[메디칼업저버 손형민 기자] Daewoong Pharmaceutical is accelerating the global expansion of its 34th domestically produced new drug, Fexuclu (ingredient: Fexuprazan).
Daewoong Pharmaceutical (CEOs Jeon Seung-ho and Lee Chang-jae) announced on the 14th that they recently submitted a New Drug Application (NDA) for Fexuclu, a new drug for gastroesophageal reflux disease, to Colombia and Vietnam. As a result, Daewoong Pharmaceutical completed NDA applications to 10 countries worldwide within a year of obtaining approval for Pexuclu in Korea.
According to the 2021 standard of IQVIA, a pharmaceutical market research organization, the cumulative anti-ulcer drug market in 10 countries, including the two countries that submitted the product approval this time, is known to be worth about 2 trillion won. The 10 countries that Daewoong Pharmaceutical has so far submitted an application for permission for Fexuclu are Brazil, the Philippines, Indonesia, Thailand, Mexico, Chile, Ecuador, Peru, Colombia and Vietnam.
Daewoong Pharmaceutical has completed the submission of licenses for four Latin American countries (Chile, Ecuador, Peru, and Colombia) and signed an external license contract in 2021 with Colombia as the last, and has submitted an NDA to Vietnam to further accelerate its progress. into the Asian market.
Daewoong Pharmaceutical plans to further accelerate its global expansion for the growth of blockbuster new drug Pexuclu. Daewoong Pharmaceutical, which has prepared a step-by-step mapping strategy, aims to apply for product approval in 30 countries worldwide by 2025 and launch Fexuclu in 20 countries.
In particular, in November, it obtained approval of an item in the Philippines for the first time in a global country, and in 2023, it plans to submit an application for approval of an item to move on to China, which has grown into the largest market of a world beyond the market. The United States won with an anti-ulcer drug market size of 4.37 trillion (21 years). .
Daewoong Pharmaceutical said, “The fact that Pexuglu completed applications for approval in most countries in a short period of time after approval in Korea among new drugs developed in Korea proves the knowledge accumulated over a long period of time in foreign business and the ability to cultivate new global drug blockbusters. “By reducing the gap between the release schedule in Korea and abroad, we can ensure the maximum patent deadline period for new drugs overseas.”
“This year, we completed the submission of consent in 10 countries and achieved a high achievement of approval in the Philippines in November last year after 8 months of first submission of consent among foreign countries, and next year, through overseas approval sequential. and release, Pexuclu will become a major worldwide success. We intend to continue to nurture it.”
