Withus Pharmaceutical

Withus Pharmaceutical is a finished-dosage drug manufacturer focused on treatments for chronic and age-related diseases. Its core business centers on circulatory and endocrine prescription drugs and first-generic development and production, alongside antibiotic products with seasonal demand.

Since 2022 the company has diversified its distribution structure by shifting some products to a CSO (contract sales organization) model.

As a new growth driver, it has been cultivating a long-acting injectable hair-loss treatment business, pursued through a 2020 contract manufacturing partnership with Inventage Lab and a 2021 tripartite agreement that added Daewoong Pharmaceutical.

In this structure, Daewoong Pharmaceutical handles Phase 3 trials, approval and sales, Inventage Lab covers preclinical work and Phase 1, and Withus Pharmaceutical is solely responsible for manufacturing.

The Anseong plant, completed in September 2023, is described as the world's first dedicated microfluidic production facility, built with an investment of KRW 26.9 billion and capacity for about 2.5 million vials per year.

More recently, the company signed a contract development and manufacturing (CDMO) agreement with Chong Kun Dang for the dutasteride-based long-acting hair-loss candidate 'CKD-843', extending its CDMO business beyond its own pipeline.

The domestic generic and CDMO market features numerous small and mid-sized pharmaceutical competitors, making bioequivalence-test investment and dedicated production facilities key differentiating factors.

Annual revenue rose for four consecutive years, from KRW 64.68 billion in 2022 to KRW 80.12 billion in 2023, KRW 102.72 billion in 2024 and KRW 106.44 billion in 2025.

However, operating profit peaked at KRW 7.91 billion (9.9% margin) in 2023 before falling to KRW 5.66 billion (5.5%) in 2024 and KRW 5.66 billion (5.3%) in 2025, remaining at a similar plateau.

Net income attributable to owners likewise surged from KRW 2.48 billion in 2022 to KRW 7.96 billion in 2023, then eased to KRW 4.78 billion in 2024 and KRW 4.97 billion in 2025.

On a quarterly basis, revenue was KRW 26.25 billion, operating profit KRW 0.83 billion and net income KRW 1.30 billion in Q2 2025, improving to revenue of KRW 27.25 billion, operating profit of KRW 1.37 billion and net income of KRW 2.14 billion in Q3.

In Q4, however, despite revenue of KRW 27.18 billion and operating profit of KRW 1.38 billion, net income swung to a loss of KRW 0.12 billion, suggesting a drag from non-operating items.

In Q1 2026, revenue rose to KRW 28.22 billion but operating profit fell sharply to KRW 0.24 billion, while net income surged to KRW 3.97 billion, highlighting pronounced volatility in non-operating results.

In Q2 2026, revenue reached KRW 29.07 billion, operating profit KRW 1.08 billion and net income KRW 1.97 billion, extending revenue growth to a fifth consecutive quarter.

Over the most recent four quarters (Q3 2025 through Q2 2026), revenue growth has been steady while operating and net income have shown considerable quarter-to-quarter variance, leaving stable margin capture as an ongoing challenge.

The domestic generic drug market is operating under government drug-price cut policies and tightening bioequivalence-test requirements.

In July 2020 the Ministry of Health and Welfare introduced a new pricing system requiring previously listed generics to submit both bioequivalence test results and registered active pharmaceutical ingredient usage data to retain their existing price, a rule applied in stages during 2022 and 2023 that led to price cuts for numerous generics.

Withus Pharmaceutical has pursued a strategy of minimizing such price cuts by investing in in-house bioequivalence testing over several years.

Across the domestic pharmaceutical industry more broadly, securing stable production infrastructure alongside new drug pipelines has become a key competitive factor, driving expanded facility investment.

Long-acting injectables are drawing growing interest from domestic and global pharmaceutical companies as a dosage form that can improve medication adherence and convenience.

Withus Pharmaceutical is one of a small number of companies that already operate a dedicated microfluidic production facility, and it is broadening its market position through external CDMO partnerships.

Under the CKD-843 CDMO contract signed with Chong Kun Dang in September 2026, Withus Pharmaceutical plans to upgrade related facilities at the Anseong plant's injectable building and proceed with GMP-related production readiness in stages through 2027.

The company has stated a target of filing for product approval in 2028 and commercializing in 2029, aligned with product development and clinical timelines, while noting that the schedule could change depending on clinical trial and approval progress.

The company describes the Anseong plant's injectable building as equipped with facilities specialized for hormone products and long-acting sterile injectables, along with a GMP-based quality management system.

Withus Pharmaceutical said it plans to use this contract as a springboard to expand its long-acting injectable CDMO pipeline and continue seeking additional partnerships with domestic and international pharmaceutical and biotech companies.

Its own in-house long-acting hair-loss injectable program, developed jointly with Inventage Lab and Daewoong Pharmaceutical, also remains a core part of the company's growth narrative, with the progress of related clinical trials and approvals flagged as a variable for future results.

In the circulatory and endocrine lineup, newly launched products such as Litragen Tablet and Widiang Tablet/Widiang Duo Tablet continue to contribute to revenue.