Hainan Poly Pharm.Co.Ltd(300630) (300630) announced on the evening of February 10 that the company recently received the notification of the technical review report of esmeprazole sodium for injection approved by the Dutch drug evaluation committee (hereinafter referred to as “CBG”).
According to the announcement, esmeprazole is a single L-isomer of omeprazole. Both belong to proton pump inhibitors, which can effectively inhibit gastric acid secretion. It is clinically used to treat gastroesophageal reflux disease, erosive reflux esophagitis, etc. The drug is one of the successful examples of isomer development. Compared with the first generation omeprazole, it has stronger inhibitory effect on gastric acid and less adverse reactions. The drug was first developed by AstraZeneca. Its oral preparation was listed in Sweden in 2000. Its trade name is Nexium. The injection was launched in 2003.
Hainan Poly Pharm.Co.Ltd(300630) was successfully developed and applied for generic drug registration in Europe, the United States and China respectively. Recently, the company received the approval notice from the Dutch drug evaluation committee, and the review conclusion was approval. At present, it has entered the review and approval stage of product feature summary, instructions and labels in the national stage of the Netherlands and Germany, and then the product can be listed and sold in the markets of the Netherlands and Germany.
