▎WuXi AppTec Content Team Report

Screenshot source: CDE official website

TilizumabYesA“first-in-class”CD3-targeting monoclonal antibodyIt can protect pancreatic β-cells from the etiological aspect, thereby delaying the onset of type 1 diabetes by nearly 3 years.The drug was approved in the United States in November 2022.Approved（The trade name isTzield）, 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. This is alsoThe first innovative targeted therapy approved by the FDA to delay the onset of type 1 diabetes.Tilizumab byDeveloped by Provention BioSanofi announced in March 2023 for nearly 2.9 billion US dollarsAcquisitionProvention Bio, and acquire this new drug.

In a clinical trial named TN-10In the study, compared with the placebo group,Lasting 14 Days for AcceptanceTilizumabTreatment can delay the onset of Type 1 diabetes by an average of nearly 3 years.。

In addition,Tislelizumab alsoHas PotentialDelay newly diagnosed Stage 3Type 1 DiabetesDisease Progression in Children and AdolescentsIn October 2023, Sanofi announced that the Phase 3 clinical trial of TilizumabPROTECT StudyAchieved the primary endpoint in China. Compared with placebo,TilizumabIn children and adolescents aged 8-17 diagnosed with stage 3 autoimmune type 1 diabetes within the previous 6 weeks, slow β-cell loss and preserve β-cell function.

Type 1 Diabetes (T1D) is a chronic autoimmune disease where the pancreatic β-cells are damaged, resulting in little to no insulin secretion in the body.Type 1 DiabetesProgression occurs in three stages. By the third stage, patients' blood glucose levels rise to clinically significant hyperglycemia, and many patients may experience accompanying symptoms such as increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue.Develop intoPatients at this stage require daily intensive insulin replacement therapy.，With frequent blood glucose monitoring, patients have to endure the pain of "needles" over the long term. For children and adolescents, the burden of the disease is even more severe.

The submission of the marketing application for Tilizumab in China this time means that the drug is expected to be approved in China in the near future, bringing a new treatment option for patients with type 1 diabetes.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 28, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Heavyweight | A Century Breakthrough, Tzield® Lands in Boao for Delaying the Onset of Type 1 Diabetes. Retrieved June 28， 2024, from  https://mp.weixin.qq.com/s/g-MonDRY0gkClu7npZYQfA