The first trial ruling in the lawsuit Boryung filed against the Ministry of Health and Welfare to cancel the price cut disposition for 11 items in the "Kanarb family" will be delivered on the 12th. With industry attention focused on the ruling that will determine the profitability of the Kanarb series, the company's core revenue source, Boryung is attempting a head-on breakthrough by pushing ahead with entry into the market for four-drug combination therapies based on its in-house developed hypertension treatment "Kanarb."
Boryung recently secured phase 3 clinical results for BR1018, a four-drug combination new drug candidate that simultaneously treats hypertension and dyslipidemia, giving a green light to its approval timeline. Having successively launched two- and three-drug combinations based on Kanarb and grown the "Kanarb family" into the company's main pillar, the four-drug combination is likewise seen as a key card to drive performance growth going forward.
But to make the results of new drug development shine, the task of "defending prices" must be addressed first. That is because the outcome of this administrative suit, underway alongside changes in the government's generic drug pricing policy, will directly affect the price competitiveness of the flagship product group. How much the ambitiously prepared new drug BR1018 can contribute to results will ultimately hinge on the court's decision on the 12th.
◇BR1018 proves efficacy in phase 3…preparing approval procedures
Even as legal risks rise, Boryung is seeking to turn the tide by delivering R&D results. Boryung disclosed on the 10th that phase 3 for BR1018 confirmed significant improvements in blood pressure and cholesterol levels.
BR1018 is an improved new drug that combines the Kanarb active ingredient fimasartan with the hypertension drug amlodipine and the dyslipidemia treatments atorvastatin and ezetimibe. In clinical results conducted by researchers from Apr. 2024 to Nov. 2025, the combination therapy group's systolic blood pressure decreased by an average of 10.09 mmHg more than the control group (p=0.0003), and the LDL cholesterol reduction rate was also 52.36% lower than the control group. No serious adverse drug reactions or deaths were reported.
Boryung will begin preparing a marketing authorization application to the Ministery of Food and Drug Safety based on these phase 3 results. However, because phase 1 and phase 3 were conducted in parallel due to the nature of improved new drugs, the timing of the final application is fluid. If the application is filed after phase 1, which began in Dec. 2024, is completed, approval is expected to take typically 9 to 12 months.
◇Expanding market for four-drug combinations…a challenge to Hanmi Pharmaceutical's solo run
Boryung's push into four-drug combinations aligns with market growth. As the number of patients with both hypertension and dyslipidemia increases, the market for four-drug combinations that improve dosing convenience is expanding rapidly.
The current market is led by Hanmi Pharmaceutical, which opened the door with the 2021 launch of Amozaltan XQ and holds more than 70% share. According to Ubist, out-of-hospital prescriptions for four-drug combinations, which were at 2.3 billion won in 2021, surged to 12.7 billion won in 2023 and 17.3 billion won in 2024. GC Biopharma, Chong Kun Dang pharmaceutical, and JEIL PHARMACEUTICAL follow.
Boryung plans to deploy BR1018 to the market based on its prescribing experience with the Kanarb line. The Kanarb family comprises seven types: ▲Kanarb ▲Kanarb Plus ▲Ducarb ▲Tubero ▲Ducaro ▲Acarb ▲Ducarb Plus. According to Ubist, out-of-hospital prescriptions rose to 150.3 billion won in 2022, 169.7 billion won in 2023, 183.7 billion won in 2024, and 194.8 billion won in 2025.
Last year, these products posted 164.4 billion won in sales, accounting for 15.9% of Boryung's total revenue. The company set this year's sales target for the Kanarb lineup at 200 billion won.
A company official said, "As the number of patients with hypertension and dyslipidemia increases, four-drug combinations have potential for market expansion by reducing the number of doses compared with single agents."
◇Double whammy of price-cut lawsuit and policy changes…emerges as a performance variable
The issue is the price. The first-trial administrative ruling to be handed down that day is a critical watershed that will determine the fate of the Kanarb family, Boryung's cash cow.
Earlier, after the fimasartan compound patent expired in Feb. 2023 and generics were launched, the Ministry of Health and Welfare imposed sharp price cuts on original drugs such as Kanarb tablets (30%), Ducarb tablets (21%), and Kanarb Plus tablets (47%). Boryung contested the decision and filed suit, and with its request for a stay of execution granted, it has maintained existing prices to date.
If it loses at first instance that day, the stay of execution will lapse and immediate price cuts could be implemented. This would be a negative factor that could lead to the evaporation of hundreds of billions of won in annual sales. While Boryung is likely to buy time by appealing and seeking another stay, uncertainty remains.
To make matters worse, an overhaul of the government's pricing system is also on the horizon. The Ministry of Health and Welfare is pushing a reform plan to lower the calculation rate for generic prices starting in Jul. With generics accounting for 78% (39 cases) of Boryung's research and development output over the past five years, this is another headwind.
A Boryung official said, "As neither the lawsuit outcome nor the government's specific price-cut plan has been finalized, we are closely monitoring the situation and seeking responses."