CKD Bio

CKD Bio Corp. was established in November 2001 through a spin-off of the API business division from CKD (Chong Kun Dang), and listed on the KOSPI market the following month.

Its core business is active pharmaceutical ingredients (APIs), producing antibiotics (rifampicin, cephalosporin, tetracycline, etc.), the beta-lactamase inhibitor potassium clavulanate, the immunosuppressant cyclosporine A, the diabetes drug acarbose, and the cholesterol drug lovastatin.

Overseas sales account for roughly 80% of revenue, reflecting heavy export dependence, with the company supplying more than 30 types of API and finished products to about 170 customers across roughly 60 countries including the United States, Southeast Asia, China, Latin America, the Middle East, Europe and Africa.

The company also runs a probiotics ingredient and finished-product business, and is expanding its microbiome CDMO operations while pursuing microbiome-based drug research targeting intractable diseases such as Alzheimer's disease.

Its new growth driver is the self-developed botulinum toxin Tyemvers (CKDB-501A), distinguished by a fully non-animal (vegan) manufacturing process from strain cultivation through finished product, which helps it avoid the strain-origin disputes seen among some competitors.

Tyemvers is currently exported to Japan, Hong Kong and Russia, and in 2022 the company signed a 15-year exclusive supply agreement with China's Qutia Therapeutics covering China, Hong Kong, Macau and Taiwan.

The API segment holds competitiveness in high-value-added products through developed-market-level QA/QC capability and complex synthesis and scale-up technology, but is exposed to cost competition from China and India, while in the toxin market the company is a relative latecomer compared with global players such as AbbVie, Ipsen and Merz and domestic rivals such as Hugel, Daewoong Pharmaceutical and Medytox.

2025 consolidated revenue came to KRW 160.0bn, down 6.8% from KRW 171.7bn in 2024, while operating profit fell sharply to KRW 3.6bn from KRW 10.9bn, and the net loss attributable to owners was KRW 2.9bn, reversing the KRW 8.7bn net profit posted in 2024.

This follows two years of heavy losses in 2022 (operating loss of KRW 14.8bn, net loss of KRW 16.7bn) and 2023 (operating loss of KRW 20.2bn, net loss of KRW 24.2bn), a single profitable year in 2024, and then a slide back into loss in 2025.

On a quarterly basis, an operating profit of KRW 2.9bn in Q2 2025 gave way to an operating loss of KRW 1.5bn in Q3 and a marginal operating profit of about KRW 0.1bn in Q4, before losses widened further to KRW 1.7bn in Q1 2026 and KRW 5.0bn in Q2 2026.

Net losses attributable to owners also deepened, from roughly KRW 0.5bn in Q2 2025 to KRW 5.4bn in Q2 2026, bringing the trailing four-quarter total (Q3 2025 through Q2 2026) to about KRW 10.7bn.

Consolidated operating cash flow turned negative at KRW -4.1bn in 2025, versus a positive KRW 14.0bn in 2024, indicating a parallel deterioration in cash generation. The debt ratio has fluctuated at persistently elevated levels, moving from 111.5% in 2022 to 138.8% in 2023, 117.2% in 2024 and 136.0% in 2025.

Total equity contracted from KRW 131.0bn in 2024 to KRW 127.0bn in 2025 as accumulated losses began to erode the capital base. The company has attributed the revenue decline and margin pressure to intensifying global competition reducing API sales volumes alongside rising R&D spending.

The global API market is expected to see moderate growth driven by rising demand for chronic and geriatric disease treatment amid population aging, as well as population growth and economic development in Asia and Latin America.

Korea's API self-sufficiency rate stands below 20%, which presents an opportunity from a supply-chain localization policy perspective, but China and India continue to expand market share globally on the back of cost competitiveness.

CKD Bio has earned recognition for competitiveness in high-value-added product areas through developed-market-level QA/QC capability and complex synthesis and scale-up technology, but this structural cost competition is closely linked to the revenue and profit softness seen in recent years.

In the botulinum toxin market, China is cited as a large, fast-growing market, while the domestic market, valued at roughly KRW 200bn, is crowded with more than ten competing products.

Globally AbbVie (Botox) leads, followed by Ipsen and Merz, while domestically Hugel has already entered the China market, Daewoong Pharmaceutical awaits China approval, and Medytox is preparing an approval filing, underscoring intense competition.

Within this landscape, CKD Bio is positioning itself as a late entrant differentiated by clear strain traceability and a non-animal manufacturing process.

The company has stated that Tyemvers began generating sales more than half a year after launch, and reaffirmed its intention to expand domestic sales while pursuing overseas approvals and sales expansion over the longer term.

In April 2025 the company filed for domestic manufacturing and sales approval of the 200-unit Tyemvers formulation, with the review outcome yet to be confirmed.

In China, the January 2026 Phase 3 topline data confirmed non-inferiority versus Botox, and follow-on procedures toward commercialization are expected to proceed together with partner Qutia Therapeutics.

On the production side, the company has invested roughly KRW 150bn cumulatively in botulinum toxin manufacturing facilities and has indicated plans to further expand production capacity going forward.

In the API segment, sales volume declines tied to intensifying global competition have continued, meaning that unless the toxin business's revenue contribution grows meaningfully, it will be difficult to offset overall earnings volatility.

In the probiotics and microbiome segment, CDMO expansion and drug research targeting intractable diseases continue, though these remain mid- to long-term R&D initiatives rather than current revenue contributors.