Daewoong Pharmaceutical said Monday that its P-CAB-based drug Fexuclue recorded the highest sales growth rate in the domestic outpatient prescription market last year.

According to UBIST, a pharmaceutical statistical information service, Fexuclue generated prescription sales of 53.5 billion won ($39.1 million) last year, up from 12.9 billion won in 2022 and marking an annual growth rate of 315 percent. That compared with the 23 billion won increase in prescriptions for the top 10 Korean specialty drugs.

Fexuclue, Korea’s 34th homegrown new drug launched in July 2022, is a third-generation gastroesophageal reflux disease (GERD) treatment in the P-CAB family, which improves the shortcomings of existing GERD treatments, including H2RA (histamine-2 receptor antagonist) and PPI (proton pump inhibitor) drugs by quickly and reliably suppressing stomach acid secretion.

The drug's half-life is nine hours, the longest among GERD medications. It also improves patient convenience by requiring only one dose daily, with or without meals.

Since its launch, Fexuclue has grown at an average monthly rate of 8.6 percent and achieved the No. 2 market share in GERD last year, its second year on the market. By March, it had accumulated prescriptions worth 83.3 billion won.

Daewoong Pharmaceutical also formed a joint marketing partnership with Chong Kun Dang Pharm to sell Fexuclue jointly in April. The strategy is to focus the sales and marketing capabilities of both companies on Fexuclue, which continues to grow rapidly, to drive the growth of the third-generation “P-CAB drug” in the GERD treatment market.

According to Daewoong Pharmaceutical, Fexuclue's domestic indications include erosive gastroesophageal reflux disease and improvement of gastric mucosal lesions in acute and chronic gastritis.

However, further studies are underway to expand the indications also to include the prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs), combination therapy with antibiotics to eradicate Helicobacter pylori (HP), and maintenance therapy after treatment of non-erosive reflux disease (NERD).

In the second half of this year, the indication for gastritis is expected to expand.

"Fexuclue has been experiencing explosive growth due to its excellent efficacy and solid clinical evidence," Daewoong Pharmaceutical CEO Lee Chang-jae said. "Through collaboration with Chong Kun Dang Pharm and expansion of indications and reimbursement, we will make a full-scale leap forward and achieve 300 billion won in sales by 2030 and realize our vision of '1 trillion won per 1 product.’”