AstraZeneca's Nexium (Esomeprazole Magnesium) Approved in China for GERD Treatment in Adolescents Aged 12 and Above

China Finance Network December 29th, by reporter Du Ding — AstraZeneca announced today that the National Medical Products Administration (NMPA) has officially approved Nexium (Esomeprazole Magnesium) for the treatment of Gastroesophageal Reflux Disease (GERD) in adolescents aged 12 years and above.

Gastroesophageal reflux (GER) refers to the backflow of gastric contents into the esophagus, and even the oropharynx, which is a physiological phenomenon. It is a common physiological phenomenon in children, with an incidence rate as high as 75%. When the frequency and duration of reflux increase to a certain extent, reaching a pathological state or causing discomfort to the body, it is referred to as gastroesophageal reflux disease (GERD).

Studies show that the symptoms of gastroesophageal reflux disease (GERD) in children vary in severity, usually depending on the intensity and duration of reflux, presence of complications, and the child’s age. Obesity or overweight, prolonged reflux time, bile acid reflux, and abnormal gastrin secretion are all risk factors for GERD in children. When children experience symptoms such as vomiting, abdominal pain, chest pain, and coughing, the possibility of GERD should be highly suspected.

Currently, the treatment methods for children with gastroesophageal reflux disease mainly include lifestyle changes, medication, and surgical treatment. Among these, medication is the preferred option, including acid suppressants and antacids, mucosal protectants, prokinetic agents, and proton pump inhibitors represented by esomeprazole magnesium. As the first choice for treating gastroesophageal reflux disease, proton pump inhibitors irreversibly bind to H+-K+-ATPase (commonly known as the proton pump) on gastric parietal cells, blocking the final step of gastric acid secretion by the parietal cells, thereby exerting an acid-suppressing effect with generally good prognosis.

Dr. He Jing, Senior Vice President of AstraZeneca Global and President of the Global R&D China Center, stated that the incidence of gastroesophageal reflux disease is high among children, representing an urgent medical need. "Based on extensive overseas data combined with extrapolated data from physiologically-based pharmacokinetic models, esomeprazole magnesium has been successfully approved for the treatment of gastroesophageal reflux disease in adolescents aged 12 years and older. This not only provides a new drug solution for pediatric patients in China but also reflects AstraZeneca's commitment to meeting the needs of Chinese patients while being rooted in China."

AstraZeneca China General Manager Minglong Lai stated that the expansion of the indications for Esomeprazole Magnesium to adolescents not only provides a new treatment option for children suffering from gastroesophageal reflux disease and their families, but also further enriches and enhances AstraZeneca's product pipeline in the field of digestive treatment.