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Yuhan signs $139.8 mil. API deal with Gilead, strengthening CDMO growth p...

Compared with generic API production, CDMO for innovative synthetic drugs has higher entry barriers, as it requires advanced quality control, regulatory response capabilities and long-term...

Yuhan signs $139.8 mil. API deal with Gilead, strengthening CDMO growth p...

Yuhan Corp. has signed a $139.8 million active pharmaceutical ingredient (API) supply contract with Gilead Sciences, adding to a series of large overseas API deals that are turning its synthetic drug substance contract development and manufacturing organization (CDMO) business into a more visible growth pillar.

Yuhan Corp. has signed a $139.8 million API supply deal with Gilead Sciences, adding to a series of overseas contracts backed by Yuhan Chemical’s production capacity. (Credit: Yuhan  Corp.)

The contract value is equivalent to 9.61 percent of Yuhan’s 2025 consolidated revenue of 2.19 trillion won and runs from May 19 to Dec. 31, 2027. The company did not disclose the target drug or therapeutic indication.

The latest deal marks Yuhan’s fourth API supply contract with Gilead, further expanding a relationship centered on antiviral drug substances, after securing its first contract with the U.S. company in September 2024.

Including the latest contract, the accumulated value of Yuhan’s API agreements with Gilead has reached about $270 million.

Yuhan has also been expanding its API customer base beyond Gilead. Earlier this month, the company signed a supply agreement worth about 56 billion won with U.S.-based BridgeBio Pharma for API used in a cardiomyopathy treatment.

The string of contracts highlights a business model in which Yuhan secures global orders while its wholly owned subsidiary Yuhan Chemical handles production. The arrangement has become increasingly important as global drugmakers seek stable and diversified supply chains after the Covid-19 pandemic.

Yuhan’s overseas business has grown steadily in recent years, supported by the API business. Overseas sales rose from 240 billion won in 2023 to 310 billion won in 2024 and 380 billion won in 2025. In the first quarter of this year, overseas business sales exceeded 100 billion won, up 21.4 percent from a year earlier.

The growth has been backed by Yuhan Chemical’s production expansion. The subsidiary operates manufacturing sites in Ansan and Hwaseong, with combined annual production capacity of about 995,000 liters. The Ansan plant operates four production buildings with about 460,000 liters of capacity, while the Hwaseong plant has about 530,000 liters.

The expansion has begun to show in earnings. Yuhan Chemical’s revenue reached 289.7 billion won last year, up 36.5 percent from 2024, as larger global supply volumes helped translate capacity additions into sales growth.

Yuhan Chemical is also pursuing an additional plants as utilization rates and production volumes increase at both the Ansan and Hwaseong plants. The company aims to complete the new plant in the second half of 2027 and begin commercial production in the first half of 2028.

Yuhan has positioned synthetic small-molecule API CDMO as a core part of its overseas business. Compared with generic API production, CDMO for innovative synthetic drugs has higher entry barriers, as it requires advanced quality control, regulatory response capabilities and long-term project management across a product’s life cycle.

The company said its strengths include more than 200 synthesis technologies, continuous development of platform technologies, global cGMP compliance capabilities and project execution experience from development to commercialization. Its major production areas include antivirals, oncology drugs and autoimmune disease therapies.

The market environment is also becoming more favorable for companies with established quality systems. Global pharmaceutical companies have been placing greater emphasis on supply chain resilience, geographic diversification and outsourcing of API production. In synthetic small-molecule API CDMO, where quality reliability and regulatory compliance are critical, companies with globally validated facilities are expected to have more opportunities to win long-term supply contracts.

Lee Han-soo

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