Daewoong Pharmaceutical has submitted a new drug application (NDA) for its anti-ulcer drug, Fexuprazan, to China’s Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA).
Fexuprazan is a potassium-competitive acid blocker (P-CAB) that has been developed to treat gastroesophageal reflux disease (GERD).
The company has submitted the NDA based on the data from the Phase III clinical study, which assessed the safety and efficacy of Fexuprazan to treat erosive esophagitis in China.
Sun Yat-sen University professor and Phase III clinical trial presenter Y Xiao stated: “Fexuprazan has several advantages over PPIs. It starts working within just one day and shows equal efficacy regardless of food intake. P-CAB drugs will gradually take the place of PPIs, and Fexuprazan will lead the transition.”
Fexuprazan has exhibited both safety and efficacy in its Phase III clinical trials for treating GERD in China. The studies involved 332 patients with erosive esophagitis.
The drug met all the clinical endpoints, including rapid onset of action and improvement of heartburn, cough, acid reflux and mucosal healing rate.
Daewoong Pharmaceutical CEO Jeon Sengho stated: “The successful completion of Phase III clinical trials and the submission of NDA for Fexuprazan in China, which has rapidly emerged as the world's largest market, are the results of our effective acceleration strategies.
“We are determined to submit NDAs to a total of 30 countries by 2025 and ultimately reach 100 countries by 2027, positioning Fexuprazan as a true global blockbuster new drug.”
