Sanofi's Teplizumab, First Therapy to Delay Type 1 Diabetes Onset by Nearly 3 Years, Enters Priority Review in China

Aug 20, 2024 15:40 CST Updated 15:40

Sanofi

Pharmaceutical R&D Developer

▎WuXi AppTec Content Team Report

Today (August 20), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced,Sanofi（Sanofi）DeclaredTilizumab InjectionProposed for Priority Review, Applicable toAdults and children aged 8 years and above with Stage 2 Type 1 Diabetes to delay the onset of Stage 3 Type 1 Diabetes。

Public information shows that teplizumab (trade name:Tzield) is the first to be approved by the U.S. FDA forDelay the onset of type 1 diabetesTheInnovative ImmunotherapyThe drug was approved in July this year as an urgently needed imported medication for clinical use, and has been introduced to the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China, for delaying the progression of Type 1 diabetes patients from stage 2 to stage 3.

Screenshot source: CDE official website

Type 1 Diabetes (T1D) is a chronic autoimmune disease where the pancreatic β-cells are damaged, resulting in little to no insulin secretion. T1D progresses through three stages, with the third stage also known as the clinical stage. At this point, patients experience elevated blood glucose levels reaching clinically significant hyperglycemia, accompanied by typical symptoms such as increased thirst, frequent urination, unexplained weight loss, blurred vision, and overall fatigue.This stage of T1D management requires daily and burdensome insulin replacement therapy.，With frequent daily blood glucose monitoring, patients endure the pain of "needle pricks" over the long term, and for children and adolescents, the burden of the disease is even more severe.

TilizumabYesDeveloped by Provention BioA“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 three years.The drug was approved in the United States in November 2022.Approved, applicable for delaying the progression from stage 2 to stage 3 in adult and pediatric patients aged 8 years and older with type 1 diabetes, becomingIt is the world's first innovative targeted therapy approved by the FDA to delay the onset of Type 1 diabetes. At that timeThe FDA's press release specifically noted that, unlike other drugs that alleviate diabetes symptoms, this is the first drug that can alter the course of T1D.

In March 2023, Sanofi announced an investment of nearly $2.9 billion.AcquisitionProvention Bio, and this tilizumab.The drug was also selected by TIME Magazine as one of the top in 2023.Best Invention（The Best Inventions of 2023）The list.

According to the introduction in Sanofi's previous press release,The TN-10 study showed that, compared with the placebo group,Continuous use for 14 daysTilizumabTreatment can delay the onset of type 1 diabetes by an average of nearly 3 years.This means that patients can delay the transition to long-term insulin treatment, providing a "transitional buffer period" for both patients and their families.

In addition,Tilizumab alsoHas PotentialDelay Newly Diagnosed Stage 3Type 1 DiabetesDisease Progression in Children and AdolescentsIn October 2023, Sanofi announced the Phase 3 clinical trial study of Tilizumab.PROTECT StudyAchieved the primary endpoint in China. Compared with placebo,TilizumabIn children and adolescents aged 8-17 diagnosed with stage 3 type 1 autoimmune diabetes within the previous 6 weeks, to slow β-cell loss and preserve β-cell function. The full data has been simultaneously published in The New England Journal of Medicine (NEJM).

The inclusion of Tilizumab in the priority review in China means that the drug is expected to accelerate its availability to Chinese patients, benefiting more patients with type 1 diabetes.

Related Reading:

A 30-Year Marathon: How the First Immunotherapy for Diabetes Came to Be, Despite Nearly Failing Several Times?

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 20, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[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

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