Qilu Pharmaceutical Gains Approval for Saxagliptin Tablets, Challenging AstraZeneca's Dominance in China's $700M DPP-4 Inhibitor Market

On March 17, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s saxagliptin tablets had received approval for market launch under a Class 4 generic drug application. Data from Menet shows that in recent years, sales of saxagliptin tablets at the terminal level of public medical institutions in China have grown rapidly, exceeding RMB 500 million in 2019 and achieving a year-on-year increase of over 30% in the first half of 2020. Among these, AstraZeneca holds the largest market share, accounting for more than 95%.

Information Release on Drug Approval Documents Awaiting Collection - March 17, 2021 - 1

Data indicate that saxagliptin is a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. It regulates blood glucose by inhibiting DPP-4, thereby prolonging the activity of endogenous glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is primarily used for the treatment of type 2 diabetes. Compared with conventional glucose-lowering agents, DPP-4 inhibitors offer the advantages of not increasing the risk of hypoglycemia, having a neutral effect on body weight, and demonstrating favorable cardiovascular safety.

Sales of Saxagliptin Tablets at Public Medical Institution Terminals in China in Recent Years

Source: Competitive Landscape of Public Healthcare Institutions in China

Saxagliptin tablets were developed by Bristol-Myers Squibb, first approved for marketing in the United States in July 2009, and later acquired by AstraZeneca; they were approved to enter the Chinese market in May 2011 under the brand name Onglyza. Data from Menet shows that in recent years, sales of saxagliptin tablets at terminals of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—have grown rapidly, exceeding RMB 500 million in 2019 and achieving a year-on-year increase of over 30% in the first half of 2020. Among these, AstraZeneca holds the largest market share, accounting for more than 95%.

As of now, there are five manufacturers of saxagliptin tablets, with Qilu Pharmaceutical being the fourth domestic producer. In January 2019, Jiangsu Aosaikang Pharmaceutical obtained approval for its Class 4 generic drug application, securing the first generic version. In 2020, both Chia Tai Tianqing and Hansoh Pharmaceutical also received approval for their Class 4 generic drug applications.

Source: Official website of the National Medical Products Administration, Menet Database