Oral hypoglycemic drugs "grab" first imitation Tonghua Dongbao registration application accepted

Medical Network April 4th, April 3, Tonghua Dongbao issued a notice saying that the company received the notification of the registration of the drug registration application of sitagliptin (II), and the State Food and Drug Administration applied for the drug registration of the drug. The review was decided and accepted.

Basic situation of drugs

Sitagliptin metformin tablets (II) were developed by Merck and researched in the United States. They were marketed in the United States in March 2007 for oral treatment of type 2 diabetes. They were approved for marketing in the EU the following year. In 2012, China approved imports.达®. As of the date of this announcement, there were no generic drugs approved for listing in China, and two manufacturers have applied for production registration.

According to the data, studies have shown that the combination of sitagliptin phosphate and the traditional hypoglycemic agent metformin can control blood glucose more effectively and smoothly. The combination of sitagliptin and metformin tablets provided by the drug provides two drugs in one tablet. The drug-administered preparation can be used for patients with type 2 diabetes who have poorly controlled blood glucose or are receiving combination therapy with metformin.

Sales of terminal gemcitabine metformin tablets in public medical institutions in China (unit: 10,000 yuan)

According to the data of the intranet, in 2017, the sales of metformin in China's urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) reached 63.75 million yuan.

Tonghua Dongbao said that the application for registration of sitagliptin metformin (II) was accepted, which is another breakthrough in the research and development of oral diabetes. The company's diabetes drug product line is expected to be further enriched. If the variety can be successfully approved in the future, it will provide patients with more medication options.

Source: Listed company announcement, Minenet database