Tzield (Teplizumab) Receives FDA Approval and Launches in Boao Lecheng as First-in-Class Therapy to Delay Onset of Type 1 Diabetes

On June 28, the innovative targeted therapy Tzield (Teplizumab), approved by the U.S. Food and Drug Administration (FDA) for delaying the onset of type 1 diabetes, has been granted early access for clinical use as an urgently needed imported drug in the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as "Lecheng Pilot Zone") in Hainan, China. Teplizumab is suitable for delaying the progression from stage 2 to stage 3 in adult and pediatric patients aged 8 years and older with type 1 diabetes.

Type 1 diabetes is a major pediatric endocrine disease that poses a significant threat to children's health, with children who develop the condition at a young age constantly facing serious threats to their healthy growth. As a CD3-targeting monoclonal antibody, Teplizumab protects pancreatic β-cells from the root cause, delaying the onset of type 1 diabetes by nearly three years and filling the treatment gap in disease-modifying therapies for type 1 diabetes. For example, patients with type 1 diabetes typically require at least four insulin injections per day—amounting to a cumulative total of 4,380 injections over three years. By delaying the onset of the disease by nearly three years, Teplizumab can postpone the long-term insulin-dependent treatment phase, giving families time to make adequate preparations in terms of lifestyle adjustments and knowledge acquisition, offering more hope and possibilities to patients and families burdened by this condition.

Jia Ning, Director of the Boao Lecheng International Medical Tourism Pilot Zone Administration, stated, "As a window for China's medical sector to open up to the world, Lecheng Pilot Zone is actively promoting the full utilization of pilot policies to unleash their vitality. Lecheng is becoming an innovative and open pharmaceutical industry platform, gathering high-quality medical resources from home and abroad, providing strong support for the continuous improvement of medical quality and services. Sanofi and Lecheng have carried out a series of highly efficient collaborations in areas such as the introduction of innovative drugs and real-world studies. The landing of the innovative drug Teplizumab in Lecheng represents a further deepening of this cooperation. We hope to further explore diverse cooperation pathways with advanced international pharmaceutical enterprises like Sanofi in the future, promote more innovative achievements in the medical and pharmaceutical fields, continuously enhance patients' access to innovative drugs, and provide cutting-edge and leading medical solutions for people's health."

Sanofi Greater China President Wang Shi said, "Teplizumab is a key strategic innovation product for Sanofi in the immune-mediated and diabetes fields. Thanks to the policy support from the state for innovative drugs, we have achieved rapid access in the Lecheng Pilot Zone at a globally leading speed. From the large population of Type 2 diabetes patients to the smaller but critically important group of Type 1 diabetes patients, Sanofi focuses on every unmet need, providing care and attention for patients across all ages and types of the disease, moving from treatment to prevention. In the future, we will continue to push forward in the immunology field, accelerating the introduction of breakthrough drugs and vaccines into China, reshaping the new ecosystem of disease prevention and treatment."

The trend of younger patients is obvious, and the average life expectancy of pediatric patients decreases.

Unlike the widely known type 2 diabetes, type 1 diabetes is a chronic autoimmune disease. The insulin-producing β cells in the pancreas are destroyed by the body's own immune system, leading to a lack of insulin and affecting the body’s ability to regulate blood sugar levels. The incidence rate is 1.01 per 100,000 person-years, equivalent to approximately one patient being diagnosed every hour. Studies have shown that type 1 diabetes accounts for about 90% of all types of diabetes in childhood. The incidence rate in those under 15 years old has increased nearly fourfold over the past 20 years.

Due to the greater difficulty in managing blood glucose levels in children and adolescents, the rate of achieving target blood glucose levels is less than 20%. This significantly increases the risk of complications from type 1 diabetes. Additionally, the younger the age of onset, the higher the risk of mortality and the greater the reduction in life expectancy. Research has shown that patients diagnosed before the age of 10 have a life expectancy reduced by 16 years, while those diagnosed after the age of 20 have a life expectancy reduced by 10 years.

Prevention and Control Moves Forward, Winning Back the Critical Growth Period

The progression of Type 1 diabetes is divided into three stages. In stages 1 and 2, there are no obvious symptoms. By stage 3, a significant portion of the pancreatic β-cells have been destroyed by the immune system, leading to elevated blood glucose levels that meet the clinical diagnostic criteria for diabetes. Many patients begin exhibiting the classic "three polys and one less" symptoms (increased thirst, increased hunger, frequent urination, and unexplained weight loss). The condition in children and adolescents is particularly insidious, with over 50% of patients already experiencing diabetic ketoacidosis (DKA) at the time of diagnosis. At this point, patients are in stage 3 of Type 1 diabetes, and most of their pancreatic β-cells have already been destroyed. It is urgent to shift the focus of prevention and treatment of Type 1 diabetes to earlier stages.

The 2024 American Diabetes Association (ADA) guidelines recommend screening for pre-symptomatic type 1 diabetes by detecting islet autoantibodies. For stage 2 type 1 diabetes patients aged ≥8 years, Teplizumab infusion can be considered to delay the onset of symptomatic type 1 diabetes (stage 3).

Professor Weng Jianping, Head of the Type 1 Diabetes Group of the Chinese Diabetes Society under the Chinese Medical Association, stated: "In recent years, the global incidence of type 1 diabetes has been on the rise, particularly significant among children and adolescents. At present, the clinical diagnosis and treatment level of type 1 diabetes in China continues to improve, with social policy support constantly being enhanced, placing us at an internationally leading level. This is the result of years of continuous efforts by our peers. The emergence of Teplizumab marks another major breakthrough in the field of type 1 diabetes treatment since the advent of insulin 100 years ago. Relying on innovative therapies, early screening, early diagnosis, and intervention in high-risk populations can achieve the prevention or delay of disease onset, which is of great significance for advancing the prevention and control of type 1 diabetes. In the future, we look forward to all sectors of society continuing to work together to promote the establishment of a new ecosystem for type 1 diabetes management."

Professor Zhiguang Zhou, Director of the National Clinical Research Center for Metabolic Diseases, stated: "Patients with type 1 diabetes receive at least four insulin injections daily, accumulating up to 4,380 injections over three years. Coupled with frequent daily blood glucose monitoring, they endure long-term suffering from 'needle pricks.' For children and adolescents, the disease burden is even more severe. Their three years are 'critical' for academic development and healthy physical and mental growth, spanning important life stages such as kindergarten enrollment, the high school entrance exam, and the college entrance exam. Teplizumab delays the progression of the disease by nearly three years, giving patients back their 'critical growth period,' providing families with a 'transitional buffer,' reducing treatment-related suffering, allowing time for preparation in life and knowledge, lessening the impact on household income, and enabling an earlier return to a normal life with diabetes, offering more possibilities for the future."

In November 2022, Teplizumab was approved by the U.S. Food and Drug Administration (FDA) as the world's first 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 Teplizumab could delay the onset of type 1 diabetes by an average of nearly three years. In October 2023, the phase III clinical trial PROTECT met its primary endpoint, showing that Teplizumab has the potential to slow disease progression in children and adolescents newly diagnosed with stage 3 type 1 diabetes. Currently, the drug has been included in China’s fourth batch of encouraged R&D and application list for pediatric medicines.

Tzield (Teplizumab) has not yet received marketing approval from the National Medical Products Administration and is currently only approved for use in designated medical institutions within the Boao Lecheng International Medical Tourism Pilot Zone.