CJ Healthcare said Friday that it has received sales approval for K-CAB, a gastroesophageal reflux treatment, from the Ministry of Food and Drug Safety (MFDS).
The treatment is CJ Healthcare’s first in-house developed drug and the 30th locally developed drug approved by the health regulator.
The ministry approved the drug for the treatment of erosive gastroesophageal reflux disease (ERD) and non-erosive gastroesophageal reflux disease (NERD). The company expects that the treatment will rapidly replace the conventional PPI market.
P-CAB (Potassium-Competitive Acid Blocker), K-CAB’s main ingredient, is known to be the most advanced gastroesophageal reflux drugs. The substance is also known to overcome significant limitations of existing PPI drugs.
Clinical trial results of K-CAB showed fast and robust gastric acid secretion inhibitory effect within an hour from the first day of administration. Also, the drug has increased patient convenience as patients can take the medication regardless of meals, while the individual drug efficacy differences and drug interaction concerns are relatively low.
The company also expects the drug will reduce chest pain resulting from early gastric acid reflux and sleep disorders, as it confirmed that the treatment suppressed excessive gastric acid secretion at night.
CJ Healthcare believes that K-CAB has the potential to reach sales of 100 billion won ($89.4 million) in Korea and 1 trillion won in global sales and is running various clinical trials to maximize the drug’s value.
“K-CAB, which is the 30th locally developed drug, well represents CJ Healthcare’s R&D capabilities,” CJ Healthcare CEO Kang Seok-hee said. “We will develop the therapy into a global blockbuster drug.”
The company plans to start K-CAB’s marketing from next February.
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