[exclusive] by reviewing the application of diabetes drugs in 2017, losenapeptide and lilalutide are worth looking forward to. Several first generic drugs will be launched soon!

Tumor drugs and diabetes drug research and development have always been a hot area of concern in the industry Last week, based on the registration and acceptance database of yaozhi.com, an inventory of the field of anti-tumor drugs was launched This week, we will continue our analysis in the field of diabetes to see what drugs are worth looking forward to this year! From Figure 1, we can see the overall declaration trend of diabetes drugs in recent 10 years in China In 2015, it reached the declaration peak, which was 540 (calculated according to the acceptance number, the same below) In 2016, it dropped significantly, which is consistent with the overall trend of drug declaration By 2017, the overall declaration situation had eased, and the number of Biopharmaceutics had reached the highest level over the years, with 63 declaration records (Figure 1) application of diabetes drugs in 2017: in 2017, CDE accepted 231 diabetes drugs (calculated by acceptance number, the same below), including 63 biological products, 164 chemical drugs and 4 traditional Chinese medicines Among 63 biological products, there are 15 new drugs, 7 imports, 4 re registrations and 37 supplementary applications Next, we focus on the analysis of new drugs Five enterprises competed for lilaluptide, and nine genes were approved as clinical 10 new drug records, including three varieties: lilaluptide, recombinant insulin glargine and degu insulin Among them, there are 6 lilaluptide (details are shown in Figure 2), 5 enterprises apply at the same time, and at present only 7 categories of therapeutic biological products declared by nine source genes have been approved for clinical use (Figure 2) it is reported that lilalutide is the original GLP-1 hypoglycemic drug developed by Novo Nordisk, which is used for type 2 diabetes In 2016, the global sales reached 2.97 billion US dollars, ranking 30th in the world's top 50 best-selling drugs Since it was approved for import on February 3, 2016, China has been included in the 2017 version of national medical insurance and three local medical insurance systems of Heilongjiang Province, Shanghai city and Beijing city At the same time, it has bid winning information in 29 regions The average bid winning price of 3ml: 18mg (pre filled injection pen) 1 in 2017 is 464.31, and there are no domestic enterprises obtaining production approval documents Therefore, from the perspective of market, market acceptance and price Look, this medicine is a good choice In terms of domestic application over the years, there are also application records of Jiuyuan gene and Hanyu pharmaceutical industry The first one to obtain clinical approval is 10 categories of biological products declared by Jiuyuan gene In August 2016, it has obtained clinical approval, and now it has entered clinical phase 1 Class 3.1 of chemical drugs declared by Hanyu Pharmaceutical Co., Ltd has also been approved for clinical application on September 20, 2017 Two mainstream third-generation insulin products of the two enterprises will be put on the market soon There are five application records of new drugs reported for production, including glargine insulin of Tonghua Dongbao Pharmaceutical Co., Ltd and asparagus insulin injection of Ganli Pharmaceutical Co., Ltd., both of which are mainstream products of the third-generation insulin Their performance in the diabetes market is eye-catching At present, it has entered the national medical insurance (2009 version) and multiple regional medical insurance in China, and has bid winning information in 31 regions Insulin glargine is produced by Sanofi and introduced into China At present, the domestic enterprises that have obtained the production approval are Ganli pharmaceutical and Zhuhai United pharmaceutical If Tonghua Dongbao pharmaceutical's insulin glargine is approved to be listed this time, it will break the passive situation that the company is dominated by the second generation of insulin - human insulin, without three generations of heavy-duty products Insulin asparagus is produced by Novo Nordisk and introduced into China Currently, only Novo Nordisk (China) has obtained the production approval This time, if the aspartic insulin injection declared by Ganli pharmaceutical can be approved for listing, it also means that Ganli pharmaceutical will have three third-generation insulin heavyweight products (insulin glargine, recombined insulin lysine, aspartic insulin), and its advantages in the diabetes market will be further consolidated Among the 164 chemical application records, there are 10 new drugs, 14 imports, 2 re registrations, 12 imitations, 30 imitations, 95 supplementary applications and 3 reexamines Here we mainly analyze new drugs and generic drugs Four of the 10 new drug application records of the first long-acting GLP-1 receptor agonist to be launched in China have been reported for production, including two products, i.e polyethylene glycol loseptide injection and 2.2 gliclazide sustained-release capsule (see Figure 3 for details) (Fig 3) among them, pegylated losenapeptide is a long-acting GLP-1 receptor agonist independently developed by hausen and the first long-acting GLP-1 receptor agonist applied for marketing in China It only needs to be injected once a week for the treatment of type 2 diabetes According to reports, the current two most popular long-acting GLP-1 preparations, Lilly's clinical application for dulaglutide, is in the review stage Novo Nordisk's somaluptide injection was approved for clinical application on September 26, 2016, and both are imported drugs In addition, at present, there are no domestic enterprises that have obtained two product production approvals (see Figure 4 for details) for engeliejing tablets and tragliptin Succinate Tablets reported for clinical use, but there are more enterprises that have obtained two product clinical approvals (Fig 4) 30 generic application records of the first generic drugs to be launched are all reported for production, among which 4 products of viagliptin, saggliptin, siggliptin phosphate, and agogliptin benzoate have no production approval in China There are 4 enterprises applying for viagliptin and sagletin respectively, and 3 enterprises applying for sigletin phosphate, among which Shanghai Hyundai has been approved for clinical application There are 2 enterprises applying for agliptin benzoate, among which Jiangsu chenpai pharmaceutical has been approved for clinical application (see Figure 5 for details) (Figure 5) the application records of four traditional Chinese medicines are all supplementary applications, among which Xiaokeping capsule and Qihuang Jiangtang Capsule have been certified and approved (see Figure 6 for details) (Fig 6)