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Tonghua Dongbao announces NMPA acceptance of its NDA application for repaglinide tablets
Date：2021-06-10
Author：東寶
Views：2
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (“Tonghua Dongbao” or the “Company”) received the notification of acceptance from the National Medical Products Administration (NMPA) on the NDA application for repaglinide tablets. This marks a milestone in the Company’s efforts in the consistency evaluation of the quality and efficacy of generic drugs, and lays a solid foundation for its R&D of novel diabetes drugs.
About repaglinide tablets
Insulin secretagogues are one type of glucose-lowering medicine widely used in clinical practice, and repaglinide is a non-sulfonylurea insulin secretagogue, which can provide effective glycemic control, especially in the postprandial period. Due to its good safety and tolerability, it is widely used to treat type 2 diabetes.
Repaglinide tablets were originally developed by Novo Nordisk and approved by the US FDA for clinical use in December 1997 for patients with type 2 diabetes (non-insulin-dependent) for whom diet and exercise alone fail to lower blood glucose. It is available in many countries and regions, including the UK, Germany, China, and the European Union, and was approved by the CFDA in China in 1999, with a trade name of NovoNorm?.
The Company has filed the NAD application for this product in accordance with the requirements for the consistency evaluation of the quality and efficacy of generic drugs. If the NAD application is approved, the product passes the consistency evaluation. So far, only two Chinese generic drug manufacturers (Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and Beijing Winsunny Pharmaceutical Co., Ltd.) have completed the consistency evaluation for this product.
Accelerated commercialization of R&D results enriches the Company’s product portfolios
According to data from MENET, in 2018, the sales of repaglinide in public medical institutions and brick-and-mortar pharmacies in China exceeded RMB 2.5 billion, accounting for 10% of the overall domestic market for hypoglycemic drugs.
The NDA application for repaglinide tablets provides valuable experience for the Company in the registration and consistency evaluation of generic drugs, and lays a solid foundation for the Company’s independent R&D of novel endocrine drugs. If approved for marketing, the product is expected to further enrich and upgrade the Company's diabetes product portfolio and provide patients with more choices. It will also enhance the Company’s confidence and determination to be an explorer and leader of novel drugs R&D in the field of endocrinology.
