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Photo courtesy of Yonhap News |
[Alpha Biz= Paul Lee] GERD drug project halted at commercialization stage despite prior regulatory approval
Daewoong Pharmaceutical has terminated its supply agreement in China for fexuprazan (brand name: Fexuclu), a treatment for gastroesophageal reflux disease (GERD), in a move that disrupts what had been considered a key global growth project.
In a regulatory filing on Feb. 12, the company said it had canceled its supply contract with China’s Yangtze River Pharmaceutical Group. The reason cited was the counterparty’s failure to fulfill its obligations regarding product approval acquisition and commercialization, including sales.
The agreement, originally signed in March 2021 and set to run through April 2036, was valued at approximately KRW 384.5 billion—equivalent to more than 36% of Daewoong Pharmaceutical’s consolidated revenue at the time.
Under the structure of the deal, the Chinese partner was responsible for obtaining regulatory approval and handling commercialization within China. The project had been viewed as a cornerstone of Daewoong’s global pipeline strategy.
Fexuprazan received marketing approval from China’s National Medical Products Administration (NMPA) in September last year for the treatment of erosive reflux esophagitis. However, although regulatory clearance was secured, subsequent commercialization steps—such as establishing production and distribution systems and participating in hospital bidding processes—appear not to have progressed in line with contractual timelines.
Daewoong Pharmaceutical said it now plans to explore entry into the Chinese market through its Beijing subsidiary.
Fexuprazan, approved in South Korea in 2019, is the country’s 34th domestically developed new drug. It is considered a next-generation acid suppressant developed with Korean technology, following traditional proton pump inhibitors (PPIs). In Phase 3 clinical trials conducted in China, the drug demonstrated therapeutic efficacy comparable to the standard treatment, esomeprazole.
Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)
