Roche to Invest $478M in Korea Clinical Trials; Pre-Approval Deals Signal Market Strength
Roche signed an agreement to invest $478 million in Korea clinical trials over five years, marking the largest foreign pharmaceutical investment. Korean companies are also securing pre-approval licensing deals globally, demonstrating growing competitiveness.
Global pharmaceutical company Roche signed a memorandum of understanding with the Ministry of Health and Welfare to invest 710 billion won ($478 million) over the next five years in Korea clinical trials. This is the first time the ministry has attracted such a large investment from a foreign pharmaceutical company.
Under the agreement, Roche will conduct global clinical trials in Korea for common and intractable diseases as well as advanced biopharmaceuticals. The company also plans to train R&D professionals and identify and support promising Korean biohealth companies through open innovation. The open innovation strategy includes exploring promising pipelines and expanding opportunities for joint development or technology transfer.
The collaboration was initiated by Roche. The company, which had been considering establishing an Asian clinical trial hub, highly evaluated Korea's clinical research competitiveness and approached the government first.
Multinational pharmaceutical companies invested 1.03 trillion won in clinical research in Korea in 2024, up 74 percent from 596.2 billion won in 2020, according to the 2025 R&D and Investment Status Report by the Korean Research-based Pharma Industry Association.
In a list of 379 highly cited researchers worldwide published last year by Clarivate, a global academic information analytics company, 10 Korean researchers were named in the clinical research field, more than China with seven and Japan with three. Seoul's high concentration of major hospitals is also creating synergy. The network of large medical institutions centered on tertiary general hospitals, fast patient recruitment, and standardized data management systems are cited as key factors in gaining the trust of global pharmaceutical companies.
Based on this infrastructure, Seoul ranked first in global clinical trial city rankings for seven consecutive years starting in 2017. In 2024, it fell to second place behind Beijing due to the impact of the medical dispute but remained ahead of Shanghai and Houston.
Clinical trial costs in Korea are estimated to be 30 to 40 percent lower than in the United States and Japan, and 10 to 20 percent lower than in Taiwan and Singapore, according to a global clinical trial application market report.
Korean pharmaceutical companies are also securing pre-approval licensing deals with global partners. In January, Hanmi Pharmaceutical signed an exclusive distribution agreement with Sanfer, Mexico's largest private pharmaceutical company, for Efpeglenatide, a treatment for obesity and metabolic diseases. This agreement was concluded prior to approval from Korea's Ministry of Food and Drug Safety.
Efpeglenatide is Korea's first GLP-1 class therapeutic independently developed by Hanmi Pharmaceutical. Mexico has one of the highest adult obesity rates in the world, and the early partnership with a dominant local distributor is expected to play a decisive role in expanding market share during the initial launch phase.
Medipost signed an exclusive license agreement with Japan's Teikoku Pharmaceutical in December last year for Cartistem, a knee osteoarthritis treatment, covering the Japanese market. Medipost secured approximately 11.8 billion won in upfront payments and milestone payments amounting to 14.8 billion won while the local Phase 3 clinical trial was still ongoing.
SK Biopharm's epilepsy drug Xcopri (active ingredient: cenobamate) represents a symbolic case of pre-approval deal success. In February 2019, before receiving U.S. FDA approval later that year, SK Biopharm signed a commercialization agreement with Switzerland's Arvelle Therapeutics covering 32 European countries. The total contract value at the time was $530 million, of which $100 million alone was a non-refundable upfront payment. This was the largest central nervous system technology export to the European market at the time.
When Arvelle Therapeutics was acquired by Italy's Angelini Pharma for approximately 1 trillion won, SK Biopharm reaped profits from the stake sale, and Xcopri recorded sales of 630.3 billion won in the U.S. market alone last year, firmly establishing itself as the company's core revenue source.