[Edaily Reporter KIM JI-WAN ] DaewonPharmaceutical(003220)has set its sights on the 55 billion won hyperlipidemia (dyslipidemia) market by highlighting its “small pill,” which is 43% smaller in volume, and the fact that it can be taken “regardless of meals.”

According to DaewonPharmaceutical on the 29th, UptaBa Extended-Release Tablets were launched last May. This medication is a combination drug containing 2 mg of pitavastatin calcium and 178.8 mg of fenofibrate choline, indicated for the treatment of dyslipidemia. Dyslipidemia is commonly referred to as hyperlipidemia. This condition encompasses not only high levels of cholesterol or triglycerides but also a deficiency in “good cholesterol.”

A Daily Medication: Reduced Size and No Longer Requires Post-Meal Administration

The length of Uptava Extended-Release Tablets has been reduced from 20.1 mm to 14.3 mm, and the thickness from 6.8 mm to 5.0 mm. The reduction in volume amounts to a remarkable 43%.

A DaewonPharmaceutical official emphasized, “We focused on the fact that many patients with dyslipidemia are chronic disease patients who take multiple medications simultaneously,” adding, “We believe that reducing the size of the tablets will lower the practical burden of taking medication for patients and help ensure consistent treatment.”

In addition, Uptaba Extended-Release Tablets do not require patients to take the medication at specific mealtimes. The previous Uptaba Capsules had to be taken immediately after a meal.

As the name “extended-release” suggests, Uptaba Extended-Release Tablets release the medication slowly. This is the result of using fenofibrate choline, which improves upon the poor water solubility of conventional fenofibrate.

Fenofibrate is converted into “fenofibric acid” in the body, which lowers triglycerides. Choline is hydrophilic, meaning it mixes well with water. Fenofibrate choline is formed by binding choline to fenofibric acid, which is the active ingredient. As a result, even patients who skip breakfast or have irregular meal times can take it conveniently.

In a Phase 1 clinical trial involving 60 healthy adults, the ratio of peak plasma concentrations of fenofibric acid following administration after a meal compared to administration on an empty stomach was 91.36%, and the ratio of total exposure was 94.33%. These figures compare the time when the drug’s plasma concentration reached its peak and the extent to which the body was exposed to the drug over a certain period, respectively.

A DaewonPharmaceutical official emphasized, “There was no difference between fasting and postprandial administration of Uptaba Extended-Release Tablets.”

Reduced Triglycerides by 40% and Increased “Good Cholesterol” by 21%

The efficacy of Uptaba Extended-Release Tablets was previously demonstrated in a clinical trial of the combination drug.

In the Phase 3 clinical trial for Uptaba Capsules, triglycerides in the combination therapy group decreased by 39.66% in just 8 weeks. In the group treated with pitavastatin alone, triglycerides increased by 2.09%. The difference between the two treatment groups amounted to a staggering 41.75 percentage points. A total of 347 patients with mixed dyslipidemia participated in this clinical trial.

Furthermore, high-density lipoprotein cholesterol (HDL-C)—often referred to as “good cholesterol”—showed significant improvement. HDL-C plays a role in transporting cholesterol back to the liver. In the combination therapy group, HDL-C increased by 20.65%. In contrast, the monotherapy group saw only a 2.25% increase. The difference between the two groups was 18.40 percentage points.

The overall cholesterol results also showed a significant difference. “Non-HDL cholesterol,” calculated by subtracting HDL-C from total cholesterol, decreased by 7.38% in the combination therapy group, whereas it increased by 5.07% in the monotherapy group. This indicates that the combination therapy lowered triglycerides while raising “good” cholesterol.

A DaewonPharmaceutical official explained, “Compared to the group receiving 2 mg of pitavastatin alone, we confirmed that the combination therapy lowers triglycerides and non-HDL cholesterol while raising HDL cholesterol,” adding, “Patients who are undergoing LDL cholesterol treatment but are not adequately managing their triglyceride levels would benefit from taking Uptava Extended-Release Tablets.”

Targeting the Growing Market for Hyperlipidemia Combination Therapies with Extended-Release Tablets

DaewonPharmaceutical plans to actively target

the

rapidly growing

market

for hyperlipidemia

combination therapies

with UpTaba

Extended-Release Tablets

.

According to UBIST, the domestic market for pitavastatin-fenofibrate combination drugs expanded from 28.4 billion won in 2021 to 49.1 billion won in 2024 and reached 55.9 billion won last year. This represents approximately 97% growth compared to 2021.

During the same period, UpTaba failed to keep pace with market growth. Prescription sales rose from 7.8 billion won in 2021 to 8.8 billion won in 2024 but stagnated at 8.4 billion won last year. Market share dropped from 27.39% in 2021 to 15.10% last year.

In this situation, the sustained-release formulation is DaewonPharmaceutical’s surefire countermeasure.

A DaewonPharmaceutical official stated, “We are targeting 9.5 billion won in outpatient prescription sales for Uptaba Extended-Release Tablets this year and 13.0 billion won next year.” Next year’s target is approximately 54% higher than the existing capsule’s prescription sales.

The spokesperson added, “We are receiving positive feedback—particularly from prescribers of the existing Uptaba capsules—regarding the smaller tablet size and the ability to take the medication regardless of meals,” and noted, “We aim to achieve 13 billion won in outpatient prescription sales next year, when the shift in prescriptions is expected to gain momentum.”

The strategy to expand prescriptions for Uptaba Extended-Release Tablets is also well-defined. The company plans to actively leverage “Tigifenone.” Last year, Tigifenone recorded 17.4 billion won in prescription sales and a 20.66% market share in the fenofibrate market.

A DaewonPharmaceutical official stated, “We plan to leverage our relationships with healthcare providers who prescribe TZPhenon to expand prescriptions of Uptaba Extended-Release Tablets to patients requiring comprehensive lipid management.”

The company has also revised its production structure. While the existing capsules were previously manufactured under contract, the extended-release tablets are now produced in-house.

The spokesperson explained, “Through in-house production, we are pursuing stable quality control and manufacturing cost efficiency,” adding, “We will expand prescription options tailored to patients’ conditions by linking TZ-Phenon, UpTaba Extended-Release Tablets, and Tabarozet, a combination therapy for hypercholesterolemia.” He continued, “Formulation improvements that reduce volume by approximately 43% and the ability to take the medication regardless of meals are our key competitive advantages,” adding, “We will solidify our leading position in the market by combining the prescription base of our existing capsules with the convenience of the extended-release tablets.”