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    Home > Medical News > Medical World News > Brief report on risk analysis of diabetic insulin products

    Brief report on risk analysis of diabetic insulin products

    • Last Update: 2019-12-11
    • Source: Internet
    • Author: User
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    Diabetes is a group of metabolic diseases characterized by hyperglycemia Hyperglycemia is caused by the deficiency of insulin secretion or the damage of its biological function, or both If the long-term blood glucose control of diabetic patients is not good, it can lead to multiple organ tissue damage, accompanied by heart and brain vessels, eyes, kidneys, limbs and other organs failure Diabetes can be divided into type 1 diabetes, type 2 diabetes, gestational diabetes and special type diabetes Type 2 diabetes is the type with the largest number of patients Type 1 diabetes is a kind of autoimmune disease The destruction of islet β cells leads to the absolute lack of insulin secretion The causes of type 2 diabetes include insulin resistance, insufficiencies of insulin progressive secretion or both The patients account for about 90% of the total number of diabetic patients Diabetes drugs mainly include oral hypoglycemic drugs market and insulin products Insulin is the most effective and irreplaceable drug in the treatment of diabetes and prevention of complications Type 1 diabetes patients must use insulin treatment, while type 2 diabetes patients must use insulin treatment when oral drugs can not effectively control blood sugar From the perspective of research and development process, injection insulin has developed to the third generation The first generation is animal derived insulin, which is extracted from the pancreas of animals such as pigs and cattle The second generation is recombinant human insulin Human insulin gene is expressed in E Human insulin molecules are modified, such as changing and exchanging individual amino acids, or modifying insulin molecules locally Recombinant insulin analogues have higher safety and effectiveness, improve the rate of blood glucose control and reduce the risk of hypoglycemia in patients At present, most of the insulin used in the Chinese market is second-generation and third-generation insulin The second-generation insulin mainly includes Novo Nordisk (Novolin), Tonghua Dongbao (GaN Shulin), Lilly (ubilin), federal Pharmaceutical (ulin), Bayer (chonghelin), Wanbang Pharmaceutical (Wanbang); the third-generation insulin mainly includes Novo Nordisk (novorey, nuheping), Sanofi (when it comes), Lilai (youbile), Ganli Pharmaceutical (changxiulin, suixiulin), and UL (youleling) According to the action time of insulin, it can be divided into quick acting insulin for postprandial blood glucose control, medium acting insulin and long acting insulin for long-term blood glucose control Long acting insulin includes insulin glargine, insulin detemir and insulin deglucec, while quick acting insulin includes insulin lispro, insulin aspart and insulin insulin There are about 100 million diabetics in China China has become the country with the largest number of diabetics in the world, and the number of diabetics is still growing rapidly Insulin, as the last line of defense in the treatment of diabetes, plays an important role in the treatment of diabetes in China Biopharmaceutical industry has the characteristics of high-tech barriers, which are embodied in knowledge intensive, high technical requirements for equipment and personnel, complex process routes, highly integrated multi-disciplinary and mutual penetration The leading enterprises in the insulin market have accumulated a large number of patents and technologies in the process of insulin production, involving the fermentation, purification and preparation of insulin production New enterprises are facing high technical barriers At present, the patent of recombinant human insulin has expired, but few Chinese enterprises have successfully realized the industrialization production of recombinant human insulin biological analogues In terms of drug safety and efficacy, the third generation insulin products have a long-term trend to replace the second generation insulin products However, considering the pressure of medical insurance cost control and the income difference between urban and rural areas in China, the second-generation insulin products still have a greater price advantage compared with the third-generation insulin products After the reimbursement of the third-generation insulin, the annual per capita cost is about 3500 yuan, and the annual per capita cost of the second-generation insulin products is about 2200 yuan So for a long time, the second generation insulin is still used as the first-line medicine in primary medical institutions In China, the three foreign giants, Novo Nordisk, Lilly and Sanofi, account for most of the market share, no matter in the second or third generation of insulin Table 1 lists the total import volume of insulin in China, and it can be seen that the total import volume has been relatively stable in recent years Figure 1: China's total insulin imports in 2013-2018 (unit: 10000 tons) Source: China Customs, sgrcr Until 2003, Tonghua Dongbao recombined human insulin Ganshulin series products went on the market, breaking the monopoly of foreign enterprises Now, the bidding price of Gan Shulin is about 46-56 yuan, and the highest retail price is 59.9 yuan In 2018, the output of Tonghua Dongbao recombinant human insulin injection decreased slightly to 43.6301 million pieces (Figure 2) Figure 2: output of Tonghua Dongbao insulin products in 2015-2018 (unit: 10000 pieces) Source: public information, sgrcr collation With the expiration of the third-generation insulin patent, Chinese enterprises such as Ganli pharmaceutical, UL and Tonghua Dongbao have invested a lot in the research and development of the third-generation insulin products Ganli pharmaceutical is the first three generation insulin manufacturer in China The first long-acting human insulin analogues in China, changxiulin (recombinant insulin glargine injection), suxiulin (recombinant insulin laiproline injection) and suxiulin 25 (recombinant insulin laiproline mixture injection of zinc and protamine) (25R), were listed in 2005, 2007 and 2014 respectively It can be seen from Figure 3 that the output of insulin products in the cabbage pharmaceutical industry has been growing rapidly in recent years From 2014 to 2016, changxiulin achieved sales revenue of 783222600 yuan, 1138581900 yuan and 1631823100 yuan in China, with a compound annual growth rate of 44.34% (data source: IPO prospectus 2018) Figure 3: insulin product output of Ganli pharmaceutical industry from 2014 to June 2017 (unit: 10000 pieces)
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