Xinhua Pharma’s glimepiride passes GQCE



China-based Shandong Xinhua Pharmaceutical Co., Ltd (00719.HK) announced receipt of a supplementary filing approval from the National Medical Products Administration (NMPA) in relation to glimepiride, its generic version of Sanofi's Amaryl, a sulfonylurea drug used to treat type 2 diabetes. The approval indicates completion of generic quality consistency evaluation (GQCE) by Xinhua.

Glimepiride is a safe and effective long-acting hypoglycemic drug, and was first marketed in Sweden in 1995. The drug was first introduced to China in 2000 by Sanofi-Aventis, while Yangtze River Pharmaceutical Group is among domestic firms with generic versions on the market. Glimepiride generated RMB 970 million (USD 141 million) in sales terms in China in 2017. Xinhua Pharma’s version, which has cost the company RMB 10.98 million in R&D investment, achieved domestic sales of RMB 61.26 million with the drug in 2018.


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