[THE INVESTOR] Hanmi Pharmaceutical said on July 19 it has become the first Korean firm to have a reflux esophagitis drug listed with the US Pharmacopeial Convention.

The treatment, Esomezol, was the first incrementally improved drug for gastroesophageal reflux disease that was developed by a homegrown firm to receive the US Food and Drug Administration’s approval in 2013.

Hanmi Pharmaceutical's headquarters in Seoul

“With the US listing, the sales and marketing of Esomezol are expected accelerate in the North American market as its quality and function has been internationally recognized,” said Woo Jong-soo, CEO of Hanmi Pharmaceuticals in a statement.

The designation means that Hanmi’s testing method and management specification for Esomeprazole Strontium, the active ingredient of Esomezol, is becoming a norm for other drug candidates using the same ingredient in the future.

The US convention is a nonprofit body that sets quality standards for medicines. Under the law, medical treatments that don’t meet the standards are not eligible to be sold or manufactured in the country.

Esomezol is an incrementally improved drug referencing AstraZeneca’s Nexium, which recorded more than 2 trillion won (US$1.78 billion) in sales in the US alone. Hanmi sells Esomezol in 14 states in the US through R2 Pharma and plans to further expand its sales.

By Park Han-na (hnpark@heraldcorp.com)