Daewoong submits new drug applications for Fexuclue in 10 countries

South Korea's leading drug company Daewoong Pharmaceutical is accelerating its global expansion efforts for its 34th domestically developed drug Fexuclue (active ingredient: Fexuprazan).

The company said on Wednesday that it has submitted new drug applications (NDAs) for the gastroesophageal reflux disease (GERD) drug Fexuclue to authorities in Colombia and Vietnam.

With this, Daewoong said that it has applied for authorization in 10 countries within one year of obtaining permission for the drug in Korea.

According to IQVIA, a drug market research firm, the anti-ulcer drug market in these 10 countries is worth 2 trillion won ($1.54 billion) as of 2021.

The company has completed applications for authorization in four Latin American countries with which it signed technology export agreements in 2021, with Colombia as the most recent. It also submitted an NDA to Vietnam, accelerating its foray into other parts of Asia.

Daewoong Pharmaceutical plans to accelerate its global expansion for the growth of the new drug. Its goal is to apply for approval in 30 countries by 2025, which should lead to the launch in 20 new country markets in the same year. Last month, it won product approval in the Philippines for the first time outside Korea.

Next year, it plans to submit an NDA to China, the world's largest anti-ulcer drug market ($3.4 billion as of 2021).

Daewoong is additionally undertaking phase 3 clinical trials for maintenance therapy after the treatment of erosive GERD and prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs).

Helicobacter pylori eradication clinical trials are also scheduled to commence. In addition, it is preparing to expand its product lineup by developing oral disintegrating tablets and intravenous formulations for easy administration.

"We have completed applications for Fexuclue approval in so many countries in such a short period of time after being given approval in Korea among the new drugs developed at home," said Jeon Seng-ho, CEO of Daewoong Pharmaceutical. 

"This shows our experience and the new drug development capabilities we have accumulated thus far," Jeon added.

Write to Jong-Pil Park at jp@hankyung.com