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Tonghua Dongbao announces NMPA acceptance of registration application for empagliflozin DS
Date：2022-01-25
Author：東寶
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Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received a notification of acceptance from the National Medical Products Administration (NMPA) on the registration application for empagliflozin drug substance (DS).
Empagliflozin — a highly selective sodium glucose cotransporter-2 (SGLT-2) inhibitor — is a novel, non-insulin-dependent oral anti-diabetic drug that lowers the blood glucose in patients with type 2 diabetes mellitus (T2DM).
With a unique, insulin-independent hypoglycemic mechanism, empagliflozin works by reducing the renal reabsorption of glucose, lowering the renal threshold for glucose, and increasing the urinary excretion of glucose. It can help protect the pancreatic β cells in patients with T2DM, lower their blood sugar and pressure, and mitigate the risk of hypoglycemia. According to the China Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition), empagliflozin can reduce the risk of major adverse cardiac events (MACE) by 14%, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, and hospitalization for heart failure in patients with T2DM.
There is a huge market for empagliflozin, as it is on the fast track to sales growth in China. The brand-name empagliflozin recorded total sales of more than RMB 100 million in China's public medical institutions at all levels as well as urban pharmacies in 2020, up 374.64% from 2019, according to Menet.com, a Chinese medical information aggregator. Empagliflozin was included in China's national centralized volume-based procurement catalog in 2021, which will give a strong boost to its sales in Chinese public medical institutions. At the same time, the sales of empagliflozin across China's urban pharmacies are growing steadily. According to an International Diabetes Federation (IDF) report, China had reported 141 million diabetic patients in 2021, and the figure is expected to reach 164 million by 2030. This suggests that there is a huge demand for hypoglycemic drugs.
The acceptance of the registration application for empagliflozin DS ensures a stable source of the active pharmaceutical ingredient for the Company's follow-up research on related preparations and new drug application. If the empagliflozin DS and related preparations are approved, the Company's diabetes drug portfolio will be expanded, providing diabetic patients with more medication options and boosting the Company's market presence.
