Chong Kun Dang wins Korean nod for diabetes combo as rivals crowd in

Chong Kun Dang (CKD) has pulled ahead in Korea’s diabetes race with the country’s first approval of a fixed-dose combo pairing SGLT2 inhibitor empagliflozin and DPP-4 inhibitor sitagliptin.

On Monday, the Ministry of Food and Drug Safety cleared Empamax S in two strengths—25/100 mg and 10/100 mg—for adults with type 2 diabetes who need dual therapy. CKD filed for approval in May 2024 and landed the nod less than a year later, setting up a domestic launch in November 2025.

The win puts CKD ahead of at least eight competitors with similar combinations in development, including two empagliflozin-sitagliptin duals and six triple combos that add metformin to the mix.

Backed by phase 3 data, Empamax S showed significant HbA1c—a standard blood glucose measure—reductions in patients whose blood sugar remained uncontrolled on metformin and sitagliptin. In a 24-week, placebo-controlled trial, the 10 mg empagliflozin group saw a mean HbA1c drop of 0.93 percent versus 0.19 percent with placebo. The 25 mg dose lowered HbA1c by 0.95 percent, also outperforming placebo (difference of 0.76 percentage points; p<0.0001 for both comparisons).

No statistically significant differences emerged in adverse events, drug-related events, or serious adverse events across treatment arms. No serious drug-related events were reported.

For CKD, Empamax S is the latest move in a broader strategy to carve out a stronghold in Korea’s fast-growing diabetes market. The company has already built a foundation with Duvie (lobeglitazone), a thiazolidinedione—or TZD—developed locally as an insulin sensitizer. Duvie topped Korea’s TZD class in 2023 and now anchors a broader combo franchise including Duvie S (lobeglitazone + sitagliptin) and DuviMet-S XR (lobeglitazone + sitagliptin + metformin).

CKD is also advancing CKD-383, a triple combo of lobeglitazone, empagliflozin, and metformin. A phase 1 food-effect study in healthy adults wrapped months ahead of schedule.

Beyond R&D, the company is shoring up its position with exclusive rights to the blockbuster sitagliptin portfolio. In 2023, CKD struck a long-term deal with MSD (known as Merck in the U.S. and Canada) to locally manufacture and distribute Januvia, Janumet, and Janumet XR through 2038.