BARCELONA, Spain -- Daewoong Pharmaceutical, which participated in the world's largest pharmaceutical and bio exhibition, CPHI Worldwide 2023, showed confidence in the export competitiveness of homegrown P-CAB medications.
In the CPHI 2023, held in Barcelona, Spain, from Tuesday to Thursday, Daewoong operated an exclusive booth and introduced homegrown SGLT-2 inhibitor, Envlo (enavogliflozin) and P-CAB drug Fexuclue (fexuprazan) to overseas buyers.
At a news conference at its booth on Wednesday, Daewoong unveiled its “3E Global Super Gap Strategy,” marked by rapid global item approval (Efficiency), the simultaneous expansion of a new drug lineup (Extension), and overwhelming production excellence (Excellence) in smart factories.
Daewoong also expressed its ambition to achieve global annual sales of 1 trillion won ($740 million) by 2030, centered on independently developed drugs, including Fexuclue and Envlo.
"No new drug developed in Korea has yet achieved 1 trillion won sales. However, I don't think it's just a dream. We want to achieve 1 trillion won annual sales in 2030 through one product, Fexuclue," said Kim Do-young, head of Daewoong Pharmaceutical's Global Development Center.
Daewoong has submitted applications for approvals from 12 countries for Fexuclue for a year after its domestic launch and has received nods from four countries, starting global sales from the Philippines in July.
Kim explained that the company recently received a due diligence inspection of the Osong Smart Factory from the Brazilian Food and Drug Surveillance Agency (ANVISA) and obtained bGMP certification. The Brazilian certification will allow Daewoong to accelerate the export of Fexuclue and Envlo to Latin America’s largest market.
In addition, Daewoong plans to launch the two-drug combination drug 'Envlomet' (enavogliflozin and metformin hydrochloride) this year. In September, the company received approval from the Ministry of Food and Drug Safety to conduct a phase 1 clinical trial to develop enavogliflozin as a treatment for diabetic retinopathy in the form of eye drops.
"Fexuclue is already licensed and has a longer patent period (until 2036) than other P-CAB drugs, so the treatment can maintain its exclusive position for a longer period. This is also an advantage in negotiations with overseas partners," Kim said, referring to the competition with domestic P-CAB drugs, including HK inno.N’s K-Cab and Jeil Pharmaceutical's Zastaprazan (JP-1366).