Industry watchers are paying attention to whether Daewoong Pharmaceutical will obtain the marketing approval for Fexuprazan, a gastroesophageal reflux treatment.

This month, analysts at local investment banks began to raise anticipation for the release of Fexuprazan.

Daewoong is waiting for the Ministry of Food and Drug Safety’s review of its application for the permit, and some analysts predicted that the drug could win approval in November.

Kiwoom Securities said in a report on Oct. 12 that it expected the new drug Fexuprazan to obtain the local license in November.

“If it gets approval this year and Daewoong releases it in the first half, the product is expected to generate about 10 billion won ($8.4 million) in revenue in the second half of next year,” the report said.

Sangsangin Investment & Securities also released a report on Friday, saying Daewoong’s botulinum toxin Nabota and Fexuprazan will be new growth engines for the company.

“Gastroesophageal reflux drug Fexuprazan has the potential to become a significant product. It is a next-generation potassium-competitive acid blocker (P-CAB), which competes against inno.N’s K-CAB,” Sangsangin Investment & Securities said, forecasting that Fexuprazan would win the regulatory nod in the fourth quarter this year.

The brokerage also noted that obtaining the local permit could help Daewoong submit data to Brazil and Mexico and release the product there.

In November 2019, Daewoong applied to the MFDS for Fexuprazan approval.

During the past two years, Daewoong actively signed agreements with foreign companies to license out or export the drug.

In March, Daewoong agreed with Shanghai Haini, a Yangtze River Pharmaceutical Group subsidiary, to export 380 billion won worth Fexuprazan to China.

In June, it reached a deal with Neurogastrx, a U.S. biotech firm, to license out Fexuprazan to develop, license, and sell the treatment in the U.S. and Canada.

Recently, Daewoong agreed with Aghrass Healthcare Limited, a United Arab Emirates (UAE)-based company, to export 99.1 billion won worth Fexuprazan to six Middle Eastern countries – UAE, Saudi Arabia, Qatar, Bahrain, Kuwait, and Oman.

Regarding anticipations from the market for Fexuprazan’s winning of local approval this year, an official at Daewoong refused to comment on the drug being reviewed by the government.

However, he was confident about the drug’s competitiveness.

“Fexuprazan demonstrated in clinical trials that it improved symptoms faster than existing PPIs (proton-pump inhibitors) and that its effect lasted longer,” the official said. “If we can roll out Fexuprazan in Korea next year, it will become the best-in-class drug.”