Qilu Pharmaceutical Secures First-to-File Approval in China for Metformin/Vildagliptin Tablets (ANDA Category 4)

Today (January 29), the NMPA website showed that Qilu Pharmaceutical’s application for marketing approval of metformin and vildagliptin tablets, filed under Category 4 generics, was approved and deemed to have passed the consistency evaluation, making it the first domestic generic version. Metformin and vildagliptin tablets are a combination antidiabetic drug. Data from Menet shows that in the first half of 2020, sales of metformin and vildagliptin at public medical institutions in China exceeded RMB 30 million, representing a year-on-year increase of 154.04%.

Metformin and Vildagliptin Tablets are a combination antidiabetic medication composed of metformin and vildagliptin. Metformin, a biguanide oral hypoglycemic agent, operates through multiple mechanisms of action, while vildagliptin, a DPP-4 inhibitor, promotes insulin secretion and enhances the glucose-lowering effect. The originator of this product is Novartis, and it was approved for marketing in China in 2014.

Sales of Metformin and Vildagliptin at Public Medical Institution Terminals in China

Source: Menet’s Competitive Landscape of China’s Public Medical Institution Terminals

In recent years, the domestic market size of metformin and vildagliptin tablets in China has continued to expand. Data from Menet shows that in the first half of 2020, sales of metformin and vildagliptin in Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 30 million, representing a year-on-year increase of 154.04%.

Metformin and Vildagliptin Tablets Under Review and Approval by the Company

Source: Menet MED2.0 China Drug Evaluation Database

Previously, three companies—Qilu Pharmaceutical, Yangtze River Pharmaceutical Group, and Nanjing Youke Pharmaceutical—submitted marketing applications for metformin and vildagliptin tablets under the new registration classification. The products from Yangtze River Pharmaceutical Group and Nanjing Youke Pharmaceutical are still under review and approval, while Qilu Pharmaceutical has taken the lead in obtaining approval, securing the first generic version, with another specification currently under review.

Source: Menet Database, NMPA