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    Home > Active Ingredient News > Drugs Articles > Where is the most active research and development direction for domestic pharmaceutical companies?

    Where is the most active research and development direction for domestic pharmaceutical companies?

    • Last Update: 2015-07-10
    • Source: Internet
    • Author: User
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    Source: medical economics report 2015-7-10 although there are many diabetes drugs currently used in clinical practice, there are higher clinical requirements, including better efficacy, stable blood sugar reduction, rapid postprandial control of blood sugar, avoidance of complications, more convenient administration, reduction of hypoglycemia, and even control and treatment of complications Therefore, in this huge market, R & D is still very active, new targets, new mechanisms and new drug delivery methods emerge in an endless stream, which attracts the attention of the industry According to the latest research and development data of Thomson Reuters, there are more than 200 diabetes drugs under research, among which DPP-4 inhibitors, insulin analogues, GLP-1 agonists are the most popular ones In addition, the hot research also includes glucagon receptor antagonists, hormone analogues, insulin receptor agonists, etc Advantages of DPP-4 inhibitors: in Europe and the United States as the mainstream oral drug market focus: a large number of varieties are under development, but it depends on whether there are bright spots compared with the varieties that have been or will be on the market Currently, there are about 27 DPP-4 inhibitors in the research stage DPP-4 is a kind of enzyme in vivo, whose main function is to decompose proteins in vivo One of the proteins broken down by DPP-4 is GLP-1, which can reduce blood sugar by stimulating insulin, inhibiting glucagon, inhibiting gastric emptying and regenerating islet cells Therefore, inhibition of DPP-4 can increase GLP-1 in vivo and play a role in reducing blood sugar Mosadon's genovir is the first DPP-4 inhibitor product launched in the world Compared with the traditional insulin secreting agents, genovir and other drugs have definite hypoglycemic effect, low risk of hypoglycemia, little weight gain and gastrointestinal reaction More stable drug properties and better compliance are undoubtedly a research direction of hypoglycemic drugs While DPP-4 drugs are gradually becoming the mainstream oral drugs in Europe and the United States, pharmaceutical companies are also stepping up the development of long-term DPP-4 drugs At present, Takeda Pharmaceutical Co., Ltd of Japan is in the leading position Its long-acting DPP-4 inhibitor, trelagriptin, has successfully completed its clinical research in Japan and is in the stage of new drug approval The long-acting DPP-4 inhibitor Omari gliptin has been studied in multi center phase III clinical trials all over the world The results of both drugs showed that once a week administration can also achieve the effect of once a day administration of common DPP-4 inhibitors In addition to the above two drugs, there are also several drugs in phase III research, including Hengrui's retagliptin, as an original new drug, which also shows that the level of new drug creation in China is gradually close to that in foreign countries There are a large number of original DPP-4 drugs at the early stage of research and development at home and abroad, especially in China However, it is worth noting that most of the varieties have no bright spot compared with the ones that have been or will be on the market, and the future of such original drugs is not even as good as high-end generic drugs Advantages of GLP-1 agonists: the efficacy and safety are better than DPP-4 inhibitors, but only the market focus of injection: stone medicine's exendin-4 and Hengrui's pex-168, GLP-1 agonists have entered the clinical research stage, which is another kind of diabetes drugs with very active research The mechanism is similar to that of DPP-4 inhibitor, which can regulate the GLP-1 level of diabetic patients But in comparison, its efficacy and safety are more excellent, and the action time of some drugs is longer However, because this kind of drug belongs to polypeptide drug, it can't be given orally Injection increases the difficulty of patients' administration, while high price hinders the promotion of the drug The first GLP-1 drug approved was exenatide, which was jointly sold by Lilly, AstraZeneca and BMS Since then, lilaluptide from Novo Nordisk, abilutide from GSK and ricilade from Sanofi have also been approved for marketing Among the varieties studied, semaglutide of Novo Nordisk is currently in phase III clinical research, and Novo Nordisk claims that its safety is better than that of lilalutide Roche's diabetes line is relatively weak, but its research drug rg-7697, which is in the phase II research stage, is also expected It belongs to a double target, and can activate GLP-1 and GIP at the same time At present, there are two GLP-1 drugs in clinical research stage in China, which are exendin-4 of lithopone and pex-168 of Hengrui Among them, the latter can effectively increase the drug delivery interval and improve the drug compliance through PEGylation Advantages of insulin analogues: for most type 2 patients, it is still the best treatment plan in the market According to the latest research on long-term insulin and non injected insulin, insulin is still the best treatment plan for most type 2 diabetic patients The industry has been working on better insulin analogues According to Thomson Reuters data, more than 30 insulin analogues are currently under study Long acting insulin has always been a key development direction in the future At present, the market leader is insulin glargine However, Lilly's peglispro will become a challenger The completed phase III clinical trials show that many indexes of the drug are better than insulin glargine, and the core index, reduced level of glycosylated hemoglobin, is better than insulin glargine Ultra long acting insulin may be a development direction in the future Novo Nordisk's degu insulin has been approved in Japan and the European Union The drug is the first insulin injection to extend the frequency of insulin injection to one week It has been reported that the drug quickly occupied 20% of the Japanese insulin market share after it was launched in Japan It should be noted that the drug has not been approved by FDA FDA is cautious about the long-term efficacy and safety of the drug Novo Nordisk needs more clinical data to support However, the reason why insulin is the first choice of treatment is compliance Although the new pen is becoming more convenient and less painful, the public is still afraid of multiple injections a day The development of non injectable drugs can undoubtedly eliminate the fear of these patients Although the technology has been realized, the failure cases of non insulin injection still emerge in endlessly for many years Afrezza is a non injectable insulin that seems to have a real chance to enter the market now The drug is still administered by inhalation Mankind's afrezza was approved by the FDA in July 2014, and the drug was marketed by Sanofi Whether afrezza can not repeat the mistakes of exubra still needs to be tested by the market, but the reason for the failure of exubra is not "Pfizer's inhaler design is not fashionable enough" as described by Mann kind At the same time, FDA approved afrezza, and warned its black box, excluding a large number of diabetic patients with respiratory diseases and smoking, and whether it still needs regular lung capacity test as exubra is also a problem, and the potential hypoglycemia problem will hinder the promotion of the product Ormd-0801 was non insulin injection Compared with afrezza, the innovation of this product is more difficult The drug is an oral insulin capsule developed by oramed, Israel Its phase II clinical application has been successful in the European Union Of course, whether it can be listed or not remains to be a larger scale of phase III clinical results Advantages of SGLT-2 inhibitors: improving insulin resistance, hypoglycemia, water and sodium retention and cardiovascular events, and other side effects * market points: short term, many new drugs are listed Domestic Shanghai egret and Heng Rui have research products sodium and grape polysaccharide co transporter 2 (SGLT-2 Inhibitor) is the latest clinical successful new target of diabetes, and has been approved successfully Sglt-2 inhibitor can excrete excess glucose from urine, so as to reduce glycosylated protein, improve insulin sensitivity and β cell function of liver and peripheral tissues, and further improve insulin resistance of liver, so as to restore normal glucose output of liver Compared with traditional antidiabetic drugs, the drugs have fewer side effects, are less likely to cause hypoglycemia and improve insulin resistance, * are very low in water sodium retention and cardiovascular events and are suitable for patients with renal diabetes Dapagliflozin is the first approved drug of this kind, which was first developed by AstraZeneca and approved by EMA in 2012 Since then, J & J's kangglinet has also been approved by the FDA The drugs approved in just a year also include Estelle's igreggin, Boehringer's empagliflozin and Japan's taesho's ruggligin Sglt-2 inhibitors also attracted domestic pharmaceutical companies According to Thomson Reuters data, both Shanghai egret medicine and Hengrui are in the stage of clinical research New compound combination - advantages: to enhance the efficacy: DPP-4 + sglt-2, long-acting insulin + GLP-1 compound preparation is also an important direction in the field of diabetes research Metformin and a variety of new oral preparations are very common combinations In addition, there are some new combinations with more highlights DPP-4 and sglt-2 are the latest oral hypoglycemic drugs It is believed that the combination of the two drugs may have synergistic effect The compound preparations of saxagliptin and dapagliflozin, and the compound preparations of gemigriptin and rosuvastatin have entered the phase III research stage From the clinical research results, the combination of the two drugs is better than the combination of metformin Of course, the long-term security and cost-effectiveness of such joint applications are yet to be seen In addition, the long-acting insulin + GLP-1 analogue, which is also an injection drug, is also a new combination attempt Sanofi's compound insulin glargine, lixisentate, and Novo Nordisk's compound insulin, lirarutin, have also entered the phase III clinical stage From the clinical effect, the effect of combined administration is better than that of single administration However, such combination should not be used as a choice of conventional treatment.
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