[Korean New Drugs Going Global ①] Launched in July Last Year, Already Approved in 4 Countries around the World

Fexuclue, a drug for gastroesophageal reflux disease.

[Editor’s note] Daewoong Pharmaceutical has presented a blueprint for its leap to a global big pharma. The company plans to achieve 1 trillion won in global sales by 2030, led by its gastroesophageal reflux disease (GERD) drug Fexuclue and diabetes drug Envlo, which have been successfully developed for two consecutive years. Daewoong Pharmaceutical recently announced this vision at the 'CPHI Worldwide 2023' in Spain. Its strategy is to seek to enter the global market within the patent period of a new drug by going for global product approval and contracts simultaneously during the new drug development stage and promoting domestic launches and overseas expansion. In this article, <Wikileaks Korea> covers the back story of the development of two Korean new drugs, ① Fexuclue and ② Envlo, and the status of their entry into the global market.

At the Convention on Pharmaceutical Ingredients (CPhI) 2023 in Barcelona, Spain, in October 2023, Daewoong Pharmaceutical presented its vision for global product approval and simultaneous expansion of its new drug lineup. Employees of Daewoong Pharmaceutical explain their future plans for new drug development to overseas buyers. [Photo courtesy of Daewoong Pharmaceutical]

◆ Korean new drug No. 34…”Going for the Mexican market next year”

The new drug for gastroesophageal reflux disease, Fexuclue, is growing into a "global blockbuster," having been approved in four countries and generating 55 billion won in sales within two years of its launch.

Fexuclue entered the market in July 2022 as Korea's 34th new drug. In the following two years, it has applied for product approval in 12 countries around the world and was approved in four countries, including the Philippines, Ecuador, Chile, and Mexico.

In particular, with last month's approval in Mexico, the largest pharmaceutical market in Central America, the company's entry into the Central American market has become in full swing. It is expected to be launched in the first half of next year under the Mexican product name 'ABCITO'.

According to pharmaceutical market research firm IQVIA, the market size of anti-ulcer drugs in Mexico last year was $250 million (270 billion won).

In addition to the four countries where it has received approval, Daewoong Pharmaceutical has also applied for approval in 12 other countries, including Brazil, Vietnam, Saudi Arabia, Indonesia, Colombia, Thailand, Peru and China.

The company aims to apply for approval in 20 countries within this year and 30 countries in 2025, and to enter 100 countries by 2027.
"As we have recently successfully completed due diligence with the Brazilian Health Regulatory Agency (ANVISA), we will quickly obtain approval in Brazil, the number one market in South America, to dominate the Latin American market and achieve our goal of entering 100 countries by 2027," said Mr. Jeon Seng-Ho, CEO of Daewoong Pharmaceutical.

He emphasized, "We are negotiating with several multinational pharmaceutical companies for simultaneous clinical development in North America, Europe, and Japan, and have signed export contracts with 15 countries, including China.“

Global launch status of gastroesophageal reflux disease drug 'Fexuclue'. [Photo courtesy of Daewoong Pharmaceutica]

◆ CEO Jeon Seng-Ho confidently says, "'Fexuclue' will enter 100 countries“

Fexuclue's strong growth is driven by the global revival of the P-CAB class of drugs (potassium-competitive acid blocker).

Fexuclue is a member of the P-CAB drugs that block the proton pump secreting gastric acid in the stomach lining. It has the half-life of 9 hours, the longest of any GERD drugs, which means that it works for a long time after a single dose.

The global P-CAB market is expected to grow from 61 billion won in 2015 to 1.876 trillion won by 2030, at an average annual growth rate of 25.7%, according to global market research firm BCC Research.

Today, Fexuclue's cumulative revenue is 55 billion won. With a steep monthly revenue growth rate of 15%, it surpassed 10 billion won in the sixth month after launch and 20 billion won in the ninth month.

Daewoong Pharmaceutical aims to achieve '1 trillion won in annual sales by 2030' with its self-developed new drugs.

At the CPhI held last month in Barcelona, Spain, from April 24-26, the company announced its vision to become a global pharmaceutical giant through global drug approval (Efficiency), simultaneous drug lineup expansion (Extension), and overwhelming production excellence (Excellence) in its smart factories.

[WIKI KOREA=Cho Eun, Reporter]

choeun@wikileaks-kr.org

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