Guangdong HEC Pharmaceutical’s Class 4 generic drug: Linagliptin Tablets and Nanjing Sanhome Pharmaceutical’s Class 4 generic drug: Vildagliptin Tablets were both approved in China on July 13, which will bring huge changes to the market pattern of DPP-4 inhibitors in China and receive significant attention. Let’s now check them.
Fig. I Linagliptin and Vildagliptin Approval Information
(Screenshot of CDE website)
Let’s first check the approval of Guangdong HEC Pharmaceutical’s Class 4 generic drug: Linagliptin Tablets, the first generic of the variety in China. Co-developed by Boehringer Ingelheim (BI) and Eli Lilly, the original drug of linagliptin is a highly selective, potent DPP-4 inhibitor as an oral hypoglycemic used to treat type 2 diabetes as a monotherapy or in combination with metformin or metformin and sulfonylureas. The original drug was approved for marketing in China in Apr. 2013 (trade name: Trajenta), and the related market has been occupied by Boehringer Ingelheim (China) Investment Co., Ltd. The drug approved this time is the first generic of linagliptin in China, therefore, it has received great attention.
Fig. II Linagliptin Structural Formula
According to the Center for Drug Evaluation, NMPA (CDE website), BI has filed two supplementary applications for Linagliptin Tablets this year. Furthermore, a Class 4 generic drug application of CSPC Ouyi Pharmaceutical Co., Ltd. has also been filed.
Fig. III Linagliptin Tablets Acceptance Information on CDE Website
Next, let’s check Nanjing Sanhome Pharmaceutical’s Class 4 generic drug: Vildagliptin Tablets. Originally developed by Novartis, vildagliptin is also a DPP-4 inhibitor as an oral hypoglycemic used to reduce the blood sugar of patients with type 2 diabetes, with advantages including not easily inducing hypoglycemia and producing no effect on patients’ weight. Sales of vildagliptin reached nearly USD1.3 billion in 2019. The drug first entered the Chinese market in 2011 and is used to treat patients with type 2 diabetes in combination with metformin when metformin, as a monotherapy, has poor blood sugar control.
Besides the developer Novartis, vildagliptin generic drugs of Hansoh, Qilu and Beijing Tide have b...
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