Kelun Pharma's Trelagliptin Succinate Tablets Enter Administrative Approval Stage, Racing to Become China's First Generic

Recently, Kelun Pharmaceutical's琥珀酸曲格列汀片, reported for production as a Category 3 generic drug, has entered the administrative approval stage, striving to become the first domestically produced generic version in China. 琥珀酸曲格列汀 is a new type of ultra-long-acting oral hypoglycemic drug, belonging to the DPP-4 inhibitor class. Data from MiNe Network shows that in 2020, the sales of DPP-4 inhibitors in Chinese public medical institutions and retail pharmacies in Chinese cities exceeded 3 billion yuan.

Trelagliptin succinate, a novel long-acting oral hypoglycemic agent developed by Takeda and Furiex, belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. This product was first approved for marketing in Japan in March 2015, making it the world's first once-weekly oral hypoglycemic drug.

Currently, Takeda's Zafatek (Trelagliptin Succinate) Tablets have not been submitted for marketing approval in China. There are six DPP-4 inhibitors already marketed in China, including Sitagliptin Phosphate Tablets, Saxagliptin Tablets, Alogliptin Benzoate Tablets, Vildagliptin Tablets, Linagliptin Tablets, and Teneligliptin Hydrobromide Tablets. Except for Teneligliptin Hydrobromide Tablets, multiple generic versions of the other five DPP-4 inhibitors have received marketing approval.

Data from MiNe Network shows that the market size of DPP-4 inhibitors in China's urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (referred to as China’s public medical institutions) as well as retail pharmacies in Chinese cities exceeded 3 billion yuan in 2020, representing a year-on-year increase of 29%.

DPP-4 Inhibitor Submitted for Marketing Approval by Kelun Pharmaceutical

Source: MiNeiNet MED2.0 China Drug Evaluation Database

For DPP-4 inhibitors, Kelun has submitted registration applications for four varieties, including Trelagliptin Succinate Tablets, Tigliptin Hydrobromide Tablets, Linagliptin Tablets, and Sitagliptin Phosphate Tablets. Among them, Linagliptin Tablets and Sitagliptin Phosphate Tablets have been approved for production and are considered to have passed the evaluation.

Succinate Truglitazone Tablets have only been submitted for marketing approval by Kelun and CSPC. The registration status of Kelun's product has changed to "under review". If approved, it will be considered as passing the evaluation and become the first domestically produced generic drug in China.

It is worth mentioning that the teneligliptin hydrobromide tablet, exclusively submitted for production by Kelun, is also expected to be approved by the end of 2022, becoming the first domestically produced generic drug in China.