Announcement on Acceptance of Application for Esomeprazole magnesium for delayed release oral suspension

Generic name: Esomeprazole magnesium for delayed-release oral suspension

Dosage form: delayed-release oral suspension  

Registration category: 5.2 category

Beimei Pharma and Cipla Ltd. have come to an exclusive license agreement for esomeprazole magnesium for delayed-release oral suspension in October 2020. According to the agreement, Beimei Pharma is responsible for the registration and commercialization of the product in mainland China. It only took Beimei team three months to complete the translation, write-up, proofreading, and submission of the MAA dossier, the team has officially received the acceptance letter issued by the Drug Evaluation Center of the National Medical Products Administration on April 7 2021 and the review was initiated. 

Esomeprazole is the S isomer of omeprazole and the first proton pump inhibitor drug with sole optical isomer. Compared with omeprazole and R-isomer, esomeprazole has low liver first-pass clearance, slow intrinsic clearance, high AUC value, high and long-lasting concentration in plasma, and its effect on proton pump and the inhibiting effect on gastric acid secretion is stronger. 

In 2020, the Chinese market for proton pump inhibitors exceed US$3 billion, and the market is still in a period of rapid growth. Among them, esomeprazole is the fastest-growing proton pump inhibitor, with a global market of US$ 4.3 billion and a Chinese market of US$ 522 million. The potential of esomeprazole’s future market is great and promising. 

Esomeprazole magnesium for delayed-release oral suspension will be the sole US FDA -approved child-specific imitation proton pump inhibitor in China. The oral suspension has specific advantages including stable storage, unit dose, accurate dosage, good taste, and convenient administration. The product has a lower frequency of administration and only taken once daily, which greatly improves the adherence of children. Thus, the product is the proton pump inhibitor "tailor-made" for children. The product will be the exclusive formulation in China and providing a new PPI treatment option for Chinese children and patients with dysphagia.