Daewoong Pharmaceuticals and inno.N, the two Korean frontrunners in potassium-competitive acid blocker (P-CAB) drugs for gastroesophageal reflux disease (GERD), are fiercely competing to carve out a larger share in the global market.
inno.N won the title of the first Korean company to develop a new drug for gastroesophageal reflux, according to industry sources.
However, the two-way competition in overseas markets has just begun, they noted.
On Friday, Daewoong Pharmaceuticals said it signed the sixth global license-out and supply contract for Fexuprazan, being developed as a next-generation treatment for gastroesophageal reflux disease. The company signed contracts to export it to the U.S., China, and Latin American countries last year, following the successful export contract made with Mexico and Brazil in 2020.
Daewoong made export contracts of Fexuprazan worth more than 1.1 trillion won ($927 million) over the past two years.
"In addition to the U.S., China, Latin America, we have confirmed the potential of Fexuprazan as a global blockbuster by licensing it out to the Arabian Gulf Region," said Park Hyun-jin, manager of Daewoong’s overseas business division.
inno.N, which succeeded in developing the P-CAB drug K-Cab, is also speeding up its global advancement. The company has licensed out its technology to 24 countries, including China.
The Ministry of Food and Drug Safety has authorized only inno. N's K-Cab and Takeda's Vocinti as P-CAB medicines in the domestic market.
Upon K-Cab’s winning recognition as a new drug in 2018, the company made a kick start in the domestic market, joining the list of new blockbuster medicines by recording 34.7 billion won sales in just a year of its release. Moreover, the sales grew 134 percent to reach 81.2 billion won in 2020.
The launch of Takeda's Vocinti is being delayed, and Daewoong’s Fexuprazan has yet to win the nod in the domestic market.
Daewoong completed domestic phase 3 clinical trials of Fexuprazan in 2019 and has been waiting for regulatory approval. The company expected to score an approval last year, to little avail.
Aside from the home market, inno.N and Daewoong are focusing on expanding their influence in the global market, estimated to be 20 trillion won. inno.N entered the Chinese market first, and Daewoong’s Fexuprazan has landed in the U.S. market ahead of K-Cab.
In the global market, too, inno.N took the lead by signing a deal to export the technology of K-Cab to Luoxin Biotechnology based in China in 2015. The company’s Chinese partner plans to launch the GERD drug next year.
Daewoong signed an agreement with Shanghai Haini Pharmaceutical to transfer its technology in March.
The two partners have designed an abbreviated clinical study with about 30 patients in China to verify the drug's safety and move on to phase 3 clinical trials. Daewoong plans to complete the phase 3 study by the end of 2022.
Daewoong's Fexuprazan only recently joined the global P-CAB market, but the company has gotten a head start by making technology transfer deals in the U.S. market. The company's strategy is to enter phase 3 clinical trials in the U.S.
Daewoong’s U.S. partner, Neurogastrx, has also drawn a $60 million Series B investment to speed up developing Fexuprazan.
inno.N has yet to find a U.S. partner to supply K-Cab. The company began phase 1 clinical trial in 2020 in America and negotiated to settle an agreement with local pharmaceutical companies.
"We plan to target the global market by diversifying K-Cab and expanding indications based on our solid domestic market share," an inno.N official said.