Chongqing Keyi Nanhai Pharmaceutical Nears Approval for Alogliptin Benzoate Tablets, Targeting $300 Million Oral Antidiabetic Market

Recently, Chongqing Kerui Nanhai Pharmaceutical Co.,Ltd.'s Alogliptin Benzoate Tablets, submitted for marketing approval as a Class 4 generic, have entered the administrative approval stage and are expected to be approved. According to Menet Network, in 2020, the combined sales of Alogliptin Benzoate Tablets across China's public medical institutions and urban retail pharmacies reached nearly 200 million RMB, with Takeda Pharmaceutical Company Limited being the sole marketer.

Alogliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors and is indicated for the treatment of type 2 diabetes mellitus in adults. This product was developed by Takeda Pharmaceutical Company Limited, approved for import in China in 2013, and is listed as a Class B drug in the 2020 National Reimbursement Drug List.

Sales of Alogliptin Benzoate Tablets in Chinese Public Medical Institutions and Urban Retail Pharmacies (Unit: RMB 100 Million)

Source: MENET Database

Data from MENET shows that in 2020, the combined sales of alogliptin benzoate tablets across terminal channels in China's public medical institutions (encompassing urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, collectively referred to as China's public medical institutions) and urban brick-and-mortar pharmacies reached nearly RMB 200 million, with Takeda as the sole supplier. Notably, the product has demonstrated remarkable growth in the terminal channels of China's urban public medical institutions, maintaining an annual growth rate consistently exceeding 50% in recent years.

Source: MENET One-Click Search

Currently, there are 11 manufacturers of Alogliptin Benzoate Tablets. Following Yabao Pharmaceutical's acquisition of the first generic approval for this product in late 2019, companies such as CSPC Ouyi Pharmaceutical, Guangdong HEC Pharmaceutical, and Sinopharm Guorui Pharmaceutical successively obtained approvals. Ten domestic enterprises were approved for marketing under the new classification system and are deemed to have passed the consistency evaluation. Additionally, the marketing applications of six companies, including Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. and Ruiyang Pharmaceutical, are currently under review at the Center for Drug Evaluation (CDE).

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

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