By Kim Hye-soon and Lee Eun-joo
South Korean pharmaceutical firm CJ HealthCare Corp. said on Friday that its gastroesophageal reflux disease drug K-CAB has been approved by the Ministry of Food and Drug Safety, marking the first time for the company to launch an independently-developed novel drug under its name.
K-CAB (tegoprazan) is a gastric acid blocker and a type of potassium-competitive acid blocker (P-CAB). The novel drug, in particular, is world’s first drug that has been approved for the use of both erosive gastroesophageal reflux disease and non-erosive gastroesophageal reflux disease that has been observed to be without destructed mucosa in the esophagus, according to the company. The K-CAB can be taken before or after a meal and it works fast and helps steady acid control, the company said.
CJ Healthcare plans to advance into overseas markets with its first novel drug, which has already been licensed out to China’s Shandong Luoxin Pharmaceutical Group in a 100 billion won ($89.7 million) deal in 2015. The drug is currently going through first clinical test in the country.
An unnamed official from CJ HealthCare said that K-CAB is Korea’s 30th indigenous novel drug that has been launched based on 30 years of research and development capability. The company will put out efforts to nurture the new drug not only in Korea but in global markets as a blockbuster drug.
The latest approval comes after CJ HealthCare - formerly a unit under CJ CheilJedang Corp. - was cleared to launch a preventive vaccine for bacillus pyocyaneus as a novel drug in 2003 but did not make it to the official launch due to marketability issue.
CJ Healthcare, which demerged from CJ CheilJedang as a new entity, was acquired by local cosmetics and pharmaceuticals contract manufacturer Kolmar Korea Co.