Diabetes is a chronic metabolic disease that is caused by the influence of genetic factors, environmental factors and living habits, and seriously threatens human health. In recent years, due to changes in lifestyles and the acceleration of the aging process, the number of patients with type 2 diabetes in the world has been increasing, and the field of corresponding therapeutic drugs has gradually become a huge market.

In China, the number of diabetes patients and the corresponding therapeutic drug market are also increasing year by year. Statistics show that the number of patients with diabetes and quasi-diabetes in my country has exceeded 150 million. With the increase in the prevalence of diabetes in China, the improvement of people's living standards and the improvement of medical standards, the scale of the diabetes drug market is expanding year by year. It is estimated that by 2022, the market size will be close to 43.7 billion yuan.

It is worth noting that for most patients, oral hypoglycemic drugs are more economical, practical and convenient. Therefore, in recent years, oral hypoglycemic drugs have begun to occupy more and more market shares of diabetes drugs, and the year-on-year growth is also rising.

It is understood that there are currently 7 major categories of oral hypoglycemic drugs, including biguanides, sulfonylureas, thiazolidinediones, glinides, α-glycosidase inhibitors, dipeptidyl peptidase IV (DPP-4 ) Inhibitor, sodium-glucose cotransporter 2 (SGLT-2) inhibitor. With the continuous expansion of the oral hypoglycemic drug market, many pharmaceutical companies have also begun to rush to deploy popular drugs among them, such as metformin and sitagliptin phosphate tablets.

Recently, the website of China's State Food and Drug Administration showed that Chengdu Better Pharmaceutical's metformin hydrochloride sustained-release tablets were approved for production in generic 4 categories, which are deemed to be over-reviewed. It is understood that metformin is the first-choice treatment drug for diabetic patients, which has the effects of lowering blood sugar and improving insulin resistance. In 2020, the combined sales of metformin hydrochloride sustained-release tablets at the terminals of public medical institutions in China and physical pharmacies in cities in China will be nearly 1.8 billion yuan. At present, there are more than 40 manufacturers of this product. Among them, more than 20 companies such as Chengdu Hengrui Pharmaceutical, Yichang Renfu Pharmaceutical, and Zhengda Tianqing Pharmaceutical Group have been reviewed.

Coincidentally, not long ago, China Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. has also entered the administrative approval stage for imitation of Sitagliptin Phosphate Tablets, which was reported for production in Category 4. Data show that sitagliptin phosphate tablets are an effective and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, a new type of oral anti-hyperglycemic drug based on the mechanism of incretin hormone. To improve blood sugar control in patients with type 2 diabetes. It was developed by Merck and its global sales in 2020 have exceeded US$3 billion.

In 2020, the combined sales of sitagliptin tablets at the terminals of Chinese public medical institutions and physical pharmacies in Chinese cities have exceeded 1.5 billion yuan. At present, there are 5 manufacturers of sitagliptin phosphate tablets in Guangdong Dongyang Sunshine Pharmaceutical Co., Ltd. and Chia Tai Tianqing Pharmaceutical Group. In addition, 11 companies including Qilu Pharmaceutical (Hainan), Nanjing Zhengda Tianqing Pharmaceutical, and Sichuan Kelun Pharmaceutical have submitted their listing applications and are under review and approval.

In general, under the huge demand for treatment of patients, the market for oral diabetes treatment drugs will be broader. Although there is still a big gap between domestic oral hypoglycemic drugs and foreign countries. However, the industry also pointed out that under the current R&D and innovation trend of Chinese pharmaceutical companies, it may be expected to change the monopoly of large pharmaceutical companies in the diabetes market. In the future, as more and more high-tech and high-barrier drugs are approved for listing by Chinese companies, it will be imperative for generic drugs to replace original research.