HK inno.N said Thursday that it has obtained product approval from China's National Medical Products Administration (NMPA) for K-CAB (ingredient: tegoprazan), a gastroesophageal reflux disease (GERD).

Shandong Luoxin Pharmaceutical Group, HK inno.N’s Chinese partner, has received approval for K-CAB, a gastroesophageal reflux therapy, from Chinese drug regulators.
Shandong Luoxin Pharmaceutical Group, HK inno.N’s Chinese partner, has received approval for K-CAB, a gastroesophageal reflux therapy, from Chinese drug regulators.

The indication approved in China is for erosive esophagitis.

The approval comes after HK inno.N signed a $95 million technology export contract with Shandong Luoxin Pharmaceutical Group, a Chinese partner, for K-CAB in 2015. Luoxin has submitted an application for approval to NMPA at the end of 2020.

Luoxin, which has the exclusive right for K-CAB in China, from production to distribution, plans to release the drug in the second quarter under a local name, "Taixinzan" which means helping great pleasures.

In close partnership with HK inno.N, Luoxin is steadily expanding the indications of K-CAB to include duodenal ulcer and Helicobacter pylori eradication. The company is also trying to expand the dosage form to an injection type from the existing tablet type.

HK inno.N expects that as Luoxin is a company specializing in the digestive system, which ranks third in the Chinese peptic ulcer drug market, it will be able to establish customized marketing strategies tailored to local characteristics and quickly settle the drug into the market.

"With the launch of K-CAB in China and accelerated clinical trials in the U.S., this year will be the first year for the treatment to enter the global market in earnest," HK inno.N CEO Kwak Dal-won said. "Going forward, we plan to export K-CAB to 100 countries by 2028, including Europe, and foster the drug as a global blockbuster drug."

K-Cab became Korea's 30th novel drug in 2018. It is the first potassium-competitive acid blocker (P-CAB) to obtain the indication for EE(Erosive esophagitis) and NERD(Non-erosive reflux disease) GERD in Korea.

According to the company, while conventional treatments, such as proton pump inhibitors (PPI), need three to five days to show efficacy, K-CAB drugs suppress gastric acid secretion in just one hour. In addition, K-CAB treatments also inhibit excessive secretion of gastric acid during nighttime, reducing chest pain and sleep disorder.

The company has also introduced K-CAB to 27 countries, with its export amount surpassing 1 trillion won ($829.2 million).

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