Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087. SH) is pleased to announce that our wholly-owned subsidiary Gan & Lee Pharmaceutical Jiangsu Co., Ltd. received the approval for the registration of Sitagliptin phosphate tablets issued by the National Medical Products Administration (NMPA), which is indicated for type 2 diabetes. The approval of this product means that it has reached a quality level consistent with the reference medicine, meaning it passed the consistency evaluation according to the relevant national policies and regulations, which will be conducive to future market sales and market competition of the drug.

Sitagliptin phosphate is the world's first approved oral dipeptidyl peptidase-4 (DPP-4) inhibitor, which increases insulin secretion and inhibits glucagon secretion by increasing incretin (GLP-1, GIP) levels. Sitagliptin phosphate slows gastric emptying and lowers blood glucose levels. It can also be used in conjunction with diet and exercise to improve blood glucose control in patients with type 2 diabetes1. Clinical studies have confirmed that sitagliptin phosphate tablets only need to be taken orally once a day to control blood glucose and delay the progression of diabetes effectively. In addition, sitagliptin phosphate has a low incidence of hypoglycemia. It is listed in authoritative clinical guidelines in various countries by virtue of its excellent safety and efficacy¹.

In 2006, after the approval of sitagliptin phosphate tablets in the United States,the drug grew rapidly in the global oral hypoglycemic market . According to estimates from the Pharnexcloud global drug research and development database, the global annual sales of sitagliptin phosphate tablets have stabilized at around the  $3.5-4 billion in recent years. In 2009, officially entered China; In 2017, the drug was included in China's National Medical Insurance (Class B) ，then to achieved rapid increase in volume; In 2021, the sales of sitagliptin phosphate tablets in second-level and above hospitals nationwide will reached 1.512 billion China yuan. Therefore, sitagliptin phosphate tablets have a broad market prospect².

Sitagliptin phosphate is the first oral hypoglycemic drug independently developed by Gan & Lee Pharmaceuticals and the company's first chemical generic drug. The approval and listing of sitagliptin phosphate tablets expanded the company's core hypoglycemic product line. It will help to enhance Gan & Lee’scomprehensive market competitiveness in diabetes drugs, and consolidate its leading market position in the domestic diabetes treatment field to,  provide patients with more treatment options.

References

1.   Scott L. J. (2017). Sitagliptin: A Review in Type 2 Diabetes. Drugs, 77(2), 209–224. https://doi.org/10.1007/s40265-016-0686-9

2.   The data comes from the annual report of the original research company & the Pharnexcloud database

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including long-acting glargine injection (Basalin^®), fast-acting lispro injection (Prandilin^™), fast-acting aspart injection (Rapilin^®), mixed protamine zinc lispro injection (25R) (Prandilin^™25), aspart 30 injection (Rapilin^®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin^®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine^®).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.