[exclusive] through the application of diabetes drugs in 2018, new aspartic insulin drugs and DPP-4 inhibitors will be on the market for the first time, focusing on Ganli, Kelun and Tonghua Dongbao

Towards the end of 2018, how about the application of diabetes drugs this year? Which new drugs and first imitations will meet us soon? According to the registration and acceptance database of smart drugs, as of December 18, 2018, there are 387 application records of diabetes drugs, including 33 new drugs, 64 generic drugs, 16 imported drugs, 48 imported re registration, 221 supplementary applications and 5 other applications From the application data, we find that: new forces will be added to the new insulin drugs in China, two aspartic insulin products from Ganli pharmaceutical industry, and degumendong double insulin injection imported from Novo Nordisk will be on the market soon; DPP-4 inhibitors will be popular in generic drug application, sglt-2 inhibitors will be popular new stars, sigletin declared by Sichuan Kelun and agliptin declared by Tonghua Dongbao may take the lead in breaking D Pp-4 inhibitor market has no first imitation Next, we will take a detailed look at the application of various diabetes drugs this year from three dimensions: new drugs, generic drugs and imported drugs There are 31 biological products in 33 new drug application records, including 23 insulin products, including aspartic insulin, recombinant human insulin, recombinant lysine insulin, protamine recombinant human insulin, protamine zinc recombinant human insulin and Dieter insulin There are also 8 GLP-1 receptor agonists, including lilalutide and benalutide (see Figure 1 for details) Figure 1 in 2018, the varieties and acceptance of biological products applying for new drugs and the application of aspartic insulin were popular Among the 23 insulin application records to be listed for the first time in China, 15 of them were aspartic insulin, which became the most popular insulin application this year As the second largest insulin analogue in the world, aspartic insulin is second only to insulin glargine At present, only the original aspartic insulin injection produced by Novo Nordisk is on the market in China According to the 2017 financial data of Novo Nordisk, the total sales volume of insulin asparagus in Greater China (including Mainland China, Hong Kong and Taiwan) is 5.12 billion yuan This year's declaration of aspartic insulin specifically includes four varieties of aspartic insulin, aspartic insulin injection, aspartic insulin 30 injection and aspartic insulin 50 injection, a total of four enterprises declare (see Figure 2 for details) Among them, 3 varieties declared by Zhuhai United Pharmaceutical Co., Ltd., 5 of which were recorded as production reports, and all of them were reviewed on September 20, 2018 Figure 2 in 2018, the details of the acceptance of aspartic insulin declared according to new drugs have been a hot topic in China Up to now, there are 109 application records In addition to Zhuhai federal, there are 5 production records of Ganli pharmaceutical industry, including 2 application records of aspartic insulin injection and 30 aspartic insulin injection The current processing status shows that the application has been issued and is on the market Among the other 8 insulin application records, the recombined human insulin injection of Yichang dongyangtse Pharmaceutical Co., Ltd was reported for production, and 5 enterprises such as Tonghua Dongbao Pharmaceutical Co., Ltd and Zhuhai United Pharmaceutical Co., Ltd have obtained production approval documents In addition, three records of seminal protein recombinant human insulin injection and seminal protein recombinant human insulin injection (premixed 30 / 70) of Tianmai biology are also reported production The former has been approved production by Tonghua Dongbao Pharmaceutical Co., Ltd and Zhuhai federal Pharmaceutical Co., Ltd., while the latter has only one reported production of Hefei Tianmai biology, and there is no listed enterprise in China, so Hefei Tianmai biology is likely to become a The first listed company (see Figure 3 for details) Figure 3: in 2018, the annual sales of other insulin application details by new drug exceeded US $6 billion Among the 8 GLP-1 receptor agonist application records of Tonghua Dongbao 2-pound new drug approved, 7 are clinical application records of lilalutide (see Figure 4 for details) Figure 4 details of acceptance of GLP-1 receptor agonists declared according to new drugs in 2018 lilalutide was developed by Novo Nordisk and entered the Chinese market in 2011 Currently, there is no domestic product on the market It is reported that the global sales of the drug in 2017 was US $3.939 billion, which is the highest variety of drugs sold in the field of Novo Nordisk Diabetes As the only GLP-1 receptor agonist that entered the national medical insurance catalog in 2017, the drug stands out among many hypoglycemic drugs in China This year's new drug application records specifically include two varieties of four enterprises, of which two records of Tonghua Dongbao pharmaceutical have been approved for clinical application Up to now, there are 36 application records of lilalutide, and 14 biological products applied for new drugs, all of which are reported for clinical application In addition to Tonghua Dongbao's approved clinical application, lilalutide injection applied for by Hangzhou Jiuyuan gene and Zhuhai federal pharmaceutical has also been approved for clinical application It is worth mentioning that in addition to lilaluptide, the heavy-duty varieties declared by Tonghua Dongbao this year, the recombinant insulin raw material and injection were also approved for clinical application after this year's declaration This drug is the best drug sold in the diabetes field of Lilly in 2017, with sales of US $2.865 billion At present, only Lilly and Ganli pharmaceutical industry in China have been approved for production Generic application 64 generic drug application records are all reported for production, of which 55 are the first ones, including DPP-4 inhibitors and their compounds with metformin, sglt-2 inhibitors and GLP-1 receptor agonists, including cigliptin and its compounds with metformin, wiggliptin and its compounds with metformin, agliptin, liggliptin and their compounds with metformin A total of 21 varieties are related to saggliptin, caggliptin, engegliptin, exenatide and lilalutide (see Figure 5 for details) Figure 5 declaration of generic drug varieties and acceptance in 2018 DPP-4 inhibitor declaration fever, sigletin and agliptin are on the market soon DPP-4 inhibitors and their compounds with metformin are the most popular in the field of diabetes drug imitation this year There are 42 records, including 14 acceptance numbers of sigletin and its compounds with metformin, 13 of agliptin, 9 of vigletin and its compounds with dimethylbiguanide, 4 of ligletin and its compounds with metformin, and 4 of sagletin and its compounds with metformin There are two statins Moreover, the above five varieties are all imported in China, and there is no imitation for listing Sigletin is the first DPP-4 inhibitor on the market in the world, developed by MSD, and the best drug sold in the diabetes field of MSD in 2017, with a sales volume of USD 3.737 billion At present, the domestic application for cigliptin is mainly aimed at the single product of "cigliptin phosphate tablets" and the compound "cigliptin metformin tablets" For these two varieties, China approved the import application of the original research company mosadong in 2010 and 2011 respectively For a long time, cigliptin and its compound with metformin have been popular in domestic application Up to now, there are 140 application records, 43 of which are generic applications, all of which are for production There are 26 chemical drugs declared in 6 categories, 20 of which have been approved for clinical use There are 17 categories 3 and 4 declarations in total, 14 of which are this year's declarations (see Figure 6 for details) Fig 6 in 2018, sigletin reported the production of generic drugs in categories 3 and 4 From the table, it can be seen that the rapid review is that sigletin phosphate tablets of Zhengda Tianqing, sigletin phosphate tablets and sigletin phosphate declared by Zhejiang Pharmaceutical Co., Ltd and sigletin phosphate declared by Lianyungang Runzhong Pharmaceutical Co., Ltd., with a total of 5 records, have completed the review and are on the market However, sigletin phosphate, a 4-class chemical applied by Sichuan Kelun Pharmaceutical Co., Ltd and a 3-class chemical applied by Sichuan xinkaiyuan Pharmaceutical Co., Ltd., has been accepted in 2017 and reviewed in 2018 So it's hard to say who will get the first production This year's application record of agliptin is closely followed It was originally developed by Takeda Agliptin benzoate tablets were approved to enter the Chinese market in 2013, and there is no composite product on the market Up to now, there are 117 application records for agliptin and its compound with metformin in China, including 51 for generic drugs, all for production 34 applications are classified into 6 categories, all of which have been approved for clinical application; 17 applications are classified into 3 and 4 categories, of which 13 applications are for this year (see Figure 7 for details) Fig 7 in 2018, the production of agliptin in generic drugs category 3 and 4 reports can be seen from the table For agliptin reported this year, Jiangsu Zhongtian Pharmaceutical Co., Ltd., Jiangsu Deyuan Pharmaceutical Co., Ltd and Hubei huashitong Biopharmaceutical Technology Co., Ltd all have completed the review of relevant varieties However, four records of 4 generic drugs, i.e agliptin benzoate tablets and 3 generic drugs, declared by Yabao Pharmaceutical Group, have been accepted as early as 2017 and reviewed in 2018 In China, there are relatively few generic records of viagliptin, liggliptin, saggliptin and their compounds with metformin Up to now, there are 30 generic applications for viagliptin and its compound with metformin, all of which are reported for production, and 16 generic applications for chemical drugs, 14 of which have been approved for clinical application, 14 applications for chemical drugs, and 9 applications this year There are 14 generic applications for liggliptin and its compound with metformin, all of which are reported for production, 10 of which are reported in 6 categories, all of which are approved for clinical application, and 4 of which are reported in 4 categories, all of which are reported this year, and all of which are included in the priority review There are 19 generic application records for sagletin and its compound with metformin, all of which are reported for production Among them, 12 are declared in 6 categories, all of which are approved for clinical application; 7 are declared in 3 and 4 categories of chemicals, and 2 are declared this year (see Figure 8 for details) Fig 8 production of viagliptin, liggliptin and saggliptin in Category 3 and 4 of generic drugs in 2018 It can be seen from the above table that the progress of viggliptin, liggliptin and saggliptin is relatively slow However, in addition to the production situation reported in categories 3 and 4 this year, viggliptin and viggliptin tablets of Nanjing Unocal pharmaceutical, Beijing Taide pharmaceutical, hausen and Qilu have been accepted and reviewed in 2017 In addition, Lianyungang Runzhong Pharmaceutical Co., Ltd., Jiangsu Hengrun Pharmaceutical Co., Ltd and Zhengda Tianqing Pharmaceutical Co., Ltd., which were accepted in 2017, also completed the review this year Sglt-2 inhibitor has become a new rising star In addition to DPP-4 inhibitor and its compound with metformin, sglt-2 inhibitor and GLP-1 receptor agonist have also become the hot varieties for the first application this year Sglt-2 inhibitors include cargillizine and englizine, GLP-1 receptor agonists include exenatide and lilalutide The application records of the four drugs are also very frequent in China, but most of them are new drugs, and there are not many imitations In particular, it is only this year that applications for generic drugs, such as cagregyne and engeregyne, have been accepted There are 91 application records of cagreenet, and the review of 3 generic drugs declared this year has been started; there are 105 application records of engereenet, and only 4 application records of Sichuan Kelun and Jiangsu Haosen drugs reported for imitation this year have been produced, but the review has not been started at present (see Figure 9 for details) Fig 9 in 2018, the production of sglt-2 inhibitors and GLP-1 receptor agonists was reported as generic drugs in categories 3 and 4 In addition, although there were declaration records for exenatide and lilalutide before 2018, they were all declared as Category 6, and this year they began to declare as Category 3 and 4 Among the four records declared by isenatide this year, the tablets and peptides declared by Qinghai Chenfei pharmaceutical have been included in the priority review and approval Only two records of Chengdu shengnuo biopharmaceutical application have been made for lilalutide, and the review has not yet started Declaration of imported drugs 2.4