Daewoong Pharmaceutical's gastroesophageal reflux disease treatment 'Fexuclue' is entering China. Daewoong Pharmaceutical announced on the 5th that it has received product approval for 'Fexuclue (ingredient name Fexuprazan) 40 mg' from the National Medical Products Administration (NMPA) of China. The indication is for the treatment of gastroesophageal reflux disease.
Fexuclue is a third-generation new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical, belonging to the class of 'potassium competitive acid blockers (P-CAB).' It features improvements over the existing proton pump inhibitor (PPI) formulations, which are criticized for their slow onset of action, short half-life, and requirement for pre-meal dosing. In Korea, it was approved as the 34th domestic new drug in 2021 and launched in 2022, with annual sales surpassing 100 billion won last year.
The approval for the product in China came over two years after the application was submitted in June 2023. The company plans to launch Fexuclue into the Chinese market in the second half of next year, implementing a market entry strategy that reflects local characteristics and demand. A company representative noted, 'Product approvals have also been completed in Panama and Colombia, and preparations for launch are underway.'
Daewoong Pharmaceutical aims to enter 100 countries by 2027. Currently, the product has been launched in six countries, including India, Mexico, Chile, Ecuador, and the Philippines.
Park Seong-soo, CEO of Daewoong Pharmaceutical, stated, 'This product approval in China will be a very important turning point for Fexuclue to leap to become a global blockbuster drug,' and added, 'We will do our best to ensure that Fexuclue becomes the most trusted treatment option for patients and medical professionals in China, the world's largest anti-ulcer market.'