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.


Related news
Details of the recent drug tender round convened by Shanghai’s municipal Group Purchasing Organization (GPO) have come to light, revealing growing pressure on originator brands thanks to volume-linked pricing.
The China Food and Drug Administration (CFDA) issued a notification relating to generic drug quality and efficacy consistency evaluations, providing a batch of reference preparations for such purposes.
Sanofi-aventis and the Chinese Medical Association (CMA) have jointly established a “one-stop” diabetes education center at the Second Hospital of Beijing Chaoyang District.
Recent news
Argentina-based Laboratorios Bagó this week opened a new injectable drugs production facitlity in Buenos Aires.
Brazil’s health technology company WW8 last week launched its platform Athimos (, a medical communications and patient records system.
Brazil’s Ministry of Health has requested the Oswaldo Cruz Foundation (Fiocruz) to supply the Unified Health System (SUS) with immunosuppressant tacrolimus for kidney and liver transplant patients.
Cuba’s state-run biopharmaceutical group BioCubaFarma this week presented its products to Chile’s biotechnology and pharmaceutical industry.
Beijing-headquartered Contract Research Organization (CRO) Joinn Laboratories (China) Co., Ltd (603127.SH) has entered into an equity purchase agreement with U.S.-based pre-clinical CRO Biomedical Research Models Inc​.
The National Health Commission released its annual statistical round-up of China’s national health system during 2018.
Shanghai-based Allist Pharmaceuticals Inc., raised RMB 1.18 billion (USD 162 million) via a Series A financing round led by Shenzhen Shiyu Investment Management Co., Ltd​.
Analytics Snapshot