[Edaily Reporter KIM JI-WAN ] DaewonPharmaceutical(003220) Daewon Pharmaceutical’s flagship new drug, “Felubi,” has demonstrated potential in pain management following knee replacement surgery. In a direct comparison with the widely used anti-inflammatory analgesic celecoxib, it showed pain-relieving effects that were on par with the latter. This provides a basis for expanding the drug’s established position in arthritis treatment into the surgical field.

According to the company, Felubi is currently exported to four countries, and registration procedures for sales are underway in an additional 11 countries. DaewonPharmaceutical plans to expand the number of countries to which Felubi is exported to 18 by 2028.

Felubi is the 12th domestically developed new drug created by DaewonPharmaceutical. For Felubi tablets, the company acquired all rights—from synthesis and domestic clinical trials to product launch—for the active ingredient “felubipropene” from Japan’s Sankyo Co., Ltd. After investing 6 billion won over approximately six years starting in 2002, the company successfully commercialized the product. The active ingredient is Felubipropen. It is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain, and is used to treat osteoarthritis, rheumatoid arthritis, and lower back pain.

Following the original Felubi tablets, DaewonPharmaceutical has expanded its product line to include Felubi Extended-Release Tablets, which provide a prolonged effect through gradual drug release, and Felubi ES Tablets, which feature improved solubility and absorption.

Pain scores of 36.8 vs. 37.0… Effective even for surgical patients

Postoperative care is crucial after knee replacement surgery. This is because severe pain makes it difficult to move the knee and can hinder rehabilitation. Consequently, medical staff use a combination of pain relievers to reduce postoperative pain.

DaewonPharmaceutical has demonstrated through research that Felubi is more effective than existing pain relievers following knee replacement surgery. DaewonPharmaceutical compared the efficacy of Felubipropen and celecoxib in 100 patients who underwent knee replacement surgery. Felubipropen is the active ingredient in Felubi, Korea’s 12th domestically developed new drug.

Celecoxib is also a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation associated with conditions such as arthritis. It selectively inhibits COX-2, an enzyme involved in inflammation. A representative product is “Celebrex.” Until now, celecoxib has been widely used as a pain reliever following knee replacement surgery. This study was published last August in the international academic journal *Scientific Reports*.

The research team divided 100 patients into two groups and had them take different medications. One group took felubipropfen, while the other took celecoxib. The two groups were of equal size (50 patients each), and the surgical and rehabilitation methods, as well as the other pain relievers used in conjunction, were standardized.

The study found no difference between felubipropen and celecoxib in their effectiveness at reducing postoperative pain. Pain scores two days after surgery were nearly identical (on a 100-point scale: 36.8 for felubipropen and 37.0 for celecoxib). A lower score indicates less pain.

Recovery status and patient satisfaction were also similar. One week after surgery, there were no significant differences in the degree to which the knee could be bent (117.2 degrees vs. 119.4 degrees), patient satisfaction (84.4 points vs. 83.6 points), or the number of times additional pain medication was used (average of 8.9 times vs. 8.6 times). The figures are listed in the order of felubipropen and celecoxib.

DaewonPharmaceutical officials emphasized, “We are expanding our clinical evidence beyond chronic arthritis to include acute pain management before and after joint replacement surgery.”

“Make it small, make it last”… Ease of administration is also a key differentiator

DaewonPharmaceutical cited the clinical data accumulated from Korean patients, the small, easy-to-swallow tablets, and price competitiveness as Pelubi’s strengths.

A DaewonPharmaceutical official drew a clear distinction, stating, “We have accumulated evidence of efficacy and safety through a total of nine clinical trials involving Korean patients,” and added, “This sets it apart from global clinical drugs that are primarily focused on Western populations.”

“We designed it as a small 7-mm tablet so that elderly arthritis patients, who often have difficulty swallowing, can take it consistently,” the official emphasized, adding, “On top of that, the affordable price of 234 won is a key selling point.” He continued, “Patients with chronic joint diseases must take medication long-term,” noting that “an affordable price alleviates the financial burden of treatment for patients.”

The price of Celebrex is 331 won per 100 mg capsule and 502 won per 200 mg capsule.

There are also products designed to provide long-lasting efficacy. Felubi CR is formulated so that the active ingredient is released slowly and gradually, rather than all at once.

A company representative explained, “It was designed to control drug release so that the therapeutic effect lasts for about 12 hours.”

Felubi is a “prodrug” that transforms into its active form after entering the body. It also inhibits the activity of COX-2—the enzyme responsible for producing substances that cause pain and inflammation—relatively more effectively. Simply put, it is a medication that alleviates symptoms by reducing the processes that cause pain and inflammation within the body.

Last year, global sales of celecoxib (Celebrex) totaled $272.9 million (361.9 billion won). In South Korea, sales are estimated to have reached around 40 billion won. The domestic nonsteroidal anti-inflammatory drug (NSAID) market is effectively split between Felubi and celecoxib.

Currently exported to 4 countries… Preparing to enter 11 additional markets

Felubi has grown into DaewonPharmaceutical’s flagship product, generating annual sales in the 50 billion won range. However, in the domestic market, nine generic versions of Felubi were added to the National Health Insurance reimbursement list last month. Furthermore, the prices of Felubi tablets and extended-release tablets were reduced last May. This indicates that the domestic market is becoming increasingly challenging. In fact, sales of Felubid decreased by 6.7%, from 55.4 billion won in 2024 to 51.7 billion won last year.

Faced with this reality, DaewonPharmaceutical is actively expanding its overseas sales channels.

According to DaewonPharmaceutical, Pelubi tablets and Pelubi sustained-release tablets are currently exported to four countries: Mongolia, Myanmar, Russia, and Yemen. The company has signed contracts and is proceeding with local registration in 11 additional countries. Combined with the countries where exports are already underway, the total number of countries with contracts stands at 15. Last August, a Pelubi combination drug successfully completed Phase 1 clinical trials in Vietnam. Previously, in 2023, the company signed an exclusive export supply contract worth 4 billion won with Indonesia’s PT Interbet for finished Pelubi Extended-Release Tablets.

A DaewonPharmaceutical official stated, “We expect sales to begin sequentially in the 11 countries where registration is currently underway between next year and 2030,” adding, “Our goal is to expand the total number of contracted countries to 18 by 2028.” The official continued, “Countries where we anticipate significant future sales include Russia, China, Indonesia, Vietnam, the Philippines, and the United Arab Emirates (UAE).”

Meanwhile, according to market research firm Grand View Research, the global nonsteroidal anti-inflammatory drug (NSAID) market was valued at $23.8 billion (31 trillion won) last year. It is projected to grow to $37.6 billion (50 trillion won) by 2033. This market encompasses treatments ranging from arthritis to various types of pain.