Daewoong Pharmaceutical submits NDA to China for Fexuclue

Daewoong Pharmaceutical said Tuesday that the company has submitted a new drug application for its gastroesophageal reflux treatment, Fexuclue, to China’s drug agency.

Fexuclue was officially launched in July 2022 in Korea as the country’s 34th new drug. Fexuclue is also the only P-CAB drug for gastritis indications in the country.

Daewoong Pharmaceutical has submitted its NDA to China's National Medical Products Administration based on its clinical trial of the tablet-type drug involving 332 patients with gastroesophageal reflux disease (GERD), in which the company proved the drug’s safety and efficacy.

When approved, Fexuclue will be launched in the rapidly growing Chinese GERD treatment market. According to IQVIA, the Chinese GERD treatment market in 2022 was estimated at 3.3 trillion won ($2.5 billion).

Daewoong anticipated that Fexuclue tablets will be able to increase their share in overseas markets and gradually substitute proton pump inhibitor therapy, the mainstay pharmacologic management for GERD at present.

According to Daewoong Pharmaceutical, its P-CAB treatment is characterized by faster onset of action, compared to the existing PPI-based GERD treatment. Fexuclue also has a longer half-life, meaning that the treatment has a longer duration action than PPIs.

“The latest NDA submission for Fexuclue in China is in line with Daewoong Pharmaceutical’s expansion strategy, through which it aims to accelerate business expansion in the overseas markets,” Daewoong Pharmaceutical CEO Jeon Seng-ho said.

“Daewoong Pharmaceutical plans to submit NDAs to around 30 countries by 2025 and introduce the new drug in some 100 countries by 2027,” Jeon added.

The firm said it is also currently in discussions with international drug companies for Fexuclue’s launches in the US, Europe and Japan.