Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company” or “Tonghua Dongbao”) received the Pharmaceutical Product Registration Certificate for repaglinide tablets issued by the National Medical Products Administration (NMPA). The NMPA approval number is H2022371.

The Company’s repaglinide is another oral anti-diabetic drug (OAD) that was granted a pharmaceutical product registration certificate after sitagliptin and sitagliptin metformin were approved for market last year. This drug will enhance our diabetes product range, provide more treatment options for patients, and increase the number of patients we can serve.

Repaglinide is a non-sulfonylurea secretagogue, also called a mealtime blood glucose regulator. It effectively controls blood glucose levels, especially after meals, and is safe and well-tolerated. This product is commonly used alone or with metformin and basal insulin to treat type 2 diabetes in clinical practice.

Repaglinide tablets were developed by Novo Nordisk and approved for clinical use in the US by the FDA in December 1997 for the treatment of type 2 diabetes (non-insulin-dependent) in patients for whom diet and exercise alone are not sufficient to lower blood glucose. Repaglinide is available in many countries and regions, including the UK, Germany, China, and the EU. It received approval from the China Food and Drug Administration (now known as the National Medical Products Administration or NMPA) in 1999 under the trade name NovoNorm®. The Company’s repaglinide tablets were approved for market as a Class 4 drug under the New Classification System for Registration of Chemical Drugs, and are considered to have passed the generic drug consistency evaluation. Other companies that produce repaglinide and have passed the evaluation include Hansoh Pharma, Beijing Foyou Pharma, and Beilu Pharma.

Currently, the market for repaglinide tablets is dominated by the innovator product. According to the latest data from Menet.com, a Chinese medical information aggregator, in 2021, sales in Chinese public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, exceeded RMB 1.6 billion, with a market share of 51.55% for the innovator manufacturer. Sales in urban physical pharmacies totaled RMB 410 million, with a market share of 80.82% for the innovator manufacturer. However, the inclusion of the product in China’s national centralized volume-based procurement catalog in February 2021 suggests that domestic generic drugs will see increasing market share and eventually replace the innovator drug.

The approval for market of repaglinide tablets will help the Company expand in the OAD market, and offer patients more treatment options on top of its existing insulin products. As a veteran player in China’s diabetes treatment market, the Company has developed a multi-level product portfolio to meet the needs of diverse patients, helping it hold the lead in the industry. Its products on offer and under development include long-acting, intermediate-acting, rapid-acting, and ultra-rapid-acting insulins, dual insulin compound preparations, GLP-1RA, long-acting GLP-1RA, insulin analog and GLP-1RA co-formulations, and multi-target Class 1 novel drugs.