Novo Nordisk, a new generation of insulin analogue with super long-term effect, is on the market in China

Source: 21st century report on March 13, 2018, at the 17th Novo Nordisk Diabetes Forum (nndu), Novo Nordisk announced that a new generation of ultra long-term basic insulin analog Novo Nordisk (degu insulin injection) was listed in China The drug is used to treat type 2 diabetes in adults and is the first one approved in China as a super long-acting basic insulin analogue It is also understood that novoda has been listed in more than 60 countries and regions such as Europe and Japan Ye Pu, vice president of Novo Nordisk China, stressed to reporters, "compared with insulin glargine, the risk of hypoglycemia in type 2 diabetic patients using insulin glargine is significantly reduced, especially the incidence of severe hypoglycemia at night is significantly reduced by 53% compared with insulin glargine The risk of novoderma is very small, and the real world data shows that its effect is better than that in clinical trials " Other research results show that the economic burden of hypoglycemia in Chinese diabetes patients is serious If the diabetics have hypoglycemia at night, they need to spend an additional 3151 yuan / person At the forum, Erica Nishimura, vice president of global R & D of Novo Nordisk, said: "making the action curve of the drug as close to the physiological insulin secretion curve as possible is the main source of inspiration for the R & D of Novo Nordisk." It is understood that the daily injection of novosta has the characteristics of super long-term effect and stable blood sugar reduction, which can enable patients to obtain the convenient experience of flexible injection time when they need it At the same time, the introduction of a new generation of pre filled pen, novo and DA, has further improved the convenience of its use Zhang Kezhou, vice president of China Pharmaceutical Department of Novo Nordisk, added to reporters that the half-life of Novo Nordisk is up to 25.4 hours, which can reach the steady-state blood concentration in 2-3 days, and there will be no accumulation "Novoderma is designed for flexible administration in clinical trials, i.e within a set time interval, at least 8 hours and at most 40 hours We have clinical data to confirm that if the patient forgets to take one injection after injection, it is still very reliable in terms of safety " Zhang Kezhou pointed out Yi Mingjiao, director of the Endocrinology Department of the General Hospital of the people's Liberation Army, pointed out to reporters that diabetic patients may have hypoglycemia in the treatment process, and hypoglycemia can lead to discomfort or even life-threatening, and it is the main obstacle to blood glucose standard "Novartis significantly reduced the risk of hypoglycemia compared with previous insulin analogues." Zhang Kezhou said that as a new generation of insulin analogue with super long-term effect, novoderma has obvious clinical effect Therefore, in the drug approval process of the State Food and Drug Administration of China, it is a diabetes drug that has been included in the priority review procedure of new drug listing applications In fact, thanks to the CFDA's reform in new drug review in recent years, novosta only took 25 months to complete the whole process of clinical listing in China, and was approved by the State Food and Drug Administration in September 2017, which exceeded novosta's previous expectations Zhang Kezhou also revealed that the once-a-week long-acting GLP-1 analog hypoglycemic drug somalutide approved by Novo Nordisk in the United States at the end of 2017 also accelerated the process of clinical review in China "In Novo Nordisk's global plan, China is already an important market for us Our R & D plan is almost synchronized with that of the US, Europe and Japan." Reduce medical expenses It is understood that Novartis has been listed in many countries and regions such as Japan, the United States and Europe, and the real world research in these countries and regions also shows that the conversion from previous basic insulin to Novartis can further reduce the glycated hemoglobin level of patients, reduce hypoglycemic events and insulin dosage; while improving the quality of life of patients, reduce the cost of treatment, which is a kind of Economic, effective and high-quality clinical management treatment plan Data shows that there are about 114 million diabetics in China, 46.4% of them have been diagnosed According to the "half rule" of diabetes treatment, only 12.9% of them have been effectively controlled China's annual medical expenditure for diabetes and its related diseases reaches 50 billion US dollars, accounting for 13% of the total national medical expenditure In addition, according to the prediction of the International Diabetes Federation, by 2040, China's total health expenditure for diabetes related diseases will reach 72 billion US dollars Under the severe challenge of low standard rate of diabetes treatment, Guo Lixin, director of Endocrinology Department of Beijing hospital, said: "with the increasing prevalence of diabetes, we are looking forward to the emergence of new drugs to meet the current needs of diabetes clinical treatment." Guo Lixin pointed out that hypoglycemia is one of the greatest risks for diabetic patients Hypoglycemia is a common complication of diabetic patients receiving insulin or sulfonylurea drugs, which can significantly affect their daily life, such as driving, work and leisure activities As sleep masks hypoglycemia symptoms, hypoglycemia at night is easily overlooked 50% of severe hypoglycemia in type 1 diabetes occurs at night Continuous blood glucose monitoring in adult type 2 diabetic patients treated with insulin showed that about 50% of the patients had biochemical hypoglycemia, while the proportion of the juvenile type 1 diabetic patients was as high as 80% In addition, the experts cited data from the Journal of diabetes said that hypoglycemia was associated with an increased risk of death Diabetic patients with severe hypoglycemia had a 3.4-fold higher risk of death than those with no or no hypoglycemia According to reports, insulin drugs are the most effective and irreplaceable drugs to treat diabetes and prevent complications Insulin injection is the only effective treatment for type 1 diabetes because of the destruction of islet cells Type 2 diabetes patients often face the problem of failure of oral medicine after taking oral medicine for a period of time Insulin drugs are also needed to control blood sugar From the global diabetes assessment tool research, a 4-week prospective survey (8022 cases of type 1 diabetes and 19563 cases of type 2 diabetes) on the patients treated with insulin showed that the average proportion of patients with severe hypoglycemia and night hypoglycemia was significantly higher than that of patients treated with insulin in China The occurrence of hypoglycemia in insulin treated patients in China may be underestimated In fact, in addition to helping diabetic patients to improve the standard rate of diabetes treatment, according to the principle of pharmacoeconomics, novosta can significantly help patients to reduce the economic burden According to the results of research on the occurrence and economic burden of hypoglycemia in diabetic patients treated with insulin in pharmacoeconomics of China, the economic burden of hypoglycemia in diabetic patients in China is heavy The extra expenditure for hypoglycemia at night is 3151 yuan / person, including 1591.8 yuan for medical treatment, 165.3 yuan for self blood glucose monitoring, 774.3 yuan for extra expenditure (food, etc.), and 619.5 yuan for productivity loss Yuan The survey results of 509 patients with type 2 diabetes in Beijing and Tianjin by research and development of incidence and cost of hypoglycemia in patients with type 2 diabetes show that the total cost of severe hypoglycemia can reach 5561 yuan / time, and the total cost of moderate hypoglycemia is 1513 yuan / time.