Daewoong Pharmaceutical, new drug for gastroesophageal reflux disease, Fexuclu Tablet, applied for product approval in three ASEAN countries
[e대한경제=김호윤 기자] Daewoong Pharmaceutical will further strengthen its global business by entering the Asian market of Fexuclu Tablet (ingredient name: Fexuprazan), a new drug for gastroesophageal reflux disease.
Daewoong Pharmaceutical announced on the 28th that it has submitted a New Drug Application (NDA) for Fexuclu, a new drug for gastroesophageal reflux disease, to the Philippines, Indonesia, and Thailand among countries where overseas corporations and branches are operating (hereinafter referred to as ‘branch countries’). .
| Pexuclu Tablet logo / Photo: Courtesy of Daewoong Pharmaceutical |
Daewoong Pharmaceutical prepared additional research data required by each country in the field and submitted application for product approval sequentially from February to mid-March in three countries. This is the first case of applying for product approval to the branch office as a new chemical drug developed by Daewoong Pharmaceutical since its entry into overseas business, and Daewoong Pharmaceutical holds the right of approval.
The total pharmaceutical market size of the Philippines, Indonesia, and Thailand is approximately KRW 46 trillion based on the Global IMS in 2020, and is a key pharmaceutical market among ASEAN countries. this is expected The market size of Pexuclujeong’s three branch countries is expected to be about 520 billion won.
Fexuclu Tablet is the best-in-class new drug in the gastroesophageal reflux disease family developed by Daewoong Pharmaceutical. It is a P-CAB (Potassium-Competitive Acid) Blocker).
Unlike the existing PPI-based therapeutics, it does not require an activation process, so it has a fast effect from initial administration and has a long half-life, so it is very effective in improving symptoms of heartburn at night. In particular, on the 3rd day of administration, the improvement rate of nighttime heartburn symptoms was higher than that of competitive products, proving that it has an excellent effect through clinical trials. In addition, it has the advantage that it can be taken regardless of meal.
Daewoong Pharmaceutical CEO Jeon Seung-ho said, “In 2022, we plan to accelerate our entry into the global market, starting with the domestic release of Fexuclu Tablet and submission of approvals from three branch countries, which are key markets in the ASEAN region. As the development is progressing according to the target schedule in China and the US, we will develop Fexuclu Tablet as the best-in-class product in the near future and grow it into a global blockbuster product.”
On the other hand, Fexuclu Tablet obtained approval from the Ministry of Food and Drug Safety in Korea last December, and is aiming to launch in Korea in the first half of this year.
Reporter Hoyun Kim khy2751@
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