RMB 1.5 Billion Oral Antidiabetic Drug Faces New Entrants: Merck's Market Share Under Pressure

On August 30, the official website of the National Medical Products Administration (NMPA) indicated that Tonghua Dongbao Pharmaceutical Co., Ltd.'s Sitagliptin Phosphate Tablets, submitted as a Class 4 generic drug, have been approved and are deemed to have passed the consistency evaluation. Data from Menet shows that in 2020, the combined sales of Sitagliptin Phosphate Tablets at public medical institutions and urban retail pharmacies in China exceeded RMB 1.5 billion, with MSD being the sole company marketing the product.

Information Release on Drug Approval Documents Ready for Collection on August 30, 2021

Sitagliptin Phosphate Tablets, developed by MSD, is a potent, highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor and a novel oral antihyperglycemic agent based on the incretin hormone mechanism, used to improve glycemic control in patients with type 2 diabetes mellitus.

Sales of Sitagliptin Phosphate Tablets at Public Medical Institutions and Urban Physical Pharmacies in China (Unit: RMB 100 Million)

Source: Menet Database

Data from MENET indicates that in recent years, sales of sitagliptin phosphate tablets have experienced rapid growth in the Chinese public medical institutions terminal (including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) and the urban retail pharmacy terminal in China. In 2020, combined sales exceeded RMB 1.5 billion, with MSD being the sole company marketing the product.

There are seven manufacturers of Sitagliptin Phosphate Tablets, including MSD, CSPC Ouyi Pharmaceutical, and Chia Tai Tianqing Pharmaceutical Group, among others. Of these, six pharmaceutical companies in China, including CSPC Ouyi Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group, Guangdong HEC Pharmaceutical, and Tonghua Dongbao Pharmaceutical Co., Ltd., have been approved under Category 4 for generic drugs and are deemed to have passed the consistency evaluation. Currently, ten other enterprises, including Qilu Pharmaceutical (Hainan), Zhejiang Huahai Pharmaceutical, Gan & Lee Pharmaceuticals (Jiangsu), and Shandong Langnuo Pharmaceutical, have submitted marketing applications that are under review and approval.

Data Source: Official website of the National Medical Products Administration (NMPA), MENET database

Note: The China Urban Physical Pharmacy Terminal Competitive Landscape Database is an expanded urban physical pharmacy database covering physical pharmacies in 293 prefecture-level cities and above across China (excluding those in counties and rural areas), with continuous monitoring of all product categories. The aforementioned sales figures are calculated based on the average retail price of products at the terminal.