The API and tablets of the DPP-4 inhibitor: HD118 in development by Huadong Medicine have recently obtained the Drug Clinical Trial Approval, which is a Chinese Class 1 new drug of DPP-4 inhibitor type. Thus far, another new player has joined the Class 1 new drugs of DPP-4 inhibitor type, to march into the hypoglycemic drug market in China.

Overview of DPP-4 inhibitors
DPP-4 inhibitor drugs account for about 26% of the global hypoglycemic drug market, which are the hypoglycemic drug with the second highest proportion following insulin, wherein, the sitagliptin of MSD is the world’s first marketed DPP-4 inhibitor, followed by other similar products that have been marketed including vildagliptin, saxagliptin, linagliptin, and alogliptin, etc.
|
Generic name |
Trade name |
Manufacturer |
Approval time in the U.S. |
Approval time in China |
|
Sitagliptin |
Januvia |
MSD |
2006 |
2009 |
|
Saxagliptin |
Onglyza |
BMS |
2010 |
2011 |
|
Vildagliptin |
Galvus |
Novartis |
/ |
2011 |
|
Linagliptin |
Trajenta |
Boehringer Ingelheim |
2011 |
2013 |
|
Alogliptin |
Nesina |
Takeda Pharmaceutical |
2013 |
2013 |
Sitagliptin has been accounting for the largest market share among the DPP-4 inhibitor drugs. According to the statistics of the PDB database, the market size of global DPP-4 inhibitors and compound preparations thereof exceeded USD 12 billion in 2016, wherein, the market size of sitagliptin reached USD 6.4 billion.
The current market size of the diabetes pharmaceutical products is about RMB 40 billion in China, wherein, the market size of the oral hypoglycemic drugs is about RMB 24 billion, involving many big varieties reaching RMB 1 billion level. All the new drugs of DPP-4 inhibitor type in the above table have been marketed in China, and all the single preparations of those drugs have been included in the 2017 new-edition national medical insurance catalog of China, and restricted as second-line drug.
Chinese enterprises also have conducted multi-aspect layout in the registration application of Class 1 new drugs of DPP-4 inhibitor type. See the following table for the clinical trial projects of which the status was displayed as "in progress" on the Drug Clinical Trial Registration and Information Publicity Platform in China by January 10, 2018.










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