The Korea Herald


Daewoong Pharmaceutical submits a new drug application for Fexuprazan in China challenging the world's largest market for anti-ulcer drugs


Published : July 31, 2023 - 10:10

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– Daewoong Pharmaceutical, "Expecting the smooth approval with the successful phase 3 clinical trial in China aiming to reach 100 countries by 2027"

SEOUL, South Korea, July 31, 2023 /PRNewswire/ -- 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."

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. These statements are subject to various risks, uncertainties, and assumptions that could cause actual results to differ materially from those anticipated in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.