which can delay the progression to the long-term insulin treatment phase.

In November 2022, Tislelizumab was approved for the first time by the US FDA.Is FDA-approvedThe world's first andThe Only Innovative Targeted Therapy to Delay the Onset of Type 1 Diabetes。

The TN-10 study showed that, compared with the placebo group, 14 days of continuous treatment with tilizumab,Can delay the onset of type 1 diabetes by an average of nearly 3 years.Year。

In October 2023, the Phase III clinical trial study PROTECT（NCT03875729）Achieved the primary endpoint, compared with placebo, in children and adolescents aged 8-17 diagnosed with autoimmune Type 1 Diabetes stage 3 within the prior 6 weeks.Tilizumab Can Delay the Loss of Pancreatic β-Cells and Preserve Their Function(According to C-peptide measurement)，Has the potential to delay the progression of type 1 diabetes.

PROTECT Study Overview

In China, teplizumab has been included in the fourth batch of the list of encouraged drugs for research and development applications for children. It was first implemented in July 2024 in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, used to delay the progression from stage 2 to stage 3 in adult and pediatric patients aged 8 years and older with type 1 diabetes. On June 17, 2025, the drug...Boao Issues First Prescriptions in Asia. The approval and launch of this drug in China means it is expected to benefit more patients.

Unlike the well-known type 2 diabetes,Type 1 diabetes is a chronic autoimmune disease, due to the destruction of insulin-producing pancreatic β cells by the autoimmune system, leading to insulin "deficiency" and affecting the body's ability to regulate blood sugar levels. Type 1 diabetes is highly prevalent among 10-14 year-olds and shows a significant trend towards younger ages. Studies have shown that type 1 diabetes accounts for approximately 90% of all types of diabetes in childhood.

The progression of Type 1 diabetes has three stages. In stages 1 and 2, there are no obvious symptoms yet. By stage 3, most of the pancreatic β-cells in the body have been destroyed by the immune system, and blood glucose levels rise to meet the clinical diagnostic criteria for diabetes.. The condition of children and adolescent patients is particularly insidious, with more than 50% of patients already experiencing diabetic ketoacidosis at the time of diagnosis.（DKA）At this point, the patient is already in stage 3 of type 1 diabetes, with most of the pancreatic β cells destroyed.

2024 American Diabetes Association（ADA）Guidelines recommend screening for pre-symptomatic type 1 diabetes by detecting islet autoantibodies. For patients with stage 2 type 1 diabetes aged ≥8 years, infusion may be considered.Tizibumab to Delay Symptomatic Type 1 Diabetes(Phase 3)Onset.