Daewoong Pharmaceutical applied for product approval for Gastroesophageal Reflux Disease New Drug Fexuclu Tab in three countries including the Philippines, Indonesia and Thailand, and started its entry into the Asian market.
Daewoong Pharmaceutical (CEO Jeon Seung-ho, Lee Chang-jae) is a new drug for gastroesophageal reflux disease (GERD) in the Philippines, Indonesia, and Thailand among countries where Daewoong Pharmaceutical operates overseas corporations and branches. announced on the 28th that it has submitted a New Drug Application (NDA) for
Daewoong Pharmaceutical prepared additional research data required by each country in the field and submitted application for product approval sequentially from February to mid-March in three countries. This is the first case of applying for product approval to the branch office as a new chemical drug developed by Daewoong Pharmaceutical since its entry into overseas business, and Daewoong Pharmaceutical holds the right of approval.
A company official said, “The total market size of pharmaceuticals in the three countries, the Philippines, Indonesia, and Thailand, is about 46 trillion won based on the Global IMS in 2020, which is a key drug market among ASEAN countries. expected,” he said.
Fexuclu Tablet is a new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical. It is a P-CAB (Potassium-Competitive Acid Blocker) formulation that reversibly blocks the proton pump that secretes gastric acid from the stomach wall.
According to the company, Fexuclu Tablet does not require an activation process unlike existing PPI-based treatments, so it has a quick effect from initial administration and has a long half-life, so it is effective in improving symptoms of heartburn at night.
Daewoong Pharmaceutical CEO Jeon Seung-ho said, “In 2022, we plan to accelerate our entry into the global market, starting with the domestic launch of Fexuclu Tablet and the submission of approvals from three branch countries, which are key markets in the ASEAN region.”
He continued, “As additional overseas approvals are scheduled to be submitted within this year, and developments in China and the United States are progressing according to the target schedule, we will develop Fexuclu Tablet as the best-in-class product in the near future and grow into a global blockbuster product. I will do it,” he said.
On the other hand, Fexuclu Tablet obtained approval from the Ministry of Food and Drug Safety in Korea last December, and is aiming to launch in Korea in the first half of this year.
