South Korea-based Daewoong Pharmaceutical (KRX: 069620) has revealed that a new drug application (NDA) has been filed in China for Fexuclu/Abcito (fexuprazan) in a 40mg dosage form. Fexuclu, an in-house developed potassium-competitive acid blocker (P-CAB), represents a new generation of therapies for gastroesophageal reflux disease (GERD).
Advantages of P-CABs Over Traditional PPIs
P-CABs, such as Fexuclu, are designed to offer improvements over traditional proton pump inhibitors (PPIs), with a faster onset of action, longer half-life, and fewer drug interactions. This new generation therapy has the potential to revolutionize the treatment of GERD, offering patients a more effective and safer option.
Sales Performance and Market Potential in China
The drug was approved in South Korea in July 2022 and has since generated over KRW 30 billion (USD 23 million) in sales over 11 months. Fexuclu will be marketed in China by Shanghai Haini Pharmaceutical Co., Ltd, a subsidiary of Yangtze River Pharmaceutical Group, following a licensing deal signed in 2021. The deal involved an upfront payment of USD 18 million and is worth up to USD 338 million overall.
Daewoong’s Ambitions for Fexuprazan in the GERD Market
Daewoong views fexuprazan as having best-in-class potential and has set its sights on overtaking omeprazole as the leading GERD treatment on the market. The company has noted that PPI omeprazole generates around USD 647 million in China market sales annually, with the overall market for GERD therapies worth some USD 3.2 billion. This indicates a significant opportunity for Fexuclu to capture a substantial market share.-Fineline Info & Tech
