An innovative drug approved by FDA to delay the onset of type 1 diabetes, Tzield, was approved to first try in Boao Music City
2024-07-02
Tzield (Teplizumab), an innovative targeted therapy approved by the US Food and Drug Administration (FDA) to delay the onset of type 1 diabetes, has been approved as a pilot test. As an import drug urgently needed in clinical practice, it has landed in Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as "Lecheng Pilot Zone"). Teplizumab is applicable to delay the progression of type 1 diabetes from stage 2 to stage 3 in adults and children aged 8 years and above. Type 1 diabetes is a major pediatric endocrine disease that endangers children's health. Children who have suffered from it since childhood are always facing a major threat to their healthy growth. As a CD3 targeted monoclonal antibody, Teplizumab protects pancreatic islet beta cells from etiology, thus delaying the onset of type 1 diabetes for nearly three years, filling the therapeutic gap of disease modification therapy in the field of type 1 diabetes. Take type 1 diabetes patients who receive insulin injections at least four times a day for example. The cumulative number of insulin injections in three years is up to 4380. Teplizumab has delayed the onset of the disease for nearly three years, which can delay the entry into the long-term insulin treatment phase, so that families have time to do a good job in life and knowledge reserves, and bring more hope and possibility to the troubled patients and families. Jia Ning, Director of the Management Bureau of Boao Lecheng International Medical Tourism Pilot Zone, stated that as a window for China's opening up to the outside world in the medical field, Lecheng Pilot Zone actively promotes the effective use of various policies such as pilot and trial, fully unleashing policy vitality. Lecheng is becoming an open and innovative pharmaceutical industry platform, gathering high-quality medical resources at home and abroad, and providing strong support for the continuous improvement of medical quality and services. Sanofi and Lecheng have carried out a series of efficient cooperation in the introduction of innovative drugs, real-world research, and other aspects. The landing of the innovative drug Teplizumab in Lecheng is a manifestation of further deepening cooperation between the two sides. I hope to explore diversified cooperation paths with advanced international pharmaceutical companies such as Sanofi in the future, promote the landing of more innovative achievements in the medical and pharmaceutical field, continuously improve patients' accessibility to innovative drugs, and provide cutting-edge and leading medical solutions for people's health Shi Wang, president of Sanofi Greater China, said, "Teplizumab is an important strategic innovation product of Sanofi in the field of immune mediation and diabetes. Thanks to the national policy support for innovative drugs, we have achieved rapid access to the Lecheng pilot area at a global leading speed. From a large base of type 2 diabetes groups to a small number of type 1 diabetes groups that need urgent attention, Sanofi pays attention to every unmet need, and provides care and care for patients from treatment to prevention, all ages, and all diseases. In the future, we will continue to make efforts in the field of immunization, accelerate the introduction of breakthrough drugs and vaccines to China, and reshape the new ecology of disease prevention." The trend of younger age is obvious. The reduction of average life expectancy of children is different from the well-known type 2 diabetes, Type 1 diabetes is a chronic autoimmune disease. The destruction of insulin producing islet beta cells by the autoimmune system leads to insulin "deficiency", which affects the ability of the human body to regulate blood sugar levels. The incidence rate is 101/100000 person years, which is equivalent to about one patient diagnosed every hour. Research shows that type 1 diabetes accounts for 90% of the total number of all types of diabetes in childhood. The incidence rate of under 15 years old has increased nearly fourfold in the past 20 years. Due to the difficulty of blood glucose management in children and adolescents, the rate of blood glucose reaching the standard is less than 20%, which will significantly increase the risk of complications in type 1 diabetes. At the same time, the younger the age of onset, the higher the risk of death, and the more life expectancy decreases. A study has shown that patients diagnosed before the age of 10 have a 16 year decrease in life expectancy, while patients diagnosed after the age of 20 have a 10 year decrease in life expectancy. There are three stages of the progress of type 1 diabetes in the key period of growth, the first stage and the second stage have no obvious symptoms. In the third stage, most of the pancreatic islet beta cells in the human body are immune damaged, and the blood sugar level rises to meet the clinical diagnostic criteria for diabetes. Many patients will have the typical symptoms of "more than three and less" (more water, more food, more frequent urination, and unexplained weight loss). The condition of children and adolescents is especially insidious, and more than 50% of patients have been accompanied by diabetes ketoacidosis (DKA) at the time of diagnosis. At this time, the patient is in the third stage of type 1 diabetes, and most of the pancreatic islet β cells in the body have been damaged. The prevention and treatment of type 1 diabetes is imminent. 2024 The guidelines of the American diabetes Association (ADA) recommend screening type 1 diabetes in presymptomatic stage by detecting islet autoantibodies. For patients with stage 2 type 1 diabetes ≥ 8 years old, 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 diabetes Credit Association of the Chinese Medical Association, said: "In recent years, the global incidence rate of type 1 diabetes is on the rise, especially among children and adolescents. At present, the clinical diagnosis and treatment level of type 1 diabetes in China is constantly improving, and social policy support is continuously improving, which has been at the international leading level. This is the result of the continuous efforts of colleagues over the years. The emergence of Teplizumab is another major breakthrough in the treatment of type 1 diabetes since the birth of insulin 100 years ago. Relying on innovative therapy, early screening, early diagnosis and intervention of high-risk groups can prevent or delay the occurrence of diseases, which is of great significance in promoting the advance of prevention and treatment of type 1 diabetes. In the future, it is expected that all sectors of society will continue to work together to promote the establishment of a new ecology of type 1 diabetes management. " Professor Zhou Zhiguang, director of the National Clinical Medical Research Center for Metabolic Diseases, said: "Type 1 diabetes patients receive insulin injections at least four times a day, up to 4380 times in three years. In addition to frequent daily blood glucose monitoring, patients suffer from the pain of 'needling' for a long time. For children and adolescents, the disease burden is even more serious. The three years of children and adolescents are the 'key three years' for learning development and individual physical and mental health growth, spanning important life stages such as kindergarten admission, high school entrance examination and college entrance examination. Teplizumab delays the disease for nearly three years, wins back the' critical period of growth 'for patients, brings the' transitional buffer period 'for families, reduces the pain of treatment, stores life and knowledge, and alleviates the pain of life. The impact on family economic income will bring sugar back to normal life as soon as possible, providing more possibilities for the future." In November 2022, Teplizumab was approved by the US Food and Drug Administration (FDA), which is an innovative targeted therapy approved by FDA to delay the onset of type 1 diabetes globally. TN-10 research shows that compared with the placebo group, using Teplizumab for 14 consecutive days can delay the onset of type 1 diabetes for nearly 3 years on average. In October 2023, PROTECT, a phase III clinical trial study, reached the main endpoint, indicating that Teplizumab has the potential to delay the disease progress of newly diagnosed children and adolescents with phase III type 1 diabetes. At present, the drug has been included in the fourth batch of children's drug list encouraged for research and development in China. (Lai Xin She)
Edit：Xiong Dafei Responsible editor：Li Xiang
Source：XinHuaNet
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