Daewoong Pharmaceutical’s gastroesophageal reflux disease drug Fexuprazan obtained approval for a phase-3 trial in China

Daewoong Pharmaceutical’s gastroesophageal reflux disease drug Fexuprazan obtained approval for a phase-3 trial in China - Skipped phase-2 right into approval for phase-3… ‘The goal is to complete the trial in 2022’ - Aims to be #1 in the Chinese gastric acid secretion inhibitor market valued at KRW 3.5 trillion Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced on December 30 that a phase-3 protocol for its gastroesophageal reflux disease drug Fexuprazan was approved by the National Medical Products Administration (NMPA), the pharmaceutical regulator of China. This approval acknowledged phase-1 and 2 trials conducted in Korea and allowed Daewoong to start a phase-3 trial for Fexuprazan in China. However, a short-form phase-1 trial, which is designed to demonstrate the drug’s safety in the Chinese population, must be conducted in parallel. Accordingly, Daewoong is planning to conduct a phase-1 trial on 30 subjects in the first half of the next year while ultimately completing the phase-3 trial by 2022. Daewoong’s independently developed Fexuprazan is a potassium-competitive acid blocker (P-CAB), which reversibly blocks the proton pump that secretes gastric acids from the stomach wall. It is the best-in-class drug which demonstrated a faster effect on improving symptoms in a clinical trial than traditional PPI treatments used for gastroesophageal reflux disease. Daewoong is expected to demonstrate Fexuprazan’s outstanding technology once again and increase its market share in the Chinese gastric acid secretion inhibitor market valued at KRW 3.5 trillion. The company is planning to surpass the PPI ingredient of omeprazole, which currently earns the largest revenue of KRW 70 million in the Chinese market, in a few years. Daewoong presented the results of the phase-3 trial for Fexuprazan in the American Gastroenterological Association in May. According to the presentation, Fexuprazan showed 99% in the treatment rate up to 8 weeks of endoscopic mucosal defect treatment and immediately improved heartburn symptoms regardless of day or night right from administration. In addition, the drug was also confirmed to improve cough, one of the atypical symptoms of gastroesophageal reflux disease. Hyunjin Park, head of Daewoong’s Global Business Division, said, “This protocol was approved only in 3 months after we filed for approval, and it is an achievement of Daewoong’s great development/authorization capabilities and Fexuprazan’s technology. In addition to China, we are preparing to enter the US market, which accounts for 40% of the KRW 40 trillion global market. We will do our best to provide a quality treatment alternative to gastroesophageal reflux disease patients all around the world, including Asia, Latin America and the Middle East.” # # #

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