(Health Korea News / Soon-ho Lee) Daewoong Pharmaceutical, which is leading the local production of raw drug products, has begun producing raw materials for its new drugs, which were supplied from overseas, in-house with the goal of entering the global market.
Daewoong Bio recently registered its factory as a manufacturing site for Inabogliflozin, the raw material for Daewoong Pharmaceutical’s ‘Enblow’, on the Ministry of Food and Drug Safety’s Drug Material Registration (DMF) list.
‘Enblo’ is the first domestic SGLT-2 inhibitor type 2 diabetes treatment developed by Daewoong Pharmaceutical. Daewoong Pharmaceutical has so far imported the raw materials for ‘Enblo’ from ‘Shanghai SynTheAll Pharmaceutical Co., Ltd’ in China.
Unlike the new drug ‘Fexuclu (Fexuprazan)’ for the treatment of gastroesophageal reflux disease, which was produced in-house through Daewoong Bio, it used raw materials produced in China even though it was a self-developed new drug. It is also different from the fact that most domestically produced new drugs mainly source raw materials from domestic manufacturing plants.
At the time, the company explained to this magazine, “Considering Enblo’s global expansion, we selected a raw material producer with extensive experience in global expansion,” and “However, depending on our internal strategy, raw material suppliers can be added or changed.”
Meanwhile, the addition of Daewoong Bio as a raw drug manufacturing site for ‘Enblo’ is accepted as meaning that there has been a change in Daewoong Pharmaceutical’s internal strategy. In particular, considering that Daewoong Pharmaceutical has recently been actively promoting the local production of raw pharmaceutical ingredients for its flagship products, it is believed that its own production of ‘Enblow’ raw materials is not unrelated to this.
Daewoong Group’s three core affiliates, including Daewoong Pharmaceutical, Daewoong Bio, and Daewoong Therapeutics, were selected as the overall and detailed managers of the ‘2024 Materials and Components Technology Development Project’ for the local production of raw medicines for hyperlipidemia treatment hosted by the Ministry of Trade, Industry and Energy last month. Done.
The goal of this project is to domestically produce raw materials for the treatment of hyperlipidemia in the third-generation statin series, such as pitavastatin, and to develop technology that can produce all intermediates and finished drugs domestically. This project will run for a total of 54 months from this year to December 2028, and the government will support research and development costs worth a total of 18 billion won.
Through this national project, Daewoong Pharmaceutical plans to present a successful model of vertical integration of domestic production from raw materials to finished products and increase the actual self-sufficiency rate and global competitiveness of domestically produced raw materials and finished drugs.
The rapidly increasing sales of ‘Enblow’ are also likely to have influenced Daewoong Bio’s registration as a raw drug manufacturing site for Inavogliflozin.
The ‘Enblo’ family, which consists of the single drug ‘Enblo Tablet’ and the combination drug ‘Enblomet (inavogliflozin + metformin)’, has been expanding its prescription performance, showing an average monthly growth rate of 14% since its launch. This product line, which exceeded 270,000 tablets in prescriptions in the first month of launch, achieved a cumulative outpatient prescription volume of 10.2 billion won in July of this year.
This is an impressive achievement considering the market environment in which existing competitive SGLT-2 inhibitor generics are pouring in.
In addition, ‘Enblo’ recently obtained its first overseas product approval in Ecuador and began making inroads into the global market. Applications for product approval have been submitted to a total of 12 countries, including Ecuador, Mexico, Saudi Arabia, Indonesia, Thailand, Peru, Colombia, the Philippines, Vietnam, and Malaysia, and partnering agreements have been concluded in 6 countries: Brazil, Mexico, and Russia/CIS. .
Considering the future increase in overseas supply, there is an urgent need to establish a stable source of raw drug supplies.
An industry insider said, “If you only rely on overseas manufacturing plants for raw drug products, you cannot avoid supply and demand instability,” and “As ‘Enblow’ is a strategic product of Daewoong Pharmaceutical, there is a need to establish a somewhat stable production system by domestically producing raw drug products.” He said.
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