Daewoong Pharmaceutical, "Expecting the smooth approval with the successful phase 3 clinical trial in China aiming to reach 100 countries by 2027"
The submission of NDA came after the successful completion of the phase 3 clinical trial. (Credit: valelopardo from Pixabay)
Daewoong Pharmaceutical’s domestically produced drug no. 34 Fexuprazan, a newly developed one for the treatment of gastroesophageal reflux disease (GERD), is aggressively targeting the Chinese market for anti-ulcer drug agents, which is the largest in the world, estimated at 3 trillion KRW, in less than one year since the release in South Korea last July.
Daewoong Pharmaceutical (CEO Jeon Seng-ho, Lee Chang-jae) announced the submission of a New Drug Application (NDA) for their Potassium-Competitive Acid Blocker (P-CAB) drug Fexuprazan to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China.
The submission of NDA came after the successful completion of the phase 3 clinical trial evaluating the efficacy and safety of Fexuprazan for the treatment of erosive esophagitis in China. Regarding the successive overseas advances, Daewoong Pharmaceutical said that Fexuprazan is serving as a ‘game changer’ in the global GERD market, reshaping the treatment paradigm.
With the successful phase 3 clinical trials in China, the acquisition of approval for Fexuprazan is expected to be smooth. Fexuprazan demonstrated its efficacy and safety through Phase 3 clinical trials for GERD treatment conducted on 332 patients with erosive esophagitis in China. It successfully achieved all the clinical endpoints, including rapid onset of action, mucosal healing rate, and improvement of heartburn, cough, and acid reflux.
Y. Xiao, a professor at Sun Yat-sen University, who presented the phase 3 clinical trial in China, said, “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.”
Jeon Sengho, CEO of Daewoong Pharmaceutical, said, “The successful completion of phase 3 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,” adding “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.”
Source: Company Press Release