Yangtze River Pharma Set to Challenge Merck's $3 Billion Sitagliptin Market with Generic Filing

Recently, Sitagliptin Phosphate Tablets submitted for marketing approval as a Class 4 generic by YANGTZE RIVER PHARMACEUTICAL GROUP GUANGZHOU HAIRUI PHARMACEUTICAL CO.,LTD has entered the administrative approval stage. The product was originally developed by MSD, with global sales exceeding USD 3 billion in 2020. Data from Menet shows that in 2020, the combined sales of sitagliptin tablets at public medical institution terminals and urban retail pharmacy terminals in China exceeded RMB 1.5 billion. Currently, there are five manufacturers of Sitagliptin Phosphate Tablets in China, including Guangdong HEC Pharmaceutical and Chia Tai Tianqing Pharmaceutical Group. In addition, the marketing authorization applications of 11 other companies, such as Qilu Pharmaceutical (Hainan), Nanjing Chia Tai Tianqing Pharmaceutical, and Sichuan Kelun Pharmaceutical, are currently under review and approval.

According to available data, sitagliptin phosphate tablets are a potent, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor, a novel oral anti-hyperglycemic agent based on the incretin hormone mechanism, used to improve glycemic control in patients with type 2 diabetes.

Sales Performance of Sitagliptin Tablets in China's Public Medical Institutions and Urban Physical Pharmacy Terminals

Source: MENET Database

Sitagliptin Phosphate Tablets, developed by MSD, achieved global sales exceeding USD 3 billion in 2020. According to Menet data, in recent years, sales of sitagliptin tablets have grown rapidly at terminals in Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (collectively referred to as Chinese public medical institutions), as well as at physical retail pharmacy terminals in Chinese cities, with combined sales exceeding RMB 1.5 billion in 2020.

Source: MENET One-Click Search

There are five manufacturers of sitagliptin phosphate tablets. Among them, four domestic pharmaceutical companies—Guangdong HEC Pharmaceutical Co., Ltd., CSPC Ouyi Pharmaceutical Co., Ltd., Xinchang Pharmaceutical Factory of Zhejiang Medicine Co., Ltd., and Chia Tai Tianqing Pharmaceutical Group Co., Ltd.—have been approved under the Class 4 generic drug category, which is deemed equivalent to passing the generic drug quality and efficacy consistency evaluation. Currently, marketing authorization applications from 11 other enterprises, including Qilu Pharmaceutical (Hainan) Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd., are under regulatory review and approval.

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